Morinaga Milk’s Probiotic Bifidobacterium breve B-3 Receives Approval of Individual Recognized Registration in South Korea

November 19, 2023 11:19 Korea Standard Time
  • Backed by clinical evidence, B. breve B-3 shows great promise in aiding body fat reduction. (Graphic...

    Backed by clinical evidence, B. breve B-3 shows great promise in aiding body fat reduction. (Graphic: Business Wire)

TOKYO--(Business Wire / Korea Newswire)--Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company, today announced its proprietary probiotic strain Bifidobacterium breve B-3 has received the approval of Individual Recognized Registration in South Korea for its clinically demonstrated efficacy in body fat reduction.

On March 7, 2023, the probiotic strain B. breve B-3 received the approval of Individual Recognized Registration (No. 2023-2) by the Minister of Food and Drug Safety of South Korea. The probiotic strain meets the highest standards of safety, functionality, and regulatory compliance and can be used as a functional ingredient for body fat reduction at a dosage of 5 billion CFU/day in South Korea.

Bifidobacterium breve B-3 is a unique Human-Residential Bifidobacteria (HRB) probiotic strain developed by focusing on the relationship between gut microbiota and metabolic syndrome. B. breve B-3 possesses an attractive effect in maintaining a healthy body weight and ultimately improving one's lifestyle. Backed by clinical evidence, B. breve B-3 shows great promise in aiding body fat reduction.

Set to Help Reduce Body Fat

South Korea has made impressive progress over the years in terms of introducing policies, institutions, and tools to assure high-quality regulation. Functional ingredients or elements need to obtain a notification by the Minister of Food and Drug Safety or an Individual Recognized registration approval before they can be incorporated into Health Functional Foods with a claim that bring useful health effects for the human body. In order to obtain individual recognition as a functional ingredient, the data submitted to the Minister of Food and Drug Safety by the business operator will be reviewed based on the standards and specifications, safety and functionality assessment standards and will be recognized as a functional ingredient under consultation with the ‘Health Functional Food Deliberation Committee.’

The approval of the probiotic strain B. breve B-3 signifies Morinaga Milk's commitment to developing human-residential bifidobacteria (HRB) probiotic strains backed by solid scientific and clinical research. Morinaga Milk will continue to stay at the forefront of the probiotic revolution, pushing boundaries to create even more solutions to improve the health of people everywhere.

“We are thrilled and incredibly proud to have our probiotic strain B. breve B-3 receiving the approval of South Korea’s Individual Recognized Registration for its clinical benefit on body fat reduction,” said Dr. Yoshihiko Ushida, General Manager of the International B to B Business Department of Morinaga Milk. “The probiotic market in South Korea has witnessed robust growth in recent years and is set for further growth. This approval speaks highly of the quality and safety of B. breve B-3 as well as its science-backed efficacy on body fat reduction. It highlights its potential contribution to the health of the country's people. We are looking forward to the potential implications of this new status in the growing market in South Korea,” he added.

Positive Results in a New RCT Study

The efficacy of B. breve B-3 on body fat reduction and metabolic health has been further confirmed in a recent clinical study conducted in South Korea. The double-blind, randomized clinical trial, published in the peer-reviewed journal Nutrients in December 2022, was conducted with 83 participants (42 participants in the B. breve B-3 group and 41 participants in the placebo group) over 12 weeks. The results showed a significant reduction in body weight, body fat, waist circumference, and hip circumference in the B. breve B-3 group than in the placebo group. B. breve B-3 at a dosage of 5 billion CFU/day was reported to be safe and effective for reducing body fat.

“We are extremely pleased with the results from this recent RCT study, consistent with the previous study conducted with a higher dosage of 20 billion CFU/day. We appreciate the Korean research team for their effort in demonstrating the efficacy in Korean subjects,” Dr. Ushida further commented. “These results reinforce the potential of the probiotic strain B. breve B-3 as an effective way to help support people's efforts to reduce body fat.”

The study serves as yet another example of the Morinaga team's commitment to uncovering the potential of probiotics in the battle against obesity. The company will continue to strive on the research front to open up new possibilities for people looking to improve their health.

Embrace the Future: Aim Higher!

Under the Morinaga Milk Group's 10-Year Vision, the company aims to achieve an overseas sales ratio of 15% or more by the fiscal year ending March 2029. The company will continue its effort in developing and providing effective HRB probiotics with a higher level of safety and quality and aim to strengthen its probiotic sales in the global marketplace to help achieve the goal.

About Morinaga

Morinaga Milk Industry Co., Ltd. is one of the leading dairy product companies in Japan with a century of history harnessing the nutritional properties of dairy products and functional ingredients. Morinaga Milk is also a key global probiotics manufacturer that excels in innovative technology and offers a premium line of probiotics and functional ingredients worldwide. Since the 1960s, Morinaga Milk has been engaged in research on the safety, functional health benefits, and mechanisms of action of probiotic bifidobacteria to better understand their role in maintaining human health. For more information about Morinaga Human-Residential Bifidobacteria (HRB) probiotics, please visit us at

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Morinaga Milk Industry Co., Ltd. 
Investor& Public Relations Department
Mitsunori Watanabe / Kazuaki Kajikawa

International Division
Junichi Minami / Chyn Boon Wong

This is a news release distributed by Korea Newswire on behalf of this company.