FDA 610&612 Chemistry

The sample was received on 17 July 2018, with the chemical analysis performed during the period of 17 July to 25 July 2018. The specific objective of this test was to evaluate the Extractive Substances from the nylon polymer, a critical measure of its chemical stability and safety when in contact with food. The report concludes with a definitive PASS rating, confirming compliance with U.S. FDA regulations.

Testing Methodology and Results:

The testing was performed with reference to the method outlined in FDA 21 CFR 177.1500(d), and compliance was assessed against the limits set forth in FDA 21 CFR 177.1500(b) for nylon resins. The evaluation involved subjecting the sample to extraction using four different simulating solvents, each representing various types of food characteristics, under rigorous conditions of boiling under reflux for 8 hours.

The results of the extractable substances test are detailed below. The critical metric is the percentage of material extracted by each solvent, which must not exceed the specified FDA limits.

Food Simulant Result Limit Compliance

Distilled Water < 0.1 % 0.5 % PASS (Well below limit)

Ethanol 95 % 0.65 % 1.5 % PASS (Below limit)

Ethyl Acetate < 0.1 % 0.5 % PASS (Well below limit)

Benzene < 0.1 % 0.5 % PASS (Well below limit)

Analysis and Significance:

The test results demonstrate excellent chemical stability of the material. The extraction values for water, ethyl acetate, and benzene were exceptionally low (below the detection threshold of 0.1%), indicating minimal leaching of substances into aqueous, acidic, and fatty food simulants. The result for 95% Ethanol, a stringent solvent that simulates alcoholic and strong fatty foods, was measured at 0.65%. This value is significantly below the FDA's permissible limit of 1.5%, confirming the material's robustness even under aggressive conditions.

Conclusion:

This TÜV Rheinland chemical test report provides independent and authoritative verification that the NYLON 612 + NYLON 610 SYNTHETIC MONO FILAMENT complies with the chemical extraction limits mandated by the U.S. FDA regulation 21 CFR 177.1500. The PASS conclusion for extractable substances, combined with a pass for physical properties, offers a complete safety profile. This certification is crucial for the manufacturer to demonstrate that the product is safe for its intended use as a food-contact material and is essential for accessing markets, particularly the United States, where FDA compliance is a non-negotiable requirement. The report provides confidence to downstream buyers and end-users regarding the product's safety and regulatory adherence.