Published in Regulatory Toxicology and Pharmacology
In July 2015, the journal Regulatory Toxicology and Pharmacology published “Determining the safety of microbial cultures for consumption by humans and animals.” This paper, which was recently made open source, serves as a valuable asset to ingredient manufacturers operating within the microbial cultures space. In providing a comprehensive approach for determining the safety of microbial cultures that lack an established history of safe use for their intended new applications, this resource serves as a decision tree for the safety assessment of microbial strains to be used in food applications. Access and download the full paper below.
Fermented foods and feeds have been consumed for millennia, and microorganisms isolated from traditional fermentations have been used as probiotics. There is interest in developing new microbial cultures for these uses, but to date safety evaluation procedures have only been discussed in general terms. We propose a comprehensive approach for determining the safety of microbial cultures that lack an established history of safe use for their intended new applications. Three scenarios are considered: (1) substantially increased exposure to a culture that has an established record of safety in a more limited application; (2) a new strain without a history of safe use that was isolated from a food or feed that has a history of safe use; and (3) a new strain isolated from a non-food or non-feed source. Our safety evaluation process is based on scientific procedures and is in the form of a decision tree composed of 13 questions. Our decision tree for determining the safety of microbial cultures for consumption by humans or animals is modeled on previous decision trees that are used worldwide to evaluate the safety of microbial enzymes for use in human food or animal feed.