Silicone materials and products China GB4806.11 food contact materials testing
Date：2025-07-24 09:48:25 Classification
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Silicone materials and products in China are based on the testing process and core requirements of GB4806.11 "National Food Safety Standard Rubber Materials and Products for Food Contact" (2024 Revised Edition), combined with the latest standard dynamics and industry practices:
I. Scope of application of testing and key points of standard update
1. Adjustment of scope of application
- New regulation changes:
- GB 4806.11-2024 is only applicable to natural rubber, synthetic rubber or vulcanized thermoplastic elastomers, and no longer includes silicone materials.
- Silicone products have been classified and managed separately (such as special standards such as GB 4806.12), and must be tested according to special standards for silicone.
2. Core new requirements
- Migration of aromatic primary amines: not detectable (detection limit ≤ 0.01mg/kg), applicable to materials containing amine antioxidants, azo colorants, etc.
- N-nitrosamines and their derivatives: not to be detected (detection limits are 0.01mg/kg and 0.1mg/kg respectively), applicable to products containing vulcanization accelerators.
- Adjustment of migration test simulants: vegetable oil (replacing the old version of 50% ethanol) must be used as simulants for oil-containing foods.
2. Core testing processes and projects
1. Preliminary preparation
- Submission of materials: product formula table, production process description, declaration of conformity (marked "food contact").
- Sample requirements: provide finished products and all food contact parts (such as seals, nipples, etc.).
2. Laboratory test items
Test items:
Total migration (simulated liquids such as 4% acetic acid, 20% ethanol, 50% ethanol, etc.)
Heavy metals (in terms of Pb): ≤1 mg/kg [[6]()]
Total migration of aromatic primary amines, migration of N-nitrosamines
Sensory test (color, odor), potassium permanganate consumption
If adhesives/coatings are included, they must comply with GB 4806.10 "Paints and Coatings" standard
3. Additional tests for reusable products
- Potassium permanganate consumption needs to be tested three times in a cycle, and the final result is based on the third test (the old version only needs one test).
III. Common non-conformance risks and optimization suggestions
1. Typical failure items:
- Raw material issues: The use of non-food grade vulcanizers leads to excessive N-nitrosamines.
- Labeling errors: "Food contact" is not marked or the declaration of compliance is missing.
2. Response strategy:
- Raw material control: Select additives approved by GB 9685 and related announcements.
- Simulant adaptation: Oil-containing food contact parts should be tested with vegetable oil first (to avoid deviations caused by ethanol substitution).
IV. Testing process and cycle
A[Prepare materials and samples] --> B[Send to CNAS/CMA qualified laboratory Dezewei for testing]
B --> C[Physical and chemical and migration tests]
C --> D{{Is it qualified? }}
D -->|Yes| E[Issue a test report]
D -->|No| F[Retest after formula modification]
E --> G[Affix the "food contact" label]
- Cycle: Routine testing takes about 5-7 working days
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