Coffee machine inner liner US FDA certified food contact material report
Date：2025-12-11 09:44:09 Classification
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Obtaining an FDA food contact material testing report for the coffee machine's inner liner is a crucial step in ensuring compliant export to the United States. According to FDA 21 CFR regulations, as a component that comes into direct contact with food, the coffee machine inner liner must pass a material safety assessment and migration test, with a focus on the risk of chemical release at high temperatures.
I. Core Testing Basis and Applicable Standards
1. Regulatory Framework
- Basic Regulations: FDA 21 CFR §175.300 (Metallic Substrates and Coatings), §177.1520 (Plastic Materials)
- Testing Standards:
- Metal Inner Liner (e.g., Stainless Steel): Must meet heavy metal leaching test (immersion in 4% acetic acid, lead ≤1.0μg/mL)
- Coated Inner Liner (e.g., Teflon): Must pass 260℃ high-temperature migration test (simulating coffee extraction temperature)
- Plastic Components (e.g., PP drip tray): Total migration ≤10mg/dm² (FDA migration test condition D: 70℃, 2 hours)
2. Key Test Items
| Material Type | Mandatory Test Items
| Stainless Steel Inner Liner | Lead, Cadmium, Chromium Leaching (Boiling in 4% acetic acid for 30 minutes)
| Non-stick Coating | Teflon Monomer Residue, High-Temperature Stability (260℃/1 hour)
| Silicone Sealing Ring | Nitrosamine Release and Total Migration (Water/Ethanol Simulation Solution)
II. Report Processing (5 Steps)
1. Preliminary Preparation
- Technical Documents:
- Inner Liner Material List (e.g., 304 Stainless Steel Grade, Coating Composition Table)
- Production Process Description (Welding Method, Coating Curing Temperature Curing Profile)
- Expected Usage Conditions (Maximum Operating Temperature, Types of Food to Contact)
- Sample Requirements:
- 3 Complete Inner Liners (including coating/plating), consistent with mass production
- If it is an assembled component, a disassembly diagram indicating the testing areas is required.
2. Selection of Testing Institution
- Qualification Requirements:
- Must be ISO 17025 certified and have FDA 21 CFR testing authorization.
- Selection Recommendations:
- For export to Amazon, choose an institution recognized by the platform.
3. Test Execution
- Cycle: Standard process 5-7 working days (excluding rectification), expedited service 3-5 working days (40% additional cost)
- Key Points:
- Simulate real-world usage scenarios: coffee extraction temperature (90-95℃), pH value (coffee pH≈5.0)
- Multi-media testing: water (neutral), 8% ethanol (simulating coffee oils), n-heptane (simulating oily foods)
4. Report Review and Rectification
- Report Validity:
- Must include CMA/CNAS markings, test standard number (e.g., FDA 21 CFR §175.300), and measured data (cannot simply state "qualified")
- Common Rectification Items:
- Uneven coating thickness leading to excessive migration (spraying parameters need adjustment)
- Metal polishing residue causing heavy metal leaching (cleaning process needs optimization)
5. Report Submission and Platform Compliance
- Amazon Requirements:
- Product detail page must state "Complies with FDA 21 CFR Food Contact Requirements"
- Material Safety Declaration (FDA Food Contact Substance Notification, FCN) must be submitted simultaneously
- Customs Inspection:
- Upon import, the original report and its English translation are required. The test report is typically valid for two years.
III. High-Risk Points and Prevention Measures
1. Temperature Compatibility:
- Espresso machines (extraction temperature 90-95℃) require an additional 121℃ high-pressure brewing test (simulating a cleaning and sterilization scenario).
2. Material Mixing Risk:
- If the inner container contains a plastic sealing ring, the compatibility between the rubber and metal must be tested separately (to avoid the cumulative effect of migrations).
3. Labeling Compliance:
- The product instructions must state "For food contact only," and the phrase "FDA Approved" is prohibited (the FDA only conducts safety assessments and does not grant an "approval" label).
IV. Quick Compliance Toolkit
- Self-Checklist:
1. Are the materials on the FDA's authorized list (e.g., 304 stainless steel is listed as a GRAS substance)?
2. Does the production process use FDA-banned additives (e.g., the plasticizer DEHP)?
3. Does the welding process comply with ASTM A967 (stainless steel passivation standard)?
- Report Template:
The report must include three core elements: "Migration Test Conditions," "Simulated Solution Type," and "Limit of Detection (LOD)." Example:
> Test Result: Lead leaching amount 0.02 μg/mL (Test conditions: 4% acetic acid, 95℃, 30 minutes; LOD = 0.01 μg/mL)
For contact information of specific testing institutions or case studies of rectification of similar products (such as analysis of a recall incident caused by coating peeling on a certain brand of coffee machine), product drawings can be provided for further assistance.
Shen Gongwang Security: 44030602006947