Enzymes are proteins that catalyze chemical reactions. They are highly specific and needed in only minute quantities, Certain enzymes have long been used to produce specific foods (e.g., cheese). Today they have numerous applications and are increasing in commercial importance. There has never been a health problem traced to the use of an enzyme per se in food processing. However, it is important that scientific data be provided to show that enzyme preparations, particularly those lacking a long history of safe use, are in fact safe to consume. The purpose of this report is to propose guidelines for assessing enzyme safety. We conclude that the enzymes per se now used or likely to be used in the future in food processing are inherently nontoxic. Safety evaluation should focus on possible contaminants which could be present. Assuming that current Good Manufacturing Practices (CGMPs) are followed, toxic contaminants could only come from the enzyme source itself (animal, plant or microbial). Hence, the safety of the source organism should be the prime consideration. Enzymes from animals or plants commonly regarded as food need not be subjected to animal feeding studies. Some food plants produce toxins and chemical assays may be used in these cases to assess safety. For enzymes from bacteria, it should be shown that antibiotics and acute toxins active via the oral route (enterotoxins and certain neurotoxins) are absent. Small molecular weight toxins (< 500 daltons) may be produced by certain fungi and actinomycetes. It should be shown that enzymes from such organisms are free of these materials. If it is established that a microbial culture does not produce antibiotics or toxins active via the oral route, then enzymes manufactured from that culture using CGMPs may be regarded as safe for use in food processing.

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