Helping the people of Canada maintain and improve their health

Aider les Canadiens et les Canadiennes à améliorer leur état de santé

Helping the people of Canada maintain and improve their health

Aider les Canadiens et les Canadiennes à améliorer leur état de santé

Requirements for Selling Cosmetic Products in Canada

Kimberly Liska Health Canada – Consumer Product Safety

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Colombian Government Trade Commission

October 21, 2014

Agenda • Legislation • Definitions • Claims and Classification • The Cosmetic Hotlist • Cosmetic Notification • Labelling Requirements & Warnings • Special Packaging Requirements • Summary and Resources

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Food and Drugs Act (F&DA)

• Act defines the powers of inspectors’ to search premises, take

samples, seize products, stop sale, etc. • Defines cosmetic, drug, food and device (s.2 F&DA) • Outlines general safety requirements for cosmetics (s.16 F&DA)

• Regulations under the Act:

Cosmetic Regulations Food and Drug Regulations Natural Health Product Regulations, etc.

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Food and Drugs Act (section 2)

• Classification of a product as a cosmetic or a drug* is determined by:

The claims that appear on the product (Guidelines for Cosmetic

Advertising and Labelling Claims)

The ingredients present in the product (Hotlist) * “Drug” means Therapeutic Product or NHP

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Definition of a Cosmetic – Food & Drugs Act (s.2)

“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.

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What is a Drug? “Drug” includes any substance or mixture of substances manufactured,

sold or represented for use in: a) the diagnosis, treatment, mitigation or prevention of a disease,

disorder or abnormal physical state, or its symptoms, in human beings or animals,

b) restoring, correcting or modifying organic functions in human beings or animals, or

c) disinfection in premises in which food is manufactured, prepared or kept.

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What is a Natural Health Product (NHP)?

• Defined in the Natural Health Products Regulations- not in the Act

• A subset of “drug”; it is a therapeutic product whose active ingredients come from a “natural” source.

• Came into force January 1, 2004

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General requirements for Drugs & NHPs

• Pre-market approval process • Product Licensing and Site Licensing • Requires a product ID number (DIN or NPN) on

label • GMPs • Fees (drugs only)

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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

* “Drug” means Therapeutic Product or NHP

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To represent your product as a cosmetic

• Cannot make statements to treat/prevent disease, disorders or modify organic function of the body Includes symptoms of a disease

• Products need an appropriate cosmetic function

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Why Are Claims Important?

• A large component of how a product is classified under the Food &

Drugs Act is based on how the product is represented for use i.e. the claims associated with the product.

• Claims include information found on the label, website and all other advertisements/promotions associated with the product.

• Changing a claim could cause a cosmetic to be classified as a drug and the product would be subject to different regulations under the Food and Drugs Act.

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Classification

Product Function: Cosmetic or Drug ?

Skin Cream Cosmetic: Moisturizes the skin

Diaper Rash Cream Drug: Treats a skin disorder (rash)

Lipbalm Cosmetic: Moisturizes the lips

Lipbalm with SPF 15 Drug: Protects the skin on lips from sun damage

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A few last words on claims

• Cannot make reference to Health Canada, the Act or Regulations on labels or in advertising, and cannot suggest cosmetic is a prescription

• Cannot make false or misleading claims on label and advertisement under The Consumer Packaging and Labelling Act, and The Competition Act

• Also prohibits deceptive packaging

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Good Manufacturing Practices (GMPs)

• Although there are no specific requirements for Good Manufacturing Practices (GMPs) for Cosmetics, Health Canada encourages use of the ISO Cosmetics GMP Standard

• GMPs for Cosmetic Products (ISO 22716:2007)

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Additional Product & Ingredient Safety

In addition, the Cosmetic Regulations outline controls for:

Chloroform, estrogenic substances, mercury, PPD, coal tar hair

dyes, methyl alcohol, potassium bromate, sodium bromate, genital deodorants, products that remove stains from the teeth with <pH 4, etc.

