Are there any industry-specific standards for silicone baby toys?
Industry-Specific Standards for Silicone Baby Toys
Silicone baby toys (teethers, pacifiers, chewable figures) are governed by stricter industry standards for mouthable/chewable use, food-contact safety, and infant-specific hazards. Below is a comprehensive compliance guide for manufacturers/retailers.
United States (CPSIA, ASTM F963, FDA)
• CPSIA 16 CFR 1307: 6 phthalates ≤0.1%; lead ≤100 ppm; small parts test (≤3 years).
• ASTM F963-21: No sharp edges/breakable parts; heavy metal migration limits.
• FDA 21 CFR 177.6600: Food-contact silicone (teethers/pacifiers); no BPA/phthalates; platinum-cured only.
• ASTM F2907: Pacifier safety (one-piece design, tensile strength ≥1.5 MPa).
• CPC Certification: Mandatory lab reports for CPSIA + ASTM F963 compliance.
European Union (EN 71, REACH, LFGB)
• EN 71 Series: EN 71-1 (physical safety); EN 71-3 (heavy metal migration: Pb ≤23 mg/kg); EN 71-12 (nitrosamines ≤0.01 mg/kg).
• REACH SVHC: D4/D5/D6 siloxanes ≤0.1%; vinyl siloxane ≤0.1%.
• LFGB: Food-contact silicone; no odor/taste migration; platinum catalyst ≤5 ppm.
• Toy Safety Directive 2009/48/EC: CE marking; phthalates ≤0.1% for mouthable toys.
China (GB 6675, GB 4806.16-2025, CCC)
• GB 6675.1-4: Lead ≤90 ppm; phthalates ≤0.1%; small parts test (≤3 years).
• GB 4806.16-2025: Baby silicone: lead ≤0.01 mg/kg, arsenic ≤0.002 mg/kg; volatile substances ≤0.5%.
• GB 28007-2011: Pacifier safety (one-piece design, no nitrosamines).
• CCC Certification: Mandatory for 12 toy categories; covers mechanical/chemical safety.
Industry-Specific Rules by Toy Type
| Toy Category | Key Industry Mandates | Critical Tests |
|---|---|---|
| Teethers | FDA 21 CFR 177.6600 + EN 14350-2 | Migration (4% acetic acid), tensile strength ≥1.5 MPa |
| Pacifiers | ASTM F2907 + GB 28007 | One-piece design, no nitrosamines, aging test (retention ≥80%) |
| Chewable Figures | EN 71-3 + CPSIA | Heavy metal migration, ≤0.1% phthalates |
| Teething Jewelry | ASTM F3263 + CPSIA §1501 | Breakaway clasp, no small parts |
Baby Silicone Toy Compliance Checklist
Use only platinum-cured food-grade silicone (FDA 21 CFR 177.6600/LFGB compliant).
Test 6 phthalates ≤0.1% and lead ≤100 ppm (CPSIA/ASTM F963).
Ensure no small detachable parts (choking hazard for ≤3 years).
Pass migration test (4% acetic acid, 70°C/2hr for EN 71-3; 77°C/24hr for GB 4806.16).
Label with age warnings, CE/CPC marks, and manufacturer info.
Retain lab reports from CPSC-accredited labs (US) or EN 71-accredited labs (EU).
Industry-Specific Certifications
CPC (USA)
CPSIA + ASTM F963 Compliance
CE (EU)
EN 71 + Toy Safety Directive
FDA (USA)
Food-Contact Silicone
LFGB (EU)
Stricter Food-Contact Safety
CCC (China)
GB 6675 + GB 4806.16
