1. FDA MoCRA requirements for US cosmetics imports
The Modernization of Cosmetics Regulation Act (MoCRA), signed into US law in December 2022, significantly expanded FDA authority over cosmetics. Before MoCRA, cosmetics were largely self-regulated in the United States. Now, brands and manufacturers face mandatory requirements that mirror the structure used in pharmaceutical and food regulation.
Under MoCRA, every facility that manufactures or processes cosmetics for the US market must register with the FDA and renew that registration every two years. Each cosmetic product must be listed with the FDA, including ingredient information and product category. Brands must also report serious adverse events within 15 days and maintain safety substantiation records demonstrating that each product is safe when used as directed.
MoCRA also grants the FDA authority to issue mandatory recalls, access facility records and enforce Good Manufacturing Practice (GMP) standards — though the specific GMP rule is still being finalized. For private label brands importing from China, this means your manufacturer's facility registration and your product listing are both your responsibility as the brand owner.
2. EU Cosmetics Regulation (EC 1223/2009)
The European Union has regulated cosmetics through EC 1223/2009 since 2013, and it remains one of the most comprehensive cosmetics regulatory frameworks in the world. Every cosmetic product placed on the EU market must comply with this regulation regardless of where it is manufactured.
The regulation covers banned and restricted substances (Annexes II–VI), labeling requirements, claims substantiation, nanomaterial notification and animal testing prohibitions. Products must be manufactured in compliance with ISO 22716 (GMP for cosmetics), and the Responsible Person must have a complete Product Information File available for inspection by authorities at any time.
| Requirement | US (FDA MoCRA) | EU (EC 1223/2009) |
|---|---|---|
| Facility registration | Mandatory with FDA, biennial renewal | Not required at facility level |
| Product listing | Mandatory with FDA | Mandatory via CPNP |
| Responsible Person | Brand owner or US agent | EU-established Responsible Person required |
| Safety assessment | Safety substantiation required | Cosmetic Product Safety Report (CPSR) required |
| GMP standard | FDA GMP rule (pending finalization) | ISO 22716 |
| Adverse event reporting | 15-day mandatory reporting | Serious undesirable effects reporting to authorities |
| Labeling | INCI list, net content, warnings | INCI list, Responsible Person address, batch code, PAO, warnings |
3. Responsible Person and CPNP notification
In the EU, the Responsible Person (RP) is the legal entity that ensures a cosmetic product's compliance. If you are a brand based outside the EU, you must appoint an RP established within the European Union. This can be your EU distributor, a dedicated regulatory consultancy or a third-party RP service provider.
The RP is responsible for maintaining the Product Information File (PIF), ensuring the Cosmetic Product Safety Report is completed by a qualified safety assessor, notifying the product through the Cosmetic Product Notification Portal (CPNP), and reporting any serious undesirable effects to authorities.
CPNP notification must be completed before the product is first placed on the EU market. It includes the product category, the nanomaterial content declaration (if applicable), the original label and packaging images, and the frame formulation. The CPNP system also serves as a poison center notification tool, ensuring emergency responders have ingredient data if a consumer experiences an adverse reaction.
4. Product Information File (PIF) documentation
The Product Information File is the central compliance document for any cosmetic product sold in the EU. It must be kept by the Responsible Person and made available to competent authorities upon request. A complete PIF includes:
- Cosmetic Product Safety Report (CPSR): A two-part document prepared by a qualified safety assessor. Part A covers the product description, formulation, micro quality, stability and exposure assessment. Part B is the safety assessor's signed conclusion.
- Product description: Name, category, intended use and physical form.
- Manufacturing method: A description of how the product is made, including GMP compliance evidence.
- Proof of claimed effects: Supporting data for any efficacy claims on the label or marketing materials.
- Animal testing data: A declaration that the product and its ingredients have not been tested on animals in compliance with the EU ban.
A capable Chinese cosmetics manufacturer supports PIF preparation by providing complete formulation data, raw material specifications, Certificates of Analysis, stability study results and micro test reports in the format your safety assessor needs.
5. Ingredient labeling requirements
Both the US and EU require ingredient lists using International Nomenclature of Cosmetic Ingredients (INCI) names. The rules differ slightly in presentation but share the same foundation: ingredients listed in descending order of concentration, with ingredients below 1% listed in any order after those above 1%.
EU labeling also requires the Responsible Person's name and address, the country of origin for imported products, a batch code, the Period After Opening (PAO) symbol or expiration date, and specific warning statements for certain ingredient categories. US labeling under the Fair Packaging and Labeling Act requires the net quantity of contents, the manufacturer or distributor name and address, and the INCI ingredient declaration.
Your manufacturer should provide the full INCI list with accurate percentages early in the development process so your regulatory team can begin safety assessments and label design without delays.
6. GMP standards and factory compliance
Good Manufacturing Practices are the backbone of cosmetics safety. The internationally recognized standard is ISO 22716, which covers personnel, premises, equipment, raw materials, production, quality control, waste handling and documentation.
For EU compliance, ISO 22716 is mandatory. For US compliance under MoCRA, the FDA is developing specific GMP requirements that are expected to align closely with ISO 22716. Many retailers and distributors in both markets require a copy of the manufacturer's GMP certificate before approving a supplier.
ARIS Cosmetics maintains GMP-compliant production in a 5,000+㎡ facility in Yiwu and provides GMP certificates, ISO 22716 documentation and third-party audit reports to support client compliance needs.
7. Export documents a Chinese manufacturer should provide
When importing cosmetics from China, your manufacturer should supply a comprehensive document package. The specific documents depend on your destination market, but a reliable OEM/ODM partner will proactively prepare:
- Complete INCI ingredient list with percentages and CAS numbers
- Product Safety Data Sheets (SDS) for each product
- GMP certificate and ISO 22716 documentation
- Business license and export license
- Certificate of Free Sale (issued by Chinese health authorities)
- Stability test reports (accelerated and long-term)
- Microbiology test reports (total plate count, yeast, mold, pathogens)
- Heavy metal and contaminant test reports (SGS, Intertek or equivalent)
- Bill of Materials (BOM) and manufacturing specifications
- Finished product specifications and COA (Certificate of Analysis)
A manufacturer that routinely exports to the US and EU will have these documents ready or can prepare them efficiently. ARIS Cosmetics provides this full documentation package and works with third-party labs including SGS and Intertek to ensure test reports meet destination-market requirements.
Compliance document checklist by market
| Document | US (FDA) | EU (EC 1223/2009) |
|---|---|---|
| INCI ingredient list | Required | Required |
| GMP / ISO 22716 certificate | Expected | Mandatory |
| Safety substantiation / CPSR | Required (MoCRA) | Mandatory (PIF) |
| Product listing / CPNP notification | FDA listing required | CPNP notification required |
| Stability test report | Recommended | Required in PIF |
| Microbiology test report | Recommended | Required in PIF |
| Heavy metal / contaminant testing | Recommended | Recommended |
| Certificate of Free Sale | Helpful | Helpful |
| Responsible Person designation | US agent (if needed) | Mandatory EU RP |
Regulatory compliance is not optional — it protects your brand, your customers and your market access. By understanding FDA MoCRA and EU Cosmetics Regulation requirements from the start, and working with a manufacturer that provides the right documentation, you avoid costly delays, rejected shipments and regulatory enforcement actions. Plan compliance alongside product development, not after it.