This document contains general information in relation to requirements under the Food and Drugs Act (FDA) and the Cosmetic Regulations (CR). It is not intended to substitute for, supersede or limit the requirements under the Food and Drugs Act or the Cosmetic Regulations. In case of any discrepancy between this document and the legislation, the legislation will prevail.
As per section 16a of the FDA, "No person shall sell a cosmetic that contains any substance that may cause injury to the health of the user." Therefore, Health Canada has developed the Cosmetic Ingredient Hotlist (Hotlist), which is an administrative tool used to communicate to manufacturers and others, that certain substances may cause injury to the health of the user – which may contravene the general prohibition found in section 16 of the FDA and/or one or more provisions of the CR. Although not exhaustive, the Hotlist includes substances that are restricted or prohibited in cosmetics due to safety concerns. In addition, the Hotlist includes certain substances that may make it unlikely for a product to be classified as a cosmetic under the FDA. Despite whether a substance is described on the Hotlist, Health Canada can take appropriate actions to enforce the FDA and CR.
A Cosmetic Notification Form (CNF) must be submitted by the manufacturer or importer for each unique product. One CNF covering multiple products is only permissible under certain situations and is recommended for product lines that differ by only one compositional aspect, such as colour or fragrance (for example: a line of lipsticks). A product available in different sizes does not require separate CNFs for each size.
In certain situations, manufacturers or importers may cover an entire product line with a single CNF. This may be done only when all of the following conditions are met:
Note: If the number of products in the product line changes slightly due to the addition or deletion of a few items in the product line, an amendment to the CNF is not required, unless other information, such as composition, has also changed.
The CR has mandatory warnings for certain products and for others, the Hotlist contains labelling examples such as cautionary statements that Health Canada considers acceptable to mitigate certain avoidable hazards.
For products with an avoidable hazard, documents such as product labels must be submitted at the time of notification.
A cosmetic ingredient is any substance or component that is deliberately added to the formulation. Ingredients usually have a cosmetic function and give a certain physical property to the final product. Examples include conditioning agents, fragrances, colouring agents, preservatives and flavours, but excludes impurities or ingredients consumed during the manufacturing process.
The CNF is comprised of nine sections. Following the instructions below will help you to fill out all sections correctly. Note that all fields marked with an asterisk are mandatory. The CNF cannot be submitted unless all mandatory fields are properly filled. Supplying complete information will help in the processing of the CNF.
Select the appropriate type of notification from the drop down list.
New: If the product has not previously been notified to Health Canada, select "new." A new notification is the first one submitted for a product with the name indicated in Section 2 and sold by the manufacturer or importer indicated in Section 4.
Amendment: If the information related to a product that has previously been notified to Health Canada requires amendment, and the intention is to continue to sell the product, select "Amendment." Although all sections of the CNF must be completed in an amendment, this can be avoided if the information from your previous CNF has been saved. Provide the Cosmetic Number (see Section 8; Reference numbers associated with Cosmetic Notification Forms) to help identify your product. If Health Canada is unable to match an amendment with a previously submitted CNF, the notification will be treated as "New." In all cases, resubmission of required documents is necessary, including safety data and labels.
Discontinue sale: If a cosmetic product has been discontinued from sale on the Canadian market by the manufacturer or importer (but not necessarily by retailers), provide a notification to this effect within 10 days of the change. Note that a notification of discontinuation of sale should take place upon cessation of sale by a manufacturer or importer, and not upon cessation of production of the cosmetic. To help identify your product, include the Cosmetic Number (see Section 8; Reference numbers associated with Cosmetic Notification Forms) while submitting your discontinuation of sale.
This field is to be used by companies for their own internal purposes. For example, it can be used to identify any internal non-commercial names for the product, such as a formula code used by contract manufacturers.
Indicate the primary brand and name of the cosmetic, as it appears on the product label.
This name may or may not include the name of the manufacturer. This name should be unique to the manufacturer and should distinguish the product from all other products marketed by the company.
