Notification of Cosmetics: Common issues when submitting a notification

The notifier is responsible for ensuring that the CNF contains accurate and complete information; otherwise, it may result in the CNF not being processed.

Health Canada may request additional information or clarification. Failure to respond to an information request within the specified time may result in compliance and enforcement action.

Under section 15.3 of the Cosmetic Regulations, Health Canada may impose stop sale measures on cosmetics that have not been notified, on those for which a revised notification has not been received (when required), and on those for which the Minister has requested additional information that was not provided.

This section lists common issues and questions related to CNFs submitted to Health Canada. These issues 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 notifier could be contacted by Health Canada for additional information and may be subject to compliance action. For products with ingredients described as restricted, providing information in the notification to allow Health Canada to determine if conditions are met, for example exact concentrations or labels, will help with processing of notifications.

The notified product contains ingredients that affect the classification of the product

The presence, or use under specific conditions, of certain substances may make a product unsuitable for classification as a cosmetic under the FDA. If this is the case, the notifier 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. Such 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, in advertisements for the product, or on company websites. If product representation includes therapeutic claims, the notifier will be redirected to the appropriate program area of Health Canada.

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, milliliters, 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 get 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 of ingredient Y: (13 g / 75 g) × 100 = 17.33%

Concentration of ingredient Z: (2 g / 75 g) × 100 = 2.67%

Thus, the ingredients concentration information on the cosmetic notification form can be entered as follows:

• Ingredient X: enter either the exact concentration of 80.00% or the concentration range code "1"
• Ingredient Y: enter either the exact concentration of 17.33% or the concentration range code "7"
• Ingredient Z: enter either the exact concentration of 2.67% or the concentration range code "9"

Completing a "kit" notification

A cosmetic product "kit" is sold with two or more different components, which are intended 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.

Concentration of ingredients for products meant to be mixed but sold separately

For products where components intended for mixing may be sold separately (for example: developers sold separately from dye solutions for hair salon use), concentrations should generally reflect concentration as supplied. Additional context regarding the expected concentration when applied by the consumer in its final formulation may be provided in the Product Description in Section 2 of the CNF or as an Additional Document in Section 6.

Concentration for ingredients for products meant to be diluted

For products intended for dilution where the diluent is not supplied, such as bath bombs, CNF should reflect the final concentrations of the ingredients in the product as sold to the consumer (i.e. prior to dilution).

Gift baskets

Products supplied together but not intended to be mixed together (for example: gift basket) or sequentially (for example: treatment solution and neutralization solution) are not considered to be "kits" for the purpose of the form. Each product should be notified separately.

Where additional information is required, for example to determine if a Hotlist condition is met, Health Canada may contact the notifier.

The name of the cosmetic or list of ingredients on the form is not consistent with the submitted label

The information given in the CNF must reflect the information found on the cosmetic product label. For example, the name of cosmetic and list of ingredients. If the name or ingredients in the CNF differ from the label, Health Canada will request clarification 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, if available.

Amendment or discontinuation of a cosmetic notification submitted before October 9, 2024

For CNFs submitted before October 9, 2024, you may use your previously saved ".hcxs" file to submit an amendment or discontinuation (i.e. "discontinue sale" notification type).

For amendments, once the previous ".hcxs" file is uploaded in section 9, you will be required to fill out the following new mandatory fields in these sections:

• Product - Section 2:
  • Type of product
• Manufacturing, Importing, Label and Other Contact - Section 4:
  • Name and complete address in Canada of the manufacturer or importer
  • If you are an importer, you must provide the name of the person who manufactured or formulated the cosmetic
  • Label contact information
• Ingredients - Section 5:
  • If you previously indicated a concentration range code for an ingredient, you will be required to use the appropriate concentration range code from the updated concentration ranges, or you may provide the exact concentration.

Once you have filled out the required fields and made the changes to your CNF, proceed to submit your notification.

To help with the submission of discontinuations, the new mandatory fields above will not be required.

Cosmetic notification processed by Health Canada's automated system

Certain cosmetic notifications, such as those with no prohibited ingredients or with certain restricted ingredients, are processed immediately by our automated system. If your cosmetic notification is processed by our automated system, you will receive an automatic email from DoNotReply.RADAR@hc-sc.gc.ca, that includes an assigned Cosmetic Number. Please add this email address to your contacts to prevent delivery of these automated messages to your spam or junk mail folders. Any cosmetic notification processed by our automated system may be subject to an internal review for quality assurance purposes. You will be contacted if any issues are identified. All other cosmetic notifications continue to be processed by a Health Canada Officer.

Processing of the completed form and issuance of a Cosmetic Number by Health Canada, whether through automated or manual processing, does not constitute, in any way, an approval for sale, agreement that a product complies with all regulatory requirements or that a product meets the definition of a cosmetic. The Cosmetic Number provided is for administrative use only.

