Health Canada Publishes New Enzyme Monographs and Consultation Period

The Natural Health Products Directorate (NHPD) will be seeking your feedback on proposed revisions to the enzyme abbreviated labelling standards (AbLS).

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. These will be published for a 30-day consultation period. Consultation starts from the time the documents are officially posted on the Health Canada website.

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

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

Next steps

All comments received during the consultation period will be considered prior to finalizing the pre-cleared information.

Once finalized, the pre-cleared information will be made available on the Natural Health Products section of the Health Canada website, and NHPD will work with stakeholders to ensure a smooth transition for their products if required. To ensure minimal market disruption, companies would have a one-year transition period to make changes to their products where required.

How to Get Involved

This consultation will be open for comment for a 30 day period from the time the documents are officially posted on the Health Canada website. Stakeholders will be notified once the consultation period begins.

Enzyme AbLS pdfs (English)

2012-04-09T18:14:07-07:00