DMDM Hydantoin

The safety of DMDM Hydantoin 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 DMDM Hydantoin was safe as a cosmetic ingredient in the present practices of use. In 2005, the CIR Expert Panel considered available new data on DMDM Hydantoin and reaffirmed the above conclusion.

CIR Safety Review: DMDM Hydantoin is poorly absorbed from the skin. In a laboratory study, oral exposure to DMDM Hydantoin did not result in any adverse effects. The CIR Expert Panel noted that DMDM Hydantoin is a formaldehyde donor in aqueous media. They attributed positive results in some in vitroExperiments performed in a test tube or another artificial, controlled environment, rather than in a whole animal. mutagenicity studies to formaldehyde release. In these studies, the concentrations of DMDM Hydantoin tested were higher than those used in cosmetic and personal care products, likely resulting in much higher concentrations of formaldehyde than found in products. Clinical studies revealed some observations of skin irritation which could also be related to the release of formaldehyde from DMDM Hydantoin.

The CIR Expert Panel has reviewed the safety of formaldehyde in cosmetics and personal care products and concluded that it was safe to a great majority of consumers but has limited the concentration to 0.2% free formaldehyde due to the skin sensitivity of some individuals to this agent. The amount of DMDM Hydantoin required to preserve a product (less than 1%) does not expose the consumer to concentrations of formaldehyde above the 0.2% limit for formaldehyde recommended by the CIR Expert Panel.

DMDM Hydantoin, called Dimethylol, Dimethylhydantoin [1,3-Bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione], is listed in Annex VI, Part I (preservatives which cosmetics products may contain) of the Cosmetics Directive of the European Union and may be used in cosmetics and personal care products at a maximum concentration of 0.6%. If the concentration of released formaldehyde exceeds 0.05% in the finished product it must be labeled “contains formaldehyde.”

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