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Guide for Completing Cosmetic Notification Forms
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(PDF Version - 716 K)Table of Contents
- Overview
- 1. What Products Are Subject to Cosmetic Notification?
- 2. Who Should Notify a Cosmetic?
- 3. What Is an Ingredient?
- 4. General Information on Completing the Form
- 5. The Notification Form
- Box 1: New Notification or Amendment to an Existing Notification
- Box 2: Do You Intend to Continue the Sale of the Cosmetic in Canada?
- Box 3: Name of the Cosmetic
- Box 4: Manufacturer
- Box 5: Other Manufacturer
- Box 6: Canadian Distributor
- Box 7: Correspondence to be Sent to
- Box 8: Correspondent Language Preference
- Box 9: Purpose of the Cosmetic
- Box 10: Form of the Cosmetic
- Box 11: Cosmetic Intended for Use on
- Box 12: Number of Products Covered by this Notification
- Box 13: Composition
- Authorized By
- 6. Attachment of Labels and Inserts
- 7. Discontinuation of Sale of a Product
- 8. Submission of Completed Notification Form
- 9. Requests for Information from the Cosmetics Program
- 10. Additional Resources
- Appendix I : Purpose Definitions
- Appendix II: Forms Definitions
- Appendix III: CNF Common Errors
- Product contains a 'Hotlist' ingredient
- Therapeutic claims in the product name, label or Web site
- Missing, unknown, misspelled ingredients
- Mixtures indicated as a single ingredient and concentration
- Incorrect calculations of ingredient concentrations
- Name of cosmetic and/or list of ingredients in CNF are not consistent with the submitted label
- Amendments not clear
- Signatures missing
- Completing Box 13 "Composition" for "Multiple Notifications"
- Completing a "Kit" Notification
- Appendix IV: CNF Completeness Checklist
This guide is intended to assist cosmetic manufacturers interpret the requirements and terminology used in section 30 of the Cosmetic Regulations as well as to complete Cosmetic Notification Forms (CNFs).
Overview
Notification is a mandatory requirement for sale of cosmetics in Canada. Under the Cosmetic Regulations, all cosmetics must be notified to the Cosmetics Program of Health Canada within the first 10 days a cosmetic is available for sale. Failure to notify may result in a product being denied entry into Canada or removed from sale.
The completed CNF provides specific product information to Health Canada, including:
- address and contact information of the manufacturer(s), distributor(s), and other associated companies;
- purpose of the cosmetic;
- form of the cosmetic (e.g. cream, gel, aerosol, etc.);
- ingredients of the cosmetic;
- concentrations of the ingredients.
There is no fee associated with the cosmetic notification process.
The information obtained by the Cosmetics Program is considered to be confidential, and will be discussed only with the company (manufacturer or distributor) that submitted it.
By law, companies must inform the Cosmetics Program whenever a change affecting the information on a CNF is made. Some examples of this include (but are not limited to):
- modification to the cosmetic formulation;
- change of product name;
- discontinuation of sale;
- new company name, address, or contact information.
Please note: Completion of the CNF and submission to the Cosmetics Program does not constitute approval for sale by Health Canada, or agreement that the product is in compliance with all regulatory requirements. The manufacturer or Canadian distributor has the responsibility of ensuring that a cosmetic meets the requirements of the Food and Drugs Act and its Regulations.
If there are concerns with a submitted notification or product (i.e.: unacceptable ingredients, missing information, safety concerns, unacceptable claims, etc.) the Cosmetics Program will inform the responsible company that the product does not meet the requirements of Food and Drugs Act and Cosmetic Regulations. Failure to respond may result in compliance action taken on the product.
For information on other cosmetic regulatory requirements, such as labelling, ingredient prohibitions and restrictions and claims, see "Additional Resources" at the end of this guide, or contact your Regional Product Safety Office.
1. What Products Are Subject to Cosmetic Notification?
All cosmetic products sold in Canada are subject to notification to Health Canada under the Cosmetic Regulations. The definition of "cosmetic" can be found in section 2 of the Food and Drugs Act.
In order to be classified as a cosmetic, the product must meet the following criteria:
- The product serves a cosmetic purpose of cleansing, moisturizing, lubricating, perfuming or altering the hair, skin, teeth or complexion of humans and/or animals.
- The product is a substance or contains a substance or a mixture of substances that come into contact with the body to achieve the cosmetic effect. This is generally limited to the skin, hair, nails and teeth. Products meant to be applied to the oral, nasal and vaginal cavities may be considered cosmetics. Products meant to be applied directly into the eyes are not considered cosmetics (e.g. moisturizing eye drops), while those applied to the skin around the eyes would be considered cosmetics. Articles per se are not cosmetics (e.g. brushes, razors, applicators).
- The product does not make any representation or claims of having therapeutic properties such as the prevention or treatment of a disease, disorder or abnormal condition.
- The product does not contain ingredients that primarily have a therapeutic purpose (e.g. has a drug-like effect).
