Guidelines for Cosmetics Manufacturers, Importers and Distributors
The Food and Drugs Act and Cosmetic Regulations
The authority for the Cosmetics Program is contained in the
following legislation:
Cosmetics are subject to the provisions of the Food and
Drugs Act (FDA). The FDA also includes the Cosmetic
Regulations, which outline general safety, labelling and
notification requirements.
The Food and Drugs Act defines a “cosmetic”as:
“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 perfumes.”
This definition includes (but is not limited to) soap, grooming
products for animals, and cosmetics used by professional
esthetic services (e.g. facial masks, manicure preparations, hair
dye).This also encompasses bulk products used by institutional
services (e.g. handsoap in school restrooms).
Some products that are normally thought of as cosmetics
are not covered by the Cosmetic Regulations of the FDA.They
may need to meet the requirements of other legislation and government programs.There are four questions you can ask
to help determine if a product is a cosmetic:
- How is the product applied?
Cosmetics must normally be applied to an external part of
the body. An exception to this would be oral cosmetics (e.g.
toothpaste, mouthwash, tooth whiteners, etc.). Cosmetics
are not intentionally swallowed or inserted below the skin.
- Is the product a substance?
A substance can be defined as any distinguishable kind of
organic or inorganic matter. Only substances and mixtures
of substances are regulated as cosmetics. In contrast,
articles or equipment which contain, dispense or apply
cosmetics (e.g. hair brush, curling iron, eyeshadow brush,
tanning booth, etc.) are not regulated as cosmetics.
- What claims are being made about the product?
When a product makes a therapeutic claim (e.g. to prevent
or treat disease), it is classified as a drug under the Food
and Drugs Act and therefore requires a drug identification
number (DIN).
Drugs are managed by Health Canada’s Therapeutic
Products Directorate (TPD). Products containing
ingredients of natural origin with a therapeutic function
or claim are Natural Health Products (NHPs) under the
authority of Health Canada’s Natural Health Products
Directorate (NHPD). Each NHP must possess a Natural
Product Number (NPN).
- Does the substance contain one or more ingredients
that primarily have a therapeutic purpose?
For example, toothpastes have the cosmetic purpose
of cleaning teeth and freshening breath. However, if a
toothpaste contains ingredients to fight against cavities
and gingivitis – both therapeutic functions – it would be
considered a drug or natural health product.Therapeutic
ingredients prohibited or restricted in cosmetics are listed
on the Cosmetic Ingredient Hotlist.
IMPORTANT POINTS!
- The Health Products and Food Branch
Inspectorate (HPFBI) provides compliance and
enforcement services to both TPD and NHPD.
- Non-therapeutic products intended for ingestion are
under the direction of Health Canada’s Food Program and the Canadian Food Inspection Agency (CFIA).
- Pest repellents (e.g. insect repellent lotions) fall under urisdiction of the Pesticide Management Regulatory
Agency (PMRA).
- Animal grooming products are cosmetics, but those
which claim a therapeutic benefit for animals are
veterinary drugs and are under the management of the Veterinary Drugs Directorate of Health Canada.
- Cosmetics are currently exempt from Part II of the Hazardous Products Act (HPA): the Workplace
Hazardous Materials Information System (WHMIS).
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Product Classification:
Here are examples of how some products are classified…
Product Type |
Cosmetic, Food, Drug or NHP? |
Deodorant |
Cosmetic, because it masks the odour of
perspiration, with or without a fragrance. |
Antiperspirant |
Drug or NHP, because it suppresses the
production of perspiration. |
Face cream |
Cosmetic, because it moisturizes skin. |
Face cream with
Sun Protection
Factor (SPF) 15
|
Drug, because it protects the skin from sun
damage. |
Chewing Gum |
Food, because it is meant for oral
consumption. |
Tooth Whitening
Gum |
Cosmetic + Food, because consumption is
secondary to its cosmetic cleansing property. |
Massage Oil* |
Cosmetic, because it lubricates and maintains
the integrity of the skin
* provided no claims on its effects on muscles are
made |
Topical herbal
remedy to speed
scar healing |
NHP, because a therapeutic function has been
claimed for the natural extract used in the
product. |
Cosmetic vs. Drug
Notification of Sale
Notification is a mandatory requirement for the sale of
cosmetics in Canada, according to section 30 of the Cosmetic
Regulations. This entails submitting a fully completed Cosmetic
Notification Form (CNF) to Health Canada within the first
10 days a cosmetic is available for sale. The completed CNF
provides specific product information, including:
- address and contact of the company
- purpose of the cosmetic
- form of the cosmetic (e.g. gel, solid, liquid, etc.)
