Status symbol: Morinaga obtains self-affirmed GRAS status for M-63 probiotic strain

By Guan Yu Lim contact

- Last updated on GMT

M-63 is included in a range of infant and children formula products (Chil-Mil, Chil-Kid, Chil-School) that is selling in Indonesia under the Morinaga brand.
M-63 is included in a range of infant and children formula products (Chil-Mil, Chil-Kid, Chil-School) that is selling in Indonesia under the Morinaga brand.

Related tags: Japan, morinaga milk industry, Probiotic

Japan’s Morinaga Milk Industry has obtained a self-affirmed Generally Recognised as Safe (GRAS) status for its Bifidobacterium infantis M-63 probiotic, for use in general foods and infant formula in US.

M-63 is a probiotic strain studied for its various health effects such as improving gastrointestinal symptoms in infants with colic, in children with irritable bowel syndrome (IBS) and alleviating allergic symptoms in children with seasonal allergic rhinitis.

In adults, administration of M-63 was found to improve mental state in patients with IBS.

The M-63 probiotic can be found in a range of Morinaga-branded infant and children formula products including the Chil-Mil, Chil-Kid and Chil-School brands, sold in Indonesia.

The company has since submitted a GRAS Notification for M-63 to the US Food and Drug Administration (FDA).

The company has been researching on bifidobacteria strains that are naturally present in human host over the past 50 years.

Dr Chyn Boon Wong, research associate at Morinaga Milk Industry, said: “Affirmation of this newest status (for M-63) is yet another confirmation of the scientific rigor and safety profile of our proprietary HRB strain. It adds value to our Human Residential Bifidobacteria (HRB) probiotics lineup, diversifying its application options available in the United States in both infant nutrition and general foods categories​.”

We are extremely delighted that M-63 has passed the stringent process to obtain this GRAS status and the potential implications of this new status are very exciting to be a part of​.”

Opportunity and demand

According to Wong, M-63 is a HRB strain that is naturally selected by human breast milk.

It is important to establish a bifidobacteria-dominant gut microbiota, and the clinically proven strain B. infantis M-63 is one strain that can provide infants the benefits and aids in its health developmental process​.”

Wong added that the first 1000 days of life represented a critical window of opportunity to shape the metabolic, immunological and neurological functions in infants.

From a population standpoint and growing affluent and increasingly health conscious population, all these factors are positive for entering the infant formula market​.”

In addition, “Given the consumer demand for mental health-promoting products, the potential market for probiotics food products that can offer dual health effects, not only gut health but also for issues such as anxiety, stress and depression is significant​,” Wong said.

Health benefits

The health benefits of the M-63 probiotic have been detailed in several studies, involving both infant/children and the adult population.

In a study published in the Italian Journal of Pediatrics​ by Michele Miraglia Del Giudice et al​ (2017), children (ages 4 to 17) administered with a probiotic mixture containing 1 billion CFU/day of M-63 for eight weeks had significantly lower allergic rhinitis symptoms compared to the placebo group. The placebo group even observed worsening of symptoms. In Japan, seasonal allergic rhinitis is common in children and is a main risk factor for asthma onset.

In another study, children (ages 8 to 17) with irritable bowel syndrome (IBS) and functional dyspepsia (FD) given a probiotic mixture containing 1 billion CFU/day of M-63 for six weeks were found to have improved abdominal pain and quality of life. The findings were published by Eleonora Giannetti et a​l (2017) in the Journal of clinical gastroenterology​.

In a RCT study in children aged 4 to 12 with constipation, a probiotic mixture containing 2.5 billion CFU/day of M-63 coupled with polyethylene glycol for eight weeks was found to improve constipating. It was published by Marina Russo et al​ (2017) in the Italian Journal of Pediatrics​.

For adults, a study published by Z F Ma (2019) in the Beneficial microbes​ journal detailed that adults with IBS had significantly improved mental state (anxiety, well-being) after receiving 2.5 billion CFU/day of M-63 for 12 weeks.

Morinaga Milk is currently working on several research projects studying M-63 in infant health.

The achievement of this self-affirmed GRAS status for M-63 marks another milestone for Morinaga Milk’s HRB strains.

Most recently, its BB536 probiotic strain obtained FDA GRAS approval for use in infant formula in 2019, adding to its earlier GRAS notification for general foods back in 2009.

In 2013, the firm’s M-16V probiotic also received FDA GRAS approval for use in both general foods and infant formula.

In 2018, its heat-killed Lactobacillus paracasei​ MCC184 received self-affirmed GRAS for use in conventional food and beverage products.

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