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:

1. 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.
   
   
2. 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.
   
   
3. 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).
   
   
4. 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.

Product Classification:

Here are examples of how some products are classified…

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.

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.

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:

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.