Rich Cream Maker™ Components, FDA Declaration, and Acrylamide Regulation

Question

I am using Rich Cream Maker™ in my cosmetic formulation and need clarification for FDA notification.

1. What are the individual components (INCI names) that make up Rich Cream Maker™?
2. How should I declare Rich Cream Maker™ and its components when submitting for FDA notification? Do I list the blend name and its percentage, or the individual components and their percentages?
3. I understand there is a regulation regarding Acrylamide. Is Rich Cream Maker™ compliant with this regulation? What is the typical level of Acrylamide impurity in Rich Cream Maker™?

I was previously given incorrect information that Polyacrylamide was prohibited, but now understand the restriction is on Acrylamide impurity. I have received the COA document for Rich Cream Maker™.

MySkinRecipes Expert · Accepted Answer

Components of Rich Cream Maker™ for FDA Notification

Dear Customer,

Regarding your inquiry about cosmetic product notification with the FDA (อย.) for a product containing Rich Cream Maker™ and your questions about its components and the Acrylamide regulation, we would like to clarify the following:

Component Breakdown: The scientific name (INCI Name) for Rich Cream Maker™ is Polyacrylamide & C13-14 Isoparaffin & Laureth-7. This means that Rich Cream Maker™ is a pre-mixed blend consisting of these three substances combined. Therefore, your understanding of the separate components as:
- Polyacrylamide
- C13-14 Isoparaffin
- Laureth-7
  is correct.
Declaring Percentages: For FDA notification, you should declare the name of the blend, which is Rich Cream Maker™, and specify the percentage of Rich Cream Maker™ used in your total cosmetic formulation. You do not need to declare the separate percentages of Polyacrylamide, C13-14 Isoparaffin, and Laureth-7 that are within the Rich Cream Maker™ blend, as it is used as a single, pre-mixed ingredient.
Acrylamide Regulation: As the staff member further clarified, the FDA regulation concerns the amount of Acrylamide, which is an impurity that may be present in Polyacrylamide, not a restriction on Polyacrylamide itself. For Rich Cream Maker™, the typical level of Acrylamide impurity is no more than 2 parts per million (2 ppm or 0.0002%). This amount is generally within the limits set by the FDA. You can verify the exact amount of Acrylamide from the Certificate of Analysis (COA) document for the specific Lot of Rich Cream Maker™ you are using.