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Drugs and Health Products

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 August 29, 2017.

ANNOUNCEMENTS

The updates to the NHPID listed below apply to the most recent version of the ePLA (electronic Product Licence Application). All new electronic submissions of a Product Licence Application must use the latest version of the e-PLA, namely version 2.3.1, which is available for downloading from e-PLA 2.3.1


New Ingredients

In this update, the following non-homeopathic ingredients were added.

NHPID Name:
Plant Ash

Role:
Non-medicinal


NHPID Name:
Silica Cetyl Silylate

Role:
Non-medicinal


NHPID Name:
Dimethyl Lauramide/Myristamide

Role:
Non-medicinal


NHPID Name:
Magnesium Carboxymethyl Beta-Glucan

Role:
Non-medicinal


NHPID Name:
Laureth-1 Phosphate

Role:
Non-medicinal


NHPID Name:
alpha-galactooligosaccharides

Role:
Medicinal


NHPID Name:
Tart cherry fruit powder

Role:
Non-medicinal


NHPID Name:
Orchid Leaf/Root/Stem Extract

Role:
Non-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:
Helianthus Annuus (Sunflower) Seedcake

New NHPID Name:
Helianthus Annuus (Sunflower) Seedcake


Revised Proper and Common Names

In this update, the following non-homeopathic ingredients had their common or proper names revised.

NHPID Name:
Undecenoic acid

New Common Name(s):
Undecenoic acid


NHPID Name:
D&C Violet No. 2

New Common Name(s):
Solvent violet 13


NHPID Name:
Dimethyl adipate

Removed Proper Name(s):
Dimethyl hexanedioate


NHPID Name:
Dimethyl adipate

New Proper Name(s):
Hexanedioic acid, dimethyl ester


NHPID Name:
Glyceryl tribenzoate

New Common Name(s):
Tribenzoin


New Roles

In this update, the roles of the following non-homeopathic ingredients were changed.

NHPID Name:
Serum albumin

Old Role:
Medicinal

New Role:
Non-NHP


NHPID Name:
Isosafrole

Old Role:
Medicinal & Non-medicinal

New Role:
Medicinal


NHPID Name:
Safrole

Old Role:
Medicinal & Non-medicinal

New Role:
Medicinal


Revised Restrictions

In this update, the following non-homeopathic ingredients underwent a modification related to their restrictions.

NHPID Name:
Phthalic Anhydride/Trimellitic Anhydride/Glycols Copolymer

New Restriction Reference added:
CIR


NHPID Name:
Phthalic Anhydride/Trimellitic Anhydride/Glycols Copolymer

Route(s) of Adminstration removed:
Topical


NHPID Name:
PVM/MA copolymer

New Restriction Reference added:
CIR


NHPID Name:
Undecenoic acid

New Non-medicinal Restriction(s) added:
For topical use only for the purposes cosmetic biocide, emulsifying agent, fragrance ingredient, and surfactant - cleansing agent.


NHPID Name:
alpha-Linolenic acid

New Non-medicinal Restriction(s) added:
For topical use only.


NHPID Name:
Azadirachta indica leaf extract

Medicinal Restriction(s) Changed :
For topical use only, on intact skin, up to 1%.


NHPID Name:
Melia azadirachta Extract

Medicinal Restriction(s) Changed :
For topical use only, on intact skin, up to 1%.


NHPID Name:
Melia Azadirachta Flower Extract

Medicinal Restriction(s) Changed :
For topical use only, on intact skin, up to 1%.


NHPID Name:
Melia azadirachta seed extract

Medicinal Restriction(s) Changed :
For topical use only, on intact skin, up to 1%.


NHPID Name:
Melia Azadirachta Seed Oil

Medicinal Restriction(s) Changed :
For topical use only, on intact skin, up to 1%.


NHPID Name:
Tall oil acid

Medicinal Restriction(s) Changed :
For topical use only, up to 8%.


NHPID Name:
Evening Primrose Oil

New Route(s) of Adminstration added:
Topical


NHPID Name:
Evening Primrose Oil

Medicinal Restriction(s) Changed :
Evening Primrose Oil is not an acceptable non-medicinal ingredient "for the maintenance of good health" claims while Evening Primrose Oil contributes to the claim. Evening Primrose Oil is acceptable as a non-medicinal ingredient at levels less than 1300 mg/day for NMI purposes which does not contribute to the claim. Additional information may be requested by NNHPD during assessment of such submissions.


