The strain approved is Bifidobacterium longum subsp.longum BB536 – a flagship probiotics ingredient of Japanese firm Morinaga Milk.
The announcement was made by the Food Safety Standards and Monitoring and Evaluation department under the National Health Commission (NHC) this month, following a one-month public consultation held by the National Center for Food Safety Risk Assessment last November.
The probiotic strain is one of the three most recently approved new food ingredients in China, alongside Chlamydomonas reinhardtii and sugarcane polyphenols. However, unlike BB536, these two raw materials cannot be used in infant foods.
It was only last year that the Bifidobacterium longum subsp.longum species was approved for use in food. Prior to that, it was Bifidobacterium longum that was approved.
The announcement said that Bifidobacterium longum subsp.longum has been included into China’s list of bacteria species that could be used in foods and was also recognised overseas, such as European Food Safety Authority (EFSA) and the International Dairy Federation.
“Bifidobacterium longum subsp.longum BB536 is isolated from the gut of healthy infants and the strain has been approved for use in infant foods in the US and Japan.
“Various clinical studies involving infants and toddlers from both local and international research showed that the strain is safe for use in foods,” the statement said.
The strain is a human-residential Bifidobacterium (HRB) strain that is backed by more than 200 scientific studies, with benefits seen in infants, children, and adults.
For example, a RCT involving 300 newborns showed that the supplementation of the probiotic strain for six months could build a healthy gut microbiota in early life, in turn leading to improved immune development in infants.
Another study published in the Italian Journal of Pediatrics showed that the strain, when taken for four weeks, could alleviate allergic rhinitis symptoms in children with pollen-induced allergic rhinitis and intermittent asthma.
So far, it has been incorporated into yogurt, infant formula, adult milk formula, and dietary supplements.
“We believe the highest safety standards that we uphold and the strong scientific evidence behind BB536 are what brought us come 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,” said Dr. Jin-Zhong Xiao, General Manager of Next Generation Science Institute of Morinaga Milk.
It was also the winner of the Editors Award for Infant and Child Nutrition of the Year in NutraIngredients-Asia Awards 2020.
Prior to the approval of BB536, Morinaga Milk’s other probiotic strain Bifidobacterium breve M-16V was also approved for use in infant foods in China in 2016.
