Digestive Enzymes

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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.

Notes

Date

June 3, 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)

Group 1: Carbohydrases

1,3-(1-3,1-4)-beta-D-glucan 3(4)-glucanohydrolase

  • beta-1,3-glucanase
  • beta-Glucanase
  • Aspergillus niger
  • Trichoderma longibrachiatum
  • Trichoderma reesei

Whole

  • 1,4-alpha-D-Glucan glucohydrolase
  • 4-alpha-D-Glucan glucohydrolase
  • Acid maltase
  • Amyloglucosidase
  • Glucoamylase
  • Aspergillus niger
  • Aspergillus oryzae
  • Rhizopus niveus
  • Rhizopus oryzae

Whole

  • 1,3-beta-D-xylan xylanohydrolase
  • 1,4-beta-D-mannan mannanohydrolase
  • 1,5-alpha-L-arabinan arabinanohydrolase
  • alpha-L-arabinofuranoside arabinofuranohydrolase

Hemicellulase

  • Aspergillus niger
  • Aspergillus oryzae
  • Trichoderma longibrachiatum
  • Trichoderma reesei

Whole

  • beta-D-fructofuranoside fructohydrolase
  • beta-Fructofuranosidase
  • Invertase
  • Sucrase
  • Aspergillus niger
  • Saccharomyces cerevisiae

Whole

4-alpha-D-Glucan glucanohydrolase

  • 1,4-alpha-D-glucan glucanohydrolase
  • alpha-Amylase
  • Diastase
  • Fungal diastase
  • Taka-Diastase (Aspergillus)
  • Aspergillus niger
  • Aspergillus oryzae

Whole

Malt diastase

  • Maltase
  • Malt diastase

Hordeum vulgare

Seed

  • (1-4)-alpha-D-galacturonan glycanohydrolase
  • Pectin pectylhydrolase
  • Poly(1,4-alpha-D-galacturonide) glycanohydrolase
  • Poly(1,4-alpha-D-galacturonide) lyase
  • Poly(methoxyl-L-galacturonide) lyase
  • Pectinase
  • Polygalacturonase
  • Aspergillus niger
  • Aspergillus oryzae
  • Trichoderma longibrachiatum
  • Trichoderma reesei

Whole

  • 1,3-beta-D-xylan xylanohydrolase
  • 1,4-beta-D-xylan xylanohydrolase
  • beta-1,3-xylanase
  • beta-1,4-xylanase
  • Xylanase
  • Trichoderma longibrachiatum
  • Trichoderma reesei

Whole

Group 2: Proteases

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

Bacterial Protease

  • Bacterial Protease
  • Neutral protease

Bacillus subtilis

Whole

  • Pepsin A
  • Pepsin B

Pepsin

Sus scrofa

Stomach

Group 3: Other enzymes

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

Hydrogen-peroxide: hydrogen-peroxide oxidoreductase

Catalase

  • Aspergillus niger
  • Saccharomyces cerevisiae

Whole

  • myo-Inositol-hexakisphosphate 3-phosphohydrolase
  • myo-Inositol-hexakisphosphate 4-phosphohydrolase
  • orthophosphoric-mono ester phosphohydrolase
  • 1-Phytase
  • 3-Phytase
  • 4-Phytase
  • 6-Phytase
  • Phytase

Aspergillus niger

Whole

References: Proper names: IUPAC-IUBMB 2012; Common names: IUPAC-IUBMB 2012; Source materials: FCC 8 2012, Justice Canada 2012, Enzyme Technical Association (no date).

Route of Administration

Oral

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(s)

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Table 2. Daily maximum of enzymatic activity unit
Medicinal ingredients Daily maximum (enzymatic activity unit/day)

Bacterial protease

Not to exceed 490,000 FCC PC

Beta-glucanase

Not to exceed 210 FCC BGU

Catalase

Not to exceed 3,200 FCC Baker

Diastase

Not to exceed 6,000 FCC DP

Glucoamylase (Amyloglucosidase)

Not to exceed 300 FCC AGU1

Hemicellulase

Not to exceed 45,000 FCC HCU

Invertase

Not to exceed 3,000 FCC INVU
or
Not to exceed 4,200 FCC SU

Malt diastase

Not to exceed 6,000 FCC DP

Pectinase

Not to exceed 180 Endo-PG

Pepsin

Not to exceed 1,900,000 FCC Pepsin

Phytase

Not to exceed 75 FCC FTU

Xylanase

Not to exceed 3,300 XU

1 For the FCC Glucoamylase Activity (Amylogucosidase Activity) assay, the Abbreviation "FCC AGU" is acceptable.

Notes
The Quantity per dosage unit must be the enzymatic activity (FCC unit). The quantity of the enzymatic preparation in mg or ml should also be included as additional quantity.

Direction(s) for use

Take with food/meal.

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)

For all medicinal ingredients and ingredient combinations

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

For products containing one or more carbohydrases

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have diabetes.

For products containing one or more proteases

Contraindication(s)

No statement required.

Known adverse reaction(s)

For all medicinal ingredients and ingredient combinations

Stop use if hypersensitivity/allergy occurs.

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 is required.

Specifications

References Cited

References Reviewed