For example, if a product is marketed by a company called "Cosmetic Brand" as "Gentle Lavender Shampoo," the primary brand and name of the product would be "Cosmetic Brand – Gentle Lavender Shampoo". Product names such as "Shampoo" are not distinctive enough for identification of the product.
In this section, indicate if the product is marketed under other names which have shade/colour, scent/fragrance and aroma/flavour variations, where the base formulation is the same. It can also be used to include alternate language translations or any alternate name.
Use this section for supplemental information to describe the product's purpose. For example: this is a shine serum for hair.
This section can also be used to identify cosmetic products that are packaged together. For example, a gift basket or "combo pack" containing soap and shampoo. Such products are not considered "kits" (see Appendix I for more details), and therefore each component must be notified separately. Provide both the name(s) and cosmetic number(s) (if available) of the product(s) with which it is packaged.
|Area of application||Description|
|Body||Applied externally to the human body. Does not include the eyes or the oral cavity.|
|Eyes||Primarily applied to the area of the eyes. In other words, the area bounded by the supraorbital and infraorbital ridges, including the eyebrows.|
|Face||Primarily applied to the skin of the face.|
|Genitals||Primarily applied to the genital area.|
|Hair||Primarily applied to body or facial hair, except eye lashes and eye brows.|
|Lips||Primarily applied on the lips.|
|Nails||Applied on nails only.|
|Oral Cavity||Applied on teeth or the mucous membrane of the oral cavity (mouth) only.|
|Function of product||Description|
|Adhesive||Product that binds opposite surfaces to each other, such as artificial nail with nail.|
|Adhesive remover||Product which is intended to remove glue from body parts, for example, from the nails and hair.|
|Antiperspirant/deodorant||Product which modifies, reduces or prevents the development of body odours.|
|Bath product||Product added to bath water. Includes, for example, bath oils, tablets, salts and bubble baths.|
|Bleach||Product which bleaches the hair. Excludes hair lighteners with colours.|
|Breath freshener||Product that is used in the oral cavity to modify or reduce mouth odours. Includes breath freshening drops, sprays and strips. Excludes lozenges and gum.|
|Cleanser||Product which cleanses the skin. Includes soap and astringents.|
|Conditioner||Non-shampoo product which increases the suppleness or body of the hair or facilitates combing, or adds gloss or texture to the hair.|
|Depilator||Product which facilitates the removal of hair by chemical means.|
|Douche||Product used for vaginal irrigation.|
|Epilator||Product which facilitates the removal of hair by mechanical means. Includes wax treatments.|
|Exfoliant - Chemical||Product that chemically removes dead cells from the surface of the skin.|
|Exfoliant - Mechanical||Product that mechanically removes dead cells from the surface of the skin.|
|Fragrance product||Product for imparting a scent. Includes perfume, cologne, "eau de toilette" and talcum powder.|
|Hair colour - Permanent||Product which changes the colour of the hair.|
|Hair colour - Temporary||Product which applies colour to the hair and washes or wears off.|
|Hair removal after-care||Product applied to the skin, after hair removal, to soften or maintain skin suppleness.|
|Lubricant (personal, non-spermicidal)||Product used to lubricate the genital area.|
|Makeup (non-permanent)||Product applied to colour and/or beautify the skin. Includes eyebrow pencil, eyeliner, eye shadow, mascara, blush, face powder, foundation, rouge and makeup fixatives.|
|Makeup (permanent)/tattoo ink||Product injected in the upper layers of the dermis for the purpose of decoration.|
|Makeup remover||Product applied to the skin to remove makeup.|
|Massage product||Product used for massaging purposes.|
|Moisturizer||Product applied to the skin to soften or maintain skin suppleness by reducing water loss or increasing the water content of the skin. Includes emollients and humectants.|
|Mouth wash||Product to freshen or deodorize the mouth and breath. Usually a liquid that is swished in the mouth and spat out (not swallowed).|
|Nail polish||Product applied to the nails. Includes nail polish, nail cream, nail lotion, cuticle softener and nail hardener.|
|Nail polish remover||Product to remove polish. See "Polish."|
|Shampoo||Product which cleanses the hair and is rinsed off after use.|
|Shaving product||Product used to care for the hair or skin during and after shaving. Includes shaving cream, pre-shave lotion, after shave lotion, beard softener and shaving soap.|