Examples of products considered to be cosmetics:
- Artificial nail builders and adhesives
- Soap
- Microdermabrasion kits / chemical peels
- Tooth whiteners
- Tattoo inks and temporary tattoos
- Cleansing wipes (i.e. cleansing ingredients contained within the wipes)
- Professional Use Products
- Institutional Use Products
- Hotel amenities
- Samples
- Feminine Douches
Examples of products NOT considered to be cosmetics:
- Brushes
- Laser treatment hair removers
- Collagen or 'Botox' injections
- Denture cleansers
- Insect repellents
- Oral supplements
- Acne treatments
- Room or fabric sprays
Products that appear to be cosmetics, but that fall outside of the above criteria may be subject to other regulations. Visit our Web site to links to these other programs: www.healthcanada.gc.ca/cosmetics
2. Who Should Notify a Cosmetic?
Cosmetics must be notified by the person or firm who is responsible for the product in Canada, or a firm or person authorized on their behalf. The responsible party may be the manufacturer, the importer or the distributor of the product. The notifying company is the main contact point for correspondence from Health Canada and consumers, as well as for questions, concerns or compliance action regarding the product.
3. What Is an Ingredient?
A product's formulation makes up the largest part of a cosmetic notification. A list of ingredients based on the International Nomenclature of Cosmetic Ingredients (INCI) dictionary is mandatory on the cosmetic product label.
A cosmetic ingredient is any substance or component that is deliberately added to the formulation and/or is found in the final cosmetic product. Ingredients usually have specific functions and impart a specific characteristic to the final product. Examples include conditioning agents, fragrances, colouring agents, preservatives and flavours.
Unacceptable cosmetic ingredients are those that may cause harm in the amounts used, exhibit pharmacological activity, or have potential adverse effects on health. A list of prohibited and restricted cosmetic ingredients, known as the Cosmetic Ingredient Hotlist, can be found on the Health Canada Web site at www.healthcanada.gc.ca/hotlist.
Please see Box 13 below for information on declaring specific ingredient types.
4. General Information on Completing the Form
Please follow the instructions below to ensure appropriate completion of all notification forms and to avoid any unnecessary delays in processing.
- a) Complete the form in triplicate. Provide the Cosmetics Program with two copies, stapled together, at the address below, and retain one copy as the manufacturer.
Cosmetics Program
269 Laurier Avenue West, 7th floor
A.L. 4907E
Ottawa, ON K1A 0K9Questions?
Telephone: 1-866-662-0666 (toll-free in Canada and the United States)
Email: cosmetics@hc-sc.gc.caElectronic submissions are currently not accepted.
- b) Ensure the completed CNF is clear and legible. Avoid messy handwriting, small print and typographical errors. To ensure accuracy in entering data, it is highly recommended that information be typed on the form. Incomplete or illegible CNFs will not be processed.
- c) If there is insufficient space to complete any item on the form, insert the term "(continued)" at the bottom of the available space, and complete the item on a second form. Complete Boxes 3 and 4, the signature and date at the bottom of the forms, and staple them together.
- d) Complete the "Page__ of__" information at the top of each CNF page (i.e. indicate the number of pages of each CNF).
- e) Notify each unique product separately. Note that one notification covering multiple products is permissible under certain conditions and is recommended for product lines that differ by only one compositional aspect, such as colour or fragrance (e.g. a line of lipsticks). A product available in different sizes does not require separate notifications for each size. See Box 12 and Box 13 below for more information.
- f) Submit all associated labelling materials with the notification form to facilitate processing time and to clarify cosmetic claims in the name of the product. Submission of labels is mandatory for products that present an avoidable hazard (see Section 6 - "Attachment of Labels and Inserts" below) and products which contain restricted ingredients as per the current Cosmetic Ingredient Hotlist. Labels are also requested for products intended for animals.
- g) When required, include a covering letter along with the CNF to outline any pertinent information regarding the form, product or ingredients.
- h) If any difficulties are encountered in completing the form, or for questions regarding the notification process, please contact the Cosmetics Program at the coordinates mentioned above.
5. The Notification Form
The cosmetic notification form is separated into 13 Boxes and an "Authorized By" section. Follow the instructions below carefully to ensure all sections are filled out completely and correctly.
Box 1: New Notification or Amendment to an Existing Notification
- New
If the product has not previously been notified with the Cosmetics Program, check the "New" Box.
A new notification is the first one submitted for a product with the unique name indicated in Box 3 and sold by the manufacturer indicated in Box 4.
- Amendment
If the product has previously been notified, and a change is required to be made to the submitted information, check the "Amendment" box.
All sections of the form must be completed in an amendment.
Please ensure that the following information is outlined on a cover letter to ensure that all changes to the CNF will be captured:
- CNF number, if known;
- name of product as listed on the original notification (in order to avoid a duplicate entry);
- summary of all changes (e.g. change of product name, ingredients added or removed, concentration changes, manufacturer change, etc.).
If the Cosmetics Program is unable to match an amendment with a previously submitted CNF, the amendment will be rejected.
Note: For any product, the CNF bearing the most recent date will be regarded as the current one, replacing all CNFs and information submitted earlier.
Resubmit any labelling materials with an amendment.
Box 2: Do You Intend to Continue Sale of the Cosmetic in Canada?
