Polyhydroxyethylmethacrylate (pHEMA)

INCI: POLYHYDROXYETHYLMETHACRYLATE

CAS Number
25249-16-5 (polymer)
Function
Film Forming
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA has extensively evaluated pHEMA for medical devices (contact lenses, IOLs, dermal fillers); systemic exposure from cosmetic use is far lower than approved device exposures

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
negligible
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Residual HEMA monomer is a potent skin sensitizer; specification must include monomer limit testing and local reaction risk assessment in cosmetic formulations.

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Concern Level: Moderate

Regulatory Flags

potential-allergen natural-origin

Frequently Asked Questions

Is Polyhydroxyethylmethacrylate (pHEMA) safe in cosmetics?

Residual HEMA monomer is a potent skin sensitizer; specification must include monomer limit testing and local reaction risk assessment in cosmetic formulations. The EU classifies Polyhydroxyethylmethacrylate (pHEMA) as "permitted". Safety rating: GOOD.

Is Polyhydroxyethylmethacrylate (pHEMA) allowed in the EU?

Polyhydroxyethylmethacrylate (pHEMA) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Polyhydroxyethylmethacrylate (pHEMA) do in cosmetics?

Polyhydroxyethylmethacrylate (pHEMA) functions as: Film Forming. It is classified as a cosmetic ingredient in our database. CAS number: 25249-16-5 (polymer).

What is the Margin of Safety for Polyhydroxyethylmethacrylate (pHEMA)?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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