Compliance and Certifications for Plastic Products in the US Market
In This Guide
FDA Compliance for Food-Contact Plastics
If a plastic product contacts food or beverages, the resin and additives must comply with FDA regulations under 21 CFR. The supplier must provide documentation showing the resin grade is listed or complies with the relevant FDA food contact notification.
- Resin supplier's FDA compliance letter
- 21 CFR citation for the resin and additives
- Test data for total migration if required
- Material certificate for each production lot
UL Certification for Electrical Plastics
Plastic materials used in electrical applications require UL recognition under UL 94 (flammability) and potentially UL 746 (polymer properties). The resin must have a valid UL Yellow Card.
| Standard | Scope | Documentation |
|---|---|---|
| UL 94 | Flammability rating (HB, V-2, V-1, V-0, 5VA) | UL Yellow Card for resin grade |
| UL 746A | Short-term material properties | Test report from UL |
| UL 746B | Long-term thermal aging | RTI rating |
| UL 746C | Electrical and mechanical | Combined assessment |
RoHS and REACH
RoHS (Restriction of Hazardous Substances) limits lead, mercury, cadmium, and other substances in electrical and electronic products. REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) applies to products sold in the EU but is commonly requested for US products too. Request:
- RoHS declaration of conformity
- REACH SVHC statement (current candidate list)
- Test reports from accredited lab if requested
California Proposition 65
Products sold in California must carry a warning if they contain chemicals listed under Prop 65 above safe harbor levels. Bisphenol A (BPA) and certain phthalates are listed and appear in some plastics. Confirm whether your product requires a Prop 65 warning or is exempt.
BPA and phthalates are the most common Prop 65 concerns for plastic products. If your resin or additive contains listed substances, test the finished product to determine if a warning is required.
CPSIA for Children's Products
Plastic products intended for children under 12 must comply with the Consumer Product Safety Improvement Act (CPSIA). Requirements include lead content limits, phthalate bans, and third-party testing by a CPSC-accepted lab.
- Lead content: ≤100 ppm in substrates
- Phthalates: ≤0.1% for specified phthalates
- Third-party testing by CPSC-accepted lab
- Children's Product Certificate (CPC)
Documentation Checklist from Supplier
For each compliance framework, request specific documents:
| Requirement | Document Needed |
|---|---|
| FDA food contact | Resin supplier compliance letter, 21 CFR citation |
| UL 94 | UL Yellow Card for the specific resin grade |
| RoHS | Declaration of conformity, test report if requested |
| REACH | SVHC statement against current candidate list |
| Prop 65 | BPA/phthalate test data or exemption statement |
| CPSIA | Third-party test report, CPC |
Verification Tips
Compliance documentation should come from the resin manufacturer, not just the molder. Verify UL Yellow Cards on UL's database. For test reports, confirm the lab is accredited (ISO 17025). Keep compliance files updated as regulations change.
Frequently Asked Questions
Who is responsible for compliance — the supplier or the importer?
The US importer is ultimately responsible for product compliance in the US market. The supplier provides documentation, but the importer must verify it, maintain records, and ensure the product meets applicable standards. Use a compliance consultant for complex products.
Do I need to test every shipment?
Not typically. Most compliance frameworks require initial testing and material certificates per lot. Periodic retesting confirms ongoing compliance. Confirm testing frequency with your compliance consultant.
How do I verify a UL Yellow Card?
UL maintains a public database at ulprospector.com where you can verify the resin grade, manufacturer, and flammability rating. Confirm the Yellow Card is current and matches the resin grade used in your product.
What happens if my product is non-compliant?
Non-compliant products may be refused entry by CBP, recalled by CPSC, or subject to private enforcement under Prop 65. Fines and product recall costs can be significant. Verify compliance before importing.
Can the supplier provide test reports?
Suppliers can provide resin manufacturer test reports and declarations. For independent verification, use a third-party lab (ISO 17025 accredited). Some buyers require periodic third-party testing of finished products.
Key Takeaways
US compliance for plastic products spans FDA, UL, RoHS, REACH, Prop 65, and CPSIA depending on the product type. Obtain documentation from resin manufacturers, verify certifications independently, and maintain records. The importer bears ultimate responsibility — invest in compliance verification before importing.
Discuss Compliance Requirements
Share your product type and target market for a compliance documentation checklist.
To get an accurate quote, include these details in your inquiry:
- Product type and application
- Target users (adult/children)
- Food or electrical contact
- States of sale (especially California)
- Existing certifications
- Testing requirements
Send your specifications to Hengmei Plastic Products and receive a tailored quotation.