|Straightening, waving and curling products (permanent/semi-permanent||Product which chemically softens the hair to facilitate straightening or curling. This is generally followed by a neutralization step.|
|Styling product||Product which is used to shape or style the hair. Includes mousse, gel, pomade and spray.|
|Sunless tanning product (non-SPF)||Product which is used to give the appearance of a tan. Excludes products which protect the skin from sun damage or enhance or accelerate the tanning process.|
|Toothpaste - Non-fluorinated||Product which cleans and/or polishes the teeth.|
|Tooth whitener||Product used to whiten teeth.|
|Form of product||Description|
|Aerosol||A suspension of fine solid particles or liquid droplets in a gas.|
|Foam||A suspension of gas in a liquid.|
|Liquid oil||A substance which is not miscible with water, and is generally slippery, viscous and liquid at room temperatures (for example mineral oil).|
|Liquid non-oily||A non-oil based, low viscosity fluid form that can be poured (for example, solutions and milky lotions).|
|Liquid suspension||A solid suspended in a liquid (for example, some moisturizers and some skin cleansers).|
|Semi-solid cream||A viscous liquid or semi-solid emulsion (for example, some hair grooming products and makeup).|
|Semi-solid gel||A viscous, usually clear, jelly-like semi-solid (for example, some hair grooming products and dentifrices).|
|Semi-solid lotion||A liquid emulsion that is usually applied to the skin (for example, some moisturizers and makeup).|
|Semi-solid ointment/balm||A thick, viscous preparation based on a fatty material (for example lanolin).|
|Solid - Cake||A solid mixture (for example, soap, bath bar and eyeliner stick).|
|Solid granules||A small particle or grain that is usually dissolved or dispersed in water or another liquid (for example, bath salts, crystals and pearls).|
|Solid powder - Loose||A loose mixture of dry, finely divided particles (for example, dusting powder, makeup and talcum).|
|Solid powder - Pressed||A compressed mixture of dry, finely divided ingredients usually applied to the skin (for example, blush and eye shadow).|
|Kit||Two or more components that must be mixed together in order to create the final product. Indicate the form of each component on one CNF. Where the products are not mixed or used together (for example gift baskets) notify each product separately (separate CNFs).|
The notifier can be the manufacturer, a Canadian importer or a person responsible on their behalf. All correspondence will be sent to the notifier. Therefore, indicate the full legal business name, complete mailing address and contact information, including the telephone number and e-mail address, of the company submitting the CNF.
In this section, enter contact information for the manufacturer or Canadian importer as it appears on the product label. If the cosmetic was not manufactured or formulated by the person whose name appears on the label, provide the contact information for any additional manufacturers. Contact information for at least one manufacturer or importer located in Canada must be provided (in either section 3 or 4). Canadian distributors can also be listed here.
When the notifier is also the manufacturer or importer, check the "Same as Notifier" box to copy the information from Section 3 into Section 4.
Use the box "Contact Type" to indicate if the contact is a distributor, importer or manufacturer. If the contact has multiple roles, for example is both the importer and a distributor, select the highest level of trade (in this case the importer).
This section is used to specify the ingredients and their concentrations in the product(s). List all of the product ingredients separately, entering only one ingredient per line on the CNF. Use the "Add Ingredient" and "Remove Ingredient" buttons to add or remove ingredients. The list of ingredients on the CNF must be consistent with the ingredients listed on the product label.
To avoid delays in notification processing:
An attached list of ingredients (for example: in a Certificate of Analysis, material safety data sheet, etc.) is not an acceptable alternative to filling out this section of the CNF.
Each ingredient must be listed separately, preferably using the INCI system.
If there is no INCI name for the ingredient, list the ingredient name, using one of the following commonly recognized naming systems below (listed in order of preference):
After entering the ingredient name, pressing the "Search Ingredient" button will validate the entry and show any important information related to the use of this ingredient in cosmetics in Canada. The results from the ingredient search will show in the "Ingredient Status" field and are as follows:
Note: The Hotlist should be consulted each time a CNF is submitted. If unsure about the acceptability of an ingredient, please contact your nearest Product Safety Office.
