Exporting baby diapers from China to the United States is a promising business opportunity, but it’s not as simple as shipping general consumer goods. The U.S. has strict safety, labeling, and regulatory requirements for products that come into contact with infants. To ensure smooth customs clearance and avoid legal risks, manufacturers and exporters must understand and comply with key certifications and regulations.
Here’s a comprehensive guide to the essential certifications and procedures you need to know.
- FDA Registration: A Mandatory Step
Baby diapers are classified as Class II Medical Devices under the U.S. Food and Drug Administration (FDA) regulations.
- Factory Registration: All manufacturers must register their production facilities with the FDA.
- 510(k) Exemption: Most baby diapers are exempt from the FDA’s 510(k) premarket notification, but they still need to meet basic safety and performance requirements under 21 CFR Part 880.5920.
Without FDA registration, your shipment will not pass U.S. customs inspections.
- Compliance with CPSC and CPSIA Regulations
The U.S. Consumer Product Safety Commission (CPSC) and the Consumer Product Safety Improvement Act (CPSIA) apply to all children’s products, including diapers.
Key safety requirements include:
- Lead Content Limit: Less than 100 ppm.
- Phthalate Content Restriction: Diapers must not contain restricted levels of phthalates.
- Small Parts Regulation: The product must not pose a choking hazard for infants.
- Tracking Labels: Each package must include traceability information, such as batch number, production date, and factory code.
If you are exporting diapers for infants under 12 years old, a Children’s Product Certificate (CPC) may also be required by the importer or retailer.
- Labeling Requirements
Diapers sold in the U.S. must comply with the Fair Packaging and Labeling Act (FPLA).
Mandatory labeling elements:
- Product name
- Manufacturer’s or distributor’s name and contact information
- Country of origin (e.g., Made in China)
- Quantity or package count
- Usage instructions and safety warnings
All labels must be in English.
- ASTM Standards (Recommended)
Although not always mandatory, compliance with ASTM D3492 (Standard Specification for Disposable Diapers) is highly recommended. This standard covers:
- Absorption performance
- Leak prevention
- Durability and material strength
Meeting ASTM standards increases buyer confidence and reduces the risk of product returns.
- Biocompatibility Testing (Recommended)
Since diapers directly contact babies’ skin, it’s advisable to conduct:
- ISO 10993 Biocompatibility Testing
- Skin irritation and sensitization tests
These tests help prove that the materials used are skin-safe and will not cause allergic reactions.
- California Proposition 65 (Optional, But Important)
If your products are sold in California, you must also comply with California Proposition 65, which regulates harmful chemicals. You need to ensure that your diapers do not contain listed substances or provide appropriate warning labels if necessary.
Conclusion: Compliance Is the Key to Success
Exporting baby diapers to the U.S. involves more than just securing a buyer and booking a shipment. It’s essential to:
- Register with the FDA
- Meet CPSC and CPSIA safety standards
- Ensure proper labeling
- Pass relevant quality and safety tests
For smooth entry into the U.S. market, partnering with experienced logistics providers, testing laboratories, and compliance consultants can help you navigate this complex process efficiently.