Morinaga Milk Industry, a Japanese dairy product company, has announced its proprietary probiotic Bifidobacterium longum BB536 has been approved by the National Health Commission (NHC) of the People’s Republic of China as a “new food ingredient” for use in infant and toddler foods (under the age of three) as of 11 May 2022.

Following a registration process, the strain has been confirmed to meet appropriate standards of safety and regulatory compliance.

“We are extremely proud to have achieved the registration process and consider it an endorsement of the core values of Morinaga Milk’s HRB (human-residential bifidobacteria),” said Dr Xiao, General Manager of Next Generation Science Institute of Morinaga Milk. “We believe the highest safety standards that we uphold and the strong scientific evidence behind BB536 are what brought us this far. It has been a long registration process and this approval is an incredible regulatory achievement given the limited number of strains that made it to the list of only 14 strains, including BB536.”

The “new food ingredient” is a regulatory system required for food ingredients to be specifically permitted for use in general foods and infant and toddler foods (<3 years) in China. The ingredient must meet certain requirements in terms of nutrition, health, and safety and comply with the regulatory standards in China. To date, there are only 13 registered probiotic strains that can be used in infant and toddler foods in China.

The company focuses on human-residential bifidobacteria (HRB) – the natural inhabitants of the human gut that exhibit numerous beneficial physiological functions. Both BB536 and M-16V approved by the NHC are HRB strains.

The strain has also received FDA GRAS notification in the US for use in conventional foods and infant and toddler milk.