This document contains generalinformation 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 therequirements under the Food and Drugs Act or the Cosmetic Regulations.In case of any discrepancy between this document and the legislation, thelegislation will prevail.

As per section 16a of the FDA, "No person shall sell a cosmetic that contains any substance thatmay cause injury to the health of the user." Therefore, Health Canada hasdeveloped the Cosmetic IngredientHotlist (Hotlist), which is an administrative tool used tocommunicate to manufacturers and others, that certain substances may causeinjury to the health of the user – which may contravene the general prohibitionfound 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 orprohibited in cosmetics due to safety concerns. In addition, the Hotlistincludes certain substances that may make it unlikely for a product to beclassified as a cosmetic under the FDA. Despite whether a substance is describedon the Hotlist, Health Canada can take appropriate actions to enforce the FDAand CR.

Table of contents

 
• When completing a Cosmetic Notification Form
• Notify each unique product separately
• Single notification of multiple products
• Submit all required documents at time of notification
• What is an ingredient?
• How to complete a Cosmetic Notification Form
• Notification - Section 1
• Notification type
• Product - Section 2
• Notifier's reference
• Primary product brand and name
• Date of First Sale
• Other product names
• Product description
• Area of application
• Function of product
• Form of product
• Notifier - Section 3
• Manufacturing and distribution - Section 4
• Product ingredients - Section 5
• Ingredient name
• Ingredient search
• Concentration of ingredients
• Additional information
• Documents and pictures - Section 6
• Submitting the Cosmetic Notification Form - Section 7
• How to save your Cosmetic Notification Form - Section 8
• How to view/edit your previous Cosmetic Notification Form – Section 9
• Appendix I: Common deficiencies

When completing a Cosmetic Notification Form

Notify each unique product separately

A Cosmetic NotificationForm (CNF) must be submitted by the manufacturer or importer for each uniqueproduct. One CNF covering multiple products is only permissible under certainsituations and is recommended for product lines that differ by only onecompositional aspect, such as colour or fragrance (for example: a line oflipsticks). A product available in different sizes does not require separateCNFs for each size.

Single notification of multiple products

In certain situations, manufacturers or importers may cover an entireproduct line with a single CNF. This may be done only when all of thefollowing conditions are met:

 
• The same basic product name or trademark applies to all individual products in the line.
 
• The product base remains unchanged in composition from one variation to another, except for slight changes in colouring, flavouring or fragrance ingredients to accommodate the variable part of the formulation.
 
• All the information inserted on the CNF other than composition is identical for each individual product in the line (for example: the manufacturer, distributor, function, and form of the cosmetic are the same for all products).

Note: If the number of products in the product line changes slightly due to theaddition or deletion of a few items in the product line, an amendment to theCNF is not required, unless other information, such as composition, has alsochanged.

Submit all required documents at time of notification

The CR has mandatory warnings for certain products and for others, theHotlist contains labelling examples such as cautionary statements that HealthCanada considers acceptable to mitigate certain avoidable hazards.

For products with an avoidable hazard, documents such as product labelsmust be submitted at the time of notification.

What is an ingredient?

A cosmetic ingredient is any substance or component that is deliberatelyadded to the formulation. Ingredients usually have a cosmetic function and givea certain physical property to the final product. Examples include conditioningagents, fragrances, colouring agents, preservatives and flavours, but excludesimpurities or ingredients consumed during the manufacturing process.

How to complete a Cosmetic Notification Form

The CNF is comprised of nine sections. Following the instructions belowwill help you to fill out all sections correctly. Note that all fields markedwith an asterisk are mandatory. The CNF cannot be submitted unless allmandatory fields are properly filled. Supplying complete information will helpin the processing of the CNF.

Notification Type - Section 1

Notification type

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 productwith the name indicated in Section 2 and sold by the manufacturer or importerindicated in Section 4.

Amendment: If the information related to a product that haspreviously been notified to Health Canada requires amendment, and the intentionis to continue to sell the product, select "Amendment." Although allsections of the CNF must be completed in an amendment, this can be avoided ifthe information from your previous CNF has been saved. Provide the CosmeticNumber (see Section 8; Reference numbers associated with Cosmetic NotificationForms) to help identify your product. If Health Canada is unable to match anamendment 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 beendiscontinued from sale on the Canadian market by the manufacturer or importer(but not necessarily by retailers), provide a notification to this effectwithin 10 days of the change. Note that a notification of discontinuation ofsale should take place upon cessation of sale by a manufacturer or importer,and not upon cessation of production of the cosmetic. To help identify yourproduct, include the Cosmetic Number (see Section 8; Reference numbersassociated with Cosmetic Notification Forms) while submitting yourdiscontinuation of sale.

