All cosmetic products that are sold in Canada must be notified to Health Canada in compliance with the Cosmetic Regulations by submitting a Cosmetic Notification Form (CNF). A product is considered a cosmetic if it meets the following definition:
- Serves the purpose of cleansing, moisturizing, lubricating, perfuming, or cosmetically altering the hair, skin, teeth, complexion of humans or animals
- Contains a substance of mixture of substances that come into contact with the body, especially the skin, hair, nails, and teeth.
- There is no representation or claims of therapeutic effects such as disease/disorder prevention or treatment.
- It does not contain ingredients with a primary therapeutic purpose.
Some products applied to the oral, nasal, or vaginal cavities may be considered cosmetics. Products applied directly into the eyes (e.g. eye drops) and articles such as brushes, razors and applicators are not considered cosmetics.
Cosmetics must be notified by the individual or firm that is responsible for the product in Canada, or a party that is authorised on their behalf. This can be the manufacturer, distributor, or importer.
Resolving Common Cosmetic Notification Form Errors
Errors on a Cosmetic Notification Form can result in delays in processing or rejection of the form. The Cosmetics Program may request additional information after receiving an incorrect CNF, and if this is not provided by the deadline it will result in the affected product(s) being declared non-compliant and prohibited for sale in Canada.
1. Product contains Hotlist Ingredients
For prohibited ingredients, the manufacturer can:
a) Confirm the product is no longer on the Canadian market or no longer contains the prohibited ingredient.
b) Confirm intent to reformulate the product and provide the anticipated date of reformulation.
c) Submit a Cosmetic Notification Form Amendment that outlines the new formulation with complete ingredient and concentration information.
For restricted ingredients, the manufacturer can:
a) Provide the exact concentration of the restricted ingredient as the concentration range
indicated on the form may not be acceptable.
b) Provide copies of the labels and inserts associated with the product that demonstrate
the required information.
c) Submit adequate safety evidence outlined in the Cosmetics Ingredient Hotlist.
2. Therapeutic claims appear in the product name, label, or website
The manufacturer can choose to:
a) Remove the inappropriate claims.
b) Remove the product from sale and market it as a drug by applying for a Drug Identification Number (DIN) or Natural Health Product Number (NPN).
3. Missing, unknown, or misspelled ingredients
a) Make sure that each ingredient is identified by its CTFA International Nomenclature Ingredient (INCI) name.
b) If an ingredient doesn’t have an INCI name, its “Title” name from the Merck Index can be used instead.
c) If the ingredient doesn’t appear in the Merck Index, it should by specified by its chemical name/composition and Chemical Abstracts Service (CAS) number if possible. In this case, basic information on the ingredient’s safety in cosmetics should also be submitted with the Cosmetic Notification Form.
4. Mixtures Indicated as a single ingredient and concentration
a) List ingredients added to the product as a premixture separately on the form with the corresponding concentration of each.
b) If the mixture is proprietary and unknown to the party submitting the Cosmetic Notification Form, they are responsible for ensuring that the supplier submits the appropriate information directly on their behalf.
5. Incorrect calculations of ingredient concentrations
a) Ensure that all ingredient quantities are in the same units of weight or volume when calculating their percentage in the total product.
6. Name of the product and/or list of ingredients in CNF are not consistent with the label submitted
a) Ensure that the ingredients and product name are consistent with those that appear on the product label submitted.
b) Ensure that ingredients that are over 1% of the total product composition appear on the product label in descending order of concentration (largest to smallest).
7. Amendments are not clear
a) Make sure that the product name on the amendment is the same as the one on the original Cosmetic Notification Form so that the changes can be tracked.
b) If the product name is being amended, include the original name in brackets after the updated name.
c) If the company information is being changed, submit a letter indicating the change and the affected notifications. A separate amendment for each CNF is not
d) If many changes are being made, submit a cover letter with the amendment indicating all changes.
8. Missing signatures
a) Ensure that all notifications are submitted with signatures of the manufacturer or their authorised party.
9. Completing a multiple notification for a line of products
To complete this option, the base ingredients across the product line must be identical, with only differing pigments or scents between each item.
a) Indicate the exact number of product covered either in Box 13 or on the Cosmetic Notification Form coversheet.
b) List each of the possible variable ingredients at the highest concentration they can appear in any of the products in the line.
10. Completing a Kit Notification
Cosmetic kits are products sold with two or more components that are meant to be mixed before application. Each component is given a different Cosmetic Notification Form number. Manufacturers can:
a) Complete a separate CNF for each component and indicate that each form is part of the same kit.
b) List all components on a single CNF and clearly separate the components using headings and spaces.
The easiest way to ensure that your cosmetic products are notified correctly and prevent delays or rejections is to submit them through a reputable regulatory affairs and quality assurance consultant. Focal Point Research Inc. has over 25 years of experience in Canadian Cosmetic Regulation and Compliance. Please do not hesitate to contact us if you require assistance with Cosmetic Notification Forms. We are industry leading Cosmetic Regulatory Consultants that you can trust to help guide your company in the right direction.