Requirements for Manufacturing, Importing, Marketing,
and Selling Cosmetic Products in Canada
Kimberly Liska
Consumer Product Safety Officer
Health Canada – Consumer Product Safety Program
Regions and Programs Bureau
————————————————————-
CAPRA
May 27, 2015
Purpose
• Overview of the requirements to sell cosmetics in Canada:
– Legislative authority
– Definition of “cosmetic”
– Safety of ingredients
– Product labelling
– Product notification
– Other requirements
• Working with Product Safety Inspectors
• Guidance for Industry
About the Cosmetics Program
Mandate
To maintain and improve the health of Canadians by minimizing
health risks associated with the use of cosmetics marketed in
Canada.
Met by:
• Defining and communicating requirements for cosmetic
manufacture, labelling, distribution and sale
• Monitoring compliance
Organization
Healthy
Environments & Regions &
Consumer Safety Programs Branch
Branch
Consumer Product
Safety Directorate
Risk Assessment Program
Bureau Development
Bureau
Risk Management
Bureau
Legislative Authority
Program’s authorities housed in:
• Food and Drugs Act (F&DA) and Cosmetic Regulations
Cosmetics are also governed by:
• Consumer Packaging and Labelling Act (CPLA) and Regulations
• Net weight declaration and false and misleading claims
• Canadian Environmental Protection Act (CEPA,1999)
• New and existing cosmetic ingredients
Legislative Authority: Food and Drugs Act
Food and Drugs Act (F&DA)
• Defines cosmetic, drug, food and device (s.2 F&DA)
• Provides general safety requirements for cosmetics (s.16 F&DA)
• Act defines the powers of inspectors’ to search premises, take samples,
seize products, stop sale, etc.
Regulations under the Act:
• Cosmetic Regulations
• Food and Drug Regulations **
• Natural Health Product Regulations, etc **
** The products governed by these regulations are not under the purview of the Consumer Product Safety Program
(CPSP)
Definition of a Cosmetic
What is a cosmetic?
“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 perfumes.
Classification: Cosmetic vs Drug
• To determine if a product is a cosmetic or a drug, one must look
at:
• the representation of the product
• the ingredients present in the product (Hotlist)
• Cosmetics do not treat/prevent disease, disorders or modify
organic functions of the body
• Includes symptoms of a disease
• Products need an appropriate cosmetic function
* “Drug” means Therapeutic Product or NHP
Food and Drugs Act (F&DA)
General Safety Requirement under s.16:
No person shall sell any cosmetic that
• has in or on it any substance that may cause injury to the health of the user
• is adulterated
• was manufactured, prepared, preserved, packaged or stored under
unsanitary conditions
• Basis for control of ingredients (in the Cosmetic Regulations and the Cosmetic
Ingred ient Hotlist)
• Also basis for need of quality control systems for impurities and micro-
organisms, packaging and storing conditions
• Although there are no specific requirements for good manufacturing practices
(GMP), Health Canada encourages use of ISO Cosmetics GMP Standard:
22716
Cosmetic Ingredient Hotlist
• List of prohibited and restricted ingredients in cosmetics in Canada
• Currently 500+ substances on list; not exhaustive
• Originally based on EU’s Cosmetics Directive’s Annex II & III
• Composed of ingredients:
• known to cause adverse health effects, or
• that are limited to pharmaceutical applications
Cosmetic Ingredient Hotlist
How are ingredients identified and prioritized for review?
• New scientific information
• New regulatory decisions (domestic or international)
• Consumer complaints/injuries
• Media
• Industry request
• Other concerns
Cosmetic Regulations
Outlines requirements for:
• Labelling
• Import
• Notification
• Some specific ingredient requirements
Labelling Requirements
• Cosmetic function
• Directions for safe use (English/French) per s24 Cosmetic
Regulations
• Requirements for cosmetics in pressurized containers (e.g. hazard
symbols)
• Warnings and Special Packaging
• Product identity and manufacturer name and full mailing address
• Ingredient Labelling using INCI
• Other bilingual requirements
Directions for Safe Use
1. The label of a cosmetic that presents an avoidable hazard must
include directions for safe use.
2. “Avoidable hazard” means a threat of injury to the health of the user
of a cosmetic that can be:
a) predicted from the cosmetic’s composition, the toxicology of its
ingredients and the site of its application;
b) reasonably anticipated during normal use; and
c) eliminated by specified limitations on the usage of the cosmetic.
