The Generally Recognized as Safe (GRAS) process is well suited for enzymes, given the general availability of scientific data supporting enzyme safety, and the generally recognized (peer-reviewed) methodology and decision trees for evaluating the safety of microbial enzymes used in food processing and in animal feed, respectively. In this paper we describe the elements of a safety evaluation of an enzyme used in food and feed and how the available published data and information related to each element can form the basis for a determination of GRAS for an intended use.
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