The GB 9685-2016 standard specifies the principles for the use of additives in food contact materials and products, including permitted additive categories, applicable scope, maximum usage levels, specific migration limits (SML) or maximum residue limits, total specific migration limits, and other restrictive requirements.
This standard also covers certain base polymer monomers or other starting substances used in the production of food contact materials and products.
I. Scope of Application
- All materials and products that come into direct or indirect contact with food, including additives used in the production of plastics, rubber, coatings, paper products, metals, etc.
- Processing aids (e.g., defoamers, dispersants) and functional additives (e.g., plasticizers, preservatives).
II. Core Compliance Requirements
1. Restrictions on Additive Use
- Positive List: Additives must comply with the permitted usage scope, maximum limits, and migration limits (SML/QM) outlined in Appendix A of GB 9685-2016.
- Migration Limits: Both total migration and specific substance migration limits must be met.
2. New Substance Notification
- Circumstances Requiring Notification: If an additive is not listed in Appendix A of GB 9685-2016, or if an existing substance requires expanded use (e.g., from plastics to silicone rubber), safety assessment materials must be submitted to the National Health Commission (NHC) for approval prior to use.
- Notification Materials: Include toxicological data, migration test reports, production process descriptions, etc.
3. Declaration of Conformity (DOC)
- For substances listed in Appendix A of GB 9685-2016, suppliers must provide downstream customers with a Declaration of Conformity to ensure compliance and safety of the final food contact material/product.
- Validity of DOC: Declarations must be updated in response to regulatory/standard changes, alterations in material composition/purity, or other relevant factors.
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Our Services
- Tracking official approvals and usage information for new food contact resins/additives.
- Developing registration proposals for new food contact resins/additives.
- Preparing and submitting registration dossiers for new food contact resins/additives.
- Monitoring registration status and liaising with the NHC.
- Issuing compliance declarations for food contact materials (FCM) in China.
