Cosmetics Export Requirements — USA, EU & Canada

1. How Cosmetics Are Regulated Differently in Each Market

The fundamental difference between these three markets is the point at which regulatory oversight kicks in. The EU requires compliance before you sell a single unit. The US is transitioning from minimal pre-market oversight to more structured regulation under MoCRA. Canada falls between the two.

2. US Requirements: FD&C Act + MoCRA

In the United States, cosmetics are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 21 CFR Parts 700–740. The FD&C Act defines a cosmetic as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance."

Modernization of Cosmetics Regulation Act (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), enacted on December 29, 2022, represents the most significant update to US cosmetics law since 1938. MoCRA introduced the following new requirements:

• Facility registration: All facilities manufacturing or processing cosmetics for the US market must register with the FDA. Enforcement began July 1, 2024, with renewals required between October 1 and December 31 of even-numbered years.
• Product listing: Each cosmetic product must be listed with the FDA, including the facility where it is manufactured, product category, and ingredient list.
• Adverse event reporting: Serious adverse events must be reported to the FDA within 15 business days of the date the responsible person receives the report. Enforcement began December 29, 2023. Records must be maintained for 6 years.
• Good Manufacturing Practice (GMP): The FDA is required to establish GMP regulations for cosmetics. Final rules are pending, but they are expected to align with existing industry standards.
• Fragrance allergen disclosure: MoCRA directs the FDA to issue rulemaking on fragrance allergen labeling. This is still pending — no final rule has been published yet.

US labeling requirements

Cosmetics sold in the US must comply with labeling requirements under the FD&C Act and the Fair Packaging and Labeling Act (FPLA) 21 CFR Part 701:

• Identity of the product on the principal display panel.
• Net contents (weight, volume, or count) on the principal display panel.
• Name and place of business of the manufacturer, packer, or distributor.
• Ingredient listing using INCI names, listed in descending order of predominance 21 CFR 701.3. Ingredients at 1% or below may be listed in any order after those above 1%.
• Warning statements where required (e.g., sunscreen drug facts, coal tar hair dye cautions).
• English language required; bilingual labeling permitted but not mandated at the federal level.

Sellers shipping to California should also be aware of Proposition 65, which requires warnings for products containing chemicals known to cause cancer or reproductive harm. California's Toxic-Free Cosmetics Act (AB 2762), effective January 1, 2025, bans or restricts 26 additional ingredients including mercury, formaldehyde as an intentional ingredient, and certain PFAS compounds.

3. EU Requirements: Cosmetics Regulation (EC) No 1223/2009

The EU Cosmetics Regulation Regulation (EC) No 1223/2009 is the most comprehensive cosmetics regulatory framework in the world. It applies directly in all 27 EU member states without the need for national transposition and covers every cosmetic product placed on the EU market, regardless of where it was manufactured.

Cosmetic Product Safety Report (CPSR)

Before any cosmetic product can be placed on the EU market, a Cosmetic Product Safety Report (CPSR) must be prepared. This is a formal two-part document:

• Part A — Safety information: Quantitative and qualitative composition, physicochemical characteristics, microbiological quality, impurities, packaging details, normal and reasonably foreseeable use, exposure data, substance-specific toxicological profiles.
• Part B — Safety assessment: Must be completed by a qualified safety assessor holding a university diploma in pharmacy, toxicology, medicine, or an equivalent discipline (as defined in Article 10(2)). This person signs off that the product is safe for human health under normal and reasonably foreseeable conditions of use.

CPNP notification and Responsible Person

After the CPSR is completed, the product must be notified through the Cosmetic Products Notification Portal (CPNP) before it is placed on the market. The CPNP notification includes the product category, name, Responsible Person details, country of origin, and the frame formulation.

Under Article 4 of the Cosmetics Regulation, every cosmetic product on the EU market must have a designated Responsible Person — a legal or natural person established within the EU. The Responsible Person is legally liable for ensuring compliance with the regulation, including maintaining the Product Information File (PIF), which must contain the CPSR, product description, manufacturing method, GMP evidence, and claims substantiation.

Ingredient restrictions and annexes

The EU Cosmetics Regulation contains the world's most extensive ingredient controls:

• Annex II — Prohibited substances: Over 1,700 substances that must not form part of a cosmetic product's composition.
• Annex III — Restricted substances: Over 300 substances permitted only under specified conditions (concentration limits, product types, warnings).
• Annex IV — Colorants: Positive list — only colorants listed in Annex IV may be used.
• Annex V — Preservatives: Positive list — only preservatives listed in Annex V may be used.
• Annex VI — UV filters: Positive list — only UV filters listed in Annex VI may be used in sunscreens.

