,"The Food Safety Commission of Japan (FSCJ) has finalized its review of a genetically modified microorganism–derived enzyme, issuing a determination that no additional food health impact assessment is required for the lipase produced using the pLps strain. The assessment results were reported during the Commission’s 1004th meeting in November 2025.
The enzyme, developed by Nagase Viita Co., Ltd., is produced through a genetically engineered Streptomyces violaceoruber strain, into which lipase-related genetic elements from several Streptomyces species were introduced. Designed to hydrolyze glyceride esters and preferentially release short-chain fatty acids, the lipase is used as an alternative to emulsifiers in bread and other bakery applications to reduce undesirable flavors.
FSCJ’s evaluation focused on whether the genetically modified microorganism introduced novel risks. Scientific evidence shows that natural gene exchange occurs among Streptomyces violaceoruber, S. thermoviolaceus, S. cinamoneus, and S. azureus, and that microorganisms with an equivalent genetic composition already exist in the natural environment. All involved strains are non-pathogenic and classified as Biosafety Level 1.
Based on Japan’s official guideline for assessing additives produced using genetically modified microorganisms, the Commission concluded that the lipase meets the category where natural equivalents exist. As a result, FSCJ determined that a dedicated food health impact assessment is unnecessary, clearing the product for regulatory progression in Japan."
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