Morinaga’s new ingredient for infant food receives Chinese regulatory approval

CHINA – Morinaga, a Japanese dairy product and sweets company has announced approval and registration of its proprietary probiotic Bifidobacterium longum BB536 by the National Health Commission (NHC) of China as a new food ingredient for use in infant and toddler foods.

The ingredient will be used in the production of infant and toddler milk and food products that will be consumed by children under the age of three. This is the company’s second strain to obtain approval after the B. breve M-16V in 2016.


According to the company, ingestion of BB536 can provide a consistent beneficial effect in improving gastrointestinal conditions, maintaining intestinal microflora balance, regulating the immune response, anti-allergy, and protecting against microbial infections.

The Japanese-based company is the only business that has managed to register BB536, which is an achievement given only a limited number of strains are approved for use in the Chinese market.

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 registered ingredient must meet certain requirements in terms of nutrition, health, and safety and comply with the regulatory standards in China.


General Manager of Next Generation Science Institute of Morinaga Milk, Dr. Xiao said: “The registration process is hard and it should be because the ingredient is dedicated to a vulnerable population. There were some changes in the regulatory frameworks and the safety requirements have become more stringent.”

The registration comes at a pertinent time when Statista research shows revenue in the Baby Food segment amounts to US$81.83billion in 2022 and the market is expected to grow annually by a CAGR of 10.07% from 2022-to 2027.

In parallel to the approval, Morinaga Milk’s B. longum BB536 has received the FDA’s Generally Recognized As Safe (GRAS)notification in the US for use in conventional foods (GRAS Notice No. GRN 000268) and infant and toddler milk (GRAS Notice No. GRN 000877).

It has been incorporated in various products worldwide for more than 50 years. Affirmation of this newest registration in China adds value to the company’s proprietary probiotic strain, diversifying its application options available in the infant category.

Morinaga Milk is now expanding its application opportunities into the new space, to be specifically permitted for use in infant and toddler milk and foods in China, and aims to strengthen its sales in China to help achieve the goal.


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