Natural Health Products Ingredients Database
WHAT'S NEW
What's New is a listing of modifications to the NHPID since the
last update. This page was most recently revised on September 11, 2012.
ANNOUNCEMENTS
The updates to the NHPID listed below apply to the most recent versions of the ePLA (electronic Product Licence Application). All new electronic submissions of a Product Licence Application must use the latest versions of the e-PLA, namely versions 1.4.4 and 2.0.1. Version 1.4.4, known as the Cfgm ePLA, is dedicated to applications of type Compendial from generated monographs (Cfgm), which are used when attesting to a generated single ingredient monograph. Version 2.0.1 is for all application types except for Compendial from generated monographs. The forms are available for downloading from http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/guidance-reference-eng.php.
New Ingredients
In this update, the following non-homeopathic ingredients were added.
NHPID Name:
Rhizoma Anemones altaicae
Role:
Medicinal
NHPID Name:
Elasmobranchii cartilage
Role:
Medicinal
NHPID Name:
Disodium Cocoyl Glutamate
Role:
Non-medicinal
NHPID Name:
Chondrodendron tomentosum
Role:
Medicinal
NHPID Name:
Fruit Juice (NMI)
Role:
Non-medicinal
NHPID Name:
L-Arabinose
Role:
Medicinal
Removed Ingredients
In this update, the following non-homeopathic ingredients were removed.
No Changes.
Revised NHPID Names
In this update, the following non-homeopathic ingredients had their NHPID name revised.
Old NHPID Name:
Thyme Oil
New NHPID Name:
Thyme Essential Oil
Revised Proper and Common Names
In this update, the following non-homeopathic ingredients had their common or proper names revised.
NHPID Name:
Thyme Essential Oil
Removed Common Name(s):
Oils, thyme; Red thyme oil; Thyme Oil; thyme oil,white; thyme oil red; White thyme oil
NHPID Name:
Thyme Essential Oil
New Common Name(s):
Thyme Essential Oil; White Thyme Essential Oil
NHPID Name:
Coffea arabica
New Common Name(s):
Green coffee
New Roles
In this update, the roles of the following non-homeopathic ingredients were changed.
NHPID Name:
Pogostemon Cablin Oil
Old Role:
Non-medicinal
New Role:
Medicinal and Non-medicinal
Revised Restrictions
In this update, the following non-homeopathic ingredients underwent a modification related to their restrictions.
NHPID Name:
Thyme Essential Oil
Non-medicinal Restriction(s) removed:
Based on safety concerns, thyme essential oil intake of up to 4.16 micrograms per kg body weight per day is allowed. Applicants must provide evidence to support the safe use of the carvacrol content of thyme essential oil, if they would like to use a higher quantity as a non-medicinal ingredient (NMI) in their product. If the daily exposure of carvacrol exceeds 0.23 micrograms per kg bw per day from the NHP in the absence of adequate safety evidence, thyme oil cannot be considered to be a NMI.
Other Ingredient Modifications
In this update, the following non-homeopathic ingredients underwent a modification different from those listed above, such as new source material, new preparation type, or new sub-ingredient relationship, etc.
NHPID Name:
Citrus Aurantium Amara (Bitter Orange) Peel
New Additional Details added :
Flavour ingredient only. No risk information is required for products providing less than or equal to 5 mg synephrine plus octopamine in a daily dose. Risk information is required for those products providing 3-50 mg synephrine plus octopamine in a total daily dose. Authorized products providing 40 mg/day or less of p-synephrine plus 320 mg/day or less of caffeine are considered safe provided that appropriate risk statements are available on the product labels.
NHPID Name:
Plasma fibronectin
Non-NHP Rationale changed:
A non-nhp because listed in Schedule D of the Food and Drug Regulations as follows: Blood and Blood derivatives. Fibronectin, which is a blood plasma derivative, will be considered as biologics and products containing such substances will be evaluated by BGTD.
NHPID Name:
Dried Yeast
Source Material(s) removed:
Saccharomyces cerevisiae (Part: Whole Cell)
NHPID Name:
Dried Yeast
New Source Material(s) added:
Saccharomyces cerevisiae (Part: Whole)
NHPID Name:
Huile de Pogostemon Cablin
Medicinal Rationale changed:
Classified as an NHP under Schedule 1 item 2 (extract) of the NHP Regulations.
NHPID Name:
Yeast Extract
Source Ingredient(s) removed:
Saccharomyces cerevisiae (Part: Whole Cell)
NHPID Name:
Yeast Extract
New Source Ingredient(s) added:
Saccharomyces cerevisiae (Part: Whole)
NHPID Name:
Fruit Juice (NMI)
New Toxicity restriction added:
The quantity of this substance must be stated in the ePLA. A cover letter listing all the components, including their Latin binomials, will need to be submitted with the Product License Application Form. Each component of this ingredient has to be food safe.
NHPID Name:
Vegetable Juice (NMI)
New Toxicity restriction added:
The quantity of this substance must be stated in the ePLA. A cover letter listing all the components, including their Latin binomials, will need to be submitted with the Product License Application Form. Each component of this ingredient has to be food safe.
NHPID Name:
Fruit Blend (NMI)
New NMI Purpose(s):
Colour Additive
NHPID Name:
Fruit Blend (NMI)
Toxicity Restriction changed:
The quantity of the blend must be stated in the ePLA. A cover letter listing all the components, including their Latin binomials, will need to be submitted with the Product License Application Form. Each component of this ingredient has to be food safe.
NHPID Name:
Fruits and Vegetables Blend (NMI)
New NMI Purpose(s):
Colour Additive
NHPID Name:
Vinpocetine
Medicinal Rationale changed:
Classified as a derivative of an NHP under Schedule 1, Item 2 (an isolate) of the Natural Health Products Regulations.
NHPID Name:
Thyme Essential Oil
Method(s) of Preparation removed:
Oil, Essential (enfleurage); Oil, Essential (enfleurage) Standardised; Oil, Essential (expression); Oil, Essential (expression) Standardised; Oil, Essential (other methods of preparation); Oil, Essential (other methods of preparation) Standardised; Oil, Essential (water steam distillation); Oil, Essential (water steam distillation) Standardised
NHPID Name:
Thyme Essential Oil
New Method(s) of Preparation added:
Oil, Essential (water steam distillation); Oil, Essential (water steam distillation) Standardised
Monograph Modifications
In this update, the following single ingredient or product monographs were added or modified.
No Changes.
AbLS Modifications
In this update, the following abbreviated labelling standards were added or modified.
No Changes.
Controlled Vocabulary Modifications
In this update, the following controlled vocabulary (dosage forms, methods of preparation, quality test methods, etc) were added or modified.
No Changes.
Homeopathic Ingredient Modifications
In this update, the following homeopathic ingredients were added or modified.
No Changes.
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