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The Cosmetic Ingredient Hotlist

• List of ingredients prohibited or restricted for use in cosmetics in Canada

• Not in the Act or Regulations. Considered to be an elaboration of s.16 of the F&DA specifically : No person shall sell any cosmetic that has in or on it any

substance that may cause injury to the health of the user

• Created in 1995 based on policies regarding certain ingredients used in cosmetics

• Currently 400+ substances on list (not exhaustive) and list is updated regularly

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Cosmetic Notification • Required per s.30 and 31 of the Cosmetic Regulations

• When? Within 10 days of the first day of sale of the product in Canada.

Can be notified before sale too.

• Required for new products, formulation changes and to update the status of discontinued products.

• Information required? Manufacturer(s)/distributor, purpose, physical form and formulation (ingredient percent ranges)

• No fee

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Cosmetic Notification

• Not a product evaluation or approval procedure

• Acceptance of the completed form or labelling by Health Canada does not constitute, in any way, agreement that the product is in compliance with all the regulatory requirements.

• Meeting the requirements is the responsibility of the establishment.

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Labelling Requirements

• Appropriate cosmetic claims • Directions for sale (English/French) per s24 Cosmetic Regulations • Warnings • Requirements for cosmetics in pressurized containers (e.g. hazard

symbols) • Special Packaging • Product identity and manufacturer name and full mailing address • Ingredient Labelling using INCI • Other bilingual requirements

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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

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Pressurized Containers

• Aerosol products in a metal pressurized container (not pump sprays or those in plastic containers) must meet the requirements of the Consumer Chemicals & Containers Regulations (CCCR, 2001) under the Canada Consumer Product Safety Act.

• See Labelling Requirements for Cosmetics in Pressurized Containers

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Special Packaging

• Mouthwashes: require tamper-evident security packaging

• Child-Resistant Containers (CRC) required for methyl alcohol, potassium bromate and sodium bromate

• Security packaging is not required for any other cosmetic at this time

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Product Identity and Manufacturer Information

• Product identity and name and address of “manufacturer” (dealer) on inner label

• 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.

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Ingredient Labelling Requirements

• Consult the Guide to Cosmetic Ingredient Labelling

• Ingredients must be on the outer label. Must be clear, visible and legible. Law does not specify a font size.

• The term “Ingredients” or “Ingredients/Ingrédients” does not need to precede the list of ingredients.

• Incidental ingredients that do not end up in final formulation do not need to be listed as ingredients

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Ingredient Labelling & INCI

• Ingredients must be listed using INCI (International Nomenclature of Cosmetic Ingredients) in descending order of predominance.

• If an ingredient has no INCI name, then the chemical name should be used.

• Ingredients in the Schedule to the Cosmetic Regulations must be listed using either the EU trivial name or the French and English equivalents.

• Botanical ingredients must be listed using either the full INCI name or at minimum identifying the Genus and Species.

• Fragrance can be listed as either “parfum” or “parfum/fragrance”. Flavour can be listed as either “aroma” or “aroma/flavour”.

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Ingredient Labelling

• Where a product has only one label, all the requirements must be on that label.

• Where product has an inner and outer label, ingredients are not required on the inner label.

• Where product has only one label and the label is very small, the ingredients can be listed on tag, tape or card that is affixed to the product.

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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.

• For products sold in the province of Quebec, all labelling (including

descriptions, except INCI) must be in French (at minimum) per the Charter of the French Language (Bill-101).

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Summary: What is needed to market a cosmetic in Canada?

Definition – Is it a cosmetic under the Act? Formulation – Any Hotlist ingredients? Labelling

Ingredients Claims Product Identity (Common Name) Warnings/Cautions/Directions for safe use Manufacturer’s name and address Bilingual labelling

Notification

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Cosmetics: Health Canada Website

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 • Guidelines for the 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, 2001

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Questions?

Kimberly Liska kimberly.liska@hc-sc.gc.ca

Gracias

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