About
Cellulase (EC 3.2.1.4) is a microbially derived food-processing enzyme that catalyzes the hydrolysis of 1,4-β-glycosidic linkages in cellulose, hemicellulose, lichenin, and cereal β-D-glucans, generating shorter β-D-glucan chains and oligosaccharides. It is widely used in baking, brewing, fruit and vegetable juice production, starch processing, wine production, and distilled alcohol production to improve yield, texture, and fermentation efficiency.
Safety summary
Multiple FDA GRAS acceptances and numerous EFSA strain-specific safety opinions have found no evidence of genotoxic, systemic-toxicological, or oral-allergenic concern at intended food use levels; NOAEL values range from 939 to 1314 mg TOS/kg bw/day, yielding wide margins of exposure against estimated dietary exposures of ≤4 mg TOS/kg bw/day. JECFA has assigned an ADI of 'not specified' for cellulase/beta-glucanase preparations used in food applications such as juice, beer, and baking. Occupational respiratory allergy following repeated inhalation of the dry enzyme powder has been reported in workers, though oral dietary exposure in finished foods poses negligible allergenic risk.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSSAI (Food Safety and Standards Authority of India) (India) | Restricted | FSS (Food Products Standards and Food Additives) Regulations, 2011 permit 'amylases and other enzymes' at GMP levels in specified food categories (e.g., baked goods). Cellulase is not individually specified in FSSAI schedules; use as a processing aid in categories beyond those explicitly covered requires prior FSSAI approval under FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017.source |
| FDA (Food and Drug Administration) (United States) | Approved | Multiple GRAS notices accepted with 'No Questions' including GRN 195, 292, 479, 584, 891, 1030, and 1276, covering cellulase from Trichoderma reesei, Aspergillus niger, and Penicillium funiculosum strains in brewing, baking, starch/grain processing, fruit and vegetable juice production, and potable alcohol production at use levels up to 166 mg TOS/kg raw material.source |
| EFSA (European Food Safety Authority) (European Union) | Under_review | Food enzymes require per-strain authorization under Regulation (EC) No 1332/2008 and must appear on the EU community list before use. EFSA has evaluated multiple cellulase preparations (T. reesei strains AR-256, AR-852, AR-999, DP-Nzc36; A. niger strains 294, NZYM-EN, HBI-AC01; P. funiculosum strain DP-Lzc35) and concluded no safety concerns under intended conditions of use. The EU community-list authorization process remains ongoing as of 2026, with new assessments still being published.source |
Who should approach with care
Research citations
- 1FDA. Agency Response Letter GRAS Notice No. GRN 001276 — Cellulase enzyme preparation from Trichoderma reesei expressing Aspergillus niger gene (AB Enzymes), 2026. fda.gov
- 2EFSA. Safety evaluation of the food enzyme cellulase from the genetically modified Aspergillus niger strain NZYM-EN, 2025. efsa.europa.eu
- 3EFSA. Safety evaluation of the food enzyme cellulase from the non-genetically modified Aspergillus niger strain 294, 2023. efsa.europa.eu
- 4FDA. Agency Response Letter GRAS Notice No. GRN 001030 — Cellulase enzyme preparation produced by Aspergillus niger (Novozymes), 2022. fda.gov
- 5PubMed. Safety evaluation of the food enzyme cellulase from Trichoderma reesei (strain DP-Nzc36), 2019. pmc.ncbi.nlm.nih.gov
- 6FDA. Agency Response Letter GRAS Notice No. GRN 000584 — Cellulase enzyme preparation from Penicillium funiculosum (DuPont/Danisco), 2015. cacmap.fda.gov