Polysorbate 80

CAS Number:

9005-65-6

Chemical Formula:

C64H124O26

EINECS/ELINCS No:

500-019-9 (Note: This is the standard number for Polysorbate 80, not listed in the provided sources)

COSING REF No:

37415 (Note: This is the standard number for Polysorbate 80, not listed in the provided sources)

Description:

Polysorbate 80 is a non-ionic,hydrophilic surfactant and emulsifier widely used in cosmetics, pharmaceuticals, and food. It is valued for its ability to solubilize oils in water, stabilize formulations, and create stable oil-in-water emulsions.

Uses:

It is a versatile solubilizer and emulsifier used across multiple industries. Its primary role is to blend oil- and water-based ingredients.

· Cosmetics & Personal Care: Found in moisturizers, shampoos, conditioners, lotions, sunscreens, cleansers, and makeup (foundation, mascara). It helps solubilize fragrances and essential oils into water-based products.

· Pharmaceuticals: Used as a stabilizing excipient in injectable formulations, vaccines, and oral medicines to prevent particle formation and improve solubility.

· Food Industry: Approved as an emulsifier (E433) in products like ice cream to improve texture and resistance to melting.

Origin:

Polysorbate 80 is a synthetic (semi-synthetic) ingredient. It is produced by the ethoxylation of sorbitan (derived from sorbitol, a sugar alcohol) followed by esterification with oleic acid. The "80" historically refers to oleic acid. The fatty acid source can be plant-based (e.g., palm oil, olive oil) or synthetic

What does POLYSORBATE 80 do in a formulation?

Its primary functions are:

• Emulsifying (primary)
• Surfactant
• Solubilizing (key function for fragrances/oils)
• Denaturant (in alcohol-based products)

Safety Profile:

· General Assessment: Approved as safe for use in cosmetics, food, and pharmaceuticals by major regulatory bodies (FDA, EU). It is generally non-irritating and non-sensitizing at standard use levels.

· Key Consideration: As an ethoxylated ingredient, there is a potential for trace contamination with 1,4-dioxane, a byproduct of manufacturing. Reputable suppliers purify the product to minimize this risk.

· Use Concentration: Widely used; specific cosmetic limits not defined by CIR but guided by Good Manufacturing Practice (GMP). It is present in approximately 1.68% of cosmetic products.

Technical profile:

Summary:

Polysorbate 80 is a versatile, hydrophilic non-ionic surfactant and emulsifier essential for stabilizing mixtures of oil and water in cosmetics, drugs, and food. Its key strengths are its excellent solubilizing power, formulation stability, and strong safety record.