1. Regulatory Authority & Framework

Cosmetics in Canada are regulated under:

• Food and Drugs Act
• Cosmetic Regulations (SOR/2007-195)
• Consumer Packaging & Labelling Act
• Cosmetic Ingredient Hotlist (Prohibited / Restricted ingredients) – updated regularly
• Health Canada — Cosmetics Program
• Mandatory Cosmetic Notification (CNF)

Canada uses a post-market notification system, not pre-market approval.

2. Definition of Cosmetic (Canada)

A product is a cosmetic if it is applied to the body for:

• Cleansing
• Improving appearance
• Perfuming
• Moisturizing
• Maintaining condition

Borderline rule:
If a claim implies treatment, prevention, curing, the product becomes a Drug or Natural Health Product (NHP).

Examples of NON-cosmetics:

• Acne treatment
• Hair growth / anti-hair loss
• Dandruff treatment
• Eczema/melasma treatment
• SPF with drug-level claim
• Antibacterial disinfectants

3. Mandatory Cosmetic Notification (CNF)

Every cosmetic sold in Canada must submit a Cosmetic Notification Form (CNF) to Health Canada within:

📌 10 days after first sale (mandatory).

Output:

• Cosmetic Notification Number
• No expiry (unless ingredient/label changes)
• Updates required for formula, label, manufacturer, or RP changes

IMPORTANT:
Products may be marketed immediately after submission — no waiting for approval.

Notification is submitted via Health Canada’s online CNF portal.

4. Responsible Person (RP) / Legal Requirements

The manufacturer or importer is responsible for:

• Filing CNF
• Ensuring safety & compliance
• Maintaining documentation (PIF-like file)
• Responding to Health Canada inspections
• Implementing recalls if required

Foreign manufacturers must appoint a Canadian importer who becomes the RP.

5. Dossier Requirements for Cosmetic Notification

Health Canada requires:

A. Cosmetic Notification Form (CNF) — includes:

• Product name & category
• Full ingredient list (INCI) with percentages
• Company name, address, contact
• Country of manufacture
• Distribution information
• Sizes/variants

B. Supporting Documents (kept internally, not submitted)

Equivalent to an internal PIF:

• Safety substantiation
• Microbiological and stability testing
• GMP documentation (ISO 22716 recommended)
• Packaging compatibility
• Claims substantiation

Health Canada may request these during inspection.

6. Ingredient Requirements (Cosmetic Ingredient Hotlist)

Canada strictly follows the HOTLIST, which includes:

• Prohibited ingredients
• Restricted ingredients (limits, warnings, max concentration)

Examples:

Prohibited:

• Hydroquinone (in most cosmetics)
• Mercury compounds
• Most prescription-grade retinoids
• Hormones, steroids
• Chlorofluorocarbons (CFCs)

Restricted:

• Salicylic acid
• Alpha hydroxy acids (AHA)
• Hair dye ingredients (PPD, PTD)
• Cosmetic-grade benzoyl peroxide (not allowed as acne treatment)
• Sun filters (must meet Hotlist limits)

If ingredients violate Hotlist → product is not classified as cosmetic and must be regulated as NHP or Drug.

7. Labeling Requirements (Mandatory)

Canada requires bilingual labeling (English & French).

Label must include:

• Product identity (common name)
• Net quantity
• Full ingredient list (INCI)
• Name & address of manufacturer/importer
• Country of origin
• Lot/batch number
• Warnings (for restricted ingredients)
• Directions for safe use (if applicable)

INCI is mandatory.

Cosmetics for professional use must include special caution statements.

8. Claims Requirements (Strict)

Allowed:

• Moisturizes
• Brightens appearance
• Improves skin radiance
• Reduces appearance of fine lines
• Helps maintain healthy skin
• Even skin tone (cosmetic-level)

NOT allowed for cosmetics:

• Treats acne
• Lightens melasma
• Removes scars
• Restores damaged skin
• Hair regrowth
• Anti-dandruff
• SPF broad-spectrum protection (→ OTC drug)

9. Fees & Timelines

Fees

• No CNF fee — Registration is completely free
• No annual renewal fee
• No market authorization fee

Timelines

• CNF submission: instant online
• Product can be marketed immediately
• Change updates: must file within 10 days

Canada is one of the fastest and most accessible cosmetic markets worldwide.

10. Post-Market Surveillance (PMS)

Health Canada conducts:

• Marketplace inspections
• Ingredient safety audits
• Label checks
• Mandatory recalls
• Enforcement actions
• Border inspections via CBSA

RP must:

• Keep technical documents for at least 6 years
• Update CNF for any changes
• Report serious adverse events

11. Borderline Product Classification (Cosmetic vs NHP vs Drug)

12. Consulting Notes for Your Portfolio

13. Advantages of the Canadian Cosmetic Market

• Free registration
• Fast (instant notification)
• Transparent ingredient rules (Hotlist)
• Harmonized with U.S. & EU safety standards
• High demand for Asian skincare products
• Ideal for cross-border e-commerce (Amazon, T&T, Sephora Canada)