- ingredients of the cosmetic
- concentrations of the ingredients (ranges specified in the Cosmetic Regulations)
There is no fee associated with the cosmetic notification
process.
The information obtained by the Cosmetics Program is
considered to be confidential, and will be discussed only with
the company (manufacturer or distributor) that submitted it.
A product with an incomplete CNF will not be processed. It is
possible that a notifying company may need information from a
third party. If requested by the third party, this information can
be kept from the notifier.
It is also necessary for companies to inform the Cosmetics
Program whenever a change affecting the information on a CNF
is made. Some examples of this include (but are not limited to):
- modification to the cosmetic formulation
- change of product name
- discontinuation of sale
- new company name/address, etc.
Consult the Guide for Completing Cosmetic Notification
Forms for more details (see Appendix II – Suggested Reading).
Failure to notify may result in a product being refused entry
into Canada or removed from sale.
Safety
The Food and Drugs Act (FDA) and the Cosmetic Regulations (CR)
set safety requirements. No person shall sell any cosmetic in
Canada that:
- has in or on it any substance that may cause injury to the
health of the user when the cosmetic is used (section 16,
FDA)
- consists in whole or in part of any filthy or decomposed
substance or of any foreign matter (section 16, FDA)
- has been manufactured, prepared, preserved, packaged or
stored under unsanitary conditions (section 16, FDA)
- has not been notified with Health Canada (section 30, CR)
It is the company’s responsibility to ensure that a cosmetic
product is safe when used as intended. Sections 22 to 28 of the
Cosmetic Regulations detail the labelling requirements for
particular products and/or containers which require cautions,
warnings and instructions to protect the consumer. Section 7
of the publication Health Canada Guidelines: Labelling of
Cosmetics presents these in detail (see Appendix II – Suggested
Reading).
Sections 29 and 30 of the Cosmetic Regulations state that
evidence of the safety of a cosmetic product must be provided
if requested by Health Canada.As a result of the reviewed
evidence, Health Canada may advise the manufacturer or
distributor to take action.This action could range from
re-labelling to voluntary recall of the product.
When a request to submit safety evidence is made, the
information must be provided within the period of time
specified by the Cosmetics Program. Once this time has lapsed,
sale of the cosmetic in question is prohibited until the required
data has been received, evaluated, and the safety of the product
is found not to be of concern.Although not exhaustive, the
Cosmetic Program’s “Hotlist” (discussed below) provides many
of the conditions for which additional data must be submitted.
The Cosmetic Ingredient Hotlist
To help companies avoid selling products which may injure the
health of the Canadian public, Health Canada has developed the
Cosmetic Ingredient Hotlist—a list of substances which are
prohibited or restricted in cosmetics.
The Hotlist is a science-based document which is reviewed
and updated on a regular basis as new data becomes available.
It keeps the cosmetic industry aware of new substances of
concern.
Prior to manufacturing or importing a new product, persons
should review the Hotlist. If a notified cosmetic contains an
ingredient which appears on the Hotlist, the manufacturer or
distributor may be advised to do one (or more) of the
following:
- Reduce the concentration of the ingredient to an acceptable
level
- Remove the substance from the formulation
- Consider marketing the product as a drug or natural health
product (requires application for a Drug Identification
Number (DIN) or Natural Product Number (NPN))
- Provide evidence that the product is safe for its intended use
- Confirm that the product is labelled as required
- Confirm that the product is sold in a child-resistant package
- Remove the product from sale
The Hotlist is available both electronically and by mail (please
see contact information (see Appendix II – Suggested Reading).