Warnings
• Some ingredients or products require warnings to alert
consumers of a specific hazard
e.g. Cosmetics containing Alpha hydroxy acids (AHAs) require a
warning to alert consumers about sun safety when using these
products
• See the Cosmetic Ingredient Hotlist and Cosmetic Regulations
for ingredients that require warnings
• If a warning is required, usually wording does not need to be
word for word if the term “to the effect of” precedes the warning
on the Hotlist.
Pressurized Containers
• See the guide: Labelling Requirements for Cosmetics in
Pressurized Containers
• Aerosol products in a metal pressurized container
• Does not include pump sprays or those in plastic containers
• Must meet the requirements of the Consumer Chemicals &
Containers Regulations (CCCR, 2001)
Pressurized Containers
• These containers require a pressurized hazard symbol along
with the appropriate signal word and hazard statement
• Also, cosmetics may need a flammability hazard symbol,
depending on whether product is tested as flammable, the
length of the flame and whether there is flashback, along with
the appropriate signal word and hazard statement
Special Packaging
• Mouthwashes: require tamper-evident security packaging
• Security packaging is not required for any other cosmetic at this
time
• Child resistant containers required for products that contain
methyl alcohol, potassium bromate and sodium bromate
Product Identity and Manufacturer
• Consumer Packaging and Labelling Act and Regulations require:
• Declaration of net quantity on inner and outer label
• Common name of the product on outer label
• Name and address of dealer on outer label
• Cosmetic Regulations complement this by requiring on inner label
• Product identity and name and address of “manufacturer” (dealer*)
* same as “dealer” under the CPLA.
Product Identity and Manufacturer
• Product identity is not required if identity is obvious (e.g. soap or
lipstick)
• Manufacturer’s address must be detailed enough so that a
mailed letter would reach the manufacturer.
• In some cases listing the city, province and postal code is sufficient.
In other cases, the street name and number is also required.
• 1-800 or email address is not sufficient, however, can be added as
additional information.
• Address does not need to be in Canada.
Ingredient Labelling
• See the Guide to Cosmetic Ingredient Labelling
• List of ingredients must be in INCI nomenclature and disclosed on outer
label
• Descending order of predominance, except
• Ingredients at concentration of less than 1%
• Colouring agents
• In case of colour cosmetics, can use the term “May contain/Peut
contenir” or “±”
• Incidental ingredients that do not end up in final formulation do not
need to be listed as ingredients
Ingredient Labelling
• Fragrance can be listed as either “parfum” or “parfum/fragrance”.
• The term “Ingredients” or “Ingredients/Ingrédients” does not need to precede
the list of ingredients
• Botanicals listed by genus and species or exactly as named in the Cosmetic
Ingredient Dictionary:
• Acceptable terms for peach fruit extract would be “Prunus Persica” or
“Prunus persica (Peach) Fruit Extract”
• Unacceptable versions “Prunus persica (Peach)”
Ingredient Labelling
• Where product has an inner and outer label, ingredients are not
required on the inner label.
• Where product has only one label and is too small, to put on the
main label, the ingredients can be listed on tag, tape or card that
is affixed to the container of the package
• See Guide to Cosmetic Ingredient Labelling: 4.1 Small Containers
Bilingual Requirements
• For products sold anywhere in Canada, all the labelling required by the
Cosmetic Regulations (except INCI) must be in both English and French
• A label would not be considered to meet the labelling requirements
unless all required information is in both official languages
• For products sold in the province of Quebec, all labelling (including
descriptions, except INCI) must be in French (at minimum)
• Additional descriptive text does not need to be in French if the product
not sold in Quebec
Cosmetic Notification
• When? Post-market: Within 10 days of the first day of sale of
the product in Canada. Can be notified before sale too.
• Required for new products, as well as amendments for original
notification such as formulation changes and discontinued
products.
• Notification information includes:
• manufacturer(s)/importer
• function
• physical form
• formulation
• No fee
Cosmetic Notification
• Health Canada has developed a new online Cosmetic Notification Form
• The Form allows you to:
• Validate ingredients before submitting
• Save the completed form with data
• Submit your notification form via the secure web page Health Canada –
Submit a form.
