Polyoxymethylene Urea

What Is It?

Polyoxymethylene Urea, also called Urea-Formaldehyde ResinA class of solid or semi-solid viscous organic substances exuded by plants. Sometimes refers to a class of synthetic products with physical properties similar to those of natural resins., can occur as a liquid with a clear to milky appearance, or as a powdery solid. In cosmetics and personal care products, Polyoxymethylene Urea is used in the formulation of makeup products such as eye shadow, blushers, face powders, lipstick, and rouges, but can also be found in perfumes and nail products.

Why Is It Used?

Polyoxymethylene Urea is a non-reactive, solid ingredient that is used to dilute other solids, or to increase the volume of a product.

Scientific Facts

Polyoxymethylene Urea, also known as Urea-Formaldehyde Resin, is a synthetic polymerA naturally occurring or synthetic molecule made up of repeating units called monomers. prepared from relatively small chemical compounds called monomers. Polyoxymethylene Urea is a large molecule composed of urea and formaldehyde monomers.

Safety Information

The Food and Drug Administration (FDA) includes Urea-Formaldehyde Resin on its list of indirect food additives. It is permitted for use as a component of adhesives, and in polymers having incidental contact with food. The safety of Polyoxymethylene Urea has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Polyoxymethylene Urea was safe for use as a cosmetic ingredient, except in aerosolized products. Free formaldehyde in products formulated with Polyoxymethylene Urea should not exceed 0.2%. The CIR Expert Panel review determined that the data were insufficient to reach a conclusion of the safety of Polyoxymethylene Urea in cosmetics and personal care products intended to be aerosolized.

CIR Safety Review: Polyoxymethylene Urea was a mild skin irritant and caused mild, transient ocular irritation. Tests in bacteria were negative for mutagenesis. Clinical data showed no irritation or sensitization. On the basis of the data, the CIR Expert Panel concluded that Polyoxymethylene Urea was safe for use as a cosmetic ingredient.

A previous determination, however, that the concentration of free formaldehyde in cosmetic formulations should not exceed 0.2% was considered appropriate for this ingredient as well. Likewise, the previous finding that the data were not sufficient to support the safety of formaldehyde in cosmetics and personal care products intended to be aerosolized was extended to this ingredient.

More information about formaldehyde

Link to FDA Code of Federal Regulations for Urea/Formaldehyde resins

Polyoxymethylene Urea may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

More Scientific Information

Polyoxymethylene Urea is a variable molecular weight polymer formed in stages from the condensation reaction of urea with formaldehyde. Because of the nature of the polymerization process, residual formaldehyde is present at levels typically between 17 and 30 ppm. In cosmetics and personal care products, Polyoxymethylene Urea functions as a bulking agentNon-reactive, solid ingredients that are used to dilute other solids, or to increase the volume of a product..

Resources

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/