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How to Check FDA Compliance When Purchasing 904L Stainless Steel?

When purchasing 904L stainless steel, how to judge the authenticity of the FDA certification report provided by the supplier?

Third-party test report: must be issued by an FDA-approved laboratory (such as SGS, Intertek), including 904L brand (UNS N08904), test conditions (such as 4% acetic acid immersion), migration data (such as nickel precipitation ≤0.1ppm);
Material Certificate (MTC): Check whether the composition meets the ASTM A240 standard (such as Ni≥23%, Mo 4-5%, C≤0.02%), especially pay attention to harmful elements such as lead (Pb≤0.01%) and cadmium (Cd≤0.005%).

Test Item Compliance Standard Test Method Typical Performance of 904L (Superior to 316L)
Total Migration ≤10mg/dm² (4% acetic acid, 70℃×2 hours) Gravimetric method 5–7mg/dm² (316L: 8–12mg/dm²)
Nickel Ion Migration ≤0.1ppm (simulated acidic food) ICP-MS instrument testing 0.05ppm (316L may exceed 0.3ppm)
Microbial Adhesion ≤10CFU/cm² (ISO 22196 standard) Agar culture method 5CFU/cm² (mirror-polished, Ra≤0.4μm)

 

Roughness control:
The food contact surface needs to be mirror polished (Ra≤0.4μm), which can be tested on site with a portable roughness meter (such as Mitutoyo SJ-210). The industrial grade commonly used Ra≤1.6μm, which cannot be used directly in food scenes.
Passivation process:
Food-grade passivation solution (20% nitric acid, no chlorine/sulfur addition) must be used to avoid residual harmful ions, and passivation records (time, temperature, solution composition) are required.

Compliance traceability of the production process
Quality management system:
Suppliers must have ISO 22000 (food quality management) or GMP (good manufacturing practice) to ensure that the entire process from steelmaking to processing is controllable;
Batch traceability: Each batch of 904L must be accompanied by a COA (composition analysis certificate) and heat treatment records, which can be traced back to the furnace number and rolling process.
Welding process:
Food contact parts need to use ER385 welding wire (containing 4.5% Mo) to prevent the weld area from becoming a migration point exceeding the standard. A liquid penetration test report of the weld is required (ASTM E165).

904L Stainless Steel

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