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For children's merchandise or promotional gifts exported to the United States and European Union, can the products fully pass CPSIA (Total Lead and Phthalates) and California Proposition 65 (Total Cadmium, Total Lead, and Phthalates) testing?

Yes. All soft PVC components engineered for export to the United States and the European Union fully comply with the statutory requirements of the Consumer Product Safety Improvement Act (CPSIA) and California Proposition 65. Finished articles consistently pass analytical testing for Total Lead (Pb), Total Cadmium (Cd), and the regulated phthalate compound groups, with concentration levels falling well below the established legal thresholds.

Regulatory Standards & Chemical Thresholds
1.US CPSIA Compliance (Children’s Products & Toys)

  • Total Lead Content (Substrate): Regulated under 15 U.S.C.§1278a. The maximum allowable limit for lead in accessible substrates of children’s products is 100 ppm (0.01%). Our soft PVC substrate material exhibits a baseline lead content of less than 10 ppm or is completely Non-Detected (ND).
  • Phthalate Restrictions: Regulated under 16 CFR Part 1308. The law permanently bans any children’s toy or child care article containing concentrations of more than 0.1% (1,000text{ ppm) for eight specified phthalates: DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, and DCHP.

2.California Proposition 65 Compliance (Safe Drinking Water and Toxic Enforcement Act)
Because Proposition 65 does not set a single statutory maximum concentration limit but operates via “Safe Harbor Numbers” (No Significant Risk Levels for carcinogens and Maximum Allowable Dose Levels for reproductive toxicants), our material formulations conform to the standard settlement thresholds enforced for vinyl/PVC consumer products:
Total Lead (Pb): Limited to 90 ppm for surface coatings and 100 ppm for polymeric substrates.
Total Cadmium (Cd): Maintained below 200 ppm (0.02%) in accordance with standard California Superior Court consent decrees for soft PVC accessories.
Phthalates (DEHP, DBP, BBP, DINP, DIDP, DnOP): Restricted to less than 0.1% (1,000 ppm) individually. Formulations meeting these criteria bypass the requirement for a Proposition 65 clear and reasonable warning label.

Technical Formulations & On-Site Production Parameters
To ensure continuous compliance across mass production cycles, the following technical controls are systematically implemented:
Heavy Metal-Free Stabilization: Traditional lead-based or cadmium-based heat stabilizers are strictly prohibited in the compounding stage. The factory utilizes Liquid Calcium-Zinc (Ca-Zn) stabilizers or organic stabilizers formulated specifically for eco-friendly polymers.
Polymer Carrier Cleanliness: All color masterbatches and liquid pigment pastes are bound in compliant plasticizer carriers (such as DOTP or ATBC) to eliminate any hidden introduction of restricted ortho-phthalates.
Baking and Curing Kinetics: Processing temperatures are monitored via automated thermal sensors within a strict 165℃to 175℃ window. This prevents thermal degradation of the Ca-Zn stabilizer, which can alter the physical and chemical stability of the soft PVC substrate.

Verification and Tracking
CPSC-Accepted Laboratories: Testing and verification are conducted by independent, third-party laboratories accredited by the Consumer Product Safety Commission (CPSC), including SGS, Intertek, and BV.
Children’s Product Certificate (CPC): For every shipment classified as a children’s product under US law, a Children’s Product Certificate (CPC) mapping back to the supporting test reports is issued to support customs clearance.

 

[Client PVC Ban]

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       ├─► Silicone Transition ──► Requires NEW Compression Tooling (Steel Shrinkage: 2.5% – 3.5%)

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       └─► TPU Transition ──────► POTENTIAL Tooling Retention (Subject to Gate & Draft Analysis)

We are a silicone manufacturing company with our own manufacturing base. We also have a trading department.

Yes, our factory’s certifications include but are not limited to ISO:9001, ISO:13485, FDA, SEDEX, BSCI, etc. Our product certifications and audit reports include UL, CPC, CE, LFGB, FDA, COC, etc.

Consumer silicone products, industrial (electronic/automotive) silicone parts, and medical silicone products. In fact, our customers come from various industries.

Our corporate headquarters is located in Xiamen, China, and our factory is also located there. It is a beautiful city. We are here to serve our customers from all over the world.

Yes, we support injection molding, we are equipped with large automatic injection molding machines to meet customers’ needs. In addition, we are also able to support compression molding (transfer molding), extrusion molding, and over-molding.

The average capacity of the factory is 500k-1000k per month. Capacity will vary depending on the size and complexity of the product.

The high-quality silicone materials we offer can be divided into liquid silicone and solid silicone.

We can also add vulcanizing agents (platinum) to change the properties of the material (Shore hardness) according to the different needs of our customers.

Services

Do you have your own factory? Or is it just a trading company?

We are a silicone manufacturing company with our own manufacturing base. We also have a trading department.

Yes, our factory’s certifications include but are not limited to ISO:9001, ISO:13485, FDA, SEDEX, BSCI, etc. Our product certifications and audit reports include UL, CPC, CE, LFGB, FDA, COC, etc.

Consumer silicone products, industrial (electronic/automotive) silicone parts, and medical silicone products. In fact, our customers come from various industries.

Our corporate headquarters is located in Zhejiang Province, China, and our factory is also located there. It is a beautiful city. We are here to serve our customers from all over the world.

Yes, we support injection molding, we are equipped with large automatic injection molding machines to meet customers’ needs. In addition, we are also able to support compression molding (transfer molding), extrusion molding, and over-molding.

The average capacity of the factory is 500k-1000k per month. Capacity will vary depending on the size and complexity of the product.

The high-quality silicone materials we offer can be divided into liquid silicone and solid silicone.

We can also add vulcanizing agents (platinum) to change the properties of the material (Shore hardness) according to the different needs of our customers.

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