Safety regulations of food enzymes

The majority of industrial enzymes available at present is used in food industry. Safety regulations of food enzymes differ among countries, including fundamental aspects, whether a pre-market approval is needed and on the level of details, e.g. what particular information manufacturers have to provide in the course of safety evaluation. Occupational safety concerns focus on allergenic properties as it is well established that enzymes are potent inhalative sensitizers and can cause allergic reactions including asthma. Otherwise toxic substances including bacterial toxins and mycotoxins might also be present in enzyme isolates and might thus constitute a safety risk to consumers. Safety evaluation procedures seem to be appropriate as no incidents have been reported so far, resulting in suggestion for reduced test packages. Safety precaution and monitoring measures established by industry have also reduced but not entirely eradicated occupational risks. Challenges to regulators and industry arise from unresolved issues, e.g. whether enzymes might be contact sensitizers, and from the lack of harmonisation of both legislation and safety evaluation. In the EU, most food enzymes are not covered by food safety regulations neither on Community nor on national level. On top of this the availability of enzymes with new and unusual properties raises questions of safety. In the EU there seems to be a chance that these challenges will be tackled in the course of establishing a harmonised legislation on food enzymes.