Essential Hygiene Standards for Silicone Resin in Food Packaging

Silicone resin has become increasingly vitalin food packaging due to its exceptional heat resistance, durability, and flexibility. For manufacturers like Biyuan, understanding and complying with the complex landscape of hygiene standards is not just about legal compliance—it’s a competitive advantagethat builds trust with consumers and business partners. This comprehensive guide explores the key hygiene standards that silicone resin used in food packaging must meet to ensure safety and quality.

1 Global Regulatory Frameworks for Food-Grade Silicone

The regulatory environment for food-contact silicone resin varies across regions, but all share a common goal: preventing harmful substancesfrom migrating into food. Compliance with these standards is essential for market access and consumer safety.

In the United States, the Food and Drug Administration (FDA)regulates silicone resin through CFR 21 §177.2600, which specifies requirements for rubber articles intended for repeated food contact. This regulation limits the amounts of certain substances that can be used in manufacturing and requires that materials be produced under Good Manufacturing Practices (GMP). FDA-approved silicone must not transfer any toxic or unsafe substances to food under normal use conditions and must undergo specific extraction tests, especially when intended for fatty food contact .

The European Union follows a more decentralized approach, with LFGB (German Food and Feed Code)setting stringent rules for chemical migration and safety. Silicone products must meet strict toxicity standards, ensuring safety in hot, acidic, or alkaline environments. Additionally, the REACH regulationaddresses chemical substances that might pose health or environmental risks, requiring manufacturers to ensure their products do not contain hazardous substances .

China recently enhanced its regulatory framework with GB 4806.16-2025, which specifically governs food-contact silicone rubber materials and products. This standard, effective September 2026, represents a significant advancement as it separates silicone from generic rubber regulations and addresses its unique material properties and risks. The standard introduces specific requirements for volatile substancesand migration teststhat better simulate real-use conditions .

2 Key Hygiene Indicators and Testing Methods

2.1 Overall Migration Limits

Overall migrationmeasures the total amount of non-volatile substances that can transfer from silicone resin to food simulants under specified conditions. This critical indicator ensures that excessive materials do not leach into food, potentially compromising safety and quality.

The Chinese standard GB 4806.16-2025maintains the overall migration limit at ≤10mg/dm² but extends the test time from 0.5 hours to 2 hours at 60°C, aligning with testing requirements for plastics and coatings. This extension provides a more accurate assessment of migration risks during prolonged food contact. For acidic foods like vinegar or tomato-based products, manufacturers must test with 3% acetic acidat 70°C for 2 hours, simulating real-use conditions with hot acidic foods .

2.2 Specific Migration Limits

Specific migrationtargets individual potentially harmful substances that may leach from silicone resin. Key restricted substances include:

• Heavy metals: Lead (≤0.01mg/kg), cadmium (≤0.005mg/kg), and mercury (≤0.001mg/kg)
• Platinum catalysts: Residual catalysts from the manufacturing process
• Siloxanes: Particularly cyclic siloxanes (D4, D5, D6) which are under increased regulatory scrutiny

The European Chemicals Agency has classified D4 as a Substance of Very High Concerndue to its persistent, bioaccumulative, and toxic properties, while D5 and D6 are considered potential bioaccumulative substances .

2.3 Volatile Organic Matter (VOM) Limits

A significant addition in GB 4806.16-2025is the volatile organic matter limitof ≤0.5%. This requirement addresses the potential migration of low molecular weight siloxanes and residual solvents, which can cause odors or pose health risks. The standard includes a precise testing methodology in Appendix B: samples are heated at 100°C for 1 hour followed by 200°C for 4 hours, with weight loss determining the VOM content .

Biyuan’s silicone resin formulation technologies effectively control VOM levels through advanced manufacturing processes and premium raw material selection, ensuring compliance with this crucial requirement.

3 Industry Application Standards and Certification Requirements

3.1 Food Packaging Applications

Different food packaging applications present unique challenges that necessitate specialized compliance approaches:

• High-temperature applications: Baking molds, steaming trays, and oven gaskets require silicone resin that maintains stability up to 230°C while resisting migration. Biyuan’s high-temperature grade silicone resins exceed these requirements, maintaining performance characteristics up to 250°C.
• Acidic food contact: Products like vinegar seals, tomato sauce lids, and pickle containers must withstand acidic conditions without degradation. Migration testing with 3% acetic acid is essential for these applications .
• Fatty food packaging: Butter containers, cheese wraps, and oil bottle seals require rigorous testing with vegetable oil or alternative fat simulants to ensure no harmful migration occurs.

