Canada Cosmetic Regulation QA

WFOE Registration, Work Permit, Special Industry Permit application according to Canada Regulations, we need to do KYC (Know your client) before engagement with your assignment.

Email: yto4ww@evershinecpa.com
Or
ES CA , One of Evershine affiliates
Manager Cindy Victoria Speaks in Bahasa, English, and Chinese.
Whats App +886-989-808-249
wechatid: victoria141193

2023/07/28 drafted by Yvonne Chen

HLF-TW-10
What are the categories of cosmetics in Canada? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD：

In Canada, cosmetics are regulated by Health Canada (HC), and cosmetic means any substance or mixture of substances, including deodorants, manufactured, marketed or represented for cleansing, improving or altering the complexion, skin, hair or teeth and perfume. Examples: soaps, artificial nails, moisturizers, tinted moisturizers (concealers), tattoo inks, makeup products, teeth whiteners, cleaning wipes, etc.

If the classification of the product is not clear, Health Canada will classify the product on a case-by-case basis and will be judged based on the following conditions:

1. Description: Whether the product is described as having a cosmetic function such as: cleansing, moisturizing, lubricating, perfuming or altering human hair, skin or teeth.
2. Composition of a product: While the composition of a product itself does not necessarily determine its classification, the presence or concentration of an ingredient may render the product unsuitable for classification as a cosmetic product.
3. Degree of action: Cosmetics are usually applied on the outside of the body, rather than being absorbed by the skin to achieve cosmetic effects.

Note

1. Cosmetics can be applied to the skin around the eyes, but the products applied directly to the eyes are not cosmetics.
2. Except tattoo inks, products applied by ingestion, inhalation or injection (e.g. intramuscular, subcutaneous or intravenous) are not cosmetic products.

【Reference Link】
https://www.canada.ca/en.html
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics.html

HLF-TW-20
If a foreign company wants to sell cosmetics in Canada, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：

No business license is required.
Health or safety incidents involving consumer products must be reported to Health Canada if the product is manufactured, imported or sold in Canada. It is the manufacturer, importer’s responsibility to provide further details on the incident and any corrective actions taken on the affected consumer product.
The report contains:

1. Product information
   ． Product brand and name
   ． Product Description
   ． Pipeline: store or other
   ． Age advice on product packaging
   ． Product number
   ． Date of manufacture or import
   ． Product purchase date
   ． The address where the product was manufactured or imported
2. Accident information
   ． Injured person’s name
   ． Type of injury
   ． Event date
   ． Event description
   ． Health care

【Reference Link】
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html#4
https://www.canada.ca/en/health-canada/services/consumer-product-safety.html

HLF-TW-30
If a foreign company wants to sell cosmetics in Canada, can it assign a Canada company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?

Evershine RD：
Non-resident importers can apply for business registration. When registering for business registration, a set of local (US/Canada) physical addresses must be kept.

Non-resident business number and account registration

1. URL: https://www.canada.ca/en/revenue-agency/services/tax/businesses/topics/gst-hst-businesses/digital-economy-gsthst/terms-conditions.html
2. Required information
   ·GST/HST
   ·Applicant identity, basic information, contact information
   ·Basic information and contact information of the person in charge
   ·Company name, ownership type (sole proprietorship/partnership, etc.), industry category, whether it is a registered company (registration date)
   ·Contact language (English/French)
   ·Company email
   ·America actual contact address (USA/Canada)
   ·Business activity content (product content)
   ·Already have a Canada Revenue Agency (CRA) business number

Product liability
When cosmetics are sold in Canada, it is the importer’s responsibility to report a health or safety incident involving a consumer product to Health Canada, providing further details about the incident and any corrective actions taken with respect to the affected consumer product.
The report contains:

1. Product information
   ． Product brand and name
   ． Product Description
   ． Pipeline: store or other
   ． Age advice on product packaging
   ． Product number
   ． Date of manufacture or import
   ． Product purchase date
   ． The address where the product was manufactured or imported
2. Accident Information
   ． Injured
   ． Type of injury
   ． Date of event
   ． Event description
   ． Medical care

【參考連結】
https://www.canada.ca/en/health-canada/services/consumer-product-safety.html
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html#4

HLF-TW-35

HLF-TW-40
Do foreign companies need to apply for an approval before importing cosmetics sold to Canada? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：

Each manufacturer and importer shall notify Health Canada, either online or in paper form, to Health Canada no later than 10 days after the first sale of the cosmetic by the manufacturer or importer.

