Are there any specific regulations or standards for silicone toys?

United States (CPSIA, ASTM F963, FDA)

• CPSIA: Phthalates (6 types) ≤0.1%; lead ≤100 ppm (paint ≤90 ppm); small parts test for choking hazards.

• ASTM F963: Mechanical safety (no sharp edges/breakable parts), flammability, heavy metal migration limits.

• FDA 21 CFR 177.6600: Food-contact silicone must be free of BPA, phthalates, and harmful migration.

• CPC Certification: Mandatory for all children’s products; requires ASTM F963 & CPSIA test reports.

European Union (EN 71, REACH, Toy Safety Directive)

• EN 71 Series: EN 71-1 (physical safety), EN 71-2 (flammability), EN 71-3 (heavy metal migration).

• REACH: SVHC reporting (e.g., D4/D5/D6 siloxanes ≤0.1%); restricted substances (phthalates, heavy metals).

• Toy Safety Directive 2009/48/EC: Phthalates (DEHP, DBP, BBP) ≤0.1%; DINP, DIDP, DNOP ≤0.1% for mouthable toys; CE marking required.

• LFGB (Germany): Stricter migration limits, sensory testing (odor/taste), VOC/nitrosamine checks.

China (GB 6675, GB 4806.16-2025, CCC)

• GB 6675: Mechanical safety, lead ≤90 ppm, phthalates ≤0.1%.

• GB 4806.16-2025: Infant silicone: lead ≤0.01 mg/kg, arsenic ≤0.002 mg/kg; migration test (4% acetic acid, 77°C, 24 h).

• CCC Certification: Mandatory for 12 toy categories; covers mechanical, flammability, and chemical safety.

Compliance Checklist for Silicone Toys

• Use only food-grade/medical-grade silicone (FDA 21 CFR 177.6600 or LFGB compliant).

• Test for phthalates, heavy metals, and SVHCs (REACH) to meet ≤0.1% limits.

• Ensure no small detachable parts (choking hazard) and smooth, non-toxic textures.

• Label with age warnings, CE/CPC marks, and manufacturer information.

• Retain test reports from accredited labs for CPSIA/ASTM F963 (US) or EN 71/REACH (EU) compliance.