Morinaga probiotic receives GRAS status

TOKYO, Japan - Morinaga Milk Industry Co., Ltd. announced today that it has been issued the Generally Recognised as Safe (GRAS) Letters of No Objection for its proprietary probiotic strain, Bifidobacterium breve M-16V for food applications and infant formulas, by the U.S. Food and Drug Administration.

On September 27, the U.S. FDA issued “letters of no objection” in response to Morinaga’s safety submissions for Bifidobacterium breve M-16V for food uses (GRAS Notice No. GRN 000453) and for use in infant formulas (GRAS Notice No. GRN 000454).

Launch at Supply West Side 2013

Bifidobacterium breve M-16V, Morinaga’s second flagship probiotic strain, will be officially introduced at Supply Side West trade show in Las Vegas, Nevada on November 14 and 15, 2013.

In 2009, Morinaga achieved GRAS status for its first flagship probiotic ingredient, Bifidobacterium longum BB536 (GRAS Notice No. GRN 000268), one of the best-selling probiotics in Japan.

 Safe for infants

“A GRAS determination for an ingredient intended for use in infant formula requires the utmost care that assurance of safety for this sensitive sub-population be completed using the most current and rigorous of scientific and regulatory standards," said Claire Kruger, Ph.D., D.A.B.T., president of Irvine, CA-based Spherix Consulting, one of the expert panel members involved in the self-affirmed GRAS determination for Bifidobacterium breve M-16V in 2012.

“The safety of Bifidobacterium breve M-16V was confirmed by a thorough Expert Panel review of this probiotic, including an evaluation of all data against the safety standards enumerated by the Food and Agriculture Organization of the United Nations’ World Health Organisation (FAO/WHO) guidelines for the evaluation of microbes for probiotic use in foods,” said Dr  Kruger.

Bifidobacterium breve M-16V is a strain of Bifidobacterium which occurs naturally in the gut microbiota of healthy infants and adults, along with Morinaga’s flagship probiotAir Jordan III 3 Shoes