1. URL: https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2. Cosmetic Notification Form (CNF) content:
   ．Manufacturer’s name and address on cosmetic labels
   ．Name
   ．Function
   ．Ingredient list (exact concentration of each ingredient or range of concentrations that include that ingredient concentration)
   ．Form
   ．Name and address in Canada of the manufacturer, importer or distributor
   ．If the cosmetic product was not manufactured by the person whose name appears on the label, include the name and address of the person who manufactured or formulated the cosmetic product
   ．Applicant’s name and position
   ．Files and pictures

Label

1. Cosmetics labels must be in English and French, except for the INCI name.
2. Must remain legible and easy to read under normal conditions of sale and use, throughout the useful life of the cosmetic product, or in the case of a refillable container.
3. The inner label shall indicate: the name of the manufacturer, the main business address of the manufacturer, the general name of the cosmetic product or its functional characteristics (unless the characteristics are obvious).
4. The outer label should indicate the list of ingredients
   ．Each ingredient is listed by its INCI name only.
   ．For cosmetics, nail polishes and enamels sold in a range of shades, if preceded by the symbol +/– or ± or a phrase, you can list all the colorants used in that range.
   ．Botanicals must specify at least the genus and species portion of the INCI name to be listed.
   ．Ingredients included in the schedule may be listed by their EU common name listed in column 1 of the schedule or by their corresponding English and French equivalents in columns 2 and 3 of the schedule.
   ．Ingredients that do not have an INCI name must be listed by their chemical name.
   ．Ingredients must be listed in descending order of their concentration by weight.
   ．Ingredients at a concentration of 1% or less and all colorants, regardless of concentration, may be listed in random order after ingredients at a concentration of more than 1%.
   ．For fragrance and fragrance, the words fragrance and aroma can be inserted respectively at the end of the list of ingredients to indicate that such ingredients have been added to the cosmetic product.
   ．If the immediate container or outer packaging of the cosmetic product is too small for the label to meet the requirements, the ingredient list can appear on the label, tape or card attached to the container or packaging.
   ．If the cosmetic product is in a decorative container with no outer packaging, the ingredient list may appear on a label, tape, or card affixed to the container.
   ．If the cosmetic product has no outer packaging and its size, shape or texture, or the size, shape or texture of its immediate container, makes it impossible to affix a label, tape or card to it, the container, the ingredient list may appear at the point of sale and must accompany Cosmetics in the flyer.
   5.Special request
   ．Hair dyes containing p-phenylenediamine or other coal tar dye bases or coal tar intermediates must carry warnings, side effects, and effects on both the inner and outer labels.
   ．For cosmetics containing mercury or its salts and their derivatives as preservatives, the name of the preservative and its concentration in the cosmetic should be indicated on the outer label.
   ．Deodorants intended for the genital area and sold in pressurized containers should have on their inside and outside labels: directions for use, conditions of application, precautions, warnings, etc.
   ．The inside and outside labels of pressurized containers shall display the hazard symbol with a caution/note signal, and a hazard statement
5. Safe packing
   ．No person may sell mouthwash for human use unless it is contained in safe packaging.
   ．The inner label of the security package must carry a statement or illustration that draws attention to it and, if only part of the outer packaging, the outer label must also bear the statement or illustration.
   ．Cosmetic products containing 5 mL or more of methanol must display the hazard symbol, cautionary word, statement on the inner and outer labels.
   ．Contains 600 mg or more of sodium bromate or 50 mg or more of potassium bromate should be kept out of the reach of children and in case of accidental ingestion contact a poison center or doctor immediately.
   .
   【Reference Link】
   https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/page-1.html#h-567428
   https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/

HLF-TW-45

HLF-TW-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：

Yes, the contact information of at least one Canadian-based manufacturer or importer is required when submitting a product license request.

Each manufacturer and importer shall notify Health Canada, either online or in paper form, to Health Canada no later than 10 days after the first sale of the cosmetic by the manufacturer or importer.

1. URL: https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2. Cosmetic Notification Form (CNF) content:
   ．Manufacturer’s name and address on cosmetic labels
   ．Name
   ．Function
   ．Ingredient list (exact concentration of each ingredient or range of concentrations that include that ingredient concentration)
   ．Form
   ．Name and address in Canada of the manufacturer, importer or distributor
   ．If the cosmetic product was not manufactured by the person whose name appears on the label, include the name and address of the person who manufactured or formulated the cosmetic product
   ．Applicant’s name and position
   ．Files and pictures