As per section 30 of the Cosmetic Regulations, manufacturers and importers must notify Health Canada within 10 days after they first sell a cosmetic in Canada. Failure to notify may result in a product being denied entry into Canada or removed from sale. The responsible company must ensure that the cosmetic meets the requirements of the Food and Drugs Act and the Cosmetic Regulations, as well as all other associated legislation.

Disclosure of fragrance allergens

The presence of each fragrance allergen identified within Annex III of the European Commission's Cosmetic Products Regulation must be listed on the label if:

1. in the case of a rinse-off product, the concentration of the fragrance allergen in the cosmetic is greater than 0.01%^{Footnote 1}; or
2. in the case of a leave-on product, the concentration of the fragrance allergen in the cosmetic is greater than 0.001%^{Footnote 1}.

Details about the list of fragrance allergens requiring disclosure and the dates these come into force in Canada are described in section 8.7 of the Industry Guide for the Labelling of Cosmetics. This requirement also applies to fragrance allergens that are a component of a mixture, fragrance mixture ("parfum"), a botanical extract, or an essential oil.

Botanical extracts or essential oils may contain multiple fragrance allergens as constituents. All fragrance allergens present at concentrations greater than 0.01% in rinse-off products and greater than 0.001% in leave-on products must be disclosed in the list of ingredients, in addition to the essential oil ingredient.

• For example: "Melissa Officinalis Extract" can contain "Geraniol" as a natural constituent. Thus, if your cosmetic contains "Melissa Officinalis Extract" as an ingredient in your formulation and you have determined that "Geraniol" is present at a concentration above the disclosure threshold, then both must be disclosed in the list of ingredients.

As per paragraph 30(2)(d) of the Cosmetic Regulations, regulated parties must provide information about ingredients on the cosmetic notification form, including fragrance allergens that are present above the specified disclosure threshold. The concentration information of certain fragrance allergens is no longer mandatory on the cosmetic notification form, and you are reminded to select the "Fragrance allergen present above the disclosure threshold" checkbox.

If a concentration-related Hotlist condition is associated with a fragrance allergen, the exact concentration or concentration range code will remain a mandatory field for the processing of the cosmetic notification.

Note that manufacturers and importers are always encouraged to provide either the exact concentration or a concentration range code on the cosmetic notification form for fragrance allergens that are present in their cosmetic.

It is the responsibility of regulated parties to make appropriate business agreements with the product manufacturer or supplier in order to be able to obtain the concentration information of fragrance allergens present in their cosmetic in order to meet the notification and labelling disclosure requirements.

How to notify concentration information of fragrance allergens

To avoid error messages and ensure the correct validation of the total lower and total upper concentrations of ingredients, please consult the example below:

• A leave-on cosmetic contains "Parfum", "Limonene" and "Citral" at the following concentrations in the final formulation:
  • Parfum : 3.00 %
  • Limonene: 0.20%
  • Citral: 0.10%

For a leave-on product, any fragrance allergen present at a concentration greater than 0.001% must be disclosed in the list of ingredients on the product label and on the cosmetic notification. The concentration information on the cosmetic notification (in section 5) can be entered as follows:

Option 1: The concentration information for "Parfum" does not include the concentration of the fragrance allergens present in the formulation:

• Parfum: enter the exact concentration of 3.0% or concentration range code 9 (more than 1% but no more than 3%)
• Limonene: enter the exact concentration of 0.20% or concentration range code 11 (more than 0.1% but no more than 0.3%)
• Citral: enter the exact concentration of 0.10% or concentration range code 12 (more than 0.001% but no more than 0.1%)

Option 2: The concentration information for "Parfum" includes the concentrations for all fragrance allergens present above the disclosure threshold:

• Parfum: enter the exact concentration of 3.30% or concentration range code 8 (more than 3% but no more than 10%)
• Limonene: leave the concentration field blank
• Citral: leave the concentration field blank

For both options, don't forget to check the "Fragrance allergen present above the disclosure threshold" box for Limonene and Citral.

Identifying grouped fragrance allergens

Grouped fragrance allergens are composed of multiple fragrance allergens that must be disclosed in the list of ingredients by their respective "group name". This helps to simplify the list of ingredients, making it easier for consumers to read and identify a substance to which they may be sensitive.

Disclosure of the "group name" on the cosmetic notification and on the label applies when the sum of the concentrations of the substances within the grouped entry exceeds 0.001% in leave-on products, or exceeds 0.01% in rinse-off products. Note that it is permitted to list the substances from a group allergen entry individually in the list of ingredients as additional information, but it is not mandatory. Guidance on this topic is provided in section 8.3.8.1 of the Industry Guide for the Labelling of Cosmetics.

When you submit a cosmetic notification containing grouped fragrance allergens, you can either:

• enter the "group name" as an ingredient, or
• enter each fragrance allergen that is included in the "group name" as an individual ingredient

Check the "Fragrance allergen present above the disclosure threshold" box for the "group name" or for each fragrance allergen that is included in the "group name". Please refer to details presented above on how to indicate the concentration for fragrance allergens on the cosmetic notification.