Disposable cup FDA food contact material report processing
Date：2026-03-03 09:52:47 Classification
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Processing a US FDA food contact material report for disposable cups (such as paper cups, plastic cups, etc.) usually refers to testing by a third-party testing agency and issuing a testing report or food contact notification (FCN) compliance certificate that meets FDA standards.
The following are detailed processing procedures, testing standards, and precautions:
1、 Core concept clarification
The US FDA (Food and Drug Administration) does not directly issue "certificates". Enterprises usually need to conduct testing through third-party laboratories to obtain test reports, in order to prove that their products comply with the relevant requirements of 21 CFR (Chapter 21 of the United States Code of Federal Regulations).
2、 Applicable regulatory standards (classified by material)
Disposable cups made of different materials correspond to different FDA testing standards:
1. Plastic cups (such as PP, PET, PS, PLA, etc.)
Regulatory Basis: 21 CFR Part 177
Common testing items:
Total migration: Use simulated solutions such as distilled water, n-heptane, and 95% ethanol to test under different temperature and time conditions.
Specific migration amount: Testing for specific monomer substances (such as styrene, vinyl chloride, etc.).
Extract testing: detecting whether excessive substances have migrated into food.
2. Paper cups (usually containing PE coating)
Regulatory Basis: 21 CFR Part 176 (Indirect Food Additives: Composition of Paper and Paperboard)
Common testing items:
Chloroform extract: detects potential harmful substances in pulp.
Heavy metal testing: lead, cadmium, mercury, etc.
Fluorescent whitening agent: Check for the presence of illegal fluorescent substances.
Polychlorinated biphenyls: testing for prohibited substances.
3. Coating/Ink (such as printed patterns on the surface of cups)
Regulatory Basis: 21 CFR Part 175 (Indirect Food Additives: Adhesive and Coating Components)
Attention: The ink must be on the outer layer of the cup and cannot directly contact food or comply with specific migration restrictions.
3、 Handling process
Step 1: Application and Evaluation
The enterprise submits an application to a third-party testing agency (such as Dezewei Testing CNAS registration number: L8083).
Provide detailed material information (BOM), production process, and expected usage conditions (such as hot drinks, cold drinks, microwave heating, etc.) of the product.
Step 2: Quotation and Contract Signing
The institution determines the testing items and provides a quotation based on the type of material and usage conditions.
Sign the agreement after confirming the quotation.
Step 3: Sample shipping
Send a sufficient quantity of samples to the laboratory (usually requiring dozens of finished products).
Step 4: Laboratory testing
The laboratory conducts simulated liquid immersion and chemical analysis according to FDA standards.
The cycle is usually 5-10 working days, depending on the complexity.
Step 5: Issue a report
After passing the test, the institution issues an FDA testing report.
If the test fails, it is necessary to improve the process or replace the raw materials before retesting.
4、 Key testing conditions (usage scenarios)
FDA testing places great emphasis on the expected usage scenarios of products, and the testing conditions must match:
Cold drink cup: usually soaked in distilled water at room temperature or refrigerated conditions.
Hot drink cup: Soak in distilled water at high temperatures (such as 100 ° C or higher).
Alcoholic beverages: Soak in ethanol solution.
Fat containing beverages (such as milk tea): Use n-hexane or edible oil to simulate.
5、 Required Information
When processing, it is usually necessary to provide:
1. Application Form: Includes applicant information, product name, model, etc.
2. Product manual: Describe the purpose of the product (hot/cold drinks).
3. Material List (BOM): List all raw material components (such as specific grades of PP materials and names of additives).
6、 Cost and cycle estimation
Cost: Depending on the complexity of the material. Single material (such as pure PP cup) has lower cost; Composite materials (such as paper cups, PE coating, and ink) have higher costs as they require separate testing for different layers.
Cycle: Usually 5-7 working days.
7、 Special attention: Food Contact Notification (FCN)
If your cup uses new materials or additives not listed in FDA regulations, simply making a test report is not enough, you must submit a Food Contact Notification (FCN) to the FDA. This is a lengthy approval process (usually 120 days), and once approved, the substance can be legally used. For conventional commercial disposable cups, it is usually only necessary to comply with existing regulations and hold a test report.
summary suggestions
If exporting to the United States, it is recommended to:
1. Clarify the material: Ensure that the raw material supplier can provide FDA compliant raw material certification.
2. Choose a compliance agency: Select a laboratory with CNAS qualification (China National Accreditation Service for Conformity Assessment) or A2LA qualification from the United States.
3. Full testing: Do not only do partial testing to save money, as the US Customs may require a complete compliance certificate during spot checks.
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