Label

1. Cosmetics labels must be in English and French, except for the INCI name.
2. Must remain legible and easy to read under normal conditions of sale and use, throughout the useful life of the cosmetic product, or in the case of a refillable container.
3. The inner label shall indicate: the name of the manufacturer, the main business address of the manufacturer, the general name of the cosmetic product or its functional characteristics (unless the characteristics are obvious).
4. The outer label should indicate the list of ingredients
   ．Each ingredient is listed by its INCI name only.
   ．For cosmetics, nail polishes and enamels sold in a range of shades, if preceded by the symbol +/– or ± or a phrase, you can list all the colorants used in that range.
   ．Botanicals must specify at least the genus and species portion of the INCI name to be listed.
   ．Ingredients included in the schedule may be listed by their EU common name listed in column 1 of the schedule or by their corresponding English and French equivalents in columns 2 and 3 of the schedule.
   ．Ingredients that do not have an INCI name must be listed by their chemical name.
   ．Ingredients must be listed in descending order of their concentration by weight.
   ．Ingredients at a concentration of 1% or less and all colorants, regardless of concentration, may be listed in random order after ingredients at a concentration of more than 1%.
   ．For fragrance and fragrance, the words fragrance and aroma can be inserted respectively at the end of the list of ingredients to indicate that such ingredients have been added to the cosmetic product.
   ．If the immediate container or outer packaging of the cosmetic product is too small for the label to meet the requirements, the ingredient list can appear on the label, tape or card attached to the container or packaging.
   ．If the cosmetic product is in a decorative container with no outer packaging, the ingredient list may appear on a label, tape, or card affixed to the container.
   ．If the cosmetic product has no outer packaging and its size, shape or texture, or the size, shape or texture of its immediate container, makes it impossible to affix a label, tape or card to it, the container, the ingredient list may appear at the point of sale and must accompany Cosmetics in the flyer.
   5.Special request
   ．Hair dyes containing p-phenylenediamine or other coal tar dye bases or coal tar intermediates must carry warnings, side effects, and effects on both the inner and outer labels.
   ．For cosmetics containing mercury or its salts and their derivatives as preservatives, the name of the preservative and its concentration in the cosmetic should be indicated on the outer label.
   ．Deodorants intended for the genital area and sold in pressurized containers should have on their inside and outside labels: directions for use, conditions of application, precautions, warnings, etc.
   ．The inside and outside labels of pressurized containers shall display the hazard symbol with a caution/note signal, and a hazard statement
5. Safe packing
   ．No person may sell mouthwash for human use unless it is contained in safe packaging.
   ．The inner label of the security package must carry a statement or illustration that draws attention to it and, if only part of the outer packaging, the outer label must also bear the statement or illustration.
   ．Cosmetic products containing 5 mL or more of methanol must display the hazard symbol, cautionary word, statement on the inner and outer labels.
   ．Contains 600 mg or more of sodium bromate or 50 mg or more of potassium bromate should be kept out of the reach of children and in case of accidental ingestion contact a poison center or doctor immediately.

【Reference Link】
https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/page-1.html#h-567428
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics/guidance-document-complete-cosmetic-notification-form.html#4
https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/

HLF-TW-55

HLF-TW-60
What documents are required when importing approved cosmetics into Canada? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Imported cosmetics need to complete the import pre-notification; at least 10 days before the sale must complete the notification.

The importer must apply to Health Canada in advance before each import, and the regulated party can fill in a plan for multiple imports within 3 months on a single form.
The Import Advance Notification Form is a new pilot program, and importers need:

1. Make sure the product is in compliance with Canadian law
2. Request a form with the Inspectorate, provide: company details, shipping details and product details, and outline the corrections/amendments to be made.
3. Submit the form by email to the Health Canada office in your region prior to shipment.
4. Make sure the product is relabeled or modified within 3 months of import.

Customs Import Process
1.Register a business number (BN) or add an import/export account identification number to an existing BN
URL:
https://www.canada.ca/en/revenue-agency/services/tax/businesses/topics/registering-your-business/register.html
2.Apply for an import license: It is necessary to show that the cosmetics meet all the requirements of the Canadian cosmetics market, such as packaging, labels, ingredient lists, etc.
3.Submit the import declaration and commodity inspection declaration: You need to contact the Canadian Customs and file with it the category, item, brand and quantity of cosmetics to be imported. At the same time, it provides necessary information such as packaging, labels, and ingredient lists of cosmetics.
4.Commodity inspection and customs inspection: The customs will check whether the packaging, labels and ingredient lists meet the standards in a series of inspections, and will also check whether the goods are damaged or contaminated by dangerous substances.

5. Required documents:
   ．Bill of lading
   ．Customs invoice or commercial invoice, indicating the buyer, seller, place of origin, price and detailed description of the goods, as well as quantity and unit price.
   ．Import permit
   ．Packing List
   ．Certificate of pre-shipment inspection
   ．Other documents: Certificate of Insurance, Bill of Lading in compliance with preferential tariffs, etc.

Each manufacturer and importer shall notify Health Canada, either online or in paper form, to Health Canada no later than 10 days after the first sale of the cosmetic by the manufacturer or importer.

