Applicable Products and Scenarios

This checklist applies to various food contact materials and articles exported to the US market, including but not limited to: tableware (bowls, plates, cups), kitchenware (spatulas, cutting boards), food packaging (cling film, plastic bags, paper boxes), baby bottles, water bottles, food processing equipment parts, etc. It is mainly intended for sellers listing related products on platforms such as Amazon and Temu, as well as importers/exporters who need to provide FDA compliance evidence during procurement or export.

Corporate Document Checklist

Basic corporate documents are the starting point for compliance files. The following documents are may requestd:

  • Business license copy (English translation or notarized translation required)
  • Manufacturer or brand FDA registration number (if applicable – some food contact substances may involve FCN or food facility registration, but not all products require this; final requirements depend on product category and platform requirements)
  • Contact person and authorization information (for applying for test reports or signing declarations)

Product Document Checklist

Each product requires detailed technical documentation so that the laboratory can accurately assess migration risks and issue corresponding reports:

  • Product model/name and clear physical photos
  • Ingredient composition table (including all raw materials, additives, and their CAS numbers or percentage content)
  • Use condition declaration: maximum use temperature, type of food contact (aqueous, acidic, fatty), contact time (e.g., microwave heating, room temperature storage)
  • Product structure and material description for each component (if composite, specify separately)

Labeling and Instruction Requirements

Product packaging and accompanying instructions are key items reviewed by platforms. They should include the following elements:

  • Manufacturer or importer name and address
  • Product material identification (e.g., PP, PE, silicone)
  • Use limitation statement (e.g., “Not microwave safe”, “Refrigeration only”)
  • FDA compliance statement or reference standard (e.g., “This product complies with FDA 21 CFR 177.1520”)

If a third-party test report already exists, the statements on the label should be consistent with the scope and conclusions of the report.

Reusing Existing Reports

If you have obtained an FDA food contact material test report from another organization, you may consider reusing it, but you must check the following elements item by item:

  • Does the report cover the current product model, material formulation, and use conditions?
  • Are the test items complete – typically including overall migration limit, specific migration limits (if applicable), heavy metal limits, etc.?
  • Does the issuing laboratory have relevant accreditation (e.g., ISO 17025)?
  • Is the report too old? The FDA does not specify a fixed validity period, but platforms may require the report to be issued within the last 2–3 years; refer to specific platform rules.

If the product undergoes material changes, formulation adjustments, or changes in use conditions, the original report will no longer apply and retesting is required.

Common Missing Items and Supplemental Tips

Based on platform review feedback, the following are the most common situations leading to document rejections:

  • Missing use condition declaration: Many sellers submit only migration test reports without a clear statement of use temperature, time, and food type, making it impossible for reviewers to assess applicability.
  • Non-compliant labeling: Labels do not show manufacturer information or an FDA compliance statement, or the statement does not match the report content.
  • Incomplete composition table: Lack of additive information or CAS numbers in the formulation, preventing the laboratory from confirming specific migration test items.
  • Mismatched report scope: The report covers only a single component, but the product contains multiple materials; corresponding test reports for each material were not submitted.

After receiving a supplemental request, it is recommended to first check the missing items against this checklist and contact a testing organization for diagnostic assistance if needed.

Pre-submission Self-check Points

Before formally uploading to the platform or submitting to a buyer, it is recommended to complete the following checks:

  • Are corporate documents complete and accurately translated?
  • Is the product documentation (formulation, use conditions, photos) complete?
  • Does the label/instruction information match the report content?
  • Is the existing report still valid and covering the current product?
  • Have all required documents (e.g., test reports, declaration letters, FCN or FDA registration numbers) been uploaded according to platform rules?

Platforms reserve the right to final review. This checklist is for document preparation reference only and does not constitute a guarantee of acceptance.

If you still have questions about preparing documents for FDA food contact material test reports, or need professional assistance with pre-reviewing documents, arranging testing, or guidance on platform uploads, please contact Prylem.