EU Agency Cleared Aspergillopepsin I Enzyme
The European Food Safety Authority found no significant safety concerns for the enzyme used in food production.
Updated on Oct. 9, 2026 in Allergies
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The European Food Safety Authority concluded that the food enzyme aspergillopepsin I does not present safety concerns when used as intended. While the panel noted that allergic reactions from dietary exposure cannot be fully ruled out, they deemed the overall risk to be low.
Why it matters
This assessment provides regulatory validation for the use of this enzyme across 16 different food manufacturing processes. By determining that the risk profile remains within acceptable margins, the authority enables manufacturers to proceed with standard industrial applications.
The study confirmed a margin of exposure of at least 385 based on a no observed adverse effect level of 1800 mg TOS/kg per day. Researchers assessed the enzyme, classified as EC 3.4.23.18, through a 90-day oral toxicity study in rats.
The players
European Food Safety Authority
This is the agency responsible for providing independent scientific advice and communication on risks associated with the food chain in the European Union.
Shin Nihon Chemical Co., Ltd.
This is the manufacturer that produces the aspergillopepsin I enzyme used in industrial food processing.
The details
Produced by Shin Nihon Chemical Co., Ltd., the enzyme is derived from a non-genetically modified strain of Aspergillus. While sequence matching identified potential respiratory and injected allergens, the safety evaluation focused on dietary intake and system toxicity.
Timeline
The 90-day duration was the length of the oral toxicity study conducted on rats.
Health Landscape
This safety assessment follows the rigorous risk evaluation criteria mandated by the EU Food Enzyme Regulation (EC) No 1332/2008. The finding highlights the evolving regulatory standards for food additives and industrial enzymes in global markets.
The assessment confirms that the enzyme is safe for use in intended food manufacturing processes, meaning no changes to consumer diet or health routines are required. Individuals with specific known sensitivities should continue to consult food labels, as the panel noted that allergic potential cannot be entirely excluded.
The takeaway
Regulators prioritize safety margins to ensure that industrial food enzymes do not pose systemic risks to the general population. Consumers can remain confident in these oversight processes while remaining mindful of individual allergy profiles.
Further reading
Learn more about food ingredient safety standards in the Allergies section.
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