Product - Section 2

Notifier's reference

This field is to be used by companies for their own internal purposes. Forexample, it can be used to identify any internal non-commercial names for theproduct, such as a formula code used by contract manufacturers.

Primary product brand and name

Indicate the primary brand and name of the cosmetic, as it appears on theproduct label.

This name may or may not include the name of the manufacturer. This nameshould be unique to the manufacturer and should distinguish the product fromall other products marketed by the company.

For example, if a product is marketed by a company called "CosmeticBrand" as "Gentle Lavender Shampoo," the primary brand and nameof the product would be "Cosmetic Brand – Gentle Lavender Shampoo".Product names such as "Shampoo" are not distinctive enough foridentification of the product.

Date of First Sale

If the product is already sold in Canada, enter the date of first sale (orapproximate). If the product is not yet sold in Canada, enter the anticipateddate of first sale.

Other product names

In this section, indicate if the product is marketed under other nameswhich have shade/colour, scent/fragrance and aroma/flavour variations, wherethe base formulation is the same. It can also be used to include alternatelanguage translations or any alternate name.

Product description

Use this section for supplemental information to describe the product'spurpose. For example: this is a shine serum for hair.

This section can also be used to identify cosmetic products that arepackaged 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 benotified separately. Provide both the name(s) and cosmetic number(s) (ifavailable) of the product(s) with which it is packaged.

Area of application

The table below describes the area(s) ofapplication of the product - choose the most appropriate.

Function of application

The table below describes the function(s)of the product – choose the most appropriate.

Function of product

The table below describes the form(s) ofthe product - choose the most appropriate. The form of the cosmetic is thestate of the final packaged product ready for sale.

Notifier - Section 3

The notifier can be the manufacturer, a Canadian importer or a personresponsible on their behalf. All correspondence will be sent to the notifier.Therefore, indicate the full legal business name, complete mailing address andcontact information, including the telephone number and e-mail address, of thecompany submitting the CNF.

Manufacturing and Distribution - Section 4

In this section, enter contact information for the manufacturer or Canadianimporter as it appears on the product label. If the cosmetic was notmanufactured or formulated by the person whose name appears on the label,provide the contact information for any additional manufacturers. Contact informationfor 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 intoSection 4.

Use the box "Contact Type" to indicate if the contact is adistributor, importer or manufacturer. If the contact has multiple roles, forexample is both the importer and a distributor, select the highest level oftrade (in this case the importer).

Product Ingredients - Section 5

This section is used to specify the ingredients and their concentrations inthe product(s). List all of the product ingredients separately, entering onlyone ingredient per line on the CNF. Use the "Add Ingredient" and"Remove Ingredient" buttons to add or remove ingredients. The list ofingredients on the CNF must be consistent with the ingredients listed on theproduct label.

To avoid delays in notification processing:

 
• List only one ingredient per ingredient entry
 
• Enter each ingredient within a proprietary blend/base formulation separately.
 
• Use International Nomenclature for Cosmetic Ingredient (INCI) names where possible.
 
• List botanical ingredients by their full INCI name, or at a minimum, the genus and species portions of the full INCI name.
 
• Ensure spelling of the ingredient is correct.
 
• Verify that the dashes and spaces in the ingredient name are in the correct location.
 
• For colouring ingredients, use the Colour Index (CI) number or colour name (not both).

An attached list of ingredients (for example: in a Certificate of Analysis,material safety data sheet, etc.) is not an acceptable alternative to fillingout this section of the CNF.

Ingredient name

Each ingredient must be listed separately, preferably using the INCIsystem.

If there is no INCI name for the ingredient, list the ingredient name,using one of the following commonly recognized naming systems below (listed inorder of preference):

 
• Chemical Abstract Service number (CAS #)
 
• Chemical name such as the Chemical Abstract Service (CAS) name, or an International Union of Pure and Applied Chemistry (IUPAC) name
 
• "Trade" name from the Merck Index (current edition) (Published by Merck & Co., Inc., Rahway, NJ, USA)
 
• Latin name (the scientific binomial name, including the genus and species)
 
• International Non-Proprietary name (INN)
 
• European or U.S. Pharmacopoeia Name (EP, USP)
 
• Common name

Ingredient search

After entering the ingredient name, pressing the "SearchIngredient" button will validate the entry and show any importantinformation related to the use of this ingredient in cosmetics in Canada. Theresults from the ingredient search will show in the "IngredientStatus" field and are as follows:

 
• Known: The ingredient is not prohibited or restricted for use in cosmetics.
 
• Restricted: The ingredient is restricted for use in cosmetics. The details of the restriction will be provided in the "Condition of use" field.
 
 
• If the ingredient has a concentration restriction, providing the exact concentration used in the product at the time of notification will help expedite processing of the CNF.
 
• If the ingredient requires warning statements, provide a copy of the product label.
 