- Yes
If the product is intended to be sold in Canada at the time of notification, check the "Yes" box.
A "Yes" answer is required if the product is being test-marketed. Later, if the results of the test marketing cause the product to be withdrawn from the market, Health Canada is to be advised of the change in status, to ensure the notification information is current. Please note that test-marketed cosmetic products must meet all requirements of the Cosmetic Regulations under the Food and Drugs Act. There are no exemptions for test-marketing.
- No
If there is very limited marketing of the product planned (for example, in the case where the sale of the product is for purposes of establishing a trade mark), check the "No" box.
If the sale of a product is to be discontinued, see Section 7, "Discontinuation of Sale of a Product" below.
Box 3: Name of the Cosmetic (as appears on label)
Indicate the primary name of the cosmetic, as it appears on the product label.
The primary name of the cosmetic is the name under which the product is sold. 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 distinguish the product from all others marketed by the firm.
For example, if a product is marketed as "Gentle Lavender Shampoo", this should be the name indicated in Box 3. Cosmetic names such as "Shampoo" are not distinctive enough for identification of the product.
The cosmetic name should be consistent with the cosmetic name indicated on any submitted labels for the product.
Box 4: Manufacturer (whose name and contact information appears on the label)
Indicate the full legal name, complete mailing address, telephone and facsimile information of the company who is responsible for the product in Canada, and which would normally be contacted by mail by consumers to obtain further information on the product.
This name and mailing address must correspond to the name and address on the label.
A manufacturer is any person, company, partnership or corporation who sells or manufactures and sells a cosmetic under its own name or a name that it controls. This is generally the brand owner or the corporation that is responsible for the brand in Canada.
Box 5: Other Manufacturer
Indicate the full legal name, complete mailing address, telephone and facsimile information of any other companies, apart from the manufacturer indicated in Box 4, that manufacture or formulate the cosmetic, or are otherwise involved in incorporating ingredients into the product. If there is no other manufacturer, check the box "Same as manufacturer".
It is not necessary to list companies that supply ingredients or that supply proprietary mixtures of ingredients, or companies that only package and/or label the product. List companies that provide pressurized aerosol fillers as they add propellant ingredients. Additional manufacturers may be listed as outlined under Section 4, part "c".
Box 6: Canadian Distributor
Indicate the full legal name, complete mailing address, telephone and facsimile information of the distributor of the cosmetic in Canada. If the Canadian distributor is the same as the manufacturer, check the box "Same as manufacturer".
The distributor is the company who sells a cosmetic to another company for the purpose of further sale by that other company. This item refers only to distribution companies located in Canada. Do not list individual retailers who do not act also as distributors. Additional distributors may be listed as outlined under Section 4, part "c".
Box 7: Correspondence to be Sent to
Indicate the name, complete mailing address, telephone, facsimile, e-mail address and Web site information of the person or company for which all correspondence regarding the cosmetic should be sent. If this information is the same as indicated in Box 4, Box 5 or Box 6, check the appropriate box.
All regulatory communications concerning the notification form will be directed to this address, telephone number, facsimile number and/or e-mail address. Normally this will correspond to the name and address of the individual authorizing the notification (see the "Signature and Identification" section below). If this section is not completed, all communication will be directed to the manufacturer at the address given in Box 4.
Box 8: Correspondent Language Preference
Indicate either English or French as the language of preference for any correspondence from Health Canada regarding the notification.
If no language of preference is indicated, the language of communication will be that of the majority of the notification form.
Box 9: Purpose of the Cosmetic
Indicate the purpose(s) of the cosmetic, using the codes and descriptions set out in the list below, which best describes the cosmetic.
See "Appendix I" for definitions of these terms.
Note: The "Other" category is used only if the product does not fall into one of the general categories above. If "Other" is indicated, please include a brief description of the product under "Description".
Box 10: Form of the Cosmetic
Indicate the form of the cosmetic, using the codes and description set out in the list below, which best describes the cosmetic.
The form of the cosmetic is the state of the packaged product ready for sale.
See Appendix II for the definition of these terms.
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) indicate form "No. 8", "Kit", and list the forms of the various components. To list the ingredients and concentrations for each form of the kit, ensure the ingredients of each form are clearly separated from the other.
Note: Indicate "Other" only if the product does not fall into one of the general categories above. If "Other" is indicated, please include a brief description of the product under "Description".
Box 11: Cosmetic Intended for Use On
Indicate if the product is meant to be used on humans, on animals or on both.
Box 12: Number of Products Covered by this Notification
- One
If only one product is covered by the notification, check the "One" box.
- Many
In certain situations, manufacturers may cover an entire product line with a single notification form. In this case, indicate "Many" and specify the number of products covered by the notification in the space to the right of the box. See Box 13 for how to list the ingredients for a notification covering multiple products.
The "Many" option may be used only if all of the following conditions are met:
- a) The same basic product name or trade mark applies to all individual products in the line. This basic name must be entered in Box 3 of the form.
