Safety and Regulatory Aspects of Food Enzymes: An Industrial Perspective.

ABSTRACT

Linkages between diet habits and the quality of life continue to surface on numerous fronts. Safety concerns associated with food enzymes in general are possible allergenic, irritative and otherwise toxic properties .Oral toxicity is especially relevant to consumers of food enzymes. The regulation of enzymes internationally is quite varied between countries, with specific country either requiring a full approval process, a notification of enzyme or no requirement thereof. Pre-market approval may depend on whether an enzyme is classified as processing aid or a food additive, though the point of consideration regardless of classification is that the safety of the enzyme must be assured. Challenges to regulators and industry arise from unresolved issues and from lack of harmonization of both legislation and safety evaluation. The regulation of enzyme for Australia and New Zealand are contained within horizontal standards of processing aids. This standard regulates the use in food manufacture, stopping them from being used in food unless there is a specific permission in standard. In US enzymes classified as food additives or as GRAS, while certain enzymes are regulated as secondary direct food additives under the regulation. Finally the act permits an individual or company to decide on its own that based on the appropriate data whether an ingredient is GRAS for a particular intended use, and to market the ingredient for that use without any prior contact with the agency. In the EU, most food enzymes are not covered by food safety regulations neither on community nor on national level. On top of this availability of enzymes with new and unusual properties raises questions of safety. There seems to be a chance that these challenges will be tackled in the course of establishing a harmonized legislation on food enzymes.