Safety assessment and regulation of food enzymes

Many industrial microbial enzymes produced currently are used in the food industry. Enzymes are proteins and do not typically represent a hazard. Those that do are well defined and include, bacterial, plant and animal toxins, allergens, and antinutrients. Enzymes are not acutely toxic, genotoxic, or toxic by repeated dose administration. The enzyme industry has performed many genotoxicity studies. Greater than 230 and > 240 mutagenicity studies on bacterial and mammalian cells, respectively have been conducted. Further > 200, 90-day oral gavage or feeding studies have been performed with no adverse findings observed. Except for the potential skin and eye irritating effects of some proteases and the potential for occupational respiratory sensitization, enzymes are safe for human exposure. These studies also confirm that any remaining fermentation materials in the product also lack toxicity. The safety of enzyme production strains continues to be the key consideration in evaluating enzyme safety. The conduct of repeated toxicological testing with enzymes derived from the same strain lineage with no adverse effects allows for the establishment of a Safe Strain Lineage (SSL). The lack of general toxicological concern on enzymes and the use of the SSL concept support the consideration of reduced Toxicology testing packages. Safety assessment requirements for food enzymes are complicated by differences in global regulations. This includes differences in the conditions under which premarket approval is required, and differences in sensitivities to perceived risks of the use of biotechnology in developing new enzyme products, resulting in discrepancies in the type of safety data manufacturers must provide. Additional research and data into the etiology of how enzymes act as respiratory allergens are also needed to differentiate between nonallergenic/weakly allergenic enzymes and those moderate/strongly allergenic enzymes via the respiratory route of exposure.