About
Protease is a broad class of enzymes that catalyze the hydrolysis of peptide bonds in proteins, breaking them into shorter peptides and amino acids. In food processing, proteases derived from plant, animal, or microbial sources are used for applications such as meat tenderization, cheese making, baking dough improvement, brewing clarification, and production of protein hydrolysates and infant formula.
Safety summary
Protease preparations have been assessed as safe at intended food-use levels by major regulatory agencies including the FDA (GRAS, 21 CFR 184.1027) and EFSA (Regulation (EC) No 1332/2008), with no specific ADI established for the enzyme class. Occupational hypersensitivity (respiratory sensitization) has been documented for workers handling enzyme dusts, but the risk of allergic reactions via oral food intake is considered low by EFSA. A theoretical risk of allergic sensitization cannot be fully excluded in infants consuming protein hydrolysates manufactured with pancreatic proteases, though EFSA judges this likelihood to be low when intact enzymes are inactivated during processing.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Food enzymes, including proteases, are regulated under Regulation (EC) No 1332/2008; each individual protease preparation must undergo EFSA safety evaluation (by the CEP Panel) and be included in the EU Union list before market placement; specific preparations (e.g., thermolysin from Anoxybacillus caldiproteolyticus AE-TP, porcine pancreatic protease complex) have been individually authorized; dietary exposure to thermolysin assessed at up to 0.989 mg TOS/kg bw/day with a margin of exposure of at least 708source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Bacterial Protease approved (ref. 06/Std/PA/Ree(954/2014)/FSSAI/2018, dated 20.06.2018) and Fungal Protease approved (ref. 25/Std/PA/Ree/Ref-(952/2014)/FSSAI/2018, dated 01.05.2018) under FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017; enzymes are further classified under FSSAI product category 99.2 (Enzymes and their preparations)source |
| FDA (Food and Drug Administration) (United States) | Approved | Protease enzyme preparation affirmed as GRAS under 21 CFR 184.1027; use conditions require nontoxicogenic production strains and compliance with current Good Manufacturing Practice (21 CFR 184.1(b)); additional specific preparations may be covered by GRAS notices in the GRAS Notice Inventorysource |
Who should approach with care
Research citations
- 1FDA. Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices for Enzyme Preparations. fda.gov
- 2EFSA. Safety evaluation of an extension of use of the food enzyme thermolysin (protease) from Anoxybacillus caldiproteolyticus strain AE-TP, 2024. efsa.europa.eu
- 3PubMed. Safety evaluation of a food enzyme containing trypsin and chymotrypsin from porcine pancreas, 2021. pubmed.ncbi.nlm.nih.gov
- 4PubMed. Safety evaluation of a food enzyme containing trypsin, chymotrypsin, elastase and carboxypeptidase from porcine pancreas, 2021. pubmed.ncbi.nlm.nih.gov
- 5FSSAI. List of product(s)/ingredient(s) applications Approved under Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017, 2018. fssai.gov.in
- 6FDA. Enzyme Preparations Used in Food (Partial List) — 21 CFR Part 184, 2018.