On August 5, 2024, the National Health Commission issued Announcement No. 3 of 2024, approving Morinaga Milk's Bifidobacterium longum subsp. infantis M-63 as a novel food ingredient. Antion completed the entire application process, including project evaluation, material preparation, testing, application submission and correction communication. It took only one and a half years for it to be officially approved and included in the List of Bacterial Species that Can be Used in Infant and Young Children Food.

Bifidobacterium longum subsp. infantis (formerly known as "Bifidobacterium infantis") has been included in China's List of Bacterial Species that Can Be Used in Foods and has also been included in the European Food Safety Authority's Qualification Permit (QPS) list of recommended microorganisms. Bifidobacterium longum subsp. infantis M-63 was isolated from the intestines of healthy infants, which is managed as a "generally recognized as safe (GRAS)" in the United States and can be used in infant and young children food. Due to its excellent safety and clinical effectiveness, it was approved to be included in the bacterial species that can be used in infant and young children food, whose food safety indicators meet the National Food Safety Standard Bacteria Preparations for Food Processing.

M-63 is the third Morinaga strain that can be used in foods for infants under three years old, following the approval of Bifidobacterium breve M-16V in 2016 and Bifidobacterium longum subsp. longum BB536 in 2022.

M-63 mainly inhabits the intestines of infants and belongs to Bifidobacterium longum subsp. infantis. Clinical studies have shown that it has a strong ability to utilize human milk oligosaccharides (HMOs) contained in breast milk and can improve the intestinal environment of healthy infants and young children. It is also known as "HMOs new era probiotics". China approved the use of HMOs in infant and young children milk powder in October 2023. The combined use of M-63 strains and HMOs is expected to effectively support the growth of beneficial intestinal bacteria and bring significant benefits to the development and health of infants.

Morinaga's Bifidobacterium strains approved as novel food ingredients

Antion has professional technical capabilities and rich application experience. We can provide customers with the full process of "three new" foods application services from project evaluation, material preparation, tesing, application submission, correction communication, etc., to help enterprises choose the appropriate application direction, improve application efficiency, reduce manpower and financial costs, and reduce application risks. If you have questions related to "three new" foods, welcome to contact us.

Source: Antion

Note: This article is compiled by Antion. Please indicate the source for reprint.