• The form is available on the HC website along with a guidance
document:
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-
declaration/index-eng.php
Canadian Environmental Protection Act (CEPA, 1999)
• In Canada, all ingredients, including those in cosmetics, are
subject to CEPA
• Two streams under CEPA treated differently:
• New Substances
• Existing Substances
• Based on whether the substance is on the national chemical
inventory (Domestic Substances List – DSL)
CEPA (cont’d)
New Substance” = Not on inventory (DSL)
• Subject to the New Substances Notification Regulations
“Existing Substance” = On DSL
• Substances screened, categorized and prioritized for assessment
under the Chemicals Management Plan (CMP)
• High priority substances are subject to an information request and
assessment under The CMP Challenge (see next slide)
The Chemicals Management Plan (CMP)
• 200 high priority substances on the DSL were part of “CMP I”
• Each batch had questionnaire for importers, manufacturers and
end users.
• “CMP II” launched October 3, 2011, to assess approximately
1,500 DSL substances over next 5 years
In Practice
• What do I need to do in order to market a new cosmetic in
Canada?
• Compliance and Enforcement: Working with an inspector
What is needed to market a new cosmetic in Canada?
• Definition – Is it a cosmetic under the Act?
• Formulation – Any Hotlist ingredients?
• Labelling
• Ingredients
• Purpose
• Common name
• Warnings/cautions/Directions for safe use
• Bilingualism
• Notification
Following notification
Following notification, you may be contacted due to:
• Missing information
• Clarification required
• Product is not a cosmetic
• Hotlist ingredient
• Safety data request
• Injury reported or complaint
Compliance and Enforcement
Working with an Inspector
• Product Safety Inspectors enforce the Cosmetic Regulations and
cosmetic related sections in the Food and Drugs Act
• Inspector authorities in the Food and Drugs Act and Cosmetic
Regulations:
• Can inspect premises where cosmetics are sold, manufactured, or
stored, and take samples for testing or photographs
• Can recommend refusal of imports or allow a non-compliant product
to be imported to be brought into compliance under their supervision
• Can seize cosmetic products
Compliance and Enforcement
Enforcement actions taken will depend upon:
• the risk to health or safety,
• the likelihood that the same problem will reoccur,
• the compliance history of the company,
• whether the company acted with indifference or premeditation,
• the degree of cooperation offered by the company,
• Branch and Programme priorities and available resources,
• the chances of success of the enforcement action being
contemplated, and
• the need to maintain public confidence.
Compliance and Enforcement
Importing Cosmetics into Canada
Section 9 of the Cosmetic Regulations says:
(1) Where a person seeks to import a cosmetic into Canada for sale and the sale
would constitute a violation of the Act or these Regulations, that person may, if the
sale of the cosmetic would be lawful in Canada after relabelling or modification of the
cosmetic, import the cosmetic into Canada on condition that
(a) he gives to an inspector notice of the proposed importation; and
(b) the cosmetic will be relabelled or modified under the supervision of an
inspector in such a manner as to enable the sale of the cosmetic to be lawful
in Canada.
(2) No person shall sell a cosmetic that has been imported into Canada under
subsection (1) unless the cosmetic is relabelled or modified in accordance with the Act
and these Regulations within three months after its importation.
Compliance and Enforcement
New ANI Pilot Process to Invoke Section 9
1. Contact the Regional Product Safety office, in advance of
importation of non-compliant cosmetic products
2. Complete a new ANI form and send it to Health Canada per
instructions from the Regional Product Safety office
3. Proceed with the modifications or relabeling with regular updates
to inspector
• Products must be quarantined
• Non-compliant product cannot be sold until these modifications
are complete
Compliance and Enforcement
• Voluntary approach typically taken before inspectors use
authorities under the Act
• If product can be brought into compliance, inspector may ask for
a written commitment from you
• In other cases, product may be refused from import or further sale,
or may need to be recalled
• Lack of cooperation with an inspector can result in a customs
target, advisory, seizure, or prosecution
References
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/index-eng.php
• Food and Drugs Act and Cosmetic Regulations
• The Guide for Completing Cosmetic Notification Forms
• Labelling of Cosmetics
• Guide to Cosmetic Ingredient Labelling
• Labelling Requirements for Cosmetics in Pressurized Containers
• Guidance on the Classification of Products at the Cosmetic-Drug
Interface
• Cosmetic Ingredient Hotlist
• Good Manufacturing Practices (GMPs) for Cosmetic Products
• Consumer Chemicals and Containers Regulations
References
• Contact your designated Regional Product Safety Office:
http://www.hc-sc.gc.ca/contact/cps-spc/hecs-dgsesc/pso-bsp_usa-eu-eng.php
or call: 1-866-662-0666
• Subscribe to “Cosmetics @ Health Canada” :
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/subscribe-abonnement/index-
eng.php
• Latest Hotlist version published April 2014:
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/hot-list-critique/hotlist-liste-eng.php
Questions
Kimberly Liska