U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) includes urea on its list of direct food additives affirmed as Generally Recognized As Safe (GRAS).

Link to the Code of Federal Regulations for urea
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Expert Panel for Cosmetic Ingredient Safety

The safety of urea has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that urea was safe as used in cosmetics and personal care products.

The 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 Expert Panel to be genotoxic, except at very high concentrations. The 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.

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 Union.

The Joint FAO/WHO Expert Committee on Food Additives has evaluated the use of urea at levels up to 3% in chewing gum and found these levels to be acceptable and of no toxicological concern.

In Canada, urea is permitted in cosmetics and personal care products at concentrations equal to or less than 10%.

Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has prepared an Existing Chemical Information Sheet for urea.