 
• Prohibited: The ingredient is prohibited for use in cosmetics, therefore the product cannot be sold in Canada as a cosmetic.
 
• Unknown/Not found: The ingredient is not recognized or not known to be used in cosmetics. Check that the ingredient is spelled correctly and is entered as per the naming conventions listed above. Also verify spaces and punctuation. Additional information may be added in Section 6 to help identify unknown ingredients (for example, Material Safety Data Sheets or Certificates of Analysis). This may trigger further review by Health Canada.

Note: The Hotlist should be consulted each time a CNF is submitted. If unsureabout the acceptability of an ingredient, please contact your nearest Product Safety Office.

Concentration of ingredients

Ingredient concentration may be indicated by entering an exactconcentration, selecting one of seven set concentration ranges/range codes, orby manually entering a lower and upper concentration. The Table in  section 30 of the Cosmetic Regulations specifies the rangecodes 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 onthe Cosmetic Ingredient Hotlist may contravene the Food and Drugs Actand/or a provision of the Cosmetic Regulations.

If a restricted ingredient is listed on the CNF, providing the exactconcentration of the ingredient (as opposed to a concentration range), andsubmitting all labelling materials with the CNF (Section 6), will help expediteprocessing of the CNF.

Exact concentration: When providing an exactconcentration, 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 areself-populated.

Lower and upper concentration: The lower and upperconcentration of the ingredient may also be entered manually.

The total concentration should add up to 100% unless the formulationincludes ingredients that are variable (i.e. "May contain" box hasbeen checked).

Additional information

"May contain" box

Check the "May contain" box to indicate variable ingredientspresent in the product such as the colouring or fragrance ingredients. Forexample, some products such as makeup or nail polish/enamel may come in variousshades. In the case of a single CNF for multiple products, list all thevariable colouring agents used in the product line, indicate the maximum concentrationrange and check the "May contain" box for each one.

Aerosol container propellants

If the product is packaged in an aerosol container, list the propellantingredient and its concentration on the CNF and product label.

Incidental ingredients

Incidental ingredients are defined as any processing aid added and removed,or converted to a declared ingredient, or any component of another ingredientor processing aid present at an insignificant level and having no technical orfunctional effect. These substances do not need to be declared on the CNF orthe product label.

Fragrance and flavouring agents

Flavouring and fragrance agents do not need to be listed by theiringredient 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, oridentifies any other deficiencies, the notifier may be contacted.

Depending on the issue, a request for one or more of the following could bemade:

 
• provide more information to demonstrate the safety of the product
 
• provide labels
 
• re-label the product
 
• reformulate the product
 
• remove the product from sale and recall the product
 
• submit a product licence application to a different Health Canada program such as the Health Products and Food Branch or the Pest Management Regulatory Agency

To avoid common deficiencies and delays in processing your CNF, consult thelist found in Appendix I.

Documents and pictures - Section 6

In cases where a cosmetic presents an avoidable hazard that is described inthe Cosmetic Regulations or on the Cosmetic Ingredient Hotlist, copiesof labels and inserts must be provided upon notification. Failure to providelabelling information will result in a CNF being considered incomplete. For anycosmetic, a label may be required to clarify the function or representation ofthe product.

To attach a document to the CNF, follow the steps below:

 
1. Click the "Choose Files/Browse" button and select the document to be attached.
 
2. Add a title to each document and select a document type from the drop-down list menu: the most common selection will be "Label - Text" for a text only label, or "Label - Marketplace" for a label including graphics or a printer's proof.
 
3. Use the "Choose Files/Browse" button each time another document needs to be attached, or use the "Remove Document #X" button to remove an attached document.

Note that the size of individual documents attached to the CNF iscumulative 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 thetotal size of your documents exceed 70 Mb, use the Submit Additional Documentsbutton on the Notification ofCosmetics webpage.

How to submit your Cosmetic Notification Form - Section 7

When submitting online for the first time or if you encounter problemssubmitting online, follow the Help on Forms page closely.

Click the "Proceed to Submit" button to submit the CNF. Aconfirmation will be displayed if the CNF has been successfully submitted,along with the assigned Case and Submission Numbers. Include the Case andSubmission numbers when communicating with Health Canada.

How to save your Cosmetic Notification Form - Section 8

Saving your Cosmetic Notification Form information

Be sure to save the information submitted in the CNF for your records. Notethat only the text entered in the online CNF will be saved, in a file with theextension format “.hcxs”, but not the form itself. The information related toyour CNF can be saved at any point while filling the online form.

Once the CNF has been successfully submitted, save the file in a locationthat will be easy to find using a name that includes the Case number andSubmission 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 easierto submit an amendment or discontinuation of sale.

