Potassium Bromate

The Food and Drug Administration (FDA) includes Potassium Bromate on its list of direct food additives. It may be used in the malting of barley. The FDA also premits Potassium Bromate to be added to flourThe fine edible powder obtained by grinding and sifting cereal grain, usually mostly freed from the bran that is used to bake bread. The safety of Sodium Bromate and Potassium Bromate 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 Sodium Bromate and Potassium Bromate may be used in permanent wave formulations at concentrations not to exceed 10.17%, measured as Sodium Bromate.

CIR Safety Review: Bromate was poorly absorbed through the skin in several in vivo and in vitroExperiments performed in a test tube or another artificial, controlled environment, rather than in a whole animal. studies. Potassium Bromate was found to be mutagenic in a mammalian cellThe basic structural and functional unit of all organisms; cells may exist as independent units of life or may form colonies or tissues as in higher plants and animals. assay and in one of three bacterial strains tested. Potassium Bromate applied to the skin or injected subcutaneously was not carcinogenic. This is in contrast to positive results observed after oral dosing. The high reactivity and poor skin absorption of these oxidizing agents was considered the likely explanation for results between routes of exposure.

Potassium Bromate was at most a mild sensitizer. On the basis of the available information, the CIR Expert Panel concluded that these ingredients may be used in permanent wave formulations and similar products at concentrations not to exceed 10.17% measured as Sodium Bromate.

Link to FDA Code of Federal Regulations for Potassium Bromate

• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Potassium Bromate is not permitted for use in cosmetics and personal care products in the European Union (see Annex II). Sodium Bromate is not specifically listed in the Cosmetics Regulation of the European Union.

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

In Canada, products containing 600