What are the specific chemical safety requirements for silicone toys?
Chemical Safety Requirements for Silicone Toys
Silicone toys for infants and children must meet strict chemical safety standards to ensure non-toxicity, with global limits on heavy metals, phthalates, residual monomers, and migration. Below is a comprehensive guide to compliance requirements and testing protocols.
Heavy Metal Migration Limits (mg/kg)
Key elements restricted by EU EN 71-3, US CPSIA/ASTM F633, and China GB 6755:
| Element | EU EN 71-3 | US CPSIA/ASTM F633 | China GB 6755 |
|---|---|---|---|
| Lead (Pb) | ≤23 | ≤100 (≤90 in paint) | ≤90 |
| Cadmium (Cd) | ≤17 | ≤75 | ≤75 |
| Arsenic (As) | ≤77 | ≤25 | ≤25 |
| Mercury (Hg) | ≤77 | ≤10 | ≤10 |
| Chromium (VI) | ≤0.033 | ≤0.03 | ≤0.03 |
Test method: ICP-OES/ICP-MS with 4% acetic acid extraction (70°C/2hr for EN 71-3).
Phthalate Limits (6 High-Risk Types)
Global standard: All 6 phthalates ≤0.1% (1,000 ppm) by weight for children’s products ≤12 years:
• DEHP, DBP, BBP (banned in all toys; ≤0.1% in all components)
• DINP, DIDP, DNOP (≤0.1% in mouthable toys; stricter for infants<3 years)
Test method: GC-MS for quantitative analysis of each phthalate.
Banned Additives & Residual Monomers
• Zero tolerance: BPA, PVC, formaldehyde, nitrosamines, organotins (TBT/DBT)
• Residual monomers: Vinyl siloxane ≤0.1%; D4/D5/D6 siloxanes ≤0.1% (EU REACH SVHC)
• Platinum catalyst residues: ≤5 ppm (medical-grade silicone); peroxide curing byproducts banned
• VOCs: Total volatile organic compounds ≤0.5% (5,000 ppm) (EU REACH/China GB 8806.16)
Food-Contact & Migration Requirements
• US FDA 21 CFR 177.6600: No migration of BPA/phthalates/heavy metals; stable at 200°C; non-toxic/non-irritating
• EU LFGB (Germany): Stricter migration limits; no odor/taste transfer; nitrosamine/VOC testing
• China GB 8806.16-2025: Lead ≤0.01 mg/kg, arsenic ≤0.002 mg/kg (10× stricter); migration test (4% acetic acid, 77°C/24h)
Regional Compliance Mandates
• US: CPSIA + ASTM F633; CPC certification required (test reports from accredited labs)
• EU: EN 71-3 + REACH; CE marking required (SVHC reporting for D4/D5/D6 siloxanes)
• China: GB 6755 + GB 8806.16; CCC certification required (lead ≤90 ppm; phthalates ≤0.1%)
Compliance Checklist for Manufacturers
Use only platinum-cured food-grade/medical-grade silicone (avoid peroxide curing)
Test heavy metal migration via ICP-OES/ICP-MS (meet EN 71-3/CPSIA limits)
Verify 6 phthalates ≤0.1% with GC-MS; ban BPA/PVC/formaldehyde
Check residual monomers (VSM/D4/D5/D6 ≤0.1%) and VOCs ≤0.5%
Obtain FDA/LFGB certification for mouthable toys; retain test reports for 5+ years
Label with CE (EU) or CPC (US) marks; include material grade and compliance statements
Key Safety Certifications
FDA (USA)
Food-Contact Silicone (21 CFR 177.6600)
LFGB (EU)
Stricter Food-Contact Safety
CE (EU)
EN 71-3 + Toy Safety Directive
CPC (USA)
CPSIA + ASTM F633 Compliance
CCC (China)
GB 6755 + GB 8806.16
