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Consumer Product Safety

2301 Midland Avenue


Toronto ON, M1P 4R7
March 2015
Re: Requirements for Selling Cosmetic Products in Canada

A 'cosmetic' includes any substance, or mixture of substances manufactured, sold or represented for use in cleansing,
improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfume. In Canada, cosmetics
are regulated under the Food and Drugs Act and the Cosmetic Regulations. The Food and Drugs Act and Cosmetic
Regulations can be viewed at the following links, respectively:
Food and Drugs Act http://laws-lois.justice.gc.ca/eng/acts/F-27/
Cosmetic Regulations http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/
It is important for you to determine if your products are cosmetics, natural health products or drugs. The classification
is dependant on the ingredients used, the intended purpose of the product, and the claims made about the product.
Some topical preparations are regulated as drugs if they have a therapeutic effect on the body, such as preventing or
controlling disease, healing or treating a condition or symptoms of that condition. A drug product must apply for and
receive a Drug Identification Number (DIN), or depending on the ingredients, a Natural Health Product Number (NPN)
prior to sale.
This letter is intended to provide information on cosmetic products. General information on the requirements to
manufacture, import, advertise or sell cosmetics in Canada is outlined below. These requirements apply to cosmetics
that are purchased by consumers directly, or those that are sold or used on clients as part of a service in a salon. Please
read and ensure that you understand these requirements.

General Guidelines
The Health Canada cosmetics homepage can be found at:
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/index-eng.php.
Overview
In order to legally import/sell cosmetics in Canada you must ensure the following:
1. All ingredients in your cosmetics are not prohibited (i.e. not on the "Hotlist" of ingredients) or meet the
requirements of any restrictions outlined on the hotlist;
2. Ingredients are listed on the package as per the INCI (International Nomenclature of Cosmetic Ingredients)
format;
3. The cosmetics you manufacture or import must be Notified with Health Canada within ten days of first sale;
4. The labelling does not have therapeutic claims and is fully compliant with the Cosmetic Regulations.
Notification
This is a mandatory requirement under the Cosmetic Regulations that involves the completion of a notification form
for each cosmetic product sold in the Canada. The form(s) must be submitted online to the Cosmetics Division at
Health Canada within ten days from the first day of sale of the product in Canada. It is illegal to sell a cosmetic that is
not notified. Please note that notifying a cosmetic is not a product evaluation or approval procedure and acceptance of
the completed form by Health Canada does not constitute, in any way, agreement that the product is in compliance
with all regulatory requirements. The cosmetic notification form, as well as the guide to completing the form can be
found at the following weblink:
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/index-eng.php
**There are no fees associated with the notification process.

