Sanzyme Biologics has obtained Generally Recognized as Safe (GRAS) approval relating to use of Bacillus coagulans SNZ 1969 in infant formula.

The US Food & Drug Administration (FDA) issued the company with a GRAS Notice known as a ‘no objection letter’. It states that it has no questions regarding the safety of Bacillus coagulans SNZ 1969spore preparation marketed by Sanzyme Biologics when used in infant formula

The FDA’s decision means Bacillus coagulans SNZ 1969spore preparation is permitted for use as an ingredient in a non-exempt infant formula for term infants, at levels up to 2x 108 colony forming units (CFU) per 100 ml infant formula, as consumed.

Bacillus coagulans SNZ 1969is a Gram-positive, spore-forming, rod-shaped bacterium, which was isolated from green malt in 1949. The SNZ 1969 strain is deposited in the Microbial Type Culture Collection as MTCC 5724 and in the Belgian Coordinated Collections of Microorganism as LMG S – 27484.

Numerous clinical studies where Bacillus coagulans SNZ 1969was consumed by both children (including infants) and adults reported no relevant adverse reactions.

Dr. Raunak Soman, Executive Director, Sanzyme Biologics said: “This approval is a significant regulatory milestone and speaks volumes about the quality and safety of our strain.  Probiotics usage has seen a sharp increase over the past few years in infants products, as the babies natural gut flora can be affected by variable factors that can lead to serious life threatening complications. We hope to benefit millions of babies with our Bacillus coagulans SNZ 1969™usage in infant formula. This strain has been used by children in India for decades, with no safety issues or concerns. This history of use and the inherent stability of the strain in food applications make SNZ 1969 the ideal strain for infant applications”

Sanzyme Biologics is a 50 year old biotechnology company based in Hyderabad, India. Sanzyme specialises in the production of probiotic bacteria. Sanzyme’s best studied probiotic product is Bacillus coagulans SNZ 1969™. SNZ 1969 is a well-studied and documented strain with 20+ Clinical Trials and multiple regulatory approvals (FDA GRAS, Infant GRAS, EFSA QPS, Health Canada, FSSAI and others). It is currently sold in and used in 30+ countries including USA, Italy, Canada, Australia and Japan.