About
Alpha-amylase (EC 3.2.1.1) is a hydrolytic enzyme that catalyses the breakdown of starch and glycogen by cleaving alpha-1,4-glucosidic bonds, releasing shorter dextrins, oligosaccharides, and sugars. It is used as a processing aid in baking, brewing, starch processing, sugar syrup manufacture, and distilled alcohol production to improve dough handling, enhance fermentation, and produce glucose syrups.
Safety summary
Alpha-amylase is broadly considered safe for the general adult population, with no genotoxicity concerns and very large margins of exposure identified in repeated EFSA evaluations. An ADI has not been formally established because residual enzyme levels in finished foods are extremely low and the enzyme is largely denatured or diluted during processing. Occupational inhalation exposure (not dietary) has been associated with baker's asthma and respiratory sensitisation, and low-level dietary allergenic risk cannot be completely excluded due to sequence homologies with known respiratory allergens, though the likelihood is considered low.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | Alpha-amylase from approved microbial sources is permitted under Australian Standard 1.3.3 (Processing Aids) as referenced in FDA GRAS dossiers cross-referencing international approvals.source |
| Health Canada (Canada) | Approved | Alpha-amylase preparations from B. licheniformis are on Canada's List of Permitted Enzymes as referenced in FDA GRAS dossiers.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | Food enzymes on the EU market are evaluated strain-by-strain under Regulation (EC) No 1332/2008; multiple alpha-amylase preparations from Bacillus licheniformis, B. amyloliquefaciens, B. subtilis, Aspergillus sp., and Trichoderma reesei have received favourable EFSA opinions. Dietary exposure estimated up to ~3 mg TOS/kg bw/day with margins of exposure exceeding 2900. Authorisation via Union list under Regulation (EC) No 1332/2008.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Alpha-amylase is permitted as a food enzyme at GMP (Good Manufacturing Practice) levels in processed cereal-based complementary foods and related categories under the Food Safety and Standards (Infant Nutrition) Regulations.source |
Who should approach with care
Research citations
- 1FDA. Agency Response Letter GRAS Notice No. GRN 001011 — alpha-amylase from Thermoactinomyces vulgaris produced in B. subtilis. fda.gov
- 2EFSA. Safety evaluation of the food enzyme α-amylase from the non-genetically modified Aspergillus sp. strain FUA, 2025. efsa.europa.eu
- 3EFSA. Safety evaluation of the food enzyme α-amylase from the non-genetically modified Bacillus licheniformis strain AE-TA, 2024. efsa.europa.eu
- 4FSSAI. Compendium of Food Additive Regulations — Infant Formula Regulations Version II (Food Safety and Standards Authority of India), 2024. fssai.gov.in
- 5EFSA. Safety evaluation of the food enzyme alpha-amylase from a genetically modified Bacillus subtilis (strain NBA), 2019. efsa.europa.eu
- 6FDA. Agency Response Letter GRAS Notice No. GRN 000594 — alpha-amylase enzyme preparation from Bacillus licheniformis carrying alpha-amylase gene from Geobacillus stearothermophilus, 2015.