Short answer: GB 4806.16-2025, the national food-safety standard for food-contact silicone rubber, took effect on 2 September 2026, giving silicone its own standard separate from rubber generally. The change demanding immediate attention is the new volatile-matter limit of ≤0.5 g/100 g — the only new physical-chemical indicator in this revision, and widely regarded as the item most likely to fail. Most other changes tighten test conditions or harmonise wording; the limits themselves are unchanged.
Previously, silicone shared GB 4806.11-2016 (rubber materials and articles for food contact) with ordinary rubber. The two differ fundamentally: silicone has a siloxane backbone, conventional rubber a carbon-carbon one, with very different heat resistance and stability — one set of criteria served neither regulators nor industry well. The new standard replaces the silicone-related portion of GB 4806.11-2016; rubber itself is now governed by GB 4806.11-2023. The point-by-point comparison follows.
| Item | GB 4806.16-2025 (new) | GB 4806.11-2016 (old) | Impact and action |
|---|---|---|---|
| Scope of the standard | Standalone standard covering silicone rubber only | Silicone shared the rubber standard with conventional rubber | Testing commissions and compliance statements must cite the new standard number |
| Terms and definitions | Adds a definition of food-contact silicone rubber articles | No dedicated definition | Gives a clear basis for deciding whether a product falls under it |
| Raw material control | Split into two categories: base materials and additives | Relatively general wording | Check Appendix A and the GB 9685 positive list separately |
| Sensory requirements | Normal colour, no off-odour, no foreign matter | Normal colour, no off-odour, no dirt | Wording harmonised; the substantive requirement is essentially unchanged |
| Overall migration | ≤10 mg/dm²; for infant-dedicated articles convert by surface-to-volume ratio to mg/kg, ≤60 mg/kg | ≤10 mg/dm²; ≤60 mg/kg where in contact with infant food | Infant products require the S/V conversion — do not apply 10 mg/dm² directly |
| Potassium permanganate consumption | ≤10 mg/kg, water (60 °C, 2 h) | ≤10 mg/kg, water (60 °C, 0.5 h) | Limit unchanged but exposure time quadrupled, raising the bar on long-term stability |
| Heavy metals (as Pb) | ≤1 mg/kg, 4% acetic acid (60 °C, 2 h) | ≤1 mg/kg, 4% acetic acid (60 °C, 0.5 h) | As above — stricter conditions, unchanged limit |
| Volatile matter (new) | ≤0.5 g/100 g, with test method in Appendix B | Not present | The single biggest change — controls residual cyclosiloxane oligomers; see below |
| Fatty-food simulant | Special provision removed; selection follows GB 31604.1-2023, usually vegetable oil | Required 50% ethanol (v/v) for fatty foods | Silicone parts contacting cooking oil, cream or baked goods need a revised migration plan |
| Listed base materials | Appendix A grows from 19 to 21, adding silica and 1-ethynylcyclohexanol | 19 materials | More formulation freedom, but new entries carry molecular-weight and residue limits |
| Other technical requirements | Adds requirements for coatings, inks and adhesives | Not specified | Printed or overmolded silicone parts need extra checks |
| Labelling | Per GB 4806.1, and state compliance with GB 4806.16-2025 | Per GB 4806.1 | Packaging and compliance declarations must be updated with the new number |
Volatile Matter: The Item That Matters Most
The new standard adds volatile matter to the general physical-chemical indicators, with a limit of ≤0.5 g/100 g and a companion test method in Appendix B. It targets residual cyclosiloxane oligomers and other small molecules, which tend to migrate out under high-temperature use, showing up as odour or a tacky surface. The industry regards this as the test item most likely to fail, because residues depend heavily on formulation and cure process: parts with incomplete crosslinking or insufficient post-cure typically carry higher residues.
One point needs stating: the standard does not mandate any particular cure system. Industry discussion often notes that peroxide-cured products carry relatively higher risk on this item while platinum-cured systems tend to comply more readily, but that is an observed tendency in practice, not a requirement of the standard. Compliance decisions should rest on measured data, not on claims such as "we use process X, so it must pass".
Four Typical Scenarios
Can I still use my existing test reports?
