FDA 610&612 Physics
FDA 610&612 Physics

FDA 610&612 Physics

Item specifics

Period
2018/7/12 - 2028/7/12
No.
0154347029c 001
Certification bodies
TÚV Rheinland (Shanghai) Co., Ltd.

Certificate description

This document is a Test Report issued by TÜV Rheinland (Shanghai) Co., Ltd., bearing the reference number 0154347029c 001 and dated 25 July 2018. The 5-page report (plus general terms and conditions) confirms the compliance of a product intended for food contact applications. The testing was performed for the client, Hangzhou Alead Rubber & Plastic Products Co., Ltd., on a sample identified as NYLON 612 + NYLON 610 SYNTHETIC MONO FILAMENT.

The sample, described as an orange plastic mono filament, was received on 17 July 2018, with testing conducted from 17 July to 25 July 2018. The primary objective of the testing was to evaluate the material's Physical Properties against the relevant U.S. Food and Drug Administration (FDA) regulations to ensure its suitability for use as a food-contact material.

The testing was specifically tailored to meet the requirements for Nylon Polymers as outlined in the FDA Code of Federal Regulations. The report conclusively states an overall PASS verdict for the tested item.

Detailed Test Results and Compliance:
The evaluation was performed with reference to FDA 21 CFR 177.1500(d), which describes the testing methods for nylon resins, and the requirements are specified under FDA 21 CFR 177.1500(b), which governs the identity and specifications for these polymers.

The specific test parameters and their results are as follows:
Specific Gravity: The tested sample yielded a result of 1.05 g/cm³. This successfully meets the FDA requirement, which stipulates a value of 1.06 +/- 0.15 g/cm³. The result of 1.05 falls well within the acceptable range of 0.91 to 1.21, confirming the material's density is consistent with the standards for nylon polymers.

Solubility in boiling 4.2N Hydrochloric Acid (HCl): The sample was found to be "Insoluble after 1 hour" of testing. This result is critical as it directly meets the FDA requirement, which mandates that the material must remain insoluble under these conditions. This test is a key indicator of the polymer's chemical resistance and stability, ensuring it will not break down undesirably when in contact with certain types of foods.

Conclusion and Significance:
This TÜV Rheinland test report provides independent verification that the submitted NYLON 612 + NYLON 610 SYNTHETIC MONO FILAMENT complies with the specific physical property requirements set forth in the U.S. FDA regulation 21 CFR 177.1500 for nylon resins used in food-contact articles.

The PASS conclusion indicates that the material's fundamental physical characteristics align with the regulatory standards, supporting its use in applications involving contact with food. This certification is essential for the manufacturer to demonstrate product safety and regulatory compliance to buyers and distributors in markets, particularly the United States, where FDA regulations are a mandatory requirement for food-contact materials. The report serves as a crucial document in the supply chain, affirming the product's eligibility for use in food-related applications.