Food Enzyme Found Safe for Manufacturing Use
Regulators concluded the enzyme aspergillopepsin I poses no safety concerns for the general population.
Updated on Oct. 9, 2026 in Allergies
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The European Food Safety Authority has determined that the food enzyme aspergillopepsin I does not present safety concerns under its intended conditions of use. This enzyme, which is produced using a non-genetically modified strain of Aspergillus, is intended for 16 different food manufacturing processes.
Why it matters
The safety assessment ensures that substances used in food production undergo rigorous testing for toxicity and potential allergens. Understanding these evaluations helps consumers stay informed about the chemical and biological processes involved in modern food manufacturing.
A 90-day oral toxicity study in rats established a no observed adverse effect level of 1800 mg TOS/kg body weight, resulting in a margin of exposure of at least 385. While genotoxicity tests showed no safety concerns, amino acid sequence analysis identified potential respiratory and injected allergens.
The players
European Food Safety Authority
An agency of the European Union that provides independent scientific advice and communication on risks associated with the food chain.
Shin Nihon Chemical Co., Ltd.
A Japanese chemical manufacturer that produces the aspergillopepsin I enzyme for food industry applications.
The details
The enzyme aspergillopepsin I (EC 3.4.23.18) is designed for use in 16 industrial food processes, with residual total organic solids removed in two of these methods. To confirm systemic safety, researchers performed a repeated dose oral toxicity study in rats to identify adverse physiological responses. While the assessment supports safe use, the potential for allergic reactions from dietary exposure cannot be entirely excluded, though it is considered low.
Timeline
The 90-day oral toxicity study in rats provided data for the assessment.
Health Landscape
This assessment is part of the ongoing regulatory review process under the European Food Safety Authority's food enzyme safety assessment framework. It reflects the broader scientific shift toward standardized, risk-based evaluations for processing aids used in global food production.
While the enzyme is deemed safe, individuals with specific sensitivities may still want to monitor their reactions to new food products. If you have concerns about ingredients in processed foods, these are valid topics to discuss with your doctor or a registered dietitian.
The takeaway
Regulators have confirmed that aspergillopepsin I is safe for its intended food manufacturing roles. If you have a history of food sensitivities, keep a record of any adverse reactions to processed goods and share that information during your next medical consultation.
Further reading
For more information on common food allergens and safety standards, visit our Allergies section.
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