Juicer filter screen US FDA food contact material FCM report application process
Date：2026-07-21 09:31:07 Classification
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Juicer Filter Screen US FDA Food Contact Material FCM Report Processing Procedure
I. Regulatory Applicability Determination
Juicer filters come into direct contact with fruit/juice during the juicing process and are therefore classified as food contact materials regulated by the FDA 21 CFR. Common Materials and Corresponding Regulations:
| Material | Applicable Regulatory Clauses | Key Limit Requirements
| Stainless Steel (e.g., 304/316) | FDA 21 CFR 184/189 (GRAS substance) + 21 CFR 184.1530 (Ni-Chromium steel indirect additive) | Heavy metal leaching: Cr≤0.4 mg/L, Ni≤0.5 mg/L, etc. (based on NSF/ANSI 51)
| Nylon Mesh (PA66/PA12) | 21 CFR 177.1500 (Nylon resin) | Density, leachates, primary aromatic amines
| Polyester Fiber Mesh (PET) | 21 CFR 177.1630 (PET food contact) | Total extract (simulated liquid extraction)
| Metal Wire/Filter Coating | 21 CFR 175.300 (Coating) | Coating Leachate Test
If the filter screen has a food-grade silicone sealing ring or plastic frame, its material compliance must also be assessed.
II. Processing Procedure (Approximately 2-3 weeks)
Step 1: Select a third-party laboratory with CNAS + CMA accreditation (Dezeway Testing CNAS Registration No.: L8083)
It is recommended to choose an institution with experience in FDA/USDA client accreditation. The types of reports that can be issued include:
✅ FDA 21 CFR Compliance Test Report (CMA Seal)
✅ DoC (Declaration of Conformity)
✅ It is recommended to also issue an English version (for direct use in the US market)
Step 2: Complete the application form and prepare product information
Product name, model, filter mesh count, material grade
List of materials for each component (metal mesh/nylon mesh/plastic frame/silicone ring)
Food contact conditions (high temperature, contact with acidic fruits, prolonged immersion)
Special requirements of the purchaser for testing conditions
Step 3: Sample submission
Finished filter (3-5 pieces) Samples (ensuring sampling from different batches)
Key components (such as nylon mesh/silicone rings) should be sampled separately.
The laboratory will disassemble and test according to 21 CFR and group them by homogeneous material.
Step 4: Laboratory Testing
Core Test Items:
| Test Item | Significance of Testing
| Total Extractives | Residue after extraction with different simulated solutions (water/4% acetic acid/8% ethanol/n-hexane)
| Specific Migrating Substances | Nickel, chromium, manganese (stainless steel), primary aromatic amines (nylon), formaldehyde, etc.
| Heavy Metal Leaching | Pb, Cd, As, Cr⁶⁺, etc. (according to FDA + NSF 51 standards)
| Simulated Usage Conditions | Simulated juicer operating temperature (room temperature or 50-100℃) and contact time
| Sensory Testing | Odor and color transfer (required by some buyers)
Step 5: Report Issuance
Test passed → Laboratory issues FCM Compliance Report + DoC Declaration (English version recommended)
Report Validity: Valid indefinitely, but retesting is required if materials, formulations, or suppliers change.
III. Fees and Timeframe Reference
| Item | Reference Data
| Reporting Timeframe | 5-7 business days (3-5 days for expedited service)
| Report Fee | 1000 ~ 2000 RMB (depending on material combination and test items)
| Report Validity | Long-term (assuming unchanged formulation)
Multiple material combinations (e.g., stainless steel mesh + nylon mesh + silicone ring) significantly increase the number of test points; it is recommended to prioritize compliance of the primary material.
IV. Key Considerations
1. Material grade must be clearly stated: For stainless steel, a specific grade (e.g., SUS 304/316) and material certification are required. The FDA has specific compositional requirements for food-grade stainless steel (Cr≥16%, Ni≥10%, etc.).
2. Nickel leaching is a frequent cause of exceeding standards: 304 stainless steel is prone to excessive nickel leaching in acidic fruit juices (lemons, oranges). It is recommended to use 316L stainless steel or undergo passivation treatment.
3. Primary aromatic amines (PAA) must be tested in nylon filters: 21 CFR 177.1500 sets limits for PAA in nylon, which is a frequent non-compliance item in nylon food contact products.
4. Juicer manufacturers often specify testing procedures: If you are supplying brand owners/OEMs, it is recommended to obtain the customer's testing standard list beforehand to avoid omissions leading to rework.
5. Differentiating from NSF/ANSI 51: FDA reports focus on regulatory compliance, while NSF 51 focuses on hygiene standards. Some US buyers may request both.
6. Difference from FDA facility registration: This report is for product material compliance, not FDA facility registration; the latter is only required for US importers (US agents). Practical advice: If your product is planned to be sold through multiple channels in the United States, it is recommended to consider engaging a US agent while processing the FCM report to facilitate subsequent FDA facility registration and close the loop for access to the US market.
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