Subtilisin
Subtilisin from Bacillus is approved as a food processing aid and enzyme. Generally regarded as safe when used per GMP; primary occupational concern is respiratory sensitization in workers handling raw enzyme.
What it is
Bacterial serine protease enzyme produced by Bacillus subtilis or related species.
Industrial enzyme; in food, used as a processing aid for protein hydrolysis. Also widely used in detergents.
Why it's flagged
- occupational respiratory sensitization (manufacturing only)
What regulators actually say
"Mixed carbohydrase and protease enzyme product is derived from Bacillus subtilis or Bacillus licheniformis... It is generally recognized as safe."
Regulatory status
United States — FDA
Bacillus subtilis-derived enzymes are GRAS for use as food processing aids (e.g., 21 CFR 184.1027)
European Union — EFSA
Subtilisin from Bacillus species evaluated as food enzyme; permitted at quantum satis
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