Food and Drugs Act & Cosmetic Regulations

The manufacturing of cosmetics in Canada falls under the jurisdiction of sections 16, 17, 18, 27 and 30 of the Food and Drugs Act (R.S.C., 1985, c. F-27) as well as the Cosmetic Regulations (C.R.C., c. 869) law. The Food and Drugs Act defines what products are labeled as cosmetics, and the Cosmetics section of states the primary rules governing the production and sale of cosmetic products in Canada. These include enforcing sanitary conditions for production, the prohibition of sale of any product not meeting these conditions and maintaining clear and consistent labeling for all products that reflects established standards.

The Cosmetic Regulations law provides the more detailed requirements for the production, distribution and sale of cosmetic products in Canada. These include the obligations for labeling, storage of items under specific conditions and for different products, and stipulations for certain ingredients. It also contains procedures for coordinating with regulatory officials.

The Consumer Packaging and Labelling Act: details of how a product should be advertised including labelling, packaging and product ads

The Canadian Environmental Protection Act (CEPA): related to any chemicals found in the cosmetic product and its respect of the environment following the Project Green engagement

New Substances Notification (NSN) Regulations: all chemical or polymer that are not registered on the Domestic Substances List (DSL) should be submitted as a new substance on the NSN and provided to the Minister of the Environment to protect consumers’ safety

Globally Harmonized System of Classification and Labelling of Chemicals (GHS): Canadian government has aligned its Workplace Hazardous Materials Information System (WHMIS) with the GHS to define and classify hazards with an international format – implemented by the United Nations.

Risk Assessment

All cosmetic regulations in Canada are based upon a foundation of determining the risk a product may pose to consumers. This applies to many other consumer product categories and is designed to prevent items from harming users when applied as intended. All cosmetic products will be subject to risk assessments of their production, distribution, and use under Health Canada’s Consumer Product Safety Program to ensure that in performing their labeled function they do not cause unexpected damage. The assessment will also consider factors such as the severity of any possible injury and potential consequences from unintended use of the product.

Storage

Cosmetics manufacturing materials and end-products must meet the cleanliness and safety standards of Health Canada in order to be deemed complaint. Both the Food and Drugs Act and the Cosmetics Regulations law require that storage spaces of said items meet certain sanitation standards that prevent items from becoming tainted and not functioning as intended during use by consumers.

The Safety Data Sheet (SDS)

As per most countries in the world and following Canada’s alignment with GHS, every material controlled by the WHMIS and covered by the Hazardous Products Act must be associated with a SDS.

SDSs are a bunch of documents providing information about the hazard of a product and advice users on its safety precautions. Most of the time, there are written by manufacturers or products’ suppliers and must be accessible to every user.

The information and documents provided on the SDS must be in both official languages of Canada, English and French. The SDS should always be updated if any changes occur to the hazardous product.

It should include – for more details visit the CCOHS website:

• Product identification: product name, manufacturer(s) and supplier(s) names, addresses, and emergency phone numbers
• Hazard identification: classification, labelling, etc.
• Composition/Information on ingredients
• First-aid measures
• Fire-fighting measures
• Accidental release measures
• Handling and storage
• Exposure controls/Personal protection
• Physical and chemical properties: appearance, odor, etc.
• Stability ad reactivity: possible hazardous reactions, etc.
• Toxicological information
• Ecological information (optional)
• Disposal consideration (optional)
• Transport information (optional)

Product Claims

All cosmetic claims must be true, verifiable and accurately communicate the product features, characteristics & performance. Claims will be evaluated within the context of the advertisement/label/name and net impression will be taken into account. In Canada the main concern in the cosmetic industry regarding claims is which claims are considered therapeutic ( these cannot appear on the labels or in advertising of cosmetic products) and which claims are non-therapeutic claims (these are allowed to appear on the labels or in advertising of cosmetic products). Therapeutic claims are associated with drug products and require a DIN (Drug Identification Number).

Example of Claims in Skincare Ingredients

Labeling Example

Our heavy-duty moisturizing hand salve cares for dry hands. This thick, rich formula provides all-day care for active and dry hands. Formulated with Avocado Oil, Eucalyptus Oil and Sesame Seed Oil, this hand moisturizer for dry skin leaves hands feeling soft, conditioned and cared for.

Notre pommade hydratante robuste pour les mains prend soin des mains sèches. Cette formule épaisse et riche offre un soin tout au long de la journée pour les mains actives et sèches. Formulé avec de l'huile d'avocat, de l'huile d'eucalyptus et de l'huile de graines de sésame, cet hydratant pour les mains pour la peau sèche laisse les mains douces, revitalisées et soignées.

Ingredients: Aqua/Water, Glycerin, Caprylic/ Capric/Stearic Triglyceride, Butylene Glycol, Aluminum Starch Octenylsuccinate, Hydrogenated Stearyl Olive Esters, Butyrospermum Park II/Shea Butter, Cetearyl Alcohol, PEG-75 Stearate, Glyceryl Stearate, Cetyl Alcohol, BIS-Diglyceryl Polyacyladipate-2, Sesamum Indicum/Sesame Seed Oil, Squalane, Dimethicone, Ceteth-20, Phenoxyethanol, Persea Gratissima/Avocado Oil, Steareth-20, Ceteareth-20, Methylparaben, Sodium Dehydroacetate, Tocopheryl Acetate, PPG-5-Ceteth-20, Eucalyptus Globulus/Eucalyptus Globulus Leaf Oil, Allantoin, Disodium EDTA, Aloe Barbadensis/Aloe Barbadensis Leaf Juice

Notification

Whether manufactured by domestic or foreign parties, all intentions to sell cosmetic products must be declared to Health Canada within 10 days of the first sale made in Canada. This must be done by completing and submitting a Cosmetic Notification Form (CNF). In the event that any changes are made to the information recorded on the CNF, the manufacturer must submit another notification to Health Canada appraising them of the situation.

The CNF, is an online form including 9 different sections that requests the following information:

• Name/address of the manufacturer
• Name of the product
• Product function and area of application – e.g. body, eyes, face, etc.
• List of ingredients with exact concentration
• The form of the cosmetic – e.g. is that a cream or a gel?
• Name and address in Canada of the manufacturer, importer or distributor
• Name and address of the formulator if different from manufacturer
• Filling the CNF does not guarantee that your product is safe to use and sell in Canada it must comply with the requirements of the Food and Drug act and its Cosmetic Regulations.

Certain items may be found by Health Canada to have properties of both cosmetic and drug products, in which case they will receive their own classification of product at the cosmetic-drug interface (PCDI). PCDIs include categories such as natural health products or any other medicinal item that is intended to affect the internal processes of the human body. These types of products fall under the jurisdiction of the Natural Health Product Regulations and are considered separate from personal care products.

Voluntary Regulatory Bodies