Applicable Product Scope

This documentation checklist is primarily intended for Chinese manufacturers and sellers who plan to export or already sell food contact materials (such as kitchenware, tableware, food packaging containers, infant feeding utensils, food processing equipment parts, etc.) on platforms such as Amazon and Temu. Product types include but are not limited to: plastic, silicone, metal, ceramic, glass, paper-based and coated food contact articles. The following list is for reference only; specific compliance requirements must be determined based on product composition, use conditions (temperature, contact time, repeated use) and relevant sections of U.S. FDA regulation 21 CFR.

Enterprise Documentation Preparation

  • Manufacturer’s or exporter’s company name (in Chinese and English), address, contact person and contact information.
  • Manufacturer’s business license or registration certificate (in Chinese/English or certified English translation).
  • Factory quality system or GMP related documents (if available, may support production process compliance).
  • For traders or brand owners: a manufacturing agreement or authorization letter between the trader and the manufacturer.

Product Documentation Preparation

  • Product name, model, material composition table (including chemical names, CAS numbers and usage ratios of all raw materials and additives).
  • Product use condition description: type of food intended to contact, contact temperature range (e.g., freezing, room temperature, hot fill, microwave heating, etc.), contact time, and whether repeated use is intended.
  • If a migration test report has been completed, provide corresponding test condition parameters (such as contact medium, temperature, time, surface area/volume ratio, etc.).
  • For colorants, additives or coatings, provide FDA compliance basis for related components (e.g., 21 CFR listing or Food Contact Notification).

Labels, Instructions and Image Documentation

  • Product photos (including overall view, close-up, food contact surface and packaging).
  • Text information on product labels and packaging (Chinese and English, covering material, use instructions, precautions, production date, manufacturer information, etc.).
  • Instruction manual (especially for special use scenarios such as microwave, oven, dishwasher).
  • Online sales page screenshots or links (for platform review to verify product information consistency).

Re-Use and Verification of Existing Reports

If you already hold a migration test report or composition analysis report issued by a third-party testing body for food contact materials, you may attempt to use it for U.S. market compliance reference, but please note:

  • Whether the test standard referenced in the report corresponds to the relevant sections of FDA 21 CFR (rather than only EU or Chinese national standards).
  • Whether the test conditions (contact medium, temperature, time) cover your product’s intended use scenario.
  • The report should not be too old (typically recommended within 2 years), and the product formulation and process must not have changed.
  • During platform review, reports are generally required to be in English or accompanied by a certified English translation.
  • Reports based on EU or other regional standards cannot directly replace FDA compliance evidence; final acceptance depends on platform review requirements.

Common Documentation Gaps and Platform Review Scenarios

When uploading FDA food contact material compliance documents on platforms such as Amazon and Temu, common reasons for supplementation requests include:

  • Missing specific 21 CFR section references corresponding to the product material.
  • Migration test conditions do not match the product’s actual use scenario (e.g., high temperature contact or repeated contact not tested).
  • Report language is not English, or the translation is not standardized.
  • Enterprise information does not match the platform registration information.
  • Failure to distinguish between “food contact material compliance” and “FDA facility registration” — these require different documentation.

Platforms retain final review authority. This article is for documentation preparation reference only and does not guarantee platform acceptance.

Pre-Submission Review Suggestions

  • Ensure all documents are in PDF or platform-acceptable format and clearly legible.
  • Verify that product name, model and manufacturer name are consistent across the report, label and platform backend information.
  • If using a third-party report, confirm that the report includes laboratory accreditation information and signature/seal.
  • Prepare a document index or cover letter listing each document and the corresponding product and compliance clause.
  • If documentation is incomplete, prioritize supplementing the migration test report (for overall migration or specific migrants) most relevant to the platform’s concerns.