Poor Cosmetic Ingredient Sensitization Data

Polyoxymethylene Urea

INCI: POLYOXYMETHYLENE UREA

CAS Number
68611-64-3 / 9011-05-6
Function
Bulking agent; viscosity controlling
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Not specifically restricted; permitted in cosmetics under general safety provisions. No CIR final report dedicated to this polymer

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Polyoxymethylene Urea based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.4%
Cross-reactivity Group
formaldehyde-releaser-group
Reaction Type
contact-dermatitis

Source: ESSCA 2019/20; IVDK; FDA

Expert Verdict

Formaldehyde donor polymer and urea-formaldehyde reaction product with CMR concern due to formaldehyde content. Residual free formaldehyde must be tested per EU 1223/2009 Annex II entry 1577; incompatible with COSMOS/ECOCERT certification.

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Concern Level: High

Frequently Asked Questions

Is Polyoxymethylene Urea safe in cosmetics?

Formaldehyde donor polymer and urea-formaldehyde reaction product with CMR concern due to formaldehyde content. Residual free formaldehyde must be tested per EU 1223/2009 Annex II entry 1577; incompatible with COSMOS/ECOCERT certification. The EU classifies Polyoxymethylene Urea as "restricted". Safety rating: POOR.

Is Polyoxymethylene Urea allowed in the EU?

Polyoxymethylene Urea EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does Polyoxymethylene Urea do in cosmetics?

Polyoxymethylene Urea functions as: Bulking agent; viscosity controlling. It is classified as a cosmetic ingredient in our database. CAS number: 68611-64-3 / 9011-05-6.

What is the Margin of Safety for Polyoxymethylene Urea?

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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