In September 2011, NHPD published 12 AbLS for enzyme ingredients outlining the minimum documentation requirements and specifications for products containing these enzymes. Since posting the new AbLS, NHPD has been consulting with stakeholders regarding the requirements for products containing enzymes.

As a result of these consultations, NHPD has revised the 12 AbLS for enzymes and developed a new Multi-Ingredient Enzyme AbLS.

This consultation is open for comment starting April 16, 2012 until May 15, 2012 and comments may be submitted via email, fax or by mail to:

Email: nhpd_consultations_dpsn@hc-sc.gc.ca 

Proposed Revised and New Enzyme Abbreviated Labelling Standards

As always, companies can choose to comply with the AbLS or apply outside the scope of these documents by providing additional evidence to support the safety and efficacy of their products.

Revised Enzyme AbLS

NHPD is publishing for consultation 12 proposed revised AbLS for amylase, alpha-galactosidase, fruit and stem bromelain, cellulose, chymotrypsin, lactase, lipase, pancreatic enzymes, papain, fungal proteases, and trypsin.

The duration of use, unless otherwise stated, has been revised from “Consult a health care practitioner for use beyond three days” to “For long term use consult a health care practitioner”.

The AbLS also have a new general claim “Digestive enzyme”

New Multi-Ingredient Enzyme AbLS

A proposed new Multi-Ingredient Enzyme AbLS which includes pre-cleared information for 25 additional enzyme ingredients.

Medicinal Ingredients

Glucanase, 1,4-Glucanase, Glucoamylase, Amyloglucosidase, Acid maltase, Hemicellulase, Invertase, Sucrase, Malt diastase, Diastase, Maltase, Pectinase, Xylanase, 1,3-xylanase, 1,4-xylanase, Bacterial protease, Neutral protease, Pepsin, Pepsine, Catalase, Phytase, 1-Phytase, 3-Phytase, 4-Phytase, and 6-Phytase.

The complete set of AbLS documents may be downloaded here: Enzyme AbLS pdfs (English)