Silicone rubber has quietly become a staple in modern kitchens—from baby bottle seals and baking molds to steam gaskets in coffee makers and pressure valves in rice cookers. Its softness, heat resistance, and safety have made it a trusted companion in food preparation. But to legally and safely contact food—directly or indirectly—it must meet rigorous, internationally recognized food contact material (FCM) standards. Silicone rubber earns this trust through inherent chemical stability and strict regulatory compliance.

The Core Principle: Safe Migration Levels

Food contact regulations are built on one key idea: any substance that might migrate into food must stay below levels that could pose health risks. For silicone rubber, this means every ingredient in its formulation must be pre-approved. Major regulations—including EU (EC) No 1935/2004, U.S. FDA 21 CFR §177.2600, and China’s GB 4806 series—specify permitted raw materials: certain polydimethylsiloxane (PDMS) gums, fumed silica, platinum catalysts, and limited additives. Unlisted substances are prohibited, regardless of technical performance.

Migration Testing: Simulating Real Use

Products undergo migration tests using food simulants:

Water (for aqueous foods)

3% acetic acid (acidic foods)

10% ethanol (low-alcohol beverages)

Olive oil or isooctane (fatty foods)

Tests are run at relevant temperatures (e.g., 20°C, 70°C, 100°C+) and durations (2h to 10 days). The total migration must stay under limits (typically ≤10 mg/dm² or 60 mg/kg food). Silicone rubber is also scrutinized for volatile organic matter (VOM) and cyclic siloxanes (D4/D5), which can cause odor or pose health concerns.

High-Temperature Safety Advantage

Unlike many plastics that leach plasticizers when heated, high-quality food-grade silicone uses addition-cure (platinum) systems that produce no by-products and maintain structural integrity. This allows safe use in ovens or microwaves—even above 200°C—making it approved globally for reusable high-heat kitchenware.

Sensory & Production Controls

Certification also requires no off-tastes, odors, or discoloration—ensured through ultra-pure raw materials, clean manufacturing, and sensory panel testing. Factories must implement traceable batch records, cleaning validation, and quality control. A Declaration of Compliance (DoC) is often required, stating usage conditions (e.g., max temperature, fat contact suitability).

Global Compliance in Practice

Export-ready products often meet multiple standards simultaneously:

EU: Compliant with Regulation (EU) No 10/2011, marked with the “glass-and-fork” symbol

USA: Meets FDA requirements

China: Certified under GB 4806.11-2016

Leading manufacturers adopt the strictest global benchmarks as internal standards to ensure universal acceptance.

A Final Note: “Food-Safe” ≠ “Edible”

While safe for contact, silicone rubber is not digestible. Physical safety—especially in infant products—must also be ensured (e.g., no small detachable parts).

In essence, silicone rubber’s presence on our tables rests on a foundation of science-based regulation, meticulous manufacturing, and continuous oversight. Every time we confidently place a silicone mold in the oven, we’re casting a quiet vote of confidence in this robust safety system—proving that modern materials can honor the ancient truth: food is life.



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