- b) The product base remains unchanged in composition from one variation to another, except for slight changes in one or two ingredients to accommodate the variable part of the formulation e.g., colouring ingredients. Instructions for listing the ingredients will be found under the "Composition" section, below.
- c) All the information inserted on the form other than composition is identical for each individual product in the line (i.e., the manufacturer, distributor, purpose, and form of the cosmetic are the same for all products).
Notes:
- With a multiple notification, if the number of products in the product line subsequently 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, is also changed.
- When the same product is offered in different types or sizes of package, it should be treated as a single product as long as the basic product name remains unchanged.
Box 13: Composition
This section is for specifying the ingredients and their respective concentrations in the product(s). Finished product test results (Certificate of Analysis) are not considered to be an adequate description of composition.
Note: Please carefully read all of the following sections in Box 13 before completing this item.
- Composition of:
Indicate the name of the product, as listed in Box 3.
- Ingredient
Indicate each ingredient separately, on the lines provided, using the INCI name (International Nomenclature Cosmetic Ingredient). See the "Additional Resources" section for more information on INCI.
If there is no INCI name for the ingredient, the commonly recognizable ingredient name should be used. These naming systems include, in order of preference:
- the "Trade" name from the Merck Index (current edition) (Published by Merck & Co., Inc., Rahway, NJ, USA);
- Chemical Abstract Service number (CAS#);
- Latin name (i.e. Scientific binomial name, genus and species);
- International Non-Proprietary name (INN);
- European or U.S. Pharmacopoeia Name (EP, USP);
- International Union of Pure and Applied Chemistry (IUPAC) name or Chemical Abstract Service (CAS) name;
- common name;
- trade name of major suppliers (list name of supplier).
Incorrect or misspelled ingredient names will cause errors or delays in the processing of the CNF.
The list of ingredients should be consistent with the ingredients listed on any submitted labels for the product.
- Concentration
Indicate the exact concentration or concentration range number from the following table below for each ingredient.
Please note: The range codes above used are specified in the Cosmetic Regulations. They may be different from the ranges specified by other organizations.
A detailed explanation of how to calculate "concentration" can be found in Appendix III: Section e.
- Additional Information/ Circumstances
- Ingredients listed on the Cosmetic Ingredient Hotlist
Some ingredients are restricted or prohibited in cosmetics due to safety concerns. Additionally, some ingredients require special labelling requirements. A list of these ingredients can be found in the Cosmetic Ingredient Hotlist, at www.healthcanada.gc.ca/hotlist. Note that the 'Hotlist' is not exhaustive. If you are unsure about the acceptability of an ingredient, please consult with the Cosmetics Program.
If a restricted ingredient is listed on the notification, the exact concentration of the ingredient must be listed (as opposed to a concentration range), and all labelling materials must be submitted with the notification, to demonstrate that the product meets the requirements of the Hotlist. A cosmetic product must not contain prohibited ingredients on the Hotlist.
It is recommended to check the Cosmetic Ingredient Hotlist regularly, or contact the Cosmetics Program directly if there are questions regarding the acceptability of an ingredient.
- More than one Concentration Range
In cases where product specifications or quality control limits for an ingredient include more than one of the ranges mentioned, indicate the range number corresponding to the largest percentage of the ingredient that might occur in the product.
- Multiple Notifications
When a "multiple notification" for a product line is being submitted (for conditions, see Box 12), the following should be followed:
- i) List the ingredients and concentration ranges of the base formula, followed by an appropriate general term such as "colouring agents" to represent all the variable ingredients.
- ii) Under the heading of the general term used, list all the variable ingredients used in the entire product line (e.g., all the colouring agents used in a lipstick line). It is understood that in most cases, only a few of these would be used in any single product. The concentration ranges reported for each of these ingredients should be based on the largest amount of the ingredient that is used in any one product.
- Along with listing the regular ingredients that make up the composition of the cosmetic, please note the following information when filling out the Notification Form:
- Adjusting Agents
If there are ingredients which are added only to some batches of a product, for final adjustment of product properties such as colour, pH or viscosity, list these separately using the heading "Adjusting Agents". Indicate the maximum possible concentration range of each of these ingredients.
- Aerosol Container Propellants
If the product is packaged in an aerosol container, list the propellant ingredient on the notification form and label. On the CNF, the propellant concentration range may be listed as "1" or "2".
- Alternative Ingredients
If alternative ingredients have been selected for the product to cope with possible material shortages or for other practical considerations, list these separately, under the heading "Alternative Ingredients", with the names of the ingredients they will replace in brackets. If an alternative ingredient becomes the normal ingredient, then an amendment to the original notification will be required.
- Complex Ingredients from Natural Sources
An ingredient derived from natural sources and which comprises many chemical substances (e.g., a fragrance, a flavour) may be treated as a single ingredient.
- Incidental Ingredients
Incidental ingredients are those that may have been present in the raw material, but are not found, or remain at quantities too insignificant to contribute to an ingredient purpose in the final product. These substances do not need to be declared on the notification form or the product label.
- Pre-Mixes or Proprietary Mixtures
If a pre-mix or proprietary mixture of ingredients (i.e. a mixture of more than one ingredient) is used in a cosmetic formulation, list each component as an individual ingredient with its corresponding concentration.
If the mixture ingredients and concentrations are unknown to the notifying company, this information must be submitted to the Cosmetics Program:
- a) List the mixture as a single ingredient on the CNF, using the supplier's name for the mixture. Indicate that the mixture information is to be submitted by the supplier.
- b) Request the supplier of the pre-mix or proprietary mixture provide the ingredient and concentration information to Cosmetics Program (see the contact coordinates listed in Section 4 above).
- c) Ensure the supplier information references the name of the notifying company, the name of the products, and the name of the mixture.
In some circumstances, a third party company may request the Cosmetics Program to prevent proprietary information from being released to the notifying company. Under the Access to Information Act, confidential business information provided to Health Canada is not released to third parties without the information owner's consent.
- Quality of Ingredients/Ingredient Impurities
As per the Food and Drugs Act and the Cosmetic Regulations, all cosmetics sold in Canada must be free from filth, foreign matter and substances that may injure the health of the user when the cosmetic is used according to label directions or customary ways of use; and manufactured, prepared, preserved packed and stored under sanitary conditions. Products are to be manufactured with the general safety conditions specified in Section 16 and 18 of the Cosmetic Regulations.
- Adjusting Agents
- Ingredients listed on the Cosmetic Ingredient Hotlist
Authorized by:
- Name
Indicate the full legal name of the individual who is completing the form and confirming that the information contained in the form is correct.
This individual should be the manufacturer or a person authorized on the manufacturer's behalf.
- Relationship of Signer to Manufacturer
Indicate the relationship the signer has to the manufacturer mentioned in Box 4. This may be an employee, an owner, a consultant or legal representative. If the person signing is not an employee or owner of the manufacturing firm, please add "Authorized representative" in this space to indicate that such authorization has been granted.
- Position
Indicate the position of the signer within his or her organization.
- Web site/ E-mail
Indicate the Web site and/or e-mail address of the signer.
- Signature
Sign the form in ink.
By signing the form, the individual attests that the information contained in the notification, as well as all information provided to Health Canada with the notification (labels, inserts, advertising, etc) is correct. Forms that do not have a signature will not be processed and will be returned to the correspondent outlined in Box 7.
- Date
Indicate the date on which the notification was completed and signed, using the format YYYY/MM/DD.
6. Attachment of Labels and Inserts
In cases where a cosmetic presents an avoidable hazard that is prescribed by the Cosmetic Regulations or the Cosmetic Ingredient Hotlist, copies or facsimiles of labels and inserts are required to be provided with notifications. Failure to provide labelling information with the CNF in these instances will result in notification being deemed non-compliant.
For any cosmetic, a label may be required to clarify the purpose or claims of the product. In order to facilitate processing time, it is strongly suggested to always submit a product label with a notification.
7. Discontinuation of Sale of a Product
If a cosmetic product has been discontinued from sale on the Canadian market by the manufacturer (but not necessarily the retailers), provide the Cosmetics Program with a written statement to this effect within 10 days of the change.
Please note that the "cancellation" of a notification should take place upon cessation of sale by a manufacturer, and not upon cessation of production of the cosmetic.
8. Submission of a Completed Notification Form
The sale of a cosmetic product may proceed after the submission of the completed Cosmetic Notification Form to Health Canada, assuming the product meets all of the requirements for sale in Canada. Confirmation of receipt of the CNF from Health Canada is not required. Health Canada receives over 17,000 notifications a year, therefore confirmation of receipt letters are not provided unless specifically requested by the manufacturer.
9. Requests for Information from the Cosmetics Program
If the Cosmetics Program has questions or concerns with a notification form or a product or identifies any other deficiencies, the manufacturer or corresponding company will be contacted by the Cosmetics Program.
Depending on the issue, the manufacturer may be requested one or more of the following:
- provide more information or labels to Health Canada;
- re-label the product;
- reformulate the product;
- remove the product from sale;
- submit a product licence application to a different Health Canada program such as the Therapeutic Products, Natural Health Products, Veterinary Drugs, Foods Directorate or the Pest Management Regulatory Agency.
To avoid problems, consult the list of common errors found in Appendix III of this document, and refer to the checklist in Appendix IV.
10. Additional Resources
- Guidelines for Cosmetics Manufacturers, Importers and Distributors
www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmet_guide/index-eng.php - The Cosmetic Ingredient Hotlist (a list of prohibited and restricted ingredients)
www.healthcanada.gc.ca/hotlist - Health Canada Guidelines: Labelling of Cosmetics
www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmetics-cosmetiques/index-eng.php - Mandatory Ingredient Labelling for Cosmetics in Canada
www.hc-sc.gc.ca/cps-spc/person/cosmet/ingredient/index-eng.php
Appendix I: Purpose Definitions
- Antiwrinkle Preparation:
- Product applied as a makeup or moisturizer generally to the face to mask or reduce the appearance of fine lines or wrinkles (see also Eye Lotion and Eye Makeup).
- Baby Product:
- Product labelled for use on infants 2 years old or less.
- Barrier Cream:
- Product which protects the hands from dirt, grease, solvents, etc.
