Glyoxal

The Food and Drug Administration (FDA) permits Glyoxal to be used as an indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage. as a component of adhesives. The safety of Glyoxal 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 reviewed the scientific data and concluded that Glyoxal was safe for use in products intended to be applied to the nail at concentrations less than or equal to 1.25%. The available data were insufficient to support the safety of Glyoxal for other uses.

CIR Safety Review: The last reported use of Glyoxal was in products intended to be applied to the nails. Composition data showed that Glyoxal may contain formaldehyde residues. Glyoxal was shown to be mutagenic, but was negative in an oral and dermal carcinogenicity studies. No reproductive or developmental toxicity was observed. Glyoxal powder was not irritating, and a commercial 40% Glyoxal solution produced none to moderate irritation. In clinical testing, Glyoxal was shown to be a sensitizer.

Test data indicate a threshold concentration of 1.25% for sensitization. Recommending that care be taken to limit the concentration of free formaldehyde, the CIR Expert Panel concluded that Glyoxal was safe for use in products intended to be applied to the nail at concentrations less than or equal to 1.25%. The available data were insufficient to support the safety for other uses.

More information about formaldehyde.

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

Glyoxal 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…