Steps for Reporting Food Contact Materials to the US FDA for Children's Water Bo
Date：2026-07-02 10:04:32 Classification
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Steps for Obtaining a Report on Food Contact Materials for Children's Water Bottles from the US FDA
I. Confirming Applicable Regulations
Core applicable regulations for children's water bottles (infant products):
21 CFR 170-199 General Framework for Food Contact Materials
21 CFR 174-179 Requirements for Indirect Additives
21 CFR 180-189 Requirements for Plastics in Food Contact
California AB 1817, BPA-Free Act (Special Provisions for Infants and Toddlers)
II. Processing Steps (6 Steps)
Step 1 | Selecting a Testing Institution
Choose a third-party laboratory with CMA and CNAS accreditations, prioritizing institutions with FDA testing experience for infant products (e.g., Dezeway Testing CNAS Registration No.: L8083).
Step 2 | Submit Product Information
Product Instructions (Chinese and English)
Complete Component List (Cup Body, Straw, Sealing Ring, Lid, etc., Material Specifications)
Raw Material Supplier Information
Testing Application Form
Step 3 | Sample Preparation and Submission
Sample Quantity: 6-10 samples per component (separate samples for multiple components)
Simulating High Temperature (Boiling Water) and Reusable Scenario for Infants and Young Children
Laboratory sampling based on material
Step 4 | Laboratory Testing
Cycle: Typically 5-7 working days
Cost: Approximately 800-3000 RMB
Testing Method: Food Simulation Liquid Immersion + Instrumental Analysis (GC-MS, ICP-OES, etc.)
Step 5 | Report Issuance
Pass: Issuance of a Chinese and English test report with CMA/ilac-MRA markings
Fail: Resubmission for testing after rectification
Step 6 | Application and Registration
Upload and register to platforms such as Amazon and Shopify
Add "BPA-Free" or similar markings to product labels
III. Core Testing Items
| Testing Items | Testing Objects | Key Limits
| Total Migration | All Materials | Non-volatile Migration in Simulated Liquids
| Bisphenol A (BPA) | Infant Products | Zero Tolerance (California Regulation)
| Phthalate (4 items) | Soft Plastics, Silicone, Straws | ≤ 0.1%
| Heavy Metal Migration | 8 Major Heavy Metals (Lead, Cadmium, etc.) | 21 CFR 109 Limit
| Sensory Testing | Finished Product | Odor, Discoloration, Foreign Matter Leakage
IV. Special Reminders for Children's Water Bottles
Separate Testing for Multiple Components: Each component, such as the cup body, straw, sealing ring, and valve, should be tested independently (different regulations apply to different materials).
High Temperature Scenarios: Migration under boiling water conditions must be tested.
Essential Warning Labels: Packaging must include "Avoid boiling" and "Microwave not..." Recommended
Suggested additional tests: BPA-Free declaration, 4 phthalates, FDA registration (if entering the US market).
For specific material testing procedures, BPA-Free label compliance requirements, or rectification suggestions, please inform us of the product material (PP/Tritan/stainless steel/silicone, etc.) for more targeted guidance.
Shen Gongwang Security: 44030602006947