Labelling
Labelling is regulated by the Food and Drugs Act (section 17),
the Cosmetic Regulations (sections 17 through to 28), and the
Consumer Packaging and Labelling Act (CPLA) and Regulations.
To comply with these requirements, cosmetic labels must
supply:
- the identity of the product in English and French (if not
obvious by looking at the package), using its common name
(e.g. “face cream”) or described in terms of its function
(e.g. “body scrub”,“moisturizing lotion”)
- a statement of net quantity in English and French (e.g. weight,
volume, number of items) in metric units of measurement
- the company name and business address
- directions, warnings or cautions in English and French where
necessary for safe use of the product
In the case of aerosols and other pressurized containers, hazard
symbols in specific sizes are required. In this case, the Cosmetic
Regulations incorporates the Consumer Chemicals and Containers
Regulations (CCCR) as they read on September 30, 2001.
This document can be obtained by contacting the Cosmetics
Program or by visiting our website at www.hc-sc.gc.ca/cosmetics.
Specific regulations also exist for the safe use of certain products,
such as hair dyes. In addition, the Competition Act prohibits false
and misleading representation or deceptive packaging.
Health Canada has amended the Cosmetic Regulations to
require that cosmetic ingredients be disclosed on the
product label.The safety of the Canadian public will be
enhanced by making this information available to
consumers and medical professionals.
The amendment requires all cosmetic products to be
identified on labelling in accordance with the International
Nomenclature of Cosmetic Ingredients (INCI) labelling
system.This Latin-based nomenclature is known worldwide
and is considered to be multi-lingual and multi-national.
It is currently being used in many countries including
the European Union and the United States.The new
requirements will be mandatory on November 16 th , 2006.
For more information, please visit our website. |
Claims
Claims for a cosmetic – whether on a label, an advertisement,
or website – must be accurate. Certain claims, such as
increased attractiveness, are subject to an interpretation, but
must never mislead the public.
Cosmetics can only make claims that are cosmetic in nature.
A product possessing claims that are both therapeutic and
cosmetic is therefore considered a drug, and must fulfill the
requirements of the Food and Drugs Act and Food and Drug
Regulations.
Unnacceptable (left) vs. Acceptable Claims
Consequently, the term “cosmeceutical” (used to describe a
cosmetic product with pharmaceutical-like benefits) is not
employed by Health Canada.Therefore, “cosmeceuticals” fall
under either cosmetics or drugs, depending on the claims made
and/or the composition of the product.
The Guidelines for Cosmetic Advertising and Labelling
Claims examine common acceptable and unacceptable claims
for cosmetics (see Appendix II – Suggested Reading).The table
below provides some examples:
Cosmetic |
Acceptable
Claim |
Unacceptable
Claim |
Moisturizer |
Softens skin |
Heals skin |
Contour cream |
Reduces the look
of cellulite |
Lose inches;
slims/slimming |
Acne-prone skin
product |
Removes Oil |
Stops acne |
Mouthwash |
Helps eliminate
odour-causing
bacteria |
Kills odour-causing
germs |
Fragrance |
Soothes |
Causes hormonal
attraction |
Anti-Aging/Anti-Wrinkle
product |
Helps prevent the
look of aging |
Eliminates wrinkles |
Most radio and television advertisements are previewed and
cleared with organizations such as Advertising Standards
Canada before they are broadcast, but printed advertisements
do not require pre-clearance review. If promotional material is
found to be non-compliant with the Cosmetic Regulations, the
advertiser is asked to change or withdraw it.
Import and Export
All cosmetics imported into Canada must be in compliance
with sections 5 through 10 of the Cosmetic Regulations.
The Canada Border Services Agency (CBSA) enforces border
legislation and the Customs Program. In some cases, shipments
may be seized by the CBSA if notification has not been
completed pursuant to section 30 of the Cosmetic Regulations.
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