Morinaga Probiotic Strain Gains GRAS Affirmations

TOKYOMorinaga Milk Industry Co. Ltd. received letters of no objection from the U.S. Food and Drug Administration (FDA) regarding its generally recognized as safe (GRAS) affirmations for its proprietary probiotic strain Bifidobacterium breve M-16V for use in food applications and infant formulas.

On Sept. 27, 2013, FDA issued letters of no objection" in response to Morinagas 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). Bifidobacterium breve M-16V, Morinagas second flagship probiotic strain, will be officially introduced at the Supply Side West trade show in Las Vegas, Nov. 14-15, 2013.

In 2009, Morinaga achieved GRAS status for its first flagship probiotic ingredient, Bifidobacterium longum BB536 (GRAS Notice No. GRN 000268).

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, Calif.-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 Organization (FAO/WHO) guidelines for the evaluation of microbes for probiotic use in foods."