- Bath Preparation:
- Product added to the bath water. Includes bath oils, tablets, salts, bubble baths, etc.
- Body Makeup:
- Product applied as makeup to the body excluding the hair, eyes or face. Includes leg and body paints (see also Eye Makeup and Face Makeup).
- Dentifrice:
- Product which cleans and/or polishes the teeth.
- Deodorant:
- Product which modifies, reduces, or prevents the development of body odours. Excludes genital deodorants.
- Douche:
- Product used for personal feminine hygiene (see also Genital Deodorant).
- Eye Lotion:
- Non-makeup product specifically indicated for use in the area of the eye. Includes lotions and moisturizers.
- Eye Makeup:
- Product specifically indicated for use in the area of the eye. Includes eyebrow pencils, eyeliners, eye shadows, eye makeup removers, mascara, etc.
- Face Makeup:
- Product for use in the area of the face. Includes blushes, face powders, foundations, rouges, makeup fixatives, etc. (see also Antiwrinkle Preparation, Eye Lotion, Eye Makeup, Lipstick and Skin Moisturizer).
- Fragrance:
- Includes perfumes, colognes, toilet water, and talcum powders.
- Genital Deodorant:
- Deodorant/cleanser intended for use in the genital area (includes non-douche feminine hygiene products).
- Genital Lubricant:
- Product for use as a lubricant in the genital area.
- Hair Bleach:
- Product which bleaches the hair. Excludes hair lighteners with colours.
- Hair Conditioner:
- Non-shampoo product which increases the suppleness or body of the hair, facilitates combing, adds gloss or texture to the hair, etc. (see also Hair Shampoo).
- Hair Dye:
- Product which changes the colour of the hair.
- Hair Grooming:
- Product which improves the appearance or is used to shape/style the hair. Includes mousses, gels, pomades, sprays, etc. (see also Hair Straightener and Hair Waving Preparation).
- Hair Removal:
- Depilatory/epilatory product which facilitates the removal of hair by chemical or mechanical means. Includes wax treatments (see also Shaving Preparation).
- Hair Shampoo:
- Product which cleanses and conditions the hair. Product is washed off after use.
- Hair Straightener:
- Product which contain agents which chemically soften the hair to facilitate straightening of the hair.
- Hair Waving Preparation:
- Product which chemically softens the hair to facilitate curling. This is generally followed by a neutralization step (see also Hair Grooming).
- Lipstick:
- Product applied to the area of the lips. Includes lip colours, glosses, moisturizers, etc.
- Manicure Preparation:
- Product applied to the nails. Includes nail polishes, nail polish removers, nail creams and lotions, cuticle softeners, nail hardeners, etc.
- Massage Preparation:
- Product used for massaging purposes. Includes gels, creams and lotions.
- Mouthwash:
- Product to freshen/deodorize the mouth and breath. Includes breath freshening drops, sprays, or strips. Excludes lozenges and gums.
- Shaving Preparation:
- Includes shaving cream, pre-shave lotion, after shave lotion, beard softener, shaving soap, etc. (see also Hair Removal).
- Skin Cleanser:
- Product, usually a soap, detergent or a shampoo, to cleanse the skin. Includes adhesive removers, astringents, towelettes, exfolients, etc.
- Skin Moisturizer:
- Product applied to the skin to soften dry skin or maintain skin suppleness by reducing water loss or increasing the water content of the skin. Includes emollients and humectants.
- Tanning Preparation:
- Product which improves the appearance of a tan (e.g. by pigments). Excludes products which protect the skin from the sun or enhance/accelerate the tanning process.
- Other (Please Specify):
- Product which does not fall into one of the general categories above. Please provide the rationale as to why the purpose is unique.
Appendix II: Forms Definitions
- Aerosol:
- A pressurized form that contains ingredients released upon activation of a valve system (e.g. some hair sprays, perfumes)
- Capsule/Tablet:
- A formulation enclosed within a capsule or pressed into a tablet (e.g. bath oil capsules)
- Cream:
- Viscous liquid or semi-solid emulsion (e.g. some hair grooming products, makeup)
- Gel:
- Viscous, usually clear, jelly-like semi-solids (e.g. some hair grooming products, dentifrices)
- Granules:
- A small particle or grain that is usually dissolved or dispersed in water or another liquid (e.g. bath pellets, crystals, pearls, etc.)
- Kit:
- If the product consists of two or more components of different forms which are mixed before use, then insert (8) "Kit", and write in brackets the forms of the various components.
- Liquid Suspension:
- A solid suspended in a liquid (e.g. some moisturizers, some skin cleansers)
- Lotion:
- A liquid emulsion that is usually applied to the skin (e.g. some moisturizers, makeup)
- Non-oily Liquid:
- A non-oil based, low viscosity fluid form that can be poured (e.g. solutions, milky lotions)
- Oil:
- A substance which not miscible with water, and is generally slippery, viscous, and liquid at room temperatures (e.g. mineral oil)
- Ointment:
- A thick, viscous preparation based on a fatty material (e.g. lanolin)
- Paste:
- A concentrate of absorptive powders usually dispersed in semi-solid base (e.g. dentifrice)
- Pencil:
- A solid paste compacted into a tapered cylinder form imitating a common pencil in shape, usually intended for application on the skin (e.g. eyebrow pencil, lip pencil)
- Powder - Loose:
- A loose mixture of dry, finely divided particles (e.g. dusting powder, makeup, talcum).
