How to get the US FDA 21 CFR 177.2600 Test Report?

We are often asked by customers exporting silicone products to the United States whether our silicone raw materials comply with FDA regulations, what testing requirements FDA has for food-grade silicone, and what the testing standards are. Today, we will conduct an in-depth analysis of FDA 21 CFR 177.2600—the core standard for food-grade silicone in the United States, helping customers understand this standard and get prepared for entering the US market.

What is FDA 21 CFR 177.2600 and which silicone products does it apply to?

FDA 21 CFR 177.2600 is a safety regulation issued by the U.S. Food and Drug Administration (FDA) for rubber products (including silicone rubber) intended for food contact. It specifies the requirements for chemical stability, non-toxicity, and temperature resistance of silicone in food contact applications.

Applicable Product Scope

• Seals for food containers (e.g., baby bottles, food storage containers)

• Baking molds (silicone baking trays, cake molds)

• Kitchen utensils (silicone spatulas, ice trays, steamer mats)

• Nipples and pacifiers (must additionally comply with FDA 21 CFR 177.2600 + USP Class VI)

• Seals for food processing equipment (e.g., seals for beverage filling lines)

Note: For medical-grade silicone (e.g., medical catheters), additional compliance with USP Class VI or ISO 10993 biocompatibility standards is required.

FDA 21 CFR 177.2600 Testing Content: What Exactly Is Tested for Silicone?

The key tests for silicone products under FDA include:

(1) Extraction Tests

These tests simulate the migration of chemical substances from silicone when in contact with different food environments, ensuring no harmful substances are released. Test solvents include:

• Water extraction (simulating aqueous foods such as milk and fruit juice)

• n-Hexane extraction (simulating fatty foods such as cooking oil and butter)

• 8% Ethanol extraction (simulating alcoholic foods such as wine and vinegar)

Passing Criteria: Extractables shall not exceed the limits specified by FDA (e.g., total non-volatile residue ≤ 0.1 mg/in²).

(2) High-Temperature Stability Test

Food-grade silicone rubber often requires high-temperature resistance (e.g., baking molds must withstand temperatures above 200°C), so the following tests are required:

• Performance changes after thermal aging (whether it becomes brittle or cracks)

• Whether odors or harmful substances are released at high temperatures

(3) Organoleptic Tests (Taste & Odor Test)

Silicone shall not affect the taste or odor of food, especially for baby products and food packaging.

How to Ensure Silicone Complies with FDA 21 CFR 177.2600?

As a manufacturer of silicone products, you need to:

• Select compliant food-grade silicone raw materials and silicone curing agents.

• Adopt appropriate production processes and perform post-curing of silicone when necessary.

• Retain test reports (e.g., extraction tests and biocompatibility tests from third-party laboratories).

Tip: If your products also target the European market, it is recommended to conduct LFGB or EU 10/2011 tests simultaneously to meet the stricter EU standards.

Benefits of Food-Grade Silicone Complying with FDA 21 CFR 177.2600

• Market Access: Mandatory for markets such as the United States and Canada.

• Consumer Trust: Parents prefer baby nipples and tableware that meet FDA standards.

• Avoid Legal Risks: Non-compliant products may be detained by customs or recalled.

US FDA 21 CFR 177.2600 Testing Process

1. Send product pictures and product specifications to JJR LAB

2. JJR provides the compliance testing fee and lead time

3. Customer confirms the fee, and a commercial invoice is issued

4. Customer sends samples and makes payment

5. JJR LAB conducts the test

6. A draft report is issued for customer confirmation

7. Upon confirmation with no errors, the official test report is issued