|
At a Glance: EFSA has published its scientific opinion on the safety assessment of lacto-N-triose II (LNTri II) as a novel food. The Panel concluded that LNTri II does not raise safety concerns under the proposed conditions of use and use levels. |
At the request of the European Commission, the European Food Safety Authority (EFSA) assessed the safety of LNTri II as a novel food.
The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) LNTri II, but it also contains d-glucose, d-galactose, d-lactose and lacto-N-triitol. The NF is produced by fermentation with a genetically modified strain (Kluyveromyces lactis DSM 709-2-02) of K. lactis DSM 70799.
The applicant intends to use the novel food in a range of food categories, including infant formula, follow-on formula, food supplements, and foods for special medical purposes, with the general population as the target population.
In line with other HiMOs, the safety assessment of this NF is mainly based on the comparison between the intake of breastfed infants and the estimated intake of the NF. The anticipated daily intake from its use in IF is similar to the estimated natural mean highest daily intake in breastfed infants. The anticipated daily intake from the NF as a food ingredient at the maximum proposed use levels exceeds the intake level of breastfed infants on a body weight basis in infants and children.
Taking all available evidence into consideration, the Panel concluded that consumption of LNTri II at the proposed uses and use levels does not raise safety concerns. Therefore, lacto-N-triose II is considered safe under the proposed conditions of use.
What CIRS Can Do for You
Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.
The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:
- Health food registration and filing in China;
- Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
- U.S. GRAS, NDI, and CAP notifications;
- EU Novel Food, food additives, and food enzymes applications; and
- Application for new feed ingredients and feed additives in China, the U.S., and the EU.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
