About
Lipase (EC 3.1.1.3) is an enzyme that catalyses the hydrolysis of ester bonds in triacylglycerols to release free fatty acids, glycerol, mono- and diacylglycerols; at very low water concentrations it can also catalyse transesterification of fatty acids. It is widely used as a food-processing aid in baking, cheese and dairy production, fat and oil modification, brewing, and pasta manufacture to improve texture, flavour, and dough handling.
Safety summary
Multiple FDA GRAS notices and repeated EFSA safety evaluations have concluded that lipase enzyme preparations do not give rise to safety concerns under intended conditions of use at typical dietary exposure levels (estimated up to ~0.039–0.020 mg total organic solids/kg bw/day). No ADI has been formally established because residual enzyme activity in the finished food is negligible. Occupational respiratory allergy following inhalation of lipase dust has been documented, and while allergenicity from dietary exposure cannot be entirely excluded, EFSA consistently rates the likelihood as low.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Regulated as a food enzyme under Regulation (EC) No 1332/2008; all food enzymes must undergo EFSA safety evaluation and be included in the EU Union list before market placement. Numerous individual triacylglycerol lipase preparations from various organisms (Aspergillus niger, Aspergillus oryzae, Rhizopus arrhizus, Trichoderma reesei, Komagataella phaffii, etc.) have been evaluated with EFSA concluding no safety concerns under intended conditions of use. The final Union positive list is still being established; lipase preparations that were on the market before January 2009 may continue under transitional provisions.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | FSSAI FSS (Food Products Standards and Food Additives) Regulations 2011, Appendix A, lists 'amylases and other enzymes' as permitted processing aids at Good Manufacturing Practice (GMP) levels in applicable food categories. Lipase falls under this 'other enzymes' category. Novel or non-specified enzyme preparations require prior approval from the Food Authority under the FSS (Non-Specified Foods and Food Ingredients) Regulations.source |
| FDA (Food and Drug Administration) (United States) | Approved | Multiple lipase preparations affirmed as GRAS under 21 CFR Part 184 or cleared via GRAS notice inventory (e.g., GRN 000631, GRN 000783, GRN 001047, GRN 001196, GRN 001201). Conditions of use include baked goods, pasta, noodles, cereal-based snack foods, fats and oils modification, brewing, and dairy. No formal ADI; enzymes are added at the lowest level to catalyse the desired reaction and dietary exposure is generally low.source |
Who should approach with care
Research citations
- 1FDA. GRAS Notice No. GRN 001201 Agency Response Letter – Lipase Enzyme Preparation (Chr. Hansen A/S), 2025. fda.gov
- 2EFSA. Safety evaluation of the food enzyme triacylglycerol lipase from the non-genetically modified Rhizopus arrhizus strain AE-N, 2023. efsa.europa.eu
- 3PubMed. Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus niger strain NZYM-DB, 2021. pmc.ncbi.nlm.nih.gov
- 4PubMed. Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Ogataea polymorpha strain DP-Jzk33, 2020. pmc.ncbi.nlm.nih.gov
- 5PubMed. Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS), 2019. pmc.ncbi.nlm.nih.gov
- 6FDA. Agency Response Letter GRAS Notice No. GRN 000631 – Triacylglycerol Lipase from Trichoderma reesei (AB Enzymes), 2018. fda.gov