The Science Behind Custom Formulations and Regulatory Compliance

The Science of Skincare: Behind Custom Formulations

While a natural skincare philosophy can be rooted in the purity of nature, the process of creating a professional-grade product is anything but simple. In today's landscape, a cosmetic product's journey from concept to consumer is governed by both scientific principles and strict regulatory standards. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has ushered in a new era of accountability and transparency, ensuring that safety is paramount. The difference between a great idea and a trustworthy, professional-grade product is a deep commitment to both cosmetic chemistry and regulatory compliance.

Beyond the Recipe: The Art of Cosmetic Chemistry

A cosmetic formulator is part alchemist, part scientist. It's not enough to simply combine ingredients; their interactions on a molecular level must be understood to create a final product that is stable and effective. This requires a deep understanding of key chemical principles:

• Emulsions: Many products are emulsions, a complex mixture of water and oil. Creating a stable emulsion requires a deep understanding of emulsifiers and surfactants that allow these two immiscible liquids to blend harmoniously without separating. A stable emulsion ensures a product's texture and efficacy remain consistent over time.

• pH Balance: The pH level of a skincare product is critical for both its efficacy and the skin's health. The skin's natural pH is slightly acidic, typically between 4.5 and 5.5. The pH of formulas is meticulously adjusted to a compatible range to support the skin's protective barrier and ensure active ingredients work as intended.

• Preservation Science: A natural product containing water is a breeding ground for microbes. Expertise in preservation science allows for the use of gentle, broad-spectrum preservative systems that protect a product from mold, yeast, and bacteria without irritating the skin. This ensures safety and a consistent shelf life.

Rigorous Testing and Regulatory Compliance

Under MoCRA, a brand (whose logo is on the finished product), or who is buying a bulk base and is filling containers is now required to substantiate the safety of a cosmetic product, meaning they must possess and maintain records that prove the product is safe for its intended use. This is a critical legal and ethical obligation. The brand (not necessarily the manufacturer) is responsible to perform:

• Stability Testing: A product is tested under various environmental conditions (temperature fluctuations, light exposure) to ensure it doesn't change in color, texture, or scent over its shelf life.

• Microbial Testing: A formula can be challenged with various microorganisms to confirm that the preservative system is robust enough to prevent any microbial growth. 

• Documentation and Record-Keeping: Be able to provide the FDA with documentation supporting the testing of their products.

In addition to safety substantiation, a cosmetic manufacturer must adhere to Good Manufacturing Practices (GMPs), a set of guidelines and procedures to ensure products are consistently produced and controlled according to quality standards.

• Documentation and Record-Keeping: Every step of the production process must be meticulously documented to ensure traceability and quality control.

Citations

1. U.S. Food & Drug Administration. (2024). Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Retrieved from FDA MoCRA Website.

2. Barel, A. O., Paye, M., & Maibach, H. I. (2014). Handbook of Cosmetic Science and Technology (4th ed.). CRC Press.

3. Lautenschlaeger, H. (2018). The Role of Emulsifiers in Cosmetic Products. Cosmetic Science and Technology, 2018, 1-10.

4. Pinto, A. L., Morais, A. C., & Pinto, M. M. (2019). Quality and Safety of Cosmetic Products. In Cosmetic and Toiletry Products (pp. 1-15). IntechOpen.

Article by: Dahlia Kelada MSHS-INTM, SALVE Founder/CEO, Integrative Medicine Educator, Cosmetic Formulator