Fragrance allergen disclosure

The EU is expanding fragrance allergen disclosure requirements under Regulation (EU) 2023/1545. The current 26 named allergens will increase to 80 fragrance allergens that must be individually listed on cosmetic product labels when present above specified thresholds (0.001% in leave-on products, 0.01% in rinse-off products). The compliance deadline is July 31, 2026 for new products and July 31, 2028 for existing products already on the market.

GMP, claims, and animal testing

• GMP: Manufacturing must comply with ISO 22716 (Cosmetics — Good Manufacturing Practices).
• Claims regulation: All cosmetic claims must comply with Regulation (EU) No 655/2013, which establishes common criteria for claims justification (legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making).
• Animal testing ban: The EU bans marketing of cosmetic products where the finished product or its ingredients have been tested on animals for cosmetics purposes. This includes importing products tested on animals in third countries.

4. Canada Requirements: Cosmetic Regulations

In Canada, cosmetics are regulated under the Food and Drugs Act R.S.C. 1985, c. F-27 and the Cosmetic Regulations C.R.C., c. 869, administered by Health Canada.

Cosmetic Notification Form

Before selling a cosmetic product in Canada, you must submit a Cosmetic Notification Form (CNF) to Health Canada at least 10 days before the product is first sold. The notification includes the product name, manufacturer details, list of ingredients, and product function. This is a mandatory notification — not an approval process. Health Canada does not "approve" cosmetics, but uses notifications to monitor the market and take enforcement action if prohibited or restricted ingredients are detected.

Cosmetic Ingredient Hotlist

Canada maintains a Cosmetic Ingredient Hotlist (officially the "List of Prohibited and Restricted Cosmetic Ingredients") containing over 600 substances that are either prohibited outright or restricted to specific concentrations and product types. The Hotlist is updated regularly by Health Canada and is legally enforceable under the Food and Drugs Act. It is more restrictive than the US federal regime but less extensive than the EU Annexes.

Canadian labeling requirements

• Bilingual labeling: All label information must appear in both English and French — no exceptions. This applies to the product identity, net quantity, ingredient list, manufacturer/distributor details, and all warnings.
• INCI ingredient listing: Ingredients must be listed using INCI nomenclature in descending order of concentration. INCI names are considered bilingual and do not need to be translated.
• Net quantity in metric: Must be declared in metric units (grams or milliliters). Imperial equivalents may be added but are not sufficient alone.
• Manufacturer or distributor: Name and address of the Canadian dealer or the manufacturer must appear on the label.

5. Ingredient Restrictions Compared

The single largest compliance challenge when selling cosmetics across these three markets is ingredient divergence. A product formulated for the US market may be illegal in the EU without reformulation.

6. Labeling Requirements Side-by-Side

Labeling is where non-compliance is most visible to enforcement authorities and marketplace reviewers. Below is a comprehensive comparison of what must appear on a cosmetic product label in each jurisdiction.

The EU requires the most label elements overall. The batch number and use-by / Period After Opening (PAO) date are particularly notable — US and Canadian sellers entering the EU market frequently overlook these and must redesign their packaging.

7. GPSR and EU Responsible Person

Cosmetics sold in the EU are subject to two overlapping regimes that each require a form of "Responsible Person": the Cosmetics Regulation and the General Product Safety Regulation (GPSR).

Responsible Person under the Cosmetics Regulation

Article 4 of Regulation (EC) No 1223/2009 requires that every cosmetic product placed on the EU market have a designated Responsible Person established within the EU. This person or entity is legally responsible for ensuring the product complies with the Cosmetics Regulation, including maintaining the Product Information File, ensuring the CPSR is completed, submitting the CPNP notification, and initiating corrective measures if safety issues arise.

GPSR overlay on cosmetics

The General Product Safety Regulation Regulation (EU) 2023/988, which has applied since December 13, 2024, introduces additional obligations that apply on top of sector-specific legislation like the Cosmetics Regulation. For cosmetics, the key GPSR additions include:

• Enhanced traceability: Products must bear the manufacturer's name, trademark, and postal address, plus the contact details of an economic operator in the EU (which, for non-EU manufacturers, means their Authorised Representative).
• Market surveillance cooperation: The economic operator must cooperate with national market surveillance authorities, provide documentation on demand, and take corrective actions if notified of a product safety issue.
• Online marketplace obligations: GPSR imposes duties on online marketplaces to ensure products listed for EU consumers display the required Responsible Person information.

8. Customs and HS Codes

Cosmetics and perfumery products are classified under HS Chapter 33 of the Harmonized System. Correct classification is essential for duty calculation, import documentation, and avoiding customs delays.

