Morinaga Milk's Probiotic BB536 Gains ANVISA Approval with Gut Health Functional Claim in Brazil

10 Sep, 2023

Morinaga Milk's Probiotic BB536 Gains ANVISA Approval with Gut Health Functional Claim in Brazil

Bifidobacterium longum subsp. longum BB536, a probiotic strain with a history of more than 50 years of safe human use and backed by over 240 scientific studies as of March 2023, has received approval from the Brazilian Health Regulatory Agency (ANVISA). This approval, granted on July 27, 2023, permits the use of Bifidobacterium longum BB536 in dietary supplements and conventional food products sold in Brazil. The strain has also been added to ANVISA's list of approved products.

Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy company, is delighted to announce this milestone. Bifidobacterium longum BB536 is a proprietary probiotic strain developed by Morinaga Milk and is considered a globally recognized functional probiotic ingredient. It has received Generally Recognized as Safe (GRAS) status in the U.S. for use in conventional foods and infant formula. Additionally, it has been approved as a "New Food Ingredient" in China for use in infant and toddler foods under the age of three.

This ANVISA approval allows for the incorporation of Bifidobacterium longum BB536 into dietary supplements and various conventional foods in Brazil. Furthermore, it is approved to carry the claim that "Bifidobacterium longum BB536 may contribute to the health of the gastrointestinal tract."

This development holds significant implications for Morinaga Milk's global growth strategy. As outlined in the company's 10-year vision, Morinaga Milk aims to achieve an overseas sales ratio of at least 15% by the fiscal year ending March 31, 2029. This approval aligns with the company's commitment to expanding its presence in international markets, including strengthening partnerships with major infant formula manufacturers and increasing sales of dietary supplements worldwide.

The Brazilian probiotic supplement market is experiencing rapid growth, with a compound annual growth rate of approximately 9% from 2013 to 2022. The market size has more than doubled, reaching approximately US$200 million*1. Morinaga Milk sees a promising future in the Brazilian market.

"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." Morinaga Milk is excited about the opportunities this milestone presents.