It depends. A report without the volatile-matter item is no longer sufficient to demonstrate compliance — that is a hard gap and needs retesting. Potassium permanganate consumption and heavy metals measured under the old 0.5 h condition also do not strictly meet the new test conditions, so retesting is advisable. Check validity and the tested model too: once the compound or formulation changes, the old report lapses. The test is simple: look at which standard number the report cites and whether volatile matter appears.
Which products carry the highest risk?
Highest to lowest risk: first, silicone articles for infants (teats, teethers, feeding spoons), which require the additional surface-to-volume conversion and are judged differently from general products; second, thick-walled or geometrically complex parts (spatula heads, large baking mats), where crosslinking is harder to complete and volatile residues run higher; third, products in prolonged contact with fat or high heat (basting brushes, bakeware, seals), whose migration plan must be redone because the simulant changed. Thin-walled, simple parts used at ambient temperature carry lower risk.
What should buyers ask suppliers?
Ask four questions, all answered in writing. One: "Can you provide a third-party test report issued to GB 4806.16-2025 that includes the volatile-matter item" — note third-party, not in-house. Two: "Can the report number be verified on the issuing lab’s website" — if it resolves, it counts. Three: "Is the tested sample the exact model I am buying" — a genuine report for a different model is the most common trap. Four: "Will you re-test if the formulation or compound changes". Those four answers reveal a supplier’s compliance posture clearly.
Are export products affected too?
Exports follow the target market’s rules, not the domestic standard. Shipments to the EU fall under EU 10/2011 plus member-state requirements (Germany’s LFGB adds specific provisions for silicone); shipments to the US fall under FDA 21 CFR. GB 4806.16-2025 binds food-contact silicone articles produced, sold or imported in mainland China. Suppliers serving both markets must prepare separately: domestic orders tested to the new national standard, export orders to the destination’s regulations. The good news is that the new volatile-matter item aligns with the EU’s direction on silicone, so one remediation often satisfies both.
Compliance Checklist
- Confirm whether the product falls under the standard’s definition of food-contact silicone articles
- Review existing reports: standard number, volatile-matter inclusion, validity, tested model
- Where volatile matter is missing, arrange retesting promptly (method in Appendix B)
- For infant-dedicated products, convert by surface-to-volume ratio to ≤60 mg/kg — do not apply 10 mg/dm²
- For fatty or high-temperature contact, rebuild the migration plan per GB 31604.1-2023
- Check the formulation: base materials against Appendix A (21 entries), additives against GB 9685
- For printed, coated or overmolded products, also check the new auxiliary-material requirements
- Update the standard number on packaging and compliance declarations
- Obtain third-party reports verifiable by number, not in-house test data
FAQ
Is the new standard mandatory or voluntary?
Mandatory. It is a national food-safety standard, and under the rules governing mandatory national standards, food-contact silicone articles produced, sold or imported in mainland China must comply once it takes effect. After 2 September 2026, products on the market must meet the currently effective mandatory standard. This is not "recommended practice" but a compliance floor — failing a spot check affects market access directly.
Does the term "food-grade silicone" still hold under the new standard?
"Food grade" is not a standard clause but a marketing shorthand — something the new standard makes clearer. Whether a silicone can contact food depends on three things: whether the base materials appear in Appendix A, whether additives comply with GB 9685, and whether test reports exist for the target market. So do not accept "we are food grade" as an answer; ask the supplier to name the specific compound and provide the report number. After implementation, also confirm the report cites GB 4806.16-2025.
Did the standard for conventional rubber change too?
Yes, but differently. GB 4806.16-2025 replaces only the silicone portion of GB 4806.11-2016; rubber materials and articles are now governed by GB 4806.11-2023. So if your product is a seal made of NBR, natural rubber or EPDM, the applicable standard is the GB 4806.11 series, not GB 4806.16. The deciding factor is the backbone: siloxane falls under 4806.16, carbon-carbon under 4806.11. When the material is uncertain, obtain a material declaration from the supplier before selecting a standard.
LXYSILICONE can arrange testing support against the GB 4806.16-2025 item list, including full-suite testing covering volatile matter through third-party laboratories, with report numbers verifiable on the issuing lab’s website. Specific test items should be defined by material, service temperature and the type of food contacted.