DigeZyme (Multienzyme Complex)

About

What it is and where it shows up.

DigeZyme® is a proprietary multienzyme complex (MEC) comprising five digestive enzymes — α-amylase, protease, cellulase, lactase, and lipase — sourced from microbial/fungal origins and manufactured by Sami Labs Limited (India). It is used as a dietary supplement ingredient to aid the breakdown of carbohydrates, proteins, cellulosic fibers, lactose, and fats, and to support digestive health.

Safety summary

The regulatory and scientific consensus.

DigeZyme® has self-affirmed GRAS status in the United States and has been evaluated in randomized, double-blind, placebo-controlled clinical trials with no significant adverse events reported at typical supplemental doses (e.g., 50 mg three times daily for 60 days). No IARC classification applies to digestive enzyme blends of this type, and no formal ADI has been established. Individuals with allergies to fungal or microbial enzyme sources should exercise caution, as allergic reactions to enzyme preparations cannot be fully excluded.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	DigeZyme® is manufactured by Sami Labs Limited in Bangalore, India. Digestive enzyme preparations are permitted as food/dietary supplement ingredients under FSSAI regulations. No specific FSSAI regulation unique to the DigeZyme® proprietary blend was identified; status inferred from manufacturer's market presence and permissibility of constituent enzymes.source
FDA (Food and Drug Administration) (United States)	Approved	DigeZyme® holds self-affirmed GRAS status in the US as a dietary supplement ingredient. Individual component enzymes (amylase, protease, lipase, cellulase, lactase) are listed or recognized under FDA's GRAS enzyme preparations framework (21 CFR Part 184). No maximum daily intake has been formally established by FDA for this proprietary blend.source
EFSA (European Food Safety Authority) (European Union)	Under_review	Under Regulation (EC) No 1332/2008, which entered into force on 20 January 2009, all food enzymes on the EU market — including multi-enzyme blends like DigeZyme® — must undergo centralized safety evaluation by EFSA and approval by the European Commission before being placed on the EU Union List. DigeZyme® as a proprietary trade blend has no specific published EFSA opinion; its individual enzyme components (amylase, protease, lipase, cellulase, lactase from microbial sources) are subject to EFSA's ongoing food enzyme assessment programme.source

Who should approach with care

Whose guidance would steer them away.

Nut Allergy — Fungal- and microbial-derived enzyme preparations can trigger allergic reactions in individuals sensitised to mould or fungal proteins; EFSA's food enzyme safety framework explicitly notes that allergic risk from such preparations cannot be fully excluded.

Ibs — While digestive enzyme supplementation may alleviate some IBS-related symptoms, individual responses vary and clinical evidence specific to DigeZyme® in IBS populations is limited; medical guidance is recommended before use.

Ibd — Patients with inflammatory bowel disease have altered GI physiology, and the safety and appropriateness of exogenous multienzyme supplementation has not been formally evaluated in this population.

Infants — DigeZyme® is formulated and studied as an adult dietary supplement; its safety in infants has not been established, and exogenous enzyme supplementation in infants requires specific clinical and regulatory evaluation.

Lactose Intolerance — Although DigeZyme® contains lactase to aid lactose digestion, individuals with severe lactose intolerance should confirm the product formulation contains no lactose-based excipients and should consult a healthcare provider before use.

Research citations

The sources behind this verdict.

1FDA. Enzyme Preparations Used in Food (Partial List) — FDA GRAS Enzyme Compilation. fda.gov
2EFSA. Food enzyme application procedure — EFSA. efsa.europa.eu
3PubMed. In vitro simulated study of macronutrient digestion in complex food using digestive enzyme supplement, 2024. pmc.ncbi.nlm.nih.gov
4PubMed. Novel foods, food enzymes, and food additives derived from food by-products of plant or animal origin: principles and overview of the EFSA safety assessment, 2024. pmc.ncbi.nlm.nih.gov
5PubMed. Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study, 2018. pmc.ncbi.nlm.nih.gov

Independently researched5 citations