Cosmetics Packaging and Labeling: International Requirements for Beauty Imports

Cosmetics labeling requirements vary dramatically between markets. A product perfectly labeled for the EU market may be detained at US customs, and vice versa.

Why Labeling Matters for Import

• Customs clearance: Non-compliant labels trigger detention and inspection
• Market access: Products cannot legally be sold without compliant labeling
• Consumer safety: Proper labeling ensures users can identify allergens and usage instructions
• Liability protection: Compliant labels reduce legal exposure

Common Multi-Market Challenges

Brands selling internationally face these recurring issues:

• Different ingredient nomenclature systems
• Varying required elements (some markets require batch codes, others don't)
• Language requirements that differ by market
• Claim restrictions that vary by jurisdiction
• Warning statements triggered by different ingredient thresholds

Labeling Strategy Approaches

• Market-specific labels: Separate packaging runs for each market—highest compliance, highest cost
• Universal labels: Single label meeting requirements of all target markets—complex to design but efficient
• Base + secondary labels: Core packaging with market-specific sticker overlays—flexible and cost-effective

The FDA regulates cosmetics labeling under the Fair Packaging and Labeling Act and the FD&C Act. Requirements are specific and strictly enforced at import.

Principal Display Panel (PDP)

The front-facing panel must include:

• Statement of identity: What the product is in common terms ("Moisturizing Cream," "Lipstick")
• Net quantity: Required in both metric and US customary units (e.g., "3.4 FL OZ / 100 mL")

Information Panel Requirements

The panel immediately to the right of the PDP must contain:

• Ingredient declaration: Full INCI listing in descending order of predominance
• Distributor statement: "Distributed by [Company], [City], [State] [Zip]" or "Manufactured for..."
• Warning statements: Required for specific ingredients or product types

Ingredient Declaration Rules

• Use INCI (International Nomenclature of Cosmetic Ingredients) names
• List in descending order by weight
• Ingredients at 1% or less can be listed in any order after higher-concentration ingredients
• Color additives listed using FDA-approved names
• "Fragrance" or "flavor" can be used without disclosing specific components

Required Warning Statements

• Aerosols: Flammability and inhalation warnings
• Products with certain acids: Sunburn sensitivity warnings
• Coal tar hair dyes: Patch test and specific toxicity warnings
• Products not tested for safety: "Warning: The safety of this product has not been determined"

EU Regulation (EC) No 1223/2009 establishes comprehensive labeling requirements that differ significantly from US rules.

Mandatory Label Elements

• Responsible Person: Name and address of EU-based RP (required for all products sold in EU)
• Country of origin: Required if manufactured outside EU
• Nominal content: Weight or volume at time of packaging
• Date of minimum durability: "Best before" date or PAO (Period After Opening) symbol
• Batch number: Lot identification for traceability
• Function: Unless obvious from presentation
• Ingredient list: Preceded by "Ingredients:"
• Precautions: Conditions of use and warnings

Language Requirements

• Member states can require specific languages
• Ingredient list always in INCI (universal)
• Other elements in language(s) of country where sold
• Symbols can substitute for text where standardized symbols exist

PAO (Period After Opening)

Products with durability over 30 months require:

• PAO symbol (open jar icon)
• Time period (e.g., "12M" for 12 months)
• Replaces expiration date for stable products

EU Allergen Disclosure

26 fragrance allergens must be individually listed if present above thresholds:

• Leave-on products: 0.001%
• Rinse-off products: 0.01%

Asian markets have their own distinct requirements, with China, Japan, and Korea being the major regulatory environments.

China (NMPA)

• Chinese labeling: All label elements must be in simplified Chinese
• Importer information: Licensed Chinese importer name and address required
• NMPA registration number: For "special use" cosmetics, registration number must appear
• Production date and shelf life: Both required, no PAO option
• Ingredient list: Chinese INCI names required

Note: Animal testing requirements for China-sold products are being phased out but still apply to some categories.

Japan (MHLW)

• Japanese labeling: Required for all consumer-facing elements
• Manufacturer or importer: Japanese entity name and address
• Ingredient list: Can use Japanese names or INCI
• Lot number: Required for traceability
• Precautions: Specific warnings mandated for certain ingredient categories

Korea (MFDS)

• Korean labeling: All information in Korean
• Manufacturer and importer: Both must be identified
• Functional cosmetics: Separate category with additional requirements
• Full ingredient disclosure: No fragrance exemption—all components must be listed
• Expiration date: "Until [date]" format required

Key Differences Summary

Beyond labeling, packaging itself must meet various standards for import clearance and market sale.

Primary Packaging Requirements

• Material safety: No prohibited substances in contact with product
• Compatibility: Packaging must not interact with or degrade product
• Child resistance: Required for certain product categories in some markets
• Tamper evidence: Required for many product types

Outer Packaging and Shipping

• Carton labeling: Batch, quantity, and handling instructions
• Master case marking: Country of origin, product codes, compliance marks
• Hazmat marking: Required for flammable or pressurized products

Recycling and Environmental Marks

• EU: Green Dot (licensing varies by country), material identification codes
• US: Voluntary recycling symbols, specific state requirements (California)
• Japan: Plastic and paper recycling marks mandatory
• Korea: Packaging material identification required

Sustainable Packaging Considerations

Regulations are evolving rapidly:

• EU Packaging and Packaging Waste Regulation (PPWR) introducing new requirements
• Extended Producer Responsibility (EPR) schemes expanding globally
• Single-use plastic restrictions affecting sample sizes and travel items

Secondary labeling—applying additional labels to existing packaging—is often the most practical solution for multi-market compliance.

When Secondary Labeling Works

• Adding market-specific language requirements
• Including local importer/distributor information
• Supplementing ingredient lists with required nomenclature
• Adding warning statements not on original label
• Including registration numbers or compliance marks

Secondary Label Requirements

• Durability: Must remain attached and legible through product life
• Placement: Cannot obscure required original label elements
• Material: Must adhere to packaging surface without peeling
• Size: Text must meet minimum size requirements for legibility

Implementation Options

• Origin country application: Labels applied before export—most controlled
• Destination country application: Labels applied after import—more flexible but requires local facility
• In-transit application: Applied at consolidation warehouse or FTZ—balance of control and flexibility

Cost Considerations

• Label design and translation: $500-2,000 per product per market
• Label printing: $0.05-0.50 per unit depending on complexity
• Application labor: $0.10-0.50 per unit depending on location

Compare against: Separate packaging runs ($5,000-20,000+ setup per market)

Use this checklist to verify labeling compliance before shipping to each market.

US Market Checklist

• ☐ Statement of identity on PDP in English
• ☐ Net quantity in metric AND US customary units
• ☐ Complete INCI ingredient list
• ☐ Ingredients in descending order of predominance
• ☐ Distributor/manufacturer name and address
• ☐ Country of origin marked on container
• ☐ Required warning statements included
• ☐ No unapproved color additive names
• ☐ No drug claims on cosmetic product

EU Market Checklist

• ☐ Responsible Person name and EU address
• ☐ Country of origin (if non-EU manufactured)
• ☐ Nominal content (weight/volume)
• ☐ PAO symbol or expiration date
• ☐ Batch number
• ☐ Product function stated
• ☐ Ingredient list with "Ingredients:" header
• ☐ Fragrance allergens individually listed if above threshold
• ☐ Required precautions in appropriate language(s)

Label Review Process

1. Internal regulatory review against target market requirements
2. Translation verification by native speakers with regulatory knowledge
3. Mock-up review for placement and legibility
4. Final proof approval before production
5. First-article inspection of printed labels
6. Retain label samples with lot records