- Powder - Pressed:
- A compressed mixture of dry, finely divided ingredients usually applied to the skin (e.g. blush, eye makeup)
- Pressed Cake:
- A solid mixture in the shape of a bar that is usually used to cleanse the skin (e.g. soap, bath bar)
- Pump Spray:
- A solution, suspension or emulsion in the form of coarse droplets or as finely divided solids, usually applied to the skin or hair (e.g. atomizers, some hair sprays) (does not include aerosols)
- Stick:
- A solid forming a block shape that may dissolve or melt at body temperature (e.g. lipsticks, some deodorants)
- Other (Please Specify):
- A product which does not fall into one of the general categories above. Please provide a brief rationale as to why the form is unique.
Appendix III: CNF Common Errors
The following is a list of common errors and deficiencies found in cosmetic notification forms (CNFs) submitted to the Cosmetic Program. These errors can lead to inaccurate data, time delays in processing and/or rejection of the CNF.
Additional information or clarification is requested by the Cosmetics Program due to errors in the CNF. Failure to respond to this formal request within the specified time frame may result in the product(s) being declared non-compliant and therefore prohibited for sale in Canada.
- Product contains a 'Hotlist' ingredient
Some ingredients are restricted or prohibited in cosmetics due to safety concerns. A list of these ingredients can be found in the Cosmetic Ingredient Hotlist, www.healthcanada.gc.ca/hotlist.
If a cosmetic contains an ingredient which appears on the Hotlist, the manufacturer may be advised to mitigate the risk via various courses of action:
- For Prohibited Ingredients (not permitted in cosmetics at any concentration):
- confirmation that the product is no longer sold in Canada or no longer contains the prohibited ingredient; OR
- confirmation of intent to reformulate the product and the anticipated date of reformulation; AND
- a CNF 'amendment' for the product outlining the new formulation, with complete ingredient and concentration information.
- For Restricted Ingredients (permitted in cosmetics at certain concentrations, require cautionary statements and/or directions for safe use indicated on the label and/or safety evidence to be provided):
- reporting of the exact concentration of the restricted ingredient in the CNF (a concentration range is not acceptable in this case);
- submission of a copy of the labels and inserts used in conjunction with the cosmetic demonstrating the required information set out in the Cosmetic Regulations and/or the Cosmetic Ingredient Hotlist;
- submission of adequate safety evidence as outlined in the Cosmetic Ingredient Hotlist, if required.
- For Prohibited Ingredients (not permitted in cosmetics at any concentration):
- Therapeutic claims in the product name, label or Web site
Claims in the name of the product, the product label or product Web site that imply therapeutic or biological activity are not appropriate for a cosmetic product. Products that make claims or advertisements of a therapeutic nature or which modify/correct an organic function of the body would meet the definition of a drug as defined in section 2 of the Food and Drugs Act.
If products are notified with inappropriate claims in the product name or label, the manufacturer will be requested to remove the claims. Lists of acceptable and unacceptable claims for cosmetics can be found in the Guidelines for Cosmetic Advertising and Labelling Claims.
If the unacceptable claims are not removed, then the product must be marketed as a drug. This involves removing the product from sale and applying for a Drug Identification Number (DIN), or Natural Health Product Number (NPN). Information on the regulatory requirements for therapeutic products is available on the Health Canada Web site.
- Missing, unknown, misspelled ingredients
Notifications which fail to provide sufficient information to allow the Cosmetics Program to identify the listed ingredients in the cosmetic ingredient database and reference texts are not considered to meet the requirements of the Cosmetic Regulations.
If the Cosmetics Program is unable to identify certain ingredients in the CNF, the manufacturer will be requested to specify each ingredient and identify it by its CTFA International Nomenclature Cosmetic Ingredient (INCI) name or, if not available, its "Title" name from the Merck Index. However, if the ingredient does not appear in either of these publications, it should be identified by using its chemical name or composition and, if possible, its Chemical Abstracts Service (CAS) number, along with basic information concerning the safety of the ingredient for use in cosmetics (e.g. supplier's data sheet or applicable bulletins, etc.).
If there are questions about how to list an ingredient that does not have an INCI name, please contact the Cosmetics Program for assistance.
- Mixtures indicated as a single ingredient and concentration
Some products contain ingredients which are added as a pre-mixture. The individual ingredients of the mixture must be entered separately on the form, along with their corresponding concentrations. In some cases, this information must be provided by the supplier of the mixture directly to the Cosmetics Program.
Notifications that provide a mixture as a single ingredient will not be processed. The manufacturer must clarify each of the ingredients in the mixture and their respective concentrations.