To save your online form information on your computer:

 
• Right click on “Save my form”
 
• from the pop-up menu presented, left click on the option “Save as…”
 
• Using the “Save as” pop-up window presented, choose where your online form’s information can be saved on your computer. The file extension used is “.hcxs”.

How to view/edit your previous Cosmetic Notification Form – Section 9

To view or edit previously saved information on the CNF, open the CNFwebpage and scroll down to the bottom to Section 9. Then proceed with thefollowing steps:

 
1. Select the information file you previously saved on your computer, using the "Choose File/Browse" button.
 
2. The file name of the selected file will be displayed to the right of the "Choose File" button.
 
3. Click on the "Upload Information" button.
 
4. The information previously saved will be presented in the online form.
 
5. If you edit the information, and you wish to submit it, please see section on "How to submit you Cosmetic Notification Form" for more details.

Note: Ensure the online form is empty (does not contain information fromanother CNF) BEFORE you upload your information file. Also, in order for othersto view OR edit the content of your CNF, they must first find the empty onlineform on the Health Canada Website, view it on their browser, then upload theinformation file you forwarded to them.

Amendments and discontinuations

Amendments are to be submitted whenever a change to the product needs to bemade, such as the product brand and name, contact information or ingredientlist. To amend or discontinue a product, open the CNF webpage and scroll downto the bottom to Section 9, then proceed with the following steps:

 
• Use the “Choose file/Browse” button to select the file containing the information; the file will have the extension “.hcxs”
 
• Use the “Upload information” button to upload the information. The information previously saved will be populated in the CNF
 
• For an amendment, select “Amendment” as the Notification Type in Section 1 of the CNF and add the Cosmetic Number
 
• Make any necessary changes and click the “Proceed to submit” button to submit online
 
• Remember to save a copy of any changes to your CNF information for your own records (refer to the Saving your Cosmetic Notification information section above for more details)
 
• For a discontinuation, follow the same process above, but rather than “Amendment” select “Discontinue Sale” as the Notification Type in Section 1 of the CNF

Reference numbers associated with CNF

Cosmetic Number (CN): The CN is a 7-digit unique identifier assigned by Health Canada. Oncethe 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 speedprocessing. This CN should also be used in any correspondence with HealthCanada 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 forsubmitted CNFs. The numbers are assigned and inserted directly into the CNFwhen submitted online. Including the Case and Submission Numbers incorrespondence with Health Canada regarding the CNF improves the department’sability to identify the product(s) referenced.

Appendix I: Common deficiencies

Additional information or clarification is often requested by HealthCanada. Missing or incomplete information may result in the CNF not beingprocessed. Failure to respond to an information request within the specifiedtimeframe may result in the product(s) becoming non-compliant with thelegislation and therefore subject to compliance action.

This section lists common deficiencies found in CNFs submitted to HealthCanada. These deficiencies can lead to inaccurate data and time delays inprocessing of the CNF.

The cosmetic contains an ingredient found on theCosmetic Ingredient Hotlist

If a cosmetic contains an ingredient which appears on the Hotlist, themanufacturer or importer could be contacted by Health Canada for additionalinformation and may be subject to compliance action.

The cosmetic contains ingredients that affect theclassification of the product

The manufacturer will be redirected to another program area of HealthCanada.

Therapeutic representation of the product in theproduct's name, label or website

Cosmetic products cannot have therapeutic claims associated with thembecause those claims may result in the product being classified as a drug ornatural health product under the Food and Drugs Act and itsregulations.  This includes claims within the name of the product, on theproduct label or in advertisements for the product as may be found on companywebsites.

Incorrect calculations of ingredient concentrations

The concentration of an ingredient is calculated as the percentage of theingredient within the total composition of the product. To calculate theconcentration, ensure that all quantities are in the same units of weight orvolume (grams, millilitres, kilograms and litres). For example, when usingweight in grams as the units, first add the weight of all the ingredientspresent 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 productand multiply the result by 100 to obtain the concentration of the product inpercent.

Concentration (in %) = (Quantity of ingredient / Quantity of allingredients 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 onthe form is not consistent with the submitted label

The information provided in the CNF must reflect the informationfound on the cosmetic product label (for example, name of cosmetic and list ofingredients). If the name or ingredients in the CNF differ from the label,clarification will be requested by Health Canada , and processing of the CNFwill be delayed.

Amendments are required if changes are made toinformation in a previously submitted CNF

CNFs are tracked according to product name and Cosmetic Number. Whensubmitting a notification amendment, please include the Cosmetic Number. At aminimum, the product name in the amendment must match the name on the CNFpreviously 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 bemixed together before the product is to be used (for example: a hair dyeproduct).

List all kit components on the same CNF and indicate "kit" in thesection "Form of product". Note that the list of ingredients on theCNF should represent the finished product (once the “kit” has been mixedtogether) and should also be the same list that is on the product label.

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