Cosmetics Export Compliance Panorama — US FDA + EU EC 1223/2009 + Japan PMD Act
Cosmetics export compliance is one of the most complex areas in global cross-border e-commerce. Regulatory systems, definition boundaries, registration requirements, and labeling specifications vary enormously across markets. This article systematically outlines the core compliance points for the three major cosmetics target markets: the US, EU, and Japan.
US FDA Cosmetics Regulation
US cosmetics are primarily governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and regulated by the FDA (U.S. Food and Drug Administration).
MoCRA 2022 — Major Changes
The Modernization of Cosmetics Regulation Act (MoCRA), passed in 2022, represents the largest expansion of FDA cosmetics regulatory authority in 84 years. Key new requirements: manufacturing facilities must complete FDA facility registration and product listing by July 2024; serious adverse events must be reported within 15 days; products must be substantiated for safety with written records.
Labeling Requirements
US cosmetic labeling must follow FDA labeling guidelines: net contents declaration, ingredient list (INCI names), name and address of the responsible firm, and country of origin marking (e.g., Made in China). The US has no pre-market approval requirement, but products must not be adulterated or misbranded.
EU Cosmetics Regulation EC 1223/2009
The EU imposes pre-market compliance management on all cosmetics, with requirements far stricter than those in the US.
Four Core Modules
Cosmetic Product Safety Report (CPSR): All cosmetics must have a CPSR (Parts A and B) prepared by a qualified safety assessor — cannot be omitted.
CPNP Notification: Products must be notified to the EU via the CPNP (Cosmetic Product Notification Portal) before they can be placed on the market.
Responsible Person: Non-EU manufacturers must designate a Responsible Person within the EU to assume product compliance liability.
Product Information File (PIF): Contains complete documentation including product formulation, CPSR, efficacy substantiation, and manufacturing method descriptions, retained by the Responsible Person for inspection.
Japan PMD Act (Former Pharmaceutical Affairs Law)
Japanese cosmetics are regulated by the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (commonly known as the "PMD Act").
Product Classification and Market Entry
Cosmetics in Japan are divided into "cosmetics" and "quasi-drugs." Ordinary cosmetics do not require pre-market approval but must comply with ingredient lists and various standards; quasi-drugs require individual product approval. Foreign manufacturers must enter the market through a Japanese Marketing Authorization Holder (MAH).
Core Differences Across the Three Markets
| Dimension | US FDA | EU EC 1223/2009 | Japan PMD Act |
|---|---|---|---|
| Pre-market Approval | None (except color additives) | None (CPSR + CPNP notification) | Quasi-drugs require approval |
| Responsible Person Requirement | None | Mandatory Responsible Person | Must designate MAH |
| Safety Assessment | MoCRA requires written records | CPSR mandatory | Depends on product category |
| Animal Testing | Not prohibited | Comprehensively banned | Partially restricted |
| INCI Ingredients | Mandatory | Mandatory | Mandatory (Japanese names) |
| Registration Cost | ~$100-400/company | CPNP notification free | Varies by category |
FAQ
Q: If exporting to the US, EU, and Japan simultaneously, can one safety assessment report be shared?
A: Not entirely. The three have different structural requirements, but test data (such as stability, compatibility, microbiology testing) can be shared, with market-specific content supplemented for each.
Q: Is US MoCRA registration mandatory?
A: Yes. From July 1, 2024, all companies selling cosmetics in the US must complete FDA facility registration and product listing. GreenArk can act as agent for FDA registration and MoCRA compliance document preparation.
Q: What is the most challenging aspect of exporting cosmetics to Japan?
A: MAH designation and ingredient compliance review are the most challenging parts. The MAH bears legal liability and must audit the legality of all ingredients and efficacy claims.
Q: Can I do EU CPNP notification myself?
A: Only the Responsible Person within the EU can submit notifications through the CPNP portal. Non-EU companies must entrust an EU Responsible Person to submit on their behalf.
GreenArk (Shenzhen) Certification Co., Ltd. provides one-stop cosmetics export compliance services including US FDA registration, EU cosmetics safety assessment and CPNP notification, and Japan MAH matching — helping brands operate compliantly across US, EU, and Japanese markets simultaneously.
GreenArk (Shenzhen) Certification Co., Ltd.
www.greenark-sz.com | sui@greenark-sz.com
