Water bottle US FDA food contact material testing report process
Date：2025-12-16 10:16:23 Classification
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The process of obtaining a Food and Drug Administration (FDA) food contact material testing report for water bottles is a crucial step for ensuring the compliant export of products to the United States. Considering the characteristics of common materials used in water bottles (plastic, stainless steel, glass, etc.), the complete process should cover six core steps, ranging from material classification to report acquisition, with a focus on migration testing and regulatory compliance.
1. Preliminary preparation: Clarify product attributes and regulatory basis
Material type determination
Plastic water bottles (such as PP/PC materials): They must comply with 21 CFR §177.1520 (plastic substances), with a focus on bisphenol A (BPA) migration ≤0.05mg/kg
Stainless steel water bottle (such as 304 stainless steel liner): It must comply with 21 CFR §175.300 (metal substrates and coatings), and undergo testing for the release of heavy metals such as lead and cadmium (soaked in 4% acetic acid, lead ≤1.0μg/mL)
Glass/ceramic water bottle: It must comply with FDA CPG 7117.06 (Glass and Ceramic Products) and undergo cadmium leaching test (≤0.5μg/mL in acidic simulated solution)
Silicone sealing ring: It must comply with 21 CFR §177.2600 (rubber-like substances), with nitrosamine release tested to be ≤0.01mg/kg
List of technical documents
| Material type | Required documents
| Plastic / Stainless Steel | Material Composition Table (such as PP brand, stainless steel model)
| Coated product | Coating curing process description (such as Teflon spraying temperature curve)
| Assembly type water bottle | Exploded view (indicating the material of each component, such as inner liner/outer shell/seal ring)
II. Selection of testing institutions: balancing qualification and efficiency
Core qualification requirements
It must have ISO 17025 laboratory accreditation, and its testing capabilities must cover all items tested under FDA 21 CFR
Preferentially choosing products tested by Dezerwei with CNAS registration number L8083 can reduce the risk of subsequent platform audits
Selection recommendation
III. Core testing items: implemented based on material differentiation
General mandatory testing items
Migration test: Simulate actual usage scenarios (95℃ hot water, acidic beverage pH=4.5), and detect a total migration amount of ≤10mg/dm² (FDA migration test condition D)
Sensory test: After immersion in three simulated liquids: water, ethanol, and n-heptane, there were no off-odors, discoloration, or turbidity observed
Special material testing
| Material | Key test items | Test standards
| PC plastic | BPA migration (4% acetic acid, 70℃, 2 hours) | ASTM F963-23
| Stainless steel inner liner | Heavy metal leaching from welding areas (boiling in 4% acetic acid for 30 minutes) | FDA 21 CFR §175.300 Appendix B
| Glass coating | Coating adhesion (cross-cut test ≥ Grade 4B) | ISO 2409
IV. Complete Process: From Sample to Report (5 Major Steps)
Sample submission
Quantity: 3 complete sets of finished products (including packaging and manuals), requiring consistency with mass production
Special requirements: If there are detachable parts (such as straws, cup lids), separate samples of these parts must be provided
Detection execution
Cycle: 5-7 working days for regular items, extended to 10 working days for complex materials (such as multi-layer composite plastics)
Key points: During the testing process, if any item is found to exceed the standard (such as excessive heavy metal leaching), the laboratory will notify the company to make rectifications and conduct a retest (the retest fee is 50% of the individual item cost)
Key points for report review
It must include the CMA/CNAS logo, testing standard number (such as 21 CFR §177.1520), and specific test data (not just labeled as "qualified")
Preparation of compliance documents
It is necessary to prepare the FDA Food Contact Substance Notification (FCN) simultaneously as a supplementary document for customs declaration
Amazon platform needs to indicate on the product detail page: "Complies with FDA 21 CFR Food Contact Requirements"
V. High-risk Points and Mitigation Plans
Risk of mixed material usage:
If a water bottle contains both a plastic shell and a stainless steel liner, it needs to be tested according to the corresponding standards separately to avoid "generalizing from the particular" and resulting in compliance loopholes
Test condition adaptation:
Sports water bottles (for high-temperature use scenarios) require an additional 121°C high-pressure steaming test (to simulate disinfection scenarios)
Label compliance:
The use of "FDA Approved" is prohibited (FDA only conducts safety assessments and does not grant "approval" marks). The correct labeling should be "Meets FDA Food Contact Standards"
VI. Reference for Fees and Validity Period
| Item | Cost range | Report validity period |
| Single Material Testing | ¥1000-¥2000 | 2 years (no change in material or process)
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