NHPID Name:
Diisodecyl adipate

Medicinal Restriction(s) Changed :
For topical use only.


NHPID Name:
Dimethyl adipate

New Medicinal Restriction(s) added :
For topical use only, up to 0.2% in rinse-off products.


NHPID Name:
Tridecyl trimellitate

New Medicinal Restriction(s) added :
For topical use only.


NHPID Name:
Sassafras Officinale Root Oil

New Route(s) of Adminstration added:
Topical


NHPID Name:
Isobutane

New Non-medicinal Restriction(s) added:
Maximum of 0.1% w/w of 1,3-butadiene impurities.


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:
Phthalic Anhydride/Trimellitic Anhydride/Glycols Copolymer

New CAS Registry Number(s) added:
186688-25-5


NHPID Name:
PVM/MA copolymer

New Toxicity restriction added:
Up to 13% in buccal, dental, and topical products.


NHPID Name:
Source Material - Bos taurus - Colostrum

New Sub-ingredient(s) added:
Immunoglobulins


NHPID Name:
Source Material - Bos taurus - Colostrum

New Sub-ingredient(s) added:
Lactoferrin


NHPID Name:
Vitamin K1

New Source Material(s) added:
Brassica oleracea var. viridis ( Parts: Leaf )


NHPID Name:
Vitamin K1

New Source Material(s) added:
Spinacia oleracea ( Parts: Leaf )


NHPID Name:
Vitamin A

New Source Material(s) added:
Brassica oleracea var. viridis ( Parts: Leaf )


NHPID Name:
Vitamin A

New Source Material(s) added:
Daucus carota


NHPID Name:
Ethylhexyl Cocoate

New CAS Registry Number(s) added:
92044-87-6


NHPID Name:
Dioctyl Adipate

Additional Details changed:
The presence of this ingredient on the List of Prohibited and Restricted Cosmetic Ingredients (the Cosmetic Ingredient Hotlist) indicates that there are potential safety issues. This ingredient must be used in accordance with the restrictions set out on the Hotlist when included in topical natural health products, unless additional evidence for safety is submitted. Reference: http://www.hc-sc.gc.ca/cps-spc/cosmet-person/hot-list-critique/hotlist-liste-eng.php.


NHPID Name:
Safrole

Additional Details changed:
The presence of this ingredient without conditions on the List of Prohibited and Restricted Cosmetic Ingredients (the Cosmetic Ingredient Hotlist) indicates that there are potential safety issues. This ingredient cannot be used in topical natural health products without the submission of additional evidence for safety. Reference: http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-critique/prohibited-eng.php.


NHPID Name:
Sassafras Officinale Root Oil

Method(s) of Preparation removed:
Oil fixed


NHPID Name:
Sassafras Officinale Root Oil

New Method(s) of Preparation added:
Oil, Essential (water steam distillation)


NHPID Name:
Acetic anhydride

Non-NHP Rationale changed:
A non-NHP because not a naturally occurring substance included in Schedule 1 of the Natural Health Products Regulations. It should be noted that this ingredient is subject to additional regulatory requirements in accordance with the Precursor Control Regulations since it is listed on Schedule VI Part 1 of the Controlled Drugs and Substances Act.


NHPID Name:
Butane

Additional Details changed:
The presence of this ingredient on the List of Prohibited and Restricted Cosmetic Ingredients (the Cosmetic Ingredient Hotlist) indicates that there are potential safety issues. This ingredient must be used in accordance with the restrictions set out on the Hotlist when included in topical natural health products, unless additional evidence for safety is submitted. Reference: http://www.hc-sc.gc.ca/cps-spc/cosmet-person/hot-list-critique/hotlist-liste-eng.php.


NHPID Name:
Isobutane

Additional Details changed:
The presence of this ingredient on the List of Prohibited and Restricted Cosmetic Ingredients (the Cosmetic Ingredient Hotlist) indicates that there are potential safety issues. This ingredient must be used in accordance with the restrictions set out on the Hotlist when included in topical natural health products, unless additional evidence for safety is submitted. Reference: http://www.hc-sc.gc.ca/cps-spc/cosmet-person/hot-list-critique/hotlist-liste-eng.php.


NHPID Name:
Isobutane

Toxicity Restriction removed:
Maximum of 0.1% w/w of 1,3-butadiene impurities.


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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