This document contains general information in relation to requirements under the Food and Drugs Act and the Cosmetic Regulations. 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.
A Cosmetic Notification Form (CNF) must be submitted for each unique product. One notification form 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 notifications for each size.
In certain situations, manufacturers or importers may cover an entire product line with a single notification form. 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 notification is not required, unless other information, such as composition, has also changed.
Submission of labels is mandatory for products that present an avoidable hazard. These documents can be attached to the CNF when submitting online.
The Cosmetic Ingredient Hotlist contains labelling examples such as cautionary statements that Health Canada considers acceptable to mitigate certain avoidable hazards.
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 Cosmetic Ingredient Hotlist is an administrative tool used to communicate to manufacturers and others, that certain substances may cause injury to the health of the user - which is a contravention of the general prohibition found in section 16 of the Food and Drugs Act and/or a provision of the Cosmetic Regulations.
The Hotlist should be consulted each time a notification is submitted. If unsure about the acceptability of an ingredient, please contact your nearest Product Safety Office.
The Cosmetic Notification Form (CNF) is comprised of seven sections. Following the instructions below will help you to fill out all sections correctly.
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 indicated in Section 4.
Amendment: If the product has previously been notified to Health Canada, and the intention is to continue sale, select "Amendment." All sections of the form must be completed in an amendment. If Health Canada is unable to match an amendment with a previously submitted notification, 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. Please 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.
This field is optional, and only for use 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 name of the cosmetic, as it appears on the product label.
This name may be in any language and 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 as "Gentle Lavender Shampoo," this should be the name indicated. Product names such as "Shampoo" are not distinctive enough for identification of the product.
If the product is marketed under other names, such as shade/colour variations, alternate language translations or multiple brandings, enter the alternate names here.
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 (non-spermicidal, not for use with condoms)||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).|
|Polish||Product applied to the nails. Includes nail polish, nail cream, nail lotion, cuticle softener and nail hardener.|
|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 which are mixed together. (Submit one CNF and indicate the form of each component.) Where the products are not mixed or used together (for example gift baskets) notify each product separately (separate CNFs).|
The form of the cosmetic is the state of the final packaged product ready for sale.
Important note on kits: If the product consists of two or more components of different forms which are mixed before use (for example, a hair dye consisting of both a colour gel and a cream developer) select "Kit" and the applicable forms of the various components. Products which are not meant to be mixed together before use are not kits in this context (see information about cosmetics packaged together in "Product description").
Indicate the full legal business name, complete mailing address and contact information of the person/company submitting the notification.
Correspondence will be sent to this address.
In this section, enter contact information for the manufacturer or importer as it appears on the product label. This section can be used to provide contact information for any additional manufacturers and Canadian distributors.
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, manufacturer or retailer. 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 should be used to specify the ingredients and their concentrations in the product(s). The list of ingredients must be consistent with the ingredients listed on the product label.
Submission of finished product test results (for example: Certificate of Analysis) is not an acceptable alternative to filling out this section.
One entry is required for each ingredient. Use the "Add an ingredient" and "Remove" buttons to add or remove ingredients to the form.
Each ingredient must be listed separately, preferably using the INCI ( International Nomenclature for Cosmetic Ingredient) 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, press the "Search Ingredient" button. The possible results from the ingredient search are as follows:
Ingredient concentration may be indicated by exact concentration, by concentration range, or by lower limit (LL) and upper limit (UL). Range codes are specified in the Table as indicated in section 30 of the Cosmetic Regulations. A detailed explanation of how to calculate "concentration" can be found in Appendix I: List of 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 notification, it is recommended that the exact concentration of the ingredient be listed (as opposed to a concentration range), and all labelling materials be submitted with the notification (Section 6), to demonstrate that the product meets the requirements of the Food and Drugs Act and the Cosmetic Regulations. This will reduce delays in processing of the CNF.
Exact concentration: When providing an exact concentration, the same value should be entered for LL and UL.
Concentration range: When a range is selected from the "Range Code" drop-down list, the LL and UL are self-populated.
Lower and upper limit: The lower and upper concentration limit of the ingredient may be entered manually.
"May contain" box
Check the "May contain" box to indicate variable ingredients present in the product such as the following:
Colouring ingredients: Some products such as makeup or nail polish/enamel may come in various shades. In the case of a single notification 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 notification form and product label.
Incidental ingredients are defined as any processing aid added, removed, or converted to a declared ingredient, or any ingredient 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 notification form 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" can be used or the terms "aroma" and "parfum", respectively.
Requests for information from Health Canada
If Health Canada has questions or concerns with a notification, 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, consult the list found in Appendix I.
In cases where a cosmetic presents an avoidable hazard that is described in the Cosmetic Regulations, copies of labels and inserts must be provided upon notification. Failure to provide labelling information will result in a notification being considered incomplete. For any cosmetic, a label may be required to clarify the function or representation of the product.
To attach a document follow the steps below:
In this section, select the submission method from the drop-down list. The instructions will appear on the box below.
Make sure to save and store the completed CNF for your records. Once the form has been submitted online, it will not be available for edits. Having a saved CNF will make it quicker and easier to submit an amendment or discontinuation of sale.
When submitting online for the first time, follow the technical requirements and instructions closely. If you encounter problems in submitting online, contact the Cosmetics Program.
Submission of a completed notification form
If the CNF is submitted online, a submission number will be provided. Include the submission number when communicating with Health Canada. The submission number is a confirmation that Health Canada received the submitted notification.
Types of reference numbers
Cosmetic number: The cosmetic number is a unique identifier assigned by Health Canada. Once the notification is processed, a cosmetic number will be assigned and sent to the notifier via email. For amendments or discontinuation of sale, enter the cosmetic number in this field to speed processing. This is equivalent to the "CNF number" used prior to 2013.
Case number: The case number is an internal tracking number for submitted notifications. The number is assigned and inserted directly into the form when submitted online. Including the case number in correspondence with Health Canada regarding the notification improves response times. If the notification is not submitted online, this number is assigned manually once the notification is received by Health Canada.
Submission number: The submission number is a unique tracking number for notifications submitted online. The number is automatically assigned and inserted directly in the form when submitted online. This number should only be used if a notification submitted online was not received by Health Canada.
Additional information or clarification is often requested by Health Canada. 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 cosmetic notifications submitted to Health Canada. These deficiencies can lead to inaccurate data and time delays in processing of the notification.
The cosmetic contains an ingredient found on the Cosmetic Ingredient Hotlist
Some ingredients are restricted or prohibited in cosmetics due to safety concerns. A list of these ingredients can be found on the Cosmetic Ingredient Hotlist.
If a cosmetic contains an ingredient which appears on the Cosmetic Ingredient Hotlist, the manufacturer or importer could be requested to take various steps:
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 under the Food and Drugs Act and its regulations. This includes claims within the name of the product, the product label or on the product's advertisement such as the product's website.
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 (for example, 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 notification 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 notification differ from the label, clarification will be requested by Health Canada , and processing of the notification will be delayed.
Amendments are required if changes are made to information in a previously submitted notification
Notifications are tracked according to product name and cosmetic number. When submitting a notification amendment, one of these identifying factors must be identified.
It is recommended to provide a cover letter to accompany the amendment indicating all of the changes.
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.
Manufacturers may choose to: