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Silicone mold FDA food contact material testing in the United States

Date:2026-04-01 10:31:17 Classification :【question】 Visits:
Silicone mold FDA food contact material testing in the United States

1、 Scope of application

Silicone molds, as food contact materials, need to meet FDA requirements if they are used to come into contact with food and enter the US market. Mainly includes:

|Product Type | Specific Example

|Baking silicone molds | Cake molds, biscuit molds, Muffin cups, etc

|Chocolate mold | Chocolate shaping mold, ice tray mold

|Silicone kitchen supplies | Silicone pads, silicone scrapers, insulated gloves

|Infant silicone products | Infant complementary food molds, silicone dental glue

2、 Testing standard basis

FDA 21 CFR Part 177- Specific Provisions for Silicone Rubber Food Contact Materials

FDA 21 CFR Part 178- Regulations on Adjuvants for Food Contact Materials

United States Pharmacopeia (USP) - Biocompatibility Testing of Medical Grade Silicone

3、 Main testing items

1. Total Migration Test

Test the migration of materials in simulated objects

Simulates include deionized water, alcohol, olive oil, etc

2. Specific substance migration testing

Residual monomers (such as D4, D5, D6 cyclic siloxanes)

Plasticizers, heavy metals, etc

3. Potassium permanganate consumption

Assess the level of organic matter migration

4. Heavy metal content detection

Lead, cadmium, arsenic, mercury, etc

5. Sensory/Taste Odor Testing

Ensure that the flavor of the food remains unchanged

4、 Handling process

|Step | Content

|1 | Submit product information (material composition table, formula, etc.)

|2 | Choose an institution with FDA testing qualifications

|3 | Sample testing (usually 3-5 sets)

|4 | Laboratory testing and result determination

|5 | Issue a testing report

5、 Precautions

Reminder:

Silicone material needs to be clearly defined as food grade or industrial grade, with different testing requirements for the two

Additional requirements of the Consumer Product Safety Improvement Act (CPSIA) must be met for use in infant products

It is recommended to choose a testing report issued by an FDA accredited laboratory for greater authority

The testing cycle is generally 5-7 working days, and the cost depends on the complexity of the product

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