How to obtain a food contact material report from the US FDA for beverage bottle
Date：2025-11-11 09:28:35 Classification
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The U.S. Food and Drug Administration (FDA), according to its regulatory requirements for food contact materials (FCM) (21 CFR Parts 174-179), requires beverage bottles to undergo compliance testing strictly following procedures:
I. Confirmation of Core Regulatory Applicability
Beverage bottles primarily fall under the category of "indirect food additives" (21 CFR 177), with specific standards varying according to material:
| Material Type | Applicable Regulations | Key Testing Requirements
| PET Bottles | 21 CFR 177.1630 | Total migration (10% ethanol, 40℃ × 10 days) ≤ 0.5 mg/in²; Acetaldehyde migration ≤ 15 ppb (additional testing required for carbonated beverage bottles)
| HDPE Bottles | 21 CFR 177.1520 | Hexane extract ≤ 5.5% (room temperature × 2 h); Heavy metal (Pb/Cd/As) leaching ≤ 1 ppm
| Recycled Plastic Bottles | 21 CFR 179.22 | New requirements added in 2025: Provide a declaration of raw material origin + contaminant screening (300 pesticide/mineral oil residues)
Note: Bottle cap seals (such as silicone) must additionally comply with 21 CFR 177.2600, and bottle printing inks must comply with FDA CPG 7117.05.
II. Detailed Application Process (Updated 2025)
Step 1: Material Composition Pre-screening (Crucial!)
- Provide Formula: Resin type (e.g., PET granules CAS 25038-59-9), CAS numbers and contents of additives (masterbatch, antioxidants, etc.)
- Prohibited Substance Verification:
Bisphenol A (BPA) residues are prohibited from 2025 (detection limit ≤0.01ppm)
Total amount of 6 phthalates (DEHP/DBP/BBP, etc.) ≤0.1%
Step 2: Select an FDA-Accredited Laboratory
- Qualification Requirements: ISO 17025 certification + FDA FCN (Food Contact Substances Notification) submission qualification
Recommended Institution: Dezewei Testing CNAS Registration Number: L8083
- Testing Package Selection:
A [Basic Compliance Testing] --> B [Full Migration Testing]
A --> C [Specific Migration Testing (Acetaldehyde/Heavy Metals)]
A --> D [Sensory Testing (Odor Assessment)]
D --> E [Recycled Material Screening]
Step 3: Sample Preparation and Submission
- Sample Specifications: Provide ≥12 complete empty bottles (including caps)
- Pretreatment: Simulate actual usage conditions (e.g., carbonated beverage bottles require CO₂ pressurization for 24 hours)
Step 4: Execution of Testing Items
| Test Type | Method Standard | Judgment Limits
| Total Migration | FDA 21 CFR 175.300 | ≤0.5mg/in²
| Acetaldehyde Migration | GC-MS (40℃×10 days) | Carbonated Beverage Bottles ≤15ppb
| Heavy Metal Leaching | ICP-MS (4% Acetic Acid, 70℃×2h) | Lead ≤0.5ppm, Cadmium ≤0.25ppm
| Phthalate Esters | EPA 8061D | Single item ≤0.01%
Step 5: Obtain Compliance Documents
1. Test Report: Bilingual report in Chinese and English issued by the laboratory (including CMA/ISO 17025 seal)
2. FDA Declaration of Compliance (DoC):
Signed by the company (template reference FDA Form 3633)
Must include material composition, testing standards, and compliance conclusions
3. Supply Chain Documents: FDA Letter of Guarantee from the resin supplier
III. New Regulations and Compliance Points in 2025
1. Recycled Plastics Traceability Requirements:
- Proof of recycled material source must be provided (PCR content ≥50% requires special testing)
- New screening for short-chain chlorinated paraffins (SCCPs) (limit ≤0.15%)
2. Digital Labeling:
- It is recommended to attach a QR code linking to the electronic DoC on the bottle (mandatory requirement by Amazon)
3. Accelerated Testing Conditions:
- Migration testing temperature for acidic beverage bottles (pH less than 4.5) increased to 60℃ (originally 40℃)
IV. Time and Cost Overview
| Project | Cycle
| Basic Testing Package | 5~7 working days
V. Common Failure Points and Avoidance Strategies
| Problem Type | Solution
| Acetaldehyde Exceeding Standard | Switch to low-acetaldehyde masterbatch + control bottle preform drying process (humidity ≤50ppm)
| Phthalate Migration | Replace plasticizer with environmentally friendly types such as ATBC/CITCM (compatibility testing required beforehand)
| Label Non-Compliance | Bottle bottom must be engraved with "resin code" (e.g., PET→♳) + "FDA Compliant" mark
| Recycled Material Contamination | Sign a Supplier Quality Agreement (SQA) requiring contaminant screening reports for each batch
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