On September 25, 2025, China’s National Health Commission (NHC) and the State Administration for Market Regulation (SAMR) jointly released Announcement No. 6 of 2025, establishing 32 new national food-safety standards and issuing two amendments. Among the most notable new standards for the packaging industry are GB 4806.16-2025 (Silicone Rubber Materials and Articles for Food Contact) and GB 4806.10-2025 (Paints and Coatings for Food Contact), both scheduled to take effect on September 2, 2026.
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Tailoring Safety: Silicone Rubber Gets Its Own Standard
Previously, silicone rubber fell under the broader rubber standard GB 4806.11-2016, but the new GB 4806.16-2025 creates a distinct regulatory category specifically for silicone-based food-contact materials. This change reflects the unique chemical, physical and safety characteristics of silicone rubber, particularly in migration behavior, volatility and their performance under heat, that justify more tailored control.
Key Technical Changes in GB 4806.16-2025
One of the most significant updates in the standard is the addition of a volatile substances limit, capped at 0.5 g per 100 g, with a test method defined in a newly added Appendix B. This addresses concerns about residual low-molecular-weight siloxanes or other volatile by-products migrating into food.
Base polymers used in silicone rubber must comply with a positive-list in Appendix A, and additives must conform to GB 9685 as well as any relevant NHC/SAMR announcements. Sensory criteria are also more rigorous, requiring both the material and migration-extract solutions to exhibit normal color and odor, without turbidity, precipitation, or off-odors.
Physicochemical performance metrics have been tightened as well. Total migration remains capped at 10 mg/dm², but test conditions for potassium (K) permanganate consumption and lead (Pb) migration have been modified to 60 °C for 2 hours, instead of the less stringent conditions under the previous standard. Moreover, specific migration limits (SML), total migration limits (SML(T)), and maximum permitted quantities (QM) are explicitly defined for both base polymers and approved additives.
Harmonization with Other FCM Standards
GB 4806.16-2025 aligns its migration-testing methodology with GB 31604.1 (National Food Safety Standard – General Rules for Migration Tests of Food Contact Materials and Articles) and references GB 5009.156, ensuring consistency with other food-contact materials like plastics and coatings. Further, silicone rubber articles that contain coatings, inks, or adhesives must also satisfy the relevant national standards for those materials (for example, GB 4806.10-2025, also released under Announcement No. 6).
Implications for the Packaging Industry
Companies should begin auditing their raw-material sources against Appendix A (positive list of substances), reviewing additive compliance with GB 9685, and redesigning quality-control workflows to include volatile-substance testing. For products that combine silicone with coatings, inks, or adhesives, alignment with GB 4806.10-2025 and other standards will be equally important.
Conclusion
By tightening migration limits, adding a volatile matter requirement, and breaking out silicone into its own standard, Chinese authorities are targeting higher consumer safety and greater material accountability. For players in the food-contact packaging industry, the coming year will be critical for building compliance into every stage, from material sourcing to final testing, to ensure continuity of access to the Chinese market and alignment with the new regulatory frame.
