Stainless steel testing and FDA food contact report processing
Date：2025-12-19 09:23:02 Classification
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Stainless steel falls under the FDA-regulated category of metallic materials and must strictly adhere to the requirements of 21 CFR 175.300, with a focus on controlling heavy metal leaching and surface coating safety.
I. Core Regulations and Testing Standards
Applicable Regulatory Framework
Basic Standard: FDA 21 CFR §175.300 (Requirements for Metal Substrates and Coatings)
Testing Basis:
Heavy Metal Leaching Test: Boiling in 4% acetic acid solution for 30 minutes, lead ≤1.0 μg/mL, cadmium ≤0.5 μg/mL
Surface Coating Assessment: If the stainless steel has a non-stick coating (such as Teflon), it must also comply with 21 CFR §177.1520 (Coating Migration Limits)
Key Test Items
| Test Type | Test Content
| Heavy Metal Migration | Leaching of elements such as lead, cadmium, chromium, and nickel
| Surface Corrosion | Integrity of Stainless Steel Passivation Layer
| Coating Compatibility | Chloroform-soluble extract (for coated products)
II. Processing Procedure (5 main steps)
Preliminary Preparation
Technical Documents:
Stainless steel grade certificate (e.g., 304/316L material report), surface treatment process description (e.g., electropolishing/passivation treatment)
If coated, a coating composition table and curing process parameters are required.
Sample Requirements:
3 complete sets of finished products (including key parts such as welding and bending), size ≥ 10cm × 10cm (or as required by the laboratory)
Laboratory Selection
Qualification Requirements: ISO certification required 17025 certified and FDA testing authorized, recommended agency: Dezewei Testing, CNAS registration number: L8083
Notes: Platforms like Amazon prioritize UL/SGS reports to avoid delays due to agency qualifications.
Testing Execution and Cycle
Standard Cycle: 5-7 business days (excluding sample shipping time), expedited service: 3 business days (40% increase in cost)
Testing Cost: Approximately ¥1000-2000 for pure stainless steel substrates
Report Review and Rectification
Report Validity: Must include CMA/CNAS markings, test standard number, and measured data (cannot simply state "qualified").
Common Rectification Items:
Excessive heavy metal leaching at welded areas → Optimize post-weld passivation process
Insufficient coating adhesion → Adjust coating thickness (recommended 8-12μm)
Compliance Document Submission
Required Export Documents:
Original FDA test report (including English translation)
Material Safety Declaration Conformity (DoC)
Customs Inspection: Report valid for 2 years; retesting is required if product process changes.
III. High-Risk Points
Material Mixing Risk: If stainless steel is welded to other metals (such as aluminum), the electrochemical corrosion risk of the welded area must be tested separately.
Label Compliance: Product instructions must state "Complies with FDA 21 CFR 175.300," and the phrase "FDA Approved" is prohibited (the FDA only conducts safety assessments and does not grant certification marks).
Batch Consistency: It is recommended to sample and test each batch (especially after adjustments to the surface treatment process) to avoid compliance failure due to production fluctuations.
IV. Quick Self-Checklist
Is the stainless steel grade on the FDA GRAS list (e.g., 304/316L is already approved)?
Does the surface treatment comply with ASTM A967 (stainless steel passivation standard)?
Does the welding process use food-grade welding materials (e.g., ER308L welding wire)?
For contact information of specific testing institutions or rectification cases of similar products (e.g., a brand of stainless steel tableware was recalled for analysis due to excessive nickel leaching), product drawings can be provided for further assistance.
Shen Gongwang Security: 44030602006947