Ingredient concentration may be indicated by entering an exact concentration, selecting one of seven set concentration ranges/range codes, or by manually entering a lower and upper concentration. The Table in section 30 of the Cosmetic Regulations specifies the range codes to be used. A detailed explanation of how to calculate "concentration" can be found in Appendix I: Common deficiencies.
A cosmetic product that contains certain ingredients that are set out on the Cosmetic Ingredient Hotlist may contravene the Food and Drugs Act and/or a provision of the Cosmetic Regulations.
If a restricted ingredient is listed on the CNF, providing the exact concentration of the ingredient (as opposed to a concentration range), and submitting all labelling materials with the CNF (Section 6), will help expedite processing of the CNF.
Exact concentration: When providing an exact concentration, enter the same value for both lower and upper concentrations.
Concentration range: When a range is selected from the "Range Code" drop-down list, the lower and upper concentrations are self-populated.
Lower and upper concentration: The lower and upper concentration of the ingredient may also be entered manually.
The total concentration should add up to 100% unless the formulation includes ingredients that are variable (i.e. "May contain" box has been checked).
"May contain" box
Check the "May contain" box to indicate variable ingredients present in the product such as the colouring or fragrance ingredients. For example, some products such as makeup or nail polish/enamel may come in various shades. In the case of a single CNF for multiple products, list all the variable colouring agents used in the product line, indicate the maximum concentration range and check the "May contain" box for each one.
Aerosol container propellants
If the product is packaged in an aerosol container, list the propellant ingredient and its concentration on the CNF and product label.
Incidental ingredients are defined as any processing aid added and removed, or converted to a declared ingredient, or any component of another ingredient or processing aid present at an insignificant level and having no technical or functional effect. These substances do not need to be declared on the CNF or the product label.
Fragrance and flavouring agents
Flavouring and fragrance agents do not need to be listed by their ingredient components on the CNF. The terms "flavouring agent" and "fragrance agent" or the terms "aroma" and "parfum" can be used respectively.
Requests for information from Health Canada
If Health Canada has questions or concerns with a CNF, product, or identifies any other deficiencies, the notifier may be contacted.
Depending on the issue, a request for one or more of the following could be made:
To avoid common deficiencies and delays in processing your CNF, consult the list found in Appendix I.
In cases where a cosmetic presents an avoidable hazard that is described in the Cosmetic Regulations or on the Cosmetic Ingredient Hotlist, copies of labels and inserts must be provided upon notification. Failure to provide labelling information will result in a CNF being considered incomplete. For any cosmetic, a label may be required to clarify the function or representation of the product.
To attach a document to the CNF, follow the steps below:
Note that the size of individual documents attached to the CNF is cumulative and the total cannot exceed 70 Mb. Furthermore, some file formats, such as .zip and .exe files, cannot be included on the online form. If the total size of your documents exceed 70 Mb, use the Submit Additional Documents button on the Notification of Cosmetics webpage.
When submitting online for the first time or if you encounter problems submitting online, follow the Help on Forms page closely.
Click the "Proceed to Submit" button to submit the CNF. A confirmation will be displayed if the CNF has been successfully submitted, along with the assigned Case and Submission Numbers. Include the Case and Submission numbers when communicating with Health Canada.
Saving your Cosmetic Notification Form information
Be sure to save the information submitted in the CNF for your records. Note that only the text entered in the online CNF will be saved, in a file with the extension format “.hcxs”, but not the form itself. The information related to your CNF can be saved at any point while filling the online form.
Once the CNF has been successfully submitted, save the file in a location that will be easy to find using a name that includes the Case number and Submission number. The product name can also be included in the file name. Saving a copy of the information from the form will make it quicker and easier to submit an amendment or discontinuation of sale.
To save your online form information on your computer:
To view or edit previously saved information on the CNF, open the CNF webpage and scroll down to the bottom to Section 9. Then proceed with the following steps:
Note: Ensure the online form is empty (does not contain information from another CNF) BEFORE you upload your information file. Also, in order for others to view OR edit the content of your CNF, they must first find the empty online form on the Health Canada Website, view it on their browser, then upload the information file you forwarded to them.
