Japanese dairy firm obtains GRAS notice for 1960’s probiotic

By Guy Montague-Jones

- Last updated on GMT

Morinaga Milk Industry has obtained GRAS with FDA non-objection for a probiotic strain that the Japanese firm has used in its own products for over 30 years.

Developed by Morinaga back in the 1960s, Bifidobacterium longum BB536 is a probiotic of human origin that is well established in the Japanese market. Indeed, Morinaga claims that it is Japan’s best selling probiotic ingredient.

Obtaining a GRAS notice for the proprietary strain will now enable Morinaga to bring it to the US functional food market.

“We are very excited that its newly achieved GRAS status will allow US manufacturers to bring the digestive benefits of BB536 to the American public,”​ said Tohru Imamura, general manager of Morinaga’s international department.


Morinaga said over 70 scientific reports, including 35 human clinical trials, have been conducted on BB536.

According to Morinaga, these studies have linked the strain to numerous gut health benefits, including protection against constipation, diarrhea, abdominal discomfort, and bloating. The Japanese company also claims that it improves the bodily ratio of beneficial to harmful bacteria and decreases ammonia and putrefactive products in the digestive tract.

From a formulation point of view, Morinaga claims BB536 offers high stability due to the unique culturing method.


BB536 may be new to the US functional food market, but the probiotic strain has already been sold as a raw material to clients in more than 30 countries for use in food and supplements. In Japan, the ingredient has been approved as Food For Specified Health Use (FOSHU) by the Japanese ministry of health, labour and, welfare.

In advance of obtaining GRAS notification in the US, Morinaga said it had strengthened the technical support for clients who are planning to use BB536 in their products. Technical staff can provide raw material handling advice, aid in the development of strain-stable products, and help navigating regulatory steps in different countries.

Employing 3,013 people, Morinaga is the second largest dairy company in Japan and one of the 11 founding members of the International Probiotics Association (IPA).

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