ABSTRACT
Microbial enzymes used in food processing are not pure substances. Rather, they are complex mixtures that include the desired enzyme as well as other metabolites generated by the production strain, in addition to intentionally added materials such as preservatives and stabilizers. Accordingly, safety evaluation of food enzyme preparations poses special challenges that are not typically encountered with other food ingredients. To address these challenges we developed a scientific framework1,2 that focuses on the safety of the production organism and its metabolites rather than simply on the desired enzyme. This framework may also serve as a model for evaluating the safety of other complex food matrices that contain intentionally modified proteins.
