FDA Letter Received in Response to GRAS Notification for Tannase enzyme preparation produced by Aspergillus oryzae
May 28, 2025
Mitsubishi Chemical Corporation (Head Office: Chiyoda-ku, Tokyo; President: Manabu Chikumoto: hereafter “MCC”) is pleased to announce that it has submitted a Generally Recognized As Safe (GRAS) notification to the U.S. Food and Drug Administration (FDA) for its Tannase preparation, an enzyme used to reduce turbidity and astringency in tea-based beverages, and received a “no questions” letter from the FDA.
Tannase is an enzyme that helps reduce turbidity and astringency in tea-based beverages, fruit juices, soft drinks, flavored water, jellies, and plant extracts, by hydrolyzing gallate-type catechins contained in green tea or chlorogenic acid found in coffee. In 1975, our Tannase preparation became the world’s first to be commercialized, and has since maintained a strong market share, primarily in Japan, as a processing aid in the production of tea-based beverages and related products.
GRAS is a safety determination for food ingredients in the U.S. A substance is deemed GRAS when qualified experts determine that it is safe under the conditions of its intended use. This time, MCC verified the safety of the Tannase preparation based on experts’ knowledge and experience, as well as scientific data, and submitted a GRAS notification to the FDA. As a result, it received a “no questions” letter indicating that the FDA has no objections to the safety determination, thereby completing the notification process.
Notably, our Tannase preparation is the world’s first tannase to be recognized as GRAS. It has been listed as GRN No. 1192 in the GRAS Notice Inventory provided by the FDA. This recognition is expected to further raise awareness and accelerate the global expansion of our Tannase business, with a primary focus on the U.S. market.
In its management vision, KAITEKI Vision 35, the Mitsubishi Chemical Group identifies ensuring food quality as one of its key focus areas. MCC is committed to accelerating the global expansion of materials that help preserve flavor and support the distribution and processing of food products.
Tannase is an enzyme that helps reduce turbidity and astringency in tea-based beverages, fruit juices, soft drinks, flavored water, jellies, and plant extracts, by hydrolyzing gallate-type catechins contained in green tea or chlorogenic acid found in coffee. In 1975, our Tannase preparation became the world’s first to be commercialized, and has since maintained a strong market share, primarily in Japan, as a processing aid in the production of tea-based beverages and related products.
GRAS is a safety determination for food ingredients in the U.S. A substance is deemed GRAS when qualified experts determine that it is safe under the conditions of its intended use. This time, MCC verified the safety of the Tannase preparation based on experts’ knowledge and experience, as well as scientific data, and submitted a GRAS notification to the FDA. As a result, it received a “no questions” letter indicating that the FDA has no objections to the safety determination, thereby completing the notification process.
Notably, our Tannase preparation is the world’s first tannase to be recognized as GRAS. It has been listed as GRN No. 1192 in the GRAS Notice Inventory provided by the FDA. This recognition is expected to further raise awareness and accelerate the global expansion of our Tannase business, with a primary focus on the U.S. market.
In its management vision, KAITEKI Vision 35, the Mitsubishi Chemical Group identifies ensuring food quality as one of its key focus areas. MCC is committed to accelerating the global expansion of materials that help preserve flavor and support the distribution and processing of food products.
