On July 22, 2026, LNTrII (Lacto-N-triose II), filed by Henglu Bio (a subsidiary of Hengkangyuan), officially passed the Novel Food safety evaluation by the European Food Safety Authority (EFSA), with the opinion now published in the EFSA Journal. LNTrII producted f rom Henglu Bio is the first synthetic-biology-manufactured product from China to receive EU Novel Food safety assessment. The company’s self-developed yeast-based HMOs biosynthetic process is a mature, domestically originated technology that has simultaneously passed food safety assessments by China, the United States, and the EU--three of the world’s most authoritative regulators. Henglu Bio thus becomes the first Chinese enterprise in the HMOs sector to complete safety evaluations from the three major jurisdictions.

The approved LNTrII is produced using third-generation yeast fermentation technology, with Kluyveromyces lactis as the chassis cell, Bacillus as the donor, and a crystallization purification process that achieves product purity of up to 99%. Since 2023, Henglu Bio’s LNTrII has successively obtained U.S. Self-GRAS, production strain safety certification from China’s National Health Commission, and U.S. FDA GRAS. The EFSA Novel Food clearance now completes the final piece of the safety assessment puzzle across the three major markets.

EFSA Novel Food Safety Assessment

EFSA is the core risk assessment body for food safety in the European Union. Under Regulation (EU) 2015/2283, Novel Food applications require comprehensive submissions covering product composition, production process, intended conditions of use, toxicological data, and more, with a typically lengthy evaluation timeline. Securing EFSA approval is a key prerequisite for legal market access across all 27 EU member states, and signifies that the product meets EU standards for safety, stability, and manufacturing quality. For HMOs in particular, EFSA safety clearance is also an essential gateway into the European food supply chain.

About LNTrII

LNTrII (Lacto-N-triose II) is a neutral core structural unit within the human milk oligosaccharides (HMOs) family, and serves as a precursor for the synthesis of larger HMOs such as Lacto-N-tetraose (LNT) and Lacto-N-neotetraose (LNnT).
In terms of functional research, several published studies have reported potential health benefits of LNTrII:

• Research from Vanderbilt University (USA) indicated that LNTrII significantly inhibits Streptococcus agalactiae (Group B Streptococcus, GBS)^[1];
• A study from the University of Groningen (Netherlands) suggested that LNTrII supports intestinal barrier development and maintenance, as well as colonization by beneficial gut microbes^[2];
• Research from Qingdao University (China) found that LNTrII can significantly ameliorate the progression of metabolic dysfunction-associated steatotic liver disease (MASLD) induced by a high-fat diet (HFD)^[3].

Since its establishment, Henglu Bio has focused on applying synthetic biology to nutrition and health. In the HMOs sector, the company has built a product portfolio covering 2'-FL, 3-FL, LNnT, LNT, LNTrII, LNB, etc. Passing the EFSA Novel Food safety assessment serves as a strong validation of our technological approach and production systems. Moving forward, we will continue to pursue product R&D and quality control with a pragmatic mindset, steadily advancing our global expansion.

Citation：
[1] Craft K M, et al. Interrogation of Human Milk Oligosaccharide Fucosylation Patterns for Antimicrobial and Antibiofilm Trends in Group B Streptococcus[J]. Acs Infectious Diseases, (2018).
[2] Kong C, et al. Human Milk Oligosaccharides Mediate the Crosstalk Between Intestinal Epithelial Caco-2 Cells and Lactobacillus PlantarumWCFS1in an In Vitro Model with Intestinal Peristaltic Shear Force[J]. The Journal of Nutrition, (2020):150.
[3] Chen K W, et al. Lacto-N-triose II alleviates metabolic dysfunction-associated Steatotic liver disease via microbiota-dependent citrulline biosynthesis. Food Research International. (2026):118448.