Urea is a colorless or white crystalline powder; it can also occur in the form of small white pellets. In cosmetics and personal care products, Urea can be found in many product types including skin care, coloring and noncoloring hair care products, and eye makeup.
The safety of Urea has been assessed by the Cosmetic Ingredient Review (CIR)Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Urea was safe as used in cosmetics and personal care products.CIR Safety Review: The CIR Expert Panel determined Urea was safe for use in cosmetic and personal care products. Acute, short-term, and chronic toxicity studies demonstrated little evidence of adverse effects, even at high exposures. Dermal irritation was not significant. Reproductive and developmental toxicity studies raised no concerns. Carcinogenicity studies were negative.
In vitro, Urea can cause uncoiling of DNA, a property used in many laboratory studies of DNA. This in vitro activity is not linked to any in vivo genotoxic activity and Urea was not considered by the CIR Expert Panel to be genotoxic, except at very high concentrations.
The CIR Expert Panel did note that Urea can increase the percutaneous absorption of other ingredients and that this should be taken into account when conducting product safety assessments.
FDA: Link to the Code of Federal Regulations for Urea
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Urea may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
The Joint FAO/WHO Expert Committee on Food Additives has evaluated the use of Urea at levels up to
In Canada, Urea is permitted in cosmetics and personal care products at concentrations equal to or less than 10%.
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/hotlist-liste_3...
Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has prepared an Existing Chemical Information Sheet for Urea
http://www.nicnas.gov.au/publications/information_sheets/exi...