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Regulatory10 min read

Cosmetic Labelling RequirementsCanada, the US, and the EU compared

I

Ingrid

M.Sc. Biochemistry · Cosmetic Scientist · Founder, Formyoule™ Inc.

Cosmetic labelling is one of the most technically demanding aspects of launching a beauty brand, and it is one of the areas where founders most frequently make compliance errors. The rules differ significantly between Canada, the United States, and the European Union — and a label that is fully compliant in one market may violate regulations in another. This guide provides a practical comparison of the key requirements across all three markets.

Canada: Health Canada’s Cosmetic Regulations

In Canada, cosmetics are regulated under the Food and Drugs Act and the Cosmetic Regulations. The mandatory label elements for a cosmetic sold in Canada are:

  • Product identity (name of the cosmetic)
  • Net quantity (weight or volume)
  • Name and address of the responsible party (manufacturer or distributor in Canada)
  • Complete ingredient list in INCI nomenclature, in descending order of concentration
  • Any required warnings or cautions
  • Bilingual labelling (English and French) for all mandatory information

2026 Update

Health Canada’s new fragrance allergen disclosure requirements came into effect in 2026. Fragrance allergens present above 0.001% in rinse-off products and 0.01% in leave-on products must now be listed individually on the label rather than hidden under the collective term “fragrance” or “parfum.”

United States: FDA MoCRA Requirements

In the United States, cosmetics are regulated by the FDA under the Modernization of Cosmetics Regulation Act (MoCRA), which significantly updated US cosmetic regulations when it came into force. The mandatory US label elements are:

  • Product identity
  • Net quantity in both metric and US customary units
  • Name and address of the manufacturer, packer, or distributor
  • Complete ingredient list in INCI nomenclature, in descending order of concentration
  • Required warnings (e.g., ‘Keep out of reach of children’ for certain product types)
  • Directions for safe use where necessary

Under MoCRA, foreign companies selling cosmetics in the US must register their facilities and list their products with the FDA. Canadian brands selling into the US must comply with these registration requirements, which are separate from and in addition to Health Canada’s notification requirements.

European Union: EU Cosmetics Regulation (EC) No 1223/2009

The EU has the most comprehensive cosmetic regulatory framework in the world. Key requirements include:

  • Product identity and function
  • Net quantity
  • Name and address of the Responsible Person (RP) — must be an EU-based entity
  • Country of origin for imported products
  • Batch number or date of manufacture
  • Period After Opening (PAO) symbol or best before date
  • Complete ingredient list in INCI nomenclature
  • Required warnings and precautions
  • A Cosmetic Product Safety Report (CPSR) prepared by a qualified safety assessor — required before market entry

Key Differences at a Glance

RequirementCanadaUSAEU
Bilingual labelRequired (EN/FR)Not requiredNot required (local language)
Safety assessmentNot requiredNot requiredRequired (CPSR)
Facility registrationNotification onlyRequired (MoCRA)Required (CPNP)
Responsible PersonCanadian addressUS addressEU-based entity required
PAO symbolNot requiredNot requiredRequired
Fragrance allergensRequired (2026)Not requiredRequired

Need help with labelling compliance?

Formyoule™ Inc. provides regulatory and label guidance as a standalone service. Book a call to discuss your specific markets and requirements.

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