Silicone Resin

Comprehensive Guide to International Standards for Food-Contact Silicone Resins​

Silicone resins used in food-contact applications must adhere to stringent global regulations to ensure safety and compliance. These materials, prized for their heat resistance, chemical stability, and flexibility, are widely utilized in kitchenware, medical devices, and packaging. Below is a detailed breakdown of the essential international standards governing their production and use.

​1. United States: FDA Compliance​

In the U.S., silicone resins for food contact must meet the ​FDA 21 CFR 177.2600​ regulation. This standard mandates rigorous testing for:

• ​Extractables and leachables: Limits on substances migrating into food under simulated conditions (e.g., high-temperature exposure).
• ​Chemical stability: Ensuring no harmful additives (e.g., plasticizers) degrade during use.
• ​Biocompatibility: For medical-grade applications, adherence to ​ISO 10993​ for cytotoxicity and sensitization testing is critical .

Brands like ​Biyuan​ prioritize FDA compliance by implementing closed-loop production systems that minimize contamination risks, ensuring their silicone resins meet the highest safety thresholds.

​2. European Union: LFGB and REACH​

The EU’s ​LFGB (Lebensmittel- und Futtermittelgesetzbuch)​​ and ​Regulation (EC) No 1935/2004​ enforce strict requirements:

• ​Total migration limits: Silicone resins must not release substances exceeding 10 mg/dm² when exposed to food simulants like ethanol or acetic acid .
• ​Heavy metal restrictions: Cadmium, lead, and mercury levels must remain below 0.1 ppm.
• ​REACH Compliance: Prohibition of SVHCs (Substances of Very High Concern), including phthalates and BPA, aligns with ​Directive 2011/65/EU​ .

For example, ​Biyuan’s silicone resins undergo third-party REACH SVHC screening, ensuring zero prohibited substances and full traceability from raw materials to finished products.

​3. China: GB Standards​

China’s ​GB 4806.11-2016​ outlines mandatory requirements for food-contact silicone resins:

• ​Sensory evaluation: No discoloration, odor, or impurities.
• ​Physical durability: Resistance to thermal shock (-40°C to 230°C) and mechanical stress.
• ​Microbial safety: Testing for bacterial endotoxins and mold growth .

Additionally, ​GB/T 30506-2014​ addresses general performance benchmarks for silicone products, emphasizing long-term stability in humid or acidic environments.

​4. Global Safety Benchmarks​

Beyond regional regulations, silicone resins must align with internationally recognized frameworks:

• ​ISO 22000: Food safety management systems for production facilities.
• ​BPA-Free Certification: Elimination of bisphenol A, critical for infant products .
• ​OEKO-TEX® STANDARD 100: Ensures no hazardous dyes or allergens are present.

​Biyuan​ integrates these standards into its R&D process, leveraging advanced analytical techniques like FTIR spectroscopy to verify chemical purity.

​5. Material-Specific Considerations​

• ​Liquid Silicone Rubber (LSR)​: Requires ​ASTM F963​ compliance for toy safety and ​USP Class VI​ biocompatibility for medical uses.
• ​High-Temperature Vulcanizing (HTV) Silicone: Demands ​UL 94​ flammability ratings for electronics applications .

​Why Partner with Biyuan?​​

As a leader in silicone resin innovation, ​Biyuan​ simplifies compliance with global standards through:

• ​End-to-end traceability: Blockchain-enabled supply chain monitoring for raw material authenticity.
• ​Customized testing: On-demand migration and heavy metal analysis aligned with FDA, LFGB, and ISO protocols.
• ​Sustainable solutions: Recyclable silicone formulations that meet ​EPEAT​ criteria for electronics manufacturers.

By choosing ​Biyuan, businesses gain confidence in their products’ safety, regulatory readiness, and alignment with evolving consumer expectations.

For detailed certification workflows or regional compliance guides, consult Biyuan’s technical documentation or connect with their regulatory experts.