3.2 Specialized Industry Certifications

Beyond basic regulatory compliance, several certifications demonstrate a manufacturer’s commitment to quality and safety:

• ISO 9001and ISO 13485: Quality management standards that ensure consistent manufacturing processes and product quality.
• USP Class VI: Particularly relevant for silicone that may have dual-use applications in food and pharmaceutical contexts, this certification assesses biocompatibility.
• EC 1935/2004: The EU’s framework regulation for materials and articles intended to come into contact with food, with specific provisions for silicone.

Biyuan’s comprehensive certification portfolio includes all major international standards, providing customers with confidence in our products’ safety and quality across global markets.

4 Common Compliance Challenges and Biyuan’s Solutions

4.1 Volatile Substance Control

Many silicone resin manufacturers struggle with volatile substance control, particularly with older manufacturing equipment and formulations. A case study from Zhejiang, China, illustrates this challenge: a silicone kitchenware manufacturer found its products had VOM levels of 0.8%, exceeding the new standard’s 0.5% limit. By investing in upgraded curing ovens with precise temperature control and adding a vacuum degassing stage, they reduced VOM to 0.3%, well within the required limit .

Biyuan’s proprietary low-VOM formulation technologyincorporates advanced polymer cross-linking and vacuum degassing during production, ensuring consistent compliance with volatile substance requirements.

4.2 Migration Test Failures

Another common challenge occurs when products pass older migration tests but fail under updated, more rigorous conditions. One manufacturer discovered their silicone frying pan passed migration testing with 50% ethanol (the old standard) but failed when tested with sunflower oil (the new requirement), with migration levels reaching 12.5mg/dm² versus the ≤10mg/dm² limit .

Biyuan addresses this challenge through accelerated compatibility testingduring product development, evaluating our silicone resins against both current and anticipated future standards across various food simulants.

4.3 Supply Chain Consistency

Maintaining consistent raw material quality is crucial for compliance. Variations in base polymers or additives can lead to non-conforming finished products. Biyuan’s Supply Chain Quality Integration Programworks closely with our raw material suppliers to ensure consistent quality and compliance from source to finished product.

5 Biyuan’s Advanced Material Technologies

Biyuan’s commitment to research and development has yielded several breakthrough technologies that address key hygiene and performance requirements:

5.1 High-Purity Platinum Cure Systems

Our food-grade platinum-cured silicone resinsoffer superior purity compared to conventional peroxide-cured systems. These advanced formulations eliminate concerns about peroxide decomposition products migrating into food, providing enhanced safety particularly for high-temperature applications.

5.2 Low-Migration Polymer Technology

Through molecular structure optimization, Biyuan has developed low-migration polymer technologythat minimizes the potential for substance transfer into food. This technology creates more stable polymer networks with reduced free oligomer content, significantly decreasing overall migration values.

5.3 Customized Compliance Formulations

Recognizing that different applications have unique requirements, Biyuan offers application-specific formulationstailored to particular compliance needs—whether for high-acid resistance, extreme temperature stability, or transparency requirements.

6 The Business Value of Compliance

Investing in compliant silicone resin delivers significant business advantagesbeyond mere regulatory adherence:

• Market access: Compliance with standards like GB 4806.16-2025, FDA, and LFGB is essential for entering and maintaining presence in regulated markets
• Brand protection: Using non-compliant materials risks product recalls, regulatory actions, and reputational damage
• Consumer confidence: Demonstrated compliance builds trust with increasingly safety-conscious consumers
• Operational efficiency: Standard-comforming products typically experience fewer production interruptions and quality issues

Biyuan’s compliance-focused approach ensures that our partners can bring products to market with confidence, supported by comprehensive documentation and testing validation.

The hygiene standards governing silicone resin in food packaging continue to evolve toward greater protectionand more realistic testing methodologies. The recent introduction of GB 4806.16-2025 in China exemplifies this trend, with its specific focus on silicone material characteristics and usage scenarios. For manufacturers, staying ahead of these requirements is not merely about compliance—it’s about embracing a culture of safety and quality that delivers real value to customers and consumers.

Biyuan’s technical expertise and commitment to exceeding regulatory requirements make us an ideal partner for businesses seeking reliable, compliant silicone resin solutions for food packaging applications. Our investment in research, manufacturing technologies, and quality systems ensures that our products not only meet today’s standards but anticipate tomorrow’s requirements.