Food Enzyme Oryzin Declared Safe for Production
Regulators found the enzyme presents no safety concerns for most, though potential allergen risks remain.
Updated on Sept. 28, 2026 in Nutrition
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The European Food Safety Authority has completed a safety assessment of the food enzyme oryzin, concluding it presents no health concerns under its intended conditions of use. The enzyme is currently approved for application in 14 specific food manufacturing processes.
Why it matters
This assessment provides a scientific baseline for the use of this enzyme in food manufacturing, weighing safety margins against potential sensitivities. It clarifies the regulatory status of the ingredient, which is produced by Shin Nihon Chemical Co., Ltd. using a non-genetically modified fungus.
A 90-day oral toxicity study in rats established a no observed adverse effect level of 1218 mg per kg of body weight per day, supporting a margin of exposure of 2731. While genotoxicity tests showed no safety concerns, homology searches matched the enzyme with 2 food, 20 respiratory, and 3 contact allergens.
The players
European Food Safety Authority
An agency that provides independent scientific advice and communication on risks associated with the food chain.
Shin Nihon Chemical Co., Ltd.
A manufacturer responsible for the production of the enzyme oryzin using an Aspergillus sp. strain.
The details
Produced from the non-genetically modified fungus Aspergillus sp. strain LP 4-1281, the enzyme is designed to facilitate 14 different food manufacturing processes. Safety was confirmed through standard repeated-dose oral toxicity models and rigorous genotoxicity screening. However, the expert panel noted that because the enzyme structure shares characteristics with various known allergens, they cannot entirely rule out the risk of an allergic reaction for some consumers.
Timeline
The repeated dose oral toxicity study in rats lasted for a 90-day period.
The European Food Safety Authority finalized its safety assessment in September 2026.
Health Landscape
This assessment is part of a standardized regulatory process for all food-processing enzymes within the European market. It aligns with the existing framework used by the European Food Safety Authority to evaluate the safety profile of biological agents in the food supply.
Most consumers will see no change, as the enzyme is used in manufacturing processes rather than as a direct additive. If you have known allergies to mold or specific Aspergillus proteins, this is a topic to discuss with your physician.
The takeaway
While the enzyme was found to have a high margin of safety in animal studies, it remains a protein derived from a mold strain. Individuals with severe or complex food allergies should consult their doctor if they have concerns about new enzymatic ingredients appearing on food labels.
Further reading
For broader insight into how additives are evaluated, visit our section on Nutrition.
Source note: This article includes information reported by Foodmate.
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Do you trust food industry safety assessments of new enzymes despite potential allergen risks?
