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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.



April 29, 2019

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s)
  • Triacylglycerol acylhydrolase
  • Triacylglycerol lipase


  • Aspergillus flavus var. oryzae
  • Aspergillus niger
  • Rhizopus oryzae


References: Proper name: IUBMB 1961; Common name: IUBMB 1961; Source materials: CABI 2012, FCC 8 2012, Bisby et al. 2010.

Route of Administration


Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Digestive enzyme



Adults 18 years and older


Not to exceed 110,000 FCC LU of enzymatic activity, per day; and 30,000 FCC LU per single dose (FCC 8 2012; Glade et al. 2001).


Direction(s) for use

All products

Take with food/meal.

Enteric-coated products

Swallow whole/Do not crush or chew (CPS 2008).

Duration(s) of Use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use.

Risk Information

Caution(s) and warning(s)

Consult a health care practitioner/health care provider /health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.


No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (Martindale 2011).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.


References Cited

References Reviewed