Amendments and discontinuations
Amendments are to be submitted whenever a change to the product needs to be made, such as the product brand and name, contact information or ingredient list. To amend or discontinue a product, open the CNF webpage and scroll down to the bottom to Section 9, then proceed with the following steps:
Reference numbers associated with CNF
Cosmetic Number (CN): The CN is a 7-digit unique identifier assigned by Health Canada. Once the CNF is processed, a CN will be assigned and sent to the notifier via email. For amendments or discontinuation of sale, enter the CN in this field to speed processing. This CN should also be used in any correspondence with Health Canada related to a product. This is equivalent to the "CNF number" used prior to 2013.
Case and Submission numbers: The Case and Submission Numbers are internal tracking numbers for submitted CNFs. The numbers are assigned and inserted directly into the CNF when submitted online. Including the Case and Submission Numbers in correspondence with Health Canada regarding the CNF improves the department’s ability to identify the product(s) referenced.
Additional information or clarification is often requested by Health Canada. Missing or incomplete information may result in the CNF not being processed. Failure to respond to an information request within the specified timeframe may result in the product(s) becoming non-compliant with the legislation and therefore subject to compliance action.
This section lists common deficiencies found in CNFs submitted to Health Canada. These deficiencies can lead to inaccurate data and time delays in processing of the CNF.
The cosmetic contains an ingredient found on the Cosmetic Ingredient Hotlist
If a cosmetic contains an ingredient which appears on the Hotlist, the manufacturer or importer could be contacted by Health Canada for additional information and may be subject to compliance action.
The cosmetic contains ingredients that affect the classification of the product
The manufacturer will be redirected to another program area of Health Canada.
Therapeutic representation of the product in the product's name, label or website
Cosmetic products cannot have therapeutic claims associated with them because those claims may result in the product being classified as a drug or natural health product under the Food and Drugs Act and its regulations. This includes claims within the name of the product, on the product label or in advertisements for the product as may be found on company websites.
Incorrect calculations of ingredient concentrations
The concentration of an ingredient is calculated as the percentage of the ingredient within the total composition of the product. To calculate the concentration, ensure that all quantities are in the same units of weight or volume (grams, millilitres, kilograms and litres). For example, when using weight in grams as the units, first add the weight of all the ingredients present in the formulation, to obtain the total weight of the product. Then, divide the weight of each of the ingredients by the total weight of the product and multiply the result by 100 to obtain the concentration of the product in percent.
Concentration (in %) = (Quantity of ingredient / Quantity of all ingredients contained in the product) × 100
Example: A product contains
60 g ingredient X
13 g ingredient Y
2 g ingredient Z
Total weight of product: 60 g + 13 g + 2 g = 75 g
Concentration of ingredient X: (60 g / 75 g) × 100 = 80.00% (concentration range "1")
Concentration of ingredient Y: (13 g / 75 g) × 100 = 17.33% (concentration range "2")
Concentration of ingredient Z: (2 g / 75 g) × 100 = 2.67% (concentration range "4")
The name of the cosmetic or list of ingredients on the form is not consistent with the submitted label
The information provided in the CNF must reflect the information found on the cosmetic product label (for example, name of cosmetic and list of ingredients). If the name or ingredients in the CNF differ from the label, clarification will be requested by Health Canada , and processing of the CNF will be delayed.
Amendments are required if changes are made to information in a previously submitted CNF
CNFs are tracked according to product name and Cosmetic Number. When submitting a notification amendment, please include the Cosmetic Number. At a minimum, the product name in the amendment must match the name on the CNF previously submitted for the same product.
Completing a "kit" notification
A cosmetic product "kit" is sold with two or more different components, which are meant to be mixed together before the product is to be used (for example: a hair dye product).
List all kit components on the same CNF and indicate "kit" in the section "Form of product". Note that the list of ingredients on the CNF should represent the finished product (once the “kit” has been mixed together) and should also be the same list that is on the product label.