If the ingredient is a proprietary mixture whose components or concentrations are unknown to the contact, it is the responsibility of the contact to ensure that the supplier has submitted a list of ingredients and their respective concentrations or concentration ranges directly on his/her behalf. The letter from the supplier must contain the following information: an indication of what CNFs are involved, the name of the firms involved, the name of the mixture, the name of the cosmetic product and an indication of whether this mixture information can be disclosed to a third party.
- 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 (i.e. grams, millilitres, kilograms, litres, etc). 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) × 100Example:
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")
- Total weight of product: 60 g + 13 g + 2 g = 75 g
- Name of cosmetic and/or list of ingredients in CNF are not consistent with the submitted label
The information entered on the CNF must reflect the information found on the cosmetic product label (e.g. name of cosmetic, ingredient lists). If the name or ingredients on the CNF differ from the label, clarification will be requested by the Cosmetics Program, and processing of the form will be delayed. g. Amendments not clear
- Amendments are required if changes are made to information in a previously submitted notification.
As notifications are tracked according to product name, the product name of the amendment must be the same as that submitted in the original notification. In the case that the amendment is for a change to the product name, indicate the original name in brackets following the updated name.
When a change is made to a company name, address or other contact information, it is not necessary to submit an amendment for each affected notification. A letter outlining the change along with the associated notifications is adequate.
If many changes are being made to the product, it is often helpful to provide a cover letter to accompany the notification indicating all the changes.
- Signatures missing
Signed copies of the notification are required as outlined in section 30(1)(a) of the Regulations. All notifications must be submitted with signatures of the manufacturer or the person authorized on their behalf. Any notifications without signatures will be rejected.
- Completing Box 13 "Composition" for "Multiple Notifications"
To complete a multiple notification, only a few ingredients must be different between a line of cosmetics. For example, a line of lipsticks has the same base ingredients, but the pigments used in each shade of lipsticks differ, or a line of soaps where an herbal element used in each type differs.
- Check "Many" under Box 12 of the CNF, and indicate the exact number of products covered either in the box, or on the coversheet for the CNF.
- List all the base ingredients which are present in every product in the line with their corresponding concentrations.
- After the base ingredients, list a heading for the variable ingredients, such as "colouring agents".
- Under the heading, list each of the possible variable ingredients which are found in one or more of the products, and list the highest concentration at which the ingredient may be found. For example, if some lipsticks contained mica at concentration range 6, and some contained mica at concentration range 5, and some lipsticks did not contain mica at all, mica should be listed as concentration range 5, as this is the highest range the ingredient would be found at in any of the products in the line.
- Completing a "Kit" notification
A "Kit" cosmetic product is sold with two or more different components, which are meant to be mixed together before the product is to be used.
Each component is given its unique CNF number, therefore manufacturers may choose to:
- 1) fill out separate CNFs for each component, ensuring it is clear to the Cosmetics Program that each notification form is part of the same kit; OR
- 2) list all kit components on the same CNF, clearly separating out the various components on the form with headings and spaces on the ingredient lines in Box 13. For example, for a hair dye, list the component general name as the heading (e.g. "hair colour cream"), with the ingredients and concentrations specific to the component below. Leave a space on the form, and list the other component general name as a new heading (e.g. "activator gel") and list the ingredients and concentrations specific to the component.
Appendix IV: CNF Completeness Checklist
- Item 1 - The completed form is clear and legible
- Yes
- No
- Item 2 - All sections of the form are filled out, including page numbers
- Yes
- No
- Item 3 - The Name of the Cosmetic on the CNF (Box 3) appears exactly as on the label
- Yes
- No
- Item 4 - The names and addresses in Boxes 4-7 are written in full with the complete mailing address, along with phone and facsimile numbers
- Yes
- No
- Item 5 - The Name and Address of Manufacturer (Box 4) and/or Distributor (Box 6) correspond to the name(s) and address(es) on the label
- Yes
- No
- Item 6 - The purpose and form of cosmetic are accurate. If "other" is specified, a brief description of the purpose and/or form is included
- Yes
- No
- Item 7 - If more than one cosmetic are covered by the notification, the "Many" box is checked in Box 12, and the number of products is listed in the space next to the box or on the CNF coversheet
- Yes
- No
- Item 8 - All ingredients are clearly listed with appropriate INCI name (or other acceptable name)
- Yes
- No
- Item 9 - All exact concentrations or concentration codes are included with their respective ingredients
- Yes
- No
- Item 10
All ingredients have been checked against the current "Cosmetic Ingredient Hotlist" to ensure the product does not contain any prohibited ingredients.
- Yes
- No
If the product contains a restricted ingredient, all requirements have been met, exact concentrations are listed, and complete labelling information is provided
- Yes
- No
- Item 11 - Authorized by Name, Relationship, Position and Signature are complete
- Yes
- No
- Item 12 - Labels are attached, and if required, any additional safety evidence
- Yes
- No
- Item 13 - All information provided in duplicate to the Cosmetics Program, and stapled together
- Yes
- No
Answering "No" to any of the 13 Items listed above means that the CNF is incomplete and may be rejected by the Cosmetics Program. If you require assistance with filling out the form please contact the Cosmetics Program at the coordinates listed in Section 4 of this guide.
