Abstract
Following the revision of the Food Sanitation Act in 1995, the scope of designated food additives was expanded from solely chemically synthesized substances to encompass all additives, including those of natural origin. Consequently, food enzymes that had been distributed as natural additives at the time were permitted to continue distribution as existing additives. However, as no official specifications had been established for existing additives at the inception of the system, there was a prompt need to develop compositional standards and incorporate them into the Japan's Standards and Specifications for Food Additives(JSFA). Since then, under the guidance of the Japan Food Additives Association, the enzyme industry has undertaken extensive deliberations, culminating in the inclusion of all existing enzyme additives (68 items) and two designated enzyme additives in the 9th edition of the JSFA, including Supplement I. This paper provides an overview of the compositional standards for enzymes as stipulated in the JSFA, along with relevant regulatory information. In addition, this paper provides an overview of the application procedures for newly designated food additives, as well as the safety evaluation submissions for food additive enzymes produced using microorganisms developed through recombinant DNA technology.
