“We need food-grade silicone oil.”
This is one of the most common statements in procurement discussions.

But once the supplier clarifies the intended application, it often becomes clear that the requested “food-grade” material may not match the actual regulatory framework required. In the worst-case scenario, choosing the wrong compliance standard can lead to shipment rejection — or even product recalls.

In reality, “food-grade silicone oil” is not a single concept. It corresponds to three major regulatory systems, each tied to entirely different application scenarios:

1️⃣ FDA 21 CFR 178.3570 (United States)

✅ Application: Lubrication points in food-processing equipment (e.g., conveyor bearings, filling pumps)
✅ Core requirement: Base oils and additives must be on the approved substance list; incidental contact limit typically ≤10 ppm
✅ Common certification: NSF International H1 registration (not mandatory, but widely recognized)

⚠️ Important: Not intended for direct food contact — only for incidental contact situations.

2️⃣ EU No 10/2011 (European Union)

✅ Application: Additives in plastic or silicone materials that directly contact food (e.g., silicone nipples, baking mats)
✅ Core requirement: Silicone oil as a polymer component must meet Specific Migration Limits (SML) and overall material compliance
✅ Key tests: Overall Migration Limit (OML), specific migration (e.g., D4/D5), heavy metals

⚠️ Important: FDA compliance alone does not guarantee eligibility for the EU market.

3️⃣ GB 4806.11-2016 (China)

✅ Application: Rubber/silicone food-contact products sold domestically (e.g., rice cooker sealing rings, baby pacifiers)
✅ Core requirement: Silicone oil must be permitted polydimethylsiloxane (PDMS); volatile content ≤0.5%; heavy metals compliant
✅ Related standard: GB 9685 for permitted additives

“Many clients assume that having an FDA certificate automatically means universal food-grade compliance,” a regulatory consultant explained. “But the three systems differ significantly in testing methods, migration limits, and permitted substance lists.”

Before purchasing, customers should clearly answer three key questions:

1. What is the final application? (Equipment lubrication / silicone raw material / defoamer?)

2. What is the target market? (China / U.S. / EU / Global?)

3. Will the material directly contact food? (Yes / No / Incidental only?)

Only by clarifying these points can the correct compliance pathway be selected.

As a professional silicone oil supplier, we provide:

• Regulatory Declarations of Compliance (DoC)

• Third-party test reports (e.g., SGS, CTI)

• Application-specific product recommendations

“Food-grade” is not a marketing slogan —
It is a precise regulatory language that must match your application.