Composition and Technical Data of PE 1090 for FDA Registration

Question

I would like to request some information. We are currently registering a surface cleaning product with the Thai FDA's Hazardous Substances division. The formulation uses PE 1090 Preservative as a preservative.

As we need to provide the specific details of the ingredients in PE 1090 Preservative, I would like to know:

What is the ratio of Phenoxyethanol and Ethylhexylglycerin in this blend?
What is the function of Ethylhexylglycerin? In the FDA system, it is categorized as a "diluent" rather than a preservative.

Please provide the technical data and advice on how to clarify this with the FDA. Thank you.

MySkinRecipes Expert · Accepted Answer

For the registration of your surface cleaning product with the Thai FDA (Hazardous Substances), here is the technical information regarding PE 1090 Preservative:

1. Composition Ratio

Based on the technical data for PE 1090 Preservative, the ratio of the ingredients is:

Phenoxyethanol: 90% (CAS No. 122-99-6)
Ethylhexylglycerin: 10% (CAS No. 70445-33-9)

2. Function of Ethylhexylglycerin

In this preservative system, Ethylhexylglycerin serves a critical role beyond being a simple diluent:

Preservative Booster (Potentiator): It acts as a booster that enhances the efficacy of Phenoxyethanol. It works by reducing the surface tension on the cell membranes of microorganisms, allowing the primary preservative (Phenoxyethanol) to penetrate and destroy the microbes more effectively.
Broad-Spectrum Support: By adding Ethylhexylglycerin, the blend becomes a broad-spectrum preservative system that is more effective against a wider range of bacteria and molds compared to using Phenoxyethanol alone.

3. Advice for Thai FDA Clarification

If the Thai FDA's Hazardous Substances system classifies Ethylhexylglycerin as a "diluent" (ตัวทำเจือจาง), you can clarify its technical role as follows:

Technical Justification: Explain that while it may have solvent-like properties, its primary technical function in this specific blend is a "Preservative Enhancer" or "Active Booster." It is included at 10% specifically to increase the antimicrobial performance of the Phenoxyethanol.
Synergy: State that this 90:10 ratio is a globally recognized synergistic combination (often found in commercial blends like Euxyl PE 9010 or Kopcerin PE1090) designed to provide effective preservation at lower total concentrations.
Documentation: If the electronic system requires you to select "Diluent" based on their database, you should proceed with that selection but attach a Technical Data Sheet (TDS) or a letter of explanation detailing its synergistic function to ensure the reviewer understands its necessity in the formula.

Referenced Product: