Protease from Aspergillus oryzae var.

About

What it is and where it shows up.

A protease (protein-digesting enzyme) derived from the filamentous fungus Aspergillus oryzae var., used as a food-processing aid to hydrolyse peptide bonds in proteins. It is widely applied in bakery (to improve dough extensibility), meat tenderisation, brewing, and dairy processing.

Safety summary

The regulatory and scientific consensus.

Protease from Aspergillus oryzae has a long history of safe use in food and holds GRAS status in the United States; JECFA has not established a numerical ADI, indicating no toxicological concern at normal use levels. The principal safety concern is occupational respiratory sensitisation in workers exposed to dust/aerosols of enzyme preparations, not in food consumers. The EU is still finalising its authorised Union List for food enzymes under Regulation (EC) No 1332/2008, so formal EU-level approval is pending.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	INS 1101(i) (Protease from Aspergillus oryzae) is listed as a permitted food additive (enzyme) under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, subject to GMP and specified food category conditions.source
FDA (Food and Drug Administration) (United States)	Approved	Enzymes from Aspergillus oryzae are approved as food additives (ENZ, FS) under 21 CFR Part 136 for bakery products; broader enzyme GRAS status affirmed per 21 CFR Part 173 and GRAS notices. Use predicated on Good Manufacturing Practices.source
EFSA (European Food Safety Authority) (European Union)	Under_review	Regulated under Regulation (EC) No 1332/2008 on food enzymes (in force 20 January 2009). The EC enzyme register lists this enzyme as submitted for evaluation, but the EU Community (Union) List has not yet been finalised; the register is explicitly NOT a list of authorised enzymes. EFSA is conducting safety evaluations including applications for Protease/Orysin from A. oryzae submitted by AMFEP.source

Who should approach with care

Whose guidance would steer them away.

Other — Workers handling concentrated enzyme preparations (bakers, enzyme-processing plant staff) face a documented risk of occupational respiratory sensitisation and asthma from inhalation of enzyme dust; this is an occupational hazard rather than a consumer food-safety concern, but allergic individuals should avoid repeated airborne exposure.

Research citations

The sources behind this verdict.

1FDA. Food Additive Status List – Enzymes from Aspergillus oryzae. fda.gov
2WHO. FAO/GSFA Online Food Additive Details – Protease from Aspergillus oryzae var. (1101(i)). fao.org
3EFSA. Scientific Opinion on the safety evaluation of a food enzyme containing aspergillopepsin I and II from the Aspergillus niger var. macrosporus strain PTG8398, 2022. pmc.ncbi.nlm.nih.gov
4other. Evolving regulatory policies regarding food enzymes produced by recombinant microorganisms, 2019. pmc.ncbi.nlm.nih.gov
5FDA. Enzyme Preparations Used in Food (Partial List), 2018. fda.gov

Independently researched5 citations