1. URL: https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2. Cosmetic Notification Form (CNF) content:
   ．Manufacturer’s name and address on cosmetic labels
   ．Name
   ．Function
   ．Ingredient list (exact concentration of each ingredient or range of concentrations that include that ingredient concentration)
   ．Form
   ．Name and address in Canada of the manufacturer, importer or distributor
   ．If the cosmetic product was not manufactured by the person whose name appears on the label, include the name and address of the person who manufactured or formulated the cosmetic product
   ．Applicant’s name and position
   ．Files and pictures

【Reference Link】
https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/advance-notice-importation-process-cosmetics-drugs.html
https://www.canada.ca/en/health-canada/services/consumer-product-safety/legislation-guidelines/guidelines-policies/importing-exporting-commercial/document.html

HLF-TW-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：

Cosmetic Good Manufacturing Practice (GMP)

1. Health Canada encourages all cosmetics manufacturers to comply with Good Manufacturing Practices (GMP) and endorses the use of the International Standards Organization (ISO) Guide to Good Manufacturing Practices for Cosmetics (ISO Standard 22716).
2. GMP is a production guideline for ensuring effective methods of product quality control and risk management. Standards are specified for the manufacture, testing, storage, handling and distribution of products to ensure that each step of manufacture is acceptable for the quality and safety of the product.
3. GMP does not provide specific details of how a product is produced, but outlines the expected outcome of the process. Each manufacturer may have a unique approach to achieving these results.

Some important considerations when manufacturing cosmetics to ensure they are free from contamination

1. Buildings and Facilities
   ．Buildings are sufficient to produce and store cosmetics
   ．Walls, floors, fixtures, pipes, plumbing, lighting, ventilation, water supply, drainage, toilet facilities are fit for purpose and in good repair
   ．The building has sufficient air supply quality
   ．The building has an adequate pest control program to prevent attracting or harboring pests
2. Equipment
   ．The equipment used in the process is adequate, well maintained and non-polluting
3. Personnel
   ．Personnel have adequate education, training, experience and personal cleanliness
4. Raw materials
   ．Storing and handling raw materials to prevent contamination or deterioration
   ．Materials are tested or inspected for quality
5. Production
   ．Written instructions for establishing manufacturing and control procedures and maintaining procedures
6. Laboratory Control
   ．Testing or inspecting raw materials, samples and finished products to ensure they comply with specified standards
   ．Water supply is not polluted
7. Record
   ．Keeping records of raw materials, manufacturing, finished products and distribution
8. Labels
   ．Labels on finished products contain required information
9. Complaints
   ．Businesses keep consumer complaint files
10. Other
    ．The product complies with all regulatory requirements
    ．The product does not contain prohibited ingredients or substances

【參考連結】
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information/good-manufacturing-practices.html

HLF-TW-75

HLF-TW-77

HLF-TW-80
After a foreign subsidiary imports cosmetics and entrusts a distributor in Canada to sell it, does the distributor need a cosmetics business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：

No business license is required, but the manufacturer/importer first sells cosmetics to notify Health Canada of the Cosmetics Notification Form (CNF) within 10 days at the latest, which can be reported online or submitted in paper.

1. URL: https://healthycanadians.gc.ca/apps/radar/CPS-SPC-0007.08.html
2. Cosmetic Notification Form (CNF) content:
   ．Manufacturer’s name and address on cosmetic labels
   ．Name
   ．Function
   ．Ingredient list (exact concentration of each ingredient or range of concentrations that include that ingredient concentration)
   ．Form
   ．Name and address in Canada of the manufacturer, importer or distributor
   ．If the cosmetic product was not manufactured by the person whose name appears on the label, include the name and address of the person who manufactured or formulated the cosmetic product
   ．Applicant’s name and position
   ．Files and pictures

Product liability
When cosmetics are sold in Canada, it is the importer’s responsibility to report a health or safety incident involving a consumer product to Health Canada, providing further details about the incident and any corrective actions taken with respect to the affected consumer product.
The report contains:

1. Product information
   ． Product brand and name
   ． Product Description
   ． Pipeline: store or other
   ． Age advice on product packaging
   ． Product number
   ． Date of manufacture or import
   ． Product purchase date
   ． The address where the product was manufactured or imported
2. Accident Information
   ． Injured
   ． Type of injury
   ． Date of event
   ． Event description
   ． Medical care

【參考連結】
https://www.canada.ca/en/health-canada/services/consumer-product-safety.html
https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/

HLF-TW-85

Contact Us

Email: yto4ww@evershinecpa.com
Or
ES CA , One of Evershine affiliates
Manager Cindy Victoria Speak in Bahasa, English, and Chinese.
Whats App +886-989-808-249
wechatid: victoria141193

For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4yto@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable for your case.
Linkedin address: Dale Chen

Additional Information
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Other cities with existent clients:
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Berlin, Stuttgart; Prague; Czech Republic; Bangalore; Surabaya;
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Evershine Potential Serviceable City (2 months preparatory period):
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Besides, Evershine is Taiwan local Partner of ADP Streamline ®.
(version: 2024/07)

Please send email to HQ4yto@evershinecpa.com

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