Japan’s Morinaga Milk gets Brazil regulatory nod for proprietary probiotic strain

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BB536 is approved for use in more than 30 countries globally, including as a functional probiotic ingredient in yogurt. Image: Getty/LauriPatterson

Bifidobacterium longum subsp. longum has been approved by the Brazilian Health Regulatory Agency, allowing the ingredient to be used in dietary supplements and food products sold in Brazil.

Bifidobacterium longum subsp. longum (designated as BB536) has been used in various products including dairy-based beverages, yogurts, infant formula and nutritional supplements. It was discovered in 1969 and numerous studies – more than 240 according to Morinaga Milk Industry Co., Ltd – have been conducted to determine its health benefits, which include stabilizing the gut microbiota and preventing inflammation.

The ingredient is used in more than 30 countries including the US, China and Japan. In the US, it has a GRAS (Generally Recognized as Safe) status for use in infant formula and food and has also been approved as a ‘new food ingredient’ in China for use in infant and toddler foods. In Brazil, BB536 can now be used in foods and as a nutritional supplement.

Morinaga Milk says it anticipates ‘a promising future’ for the Brazilian probiotic supplement market; the approval also means the company would be on track to achieve a 15% overseas sales ratio by March 31, 2029.

“We are thrilled to announce the approval of BB536 by ANVISA for use in supplements and conventional foods in Brazil,” commented 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." As Morinaga Milk moves forward, the company is enthusiastic about the opportunities presented by this milestone.

According to Euromonitor International data quoted by the company, the Brazilian probiotic supplement market is set to grow at a CAGR of about 9% from 2013 to 2022, and the market size has more than doubled to approximately $200m.