Morinaga achieves ANVISA approval for BB536 probiotic

By Stephen Daniells

- Last updated on GMT

© Aycan / Getty Images
© Aycan / Getty Images

Related tags ANVISA Probiotics Gut health Brazil

The Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) has approved Morinaga’s probiotic strain Bifidobacterium longum subsp. longum BB536 for us in dietary supplements and conventional food products sold in Brazil.

The approval’s announcement, made this week, also gives the allows for the use of the claim: "Bifidobacterium longum BB536 may contribute to the health of the gastrointestinal tract".

"We are thrilled to announce the approval of BB536 by ANVISA for use in supplements and conventional foods in Brazil," said Dr. Yoshihiko Ushida, General Manager of the International B to B Business Department of Morinaga Milk.

"This achievement underscores our commitment to producing high-quality, scientifically validated probiotics that contribute to the well-being of consumers around the world."


Bifidobacterium longum​ BB536 has a history of over 50 years of human use, supported by more than 240 scientific studies as of March 2023. The strain is Generally Recognized as Safe (GRAS) in the US for use in conventional foods and infant formula. It has also been approved as a "New Food Ingredient" in China for use in infant and toddler foods under the age of three.

One of the objectives outlined in Morinaga’s 10-year vision seeks to achieve an overseas sales ratio of at least 15% by the fiscal year ending March 31, 2029. This new approval in Brazil aligns with the company's commitment to expanding its presence in international markets, including strengthening partnerships with major infant formula manufacturers and sales for dietary supplements all over the world, said Morinaga.

The Brazilian probiotic supplement market is growing rapidly, with a compound annual growth rate of approximately 9% from 2013 to 2022, and the market size has more than doubled to approximately US$200 million, according to Euromonitor International.



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