Duty rates vary by destination and classification. EU MFN duty rates for HS 3304 products range from 0% to 6.5% depending on the specific subheading. US duty rates under HTS Chapter 33 typically range from 0% to 4.9% for finished cosmetics. Canada applies MFN rates of 0% to 6.5% for most Chapter 33 products.

Import documentation

• Commercial invoice: HS code, country of origin, declared value, detailed product descriptions.
• Packing list: Itemized contents, weights, and quantities.
• Certificate of Free Sale (CFS): Often required when exporting cosmetics internationally. This document, issued by a competent authority in the country of origin, confirms the products are legally sold in that market. The FDA issues these for US-manufactured cosmetics.
• Good Manufacturing Practice certificate: Some importing countries may request ISO 22716 certification or equivalent GMP documentation.
• Safety Data Sheets: May be requested by customs for products containing fragrances or active ingredients.

9. Compliance Checklist

USA compliance

• Register manufacturing facility with the FDA (MoCRA requirement; enforcement began July 2024)
• Submit product listing to the FDA with ingredient details and product category
• Establish adverse event reporting procedures (15 business days for serious adverse events)
• Ensure ingredient listing on label using INCI names in descending order of predominance
• Include net contents, product identity, and manufacturer/distributor name and address on label
• Verify all color additives are from FDA-approved batches (21 CFR Parts 73, 74, 82)
• Check for California Proposition 65 and Toxic-Free Cosmetics Act compliance if selling in California
• Ensure product is not making drug claims (otherwise subject to FDA drug regulations)

EU compliance

• Appoint an EU Responsible Person with a physical address in the EU
• Complete the Cosmetic Product Safety Report (CPSR) with a qualified safety assessor
• Compile the Product Information File (PIF) including CPSR, product description, GMP evidence, and claims substantiation
• Submit CPNP notification before placing the product on the market
• Verify all ingredients against Annex II (prohibited), Annex III (restricted), and positive-list Annexes IV-VI
• Confirm GMP compliance per ISO 22716
• Label with INCI ingredients, Responsible Person details, batch number, PAO or best-before date, net contents (metric), and function
• Ensure labels are in the official language(s) of each member state of sale
• Prepare for 80-allergen fragrance disclosure (July 31, 2026 deadline for new products)
• Confirm GPSR economic operator requirements are met (manufacturer/RP contact on product or packaging)

Canada compliance

• Submit Cosmetic Notification Form to Health Canada at least 10 days before first sale
• Verify all ingredients against the Cosmetic Ingredient Hotlist
• Ensure bilingual English/French labeling on all label elements
• List ingredients using INCI nomenclature in descending order of concentration
• Declare net quantity in metric units
• Include name and address of the Canadian dealer or manufacturer
• Confirm product does not make therapeutic claims (otherwise regulated as a drug or natural health product)

10. Common Mistakes to Avoid

Based on enforcement actions, customs holds, and marketplace removals, these are the most frequent errors made by cosmetics brands expanding internationally:

Assuming US compliance means global compliance

The US has the least restrictive cosmetics regime of the three markets. A product that is perfectly legal under FDA rules may contain multiple ingredients that are prohibited in the EU or restricted in Canada. Always check Annex II and the Hotlist before exporting an existing US product.

Skipping the CPSR for the EU

The Cosmetic Product Safety Report is not optional, not a formality, and not something you can do yourself. It must be prepared by a qualified safety assessor with specific academic credentials. Budget both time (4–12 weeks per product) and cost ($1,500–$5,000+ per product depending on complexity) for this assessment.

Not appointing a Responsible Person before selling in the EU

Many sellers list products on EU marketplaces without a designated Responsible Person, which is a direct violation of Article 4 of the Cosmetics Regulation. Amazon, eBay, and other marketplaces are increasingly enforcing this under GPSR and will remove listings.

Ignoring ingredient restriction differences across jurisdictions

Formulating a "one product fits all markets" approach requires starting with the most restrictive jurisdiction (the EU) and working backward. If you already have a US-market formulation, audit every ingredient against the EU Annex II/III and Canada Hotlist before assuming it can ship.

Missing the fragrance allergen disclosure deadline

The expanded 80-allergen labeling requirement under Regulation (EU) 2023/1545 has a July 31, 2026 deadline for new products. If you are launching in the EU in 2026 or later, your labels must already account for this.

Not registering with Health Canada

Submitting the Cosmetic Notification Form is legally required at least 10 days before first sale. Selling without notification exposes your products to seizure and your business to enforcement action under the Food and Drugs Act.