List of Substances

Introduction

The List of Substances (The List) includes substances that have been evaluated as admissible or non-admissible. Admissible substances are substances determined to represent a low risk when used appropriately and according to certain conditions such as route of administration, quantity or duration of use, and in doses at generally accepted safe and effective levels that are supported by available literature. Health Canada considers it unlikely that a product containing only admissible substances and that satisfies all other applicable requirements could present a significant risk to the health of humans or animals. Substances that have been altered through biotechnology and/or intended for use in food producing animals (such as beef cattle, swine and poultry) have not been considered and are excluded from the List of Substances. However, a limited group of substances for dairy cattle are now included, as they present minimal risk to animals and food safety and are important tools to maintain animal health and welfare.

Types of substances listed

Active substances (active)

These are substances that contribute to the intended benefit of the product, the general health claim, but exclude homeopathic and Traditional Chinese Medicines as they are considered separately (see below).

Inactive (Non medicinal substances, excipients) (NMI)

These are substances added to a product formulation to confer suitability or form to the active ingredients. They can include, but are not limited to, binders, lubricants, preservatives, antioxidants, carriers, colouring agents, fragrances and flavours.

They are to be used at a level not in excess of the amount required to accomplish the intended effect.

Homeopathic preparations (HOMEO)

Homeopathic preparations must be prepared according to the Homeopathic Pharmacopoeia of the United States (HPUS), the Homöopathische Arzneibuch (HAB), the Pharmacopée française (PhF), the European Pharmacopoeia (Ph.Eur), or the Encyclopedia of Homeopathic Pharmacopoeia (EHP) and administered at the minimum potency indicated on the List or higher.

Products that are prepared with acceptable homeopathic ingredients will be ineligible for Notification when they are combined with other types of ingredients, such as vitamins or western herbs, which are not established within the same healing paradigm.

Traditional Chinese Medicines (TCM)

Traditional Chinese Medicine ingredients must be prepared and used according to Traditional Chinese Medicine in order to be admissible.

Products containing acceptable Traditional Chinese Medicine (TCM) ingredients will be ineligible for Notification when they are combined with other types of ingredients, such as vitamins or western herbs, which are not established within the same healing paradigm.

Non-admissible substances (NON)

Substances determined to present an unacceptable health risk and/or requiring a higher level of oversight when administered to animals. Substances on this list may have the potential risk of causing irreversible damage, potentially lethal, toxicity to major organs, carcinogenic activity, teratogenic activity, abortifacient activity, a narrow margin of safety, the likelihood of contamination, adulteration, and/or substitution.

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