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If after reading the Guide for Completing Notification Forms, you still have questions on how to complete the form,
you can contact the Cosmetics Program at cosmetics@hc-sc.gc.ca, or your regional office at 1-866-662-0666 (toll free)
or by e-mail at tor.prodsafe@hc-sc.gc.ca.
Hotlist
The Hotlist is a list of ingredients that are restricted or prohibited for use in cosmetic products in Canada. The
"Hotlist" can be found at: http://www.hc-sc.gc.ca/cps-spc/cosmet-person/hot-list-critique/index-eng.php You should
compare your list of ingredients in your product with those listed on the hotlist. If there are restrictions placed on your
ingredient, you must follow the directions listed on the hotlist for that ingredient. If your ingredient is found on the
Hotlist with no instructions next to it, it is prohibited and is not permitted for use in your cosmetic and must be
removed from the formulation.
Labelling Requirements
The following is a link to the guidelines for labelling cosmetics: http://hc-sc.gc.ca/cps-spc/pubs/indust/cosmeticscosmetiques/index-eng.php. In addition, you may want to contact Industry Canada at 1-800-328-6189, to determine
the labelling requirements under the Consumer Packaging and Labelling Act & Regulations for your product.
***Note that under the Cosmetic Regulations, there are special warning labels required for specific products, including
hair dyes and cosmetics sold in pressurized containers.
Ingredient Listing
The Cosmetic Regulations require that all cosmetic products sold in Canada list the ingredients in descending order of
concentration on the label using the International Nomenclature for Cosmetic Ingredients (INCI) labelling system.
Please refer to the Cosmetic Regulations for the listing requirements of certain ingredients, such as botanicals and
ingredients included in the Schedule to the Cosmetic Regulations. Information on the listing of ingredients can be
found at the following link: http://www.hc-sc.gc.ca/cps-spc/pubs/indust/labelling_guide-etiquetage/index-eng.php.
Therapeutic Claims
Therapeutic claims related to diagnosing, treating, or curing a disease are not permitted for cosmetic products. Products
making therapeutic claims would be classified as drugs or natural health products under the Food and Drugs Act. If
your product falls under one of these categories please contact the following:
For drugs, the Therapeutic Products Directorate, 1-800-267-9675, http://www.hc-sc.gc.ca/dhp-mps/index-eng.php
For natural health products, the Natural Health Products Directorate http://www.hc-sc.gc.ca/dhp-mps/prodnatur/indexeng.php
While Health Canada does not endorse this document, to get an idea of what may be considered an acceptable versus
unacceptable cosmetic claim, you can view the following document Guidelines for the Nonprescription and Cosmetic
Industry Regarding Non-therapeutic Advertising and Labelling Claims:
http://www.adstandards.com/en/clearance/cosmetics/guidelinesforcosmeticadvertising.aspx
Sections 16 and 18 of the Food and Drugs Act
Section 16 and 18 of the Food and Drugs Act outline the conditions of sale and manufacture for a cosmetic product. It
is the responsibility of the manufacturer and importer to ensure that the cosmetic products they sell are safe and do not
cause harm when used as intended and that they are free of foreign matter and microbial contamination. Therefore, a
manufacturer or importer may consider including directions for safe use on the product label (e.g. frequency of use,
patch test requirements, cautionary statements - in addition to those required by the Regulations or Hotlist, etc.). An
importer or distributor may also consider requesting proof from the manufacturer that the product was manufactured
and stored under sanitary conditions (e.g. manufacturing procedures, formulas, batch records, quality control test data
and microbiological test reports). Under section 18 of the Act, manufacturers are required to ensure that they
manufacture, prepare, preserve, package and store cosmetic products under sanitary conditions. Therefore, it is
strongly encouraged that manufacturers follow general Good Manufacturing Practices (GMPs) and operate a quality
control system for their products. GMP information can be found at: http://www.hc-sc.gc.ca/cps-spc/cosmetperson/regulations-reglements/gmp_cosmet-bpf-eng.php

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Sections 16 and 18 of the Food and Drugs Act state:


16. No person shall sell any cosmetic that
(a) has in or on it any substance that may cause injury to the health of the user when the cosmetic is used,
(i) according to the directions on the label or accompanying the cosmetic, or
(ii) for such purposes and by such methods of use as are customary or usual therefor;
(b) consists in whole or in part of any filthy or decomposed substance or of any foreign matter; or
(c) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions. R.S., c. F-27, s.
18. No person shall manufacture, prepare, preserve, package or store for sale any cosmetic under unsanitary
conditions.
Applicable Regulations from Other Government Departments
Departments other than Health Canada may have requirements for your product, depending on tits function or
composition.
Consumer Packaging and Labelling Act & Regulations - Industry Canada
http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/01248.html
Canadian Environmental Protection Act (CEPA)
For additional information see: http://www.chemicalsubstanceschimiques.gc.ca/index-eng.php
Volatile Organic compounds
For information on Volatile Organic Compounds (VOCs) in consumer products, please refer to the following link:
http://www.ec.gc.ca/cov-voc/Default.asp?lang=En&n=BEE9D2C5-1

To receive updates on Health Canada's work regarding cosmetics and personal care products, you can subscribe for
free at: http://www.hc-sc.gc.ca/cps-spc/cosmet-person/subscribe-abonnement/index-eng.php
To see a list of cosmetic products that have been recalled or are subject to a public advisory, please refer to the
following link: http://hc-sc.gc.ca/cps-spc/advisories-avis/cosmet/index-eng.php
If you have several cosmetic products for which you are seeking guidance on meeting the requirements for sale in
Canada, it is suggested that you speak with a Consultant.
If you have any specific questions regarding this letter or require further assistance with the process, please contact
your local product safety office.

Health Canada
Consumer Product Safety - Ontario Region
Telephone: 416-973-1748 or 1-866-662-0666
Email: tor.prodsafe@hc-sc.gc.ca

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