EFSA Has Assessed Safety of Oryzin Food Enzyme
The European Food Safety Authority concluded the enzyme poses no safety risks despite potential allergy concerns.
Updated on Sept. 28, 2026 in Nutrition
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The European Food Safety Authority (EFSA) completed a safety assessment of the food enzyme oryzin, which is used in 14 food manufacturing processes. The panel found no safety concerns under intended conditions, though it noted that allergic reactions cannot be fully excluded.
Why it matters
Understanding the safety profile of food additives is critical for regulatory approval and consumer protection. While standard toxicity tests were cleared, the identification of potential allergen matches highlights the complexities of assessing novel food ingredients.
Assessments included homology searches that identified matches with 2 food, 20 respiratory, and 3 contact allergens. The enzyme's estimated dietary exposure is 0.446 mg TOS per kg of body weight per day in European populations.
The players
European Food Safety Authority
This is the agency of the European Union that provides independent scientific advice and communication on risks associated with the food chain.
Shin Nihon Chemical Co., Ltd.
This is a chemical manufacturer that produces oryzin for use in various food manufacturing processes.
The details
Shin Nihon Chemical Co., Ltd. manufactures the enzyme using a non-genetically modified Aspergillus sp. strain. Safety was verified through genotoxicity testing and a 90-day oral toxicity study in rats, resulting in a sufficient margin of exposure for human use.
Timeline
A 90-day oral toxicity study in rats was conducted to assess safety.
The EFSA assessment was finalized in September 2026.
The Big Picture
This assessment follows the established standardized testing protocols required by the European Food Safety Authority's food enzyme assessment program. These evaluations are essential for maintaining harmonized food safety standards across international trade borders.
Consumers with known respiratory or contact allergies should remain aware that this enzyme is present in various food manufacturing processes. Currently, there is no requirement for individuals to change their daily diet due to the enzyme's approval under intended usage conditions.
The takeaway
While regulatory bodies approve the safety of food enzymes based on extensive toxicity studies, consumers with specific allergen sensitivities should continue to monitor ingredient disclosures. This assessment confirms the enzyme meets rigorous safety benchmarks for general population consumption.
Further reading
Learn more about the latest developments in food safety and Nutrition standards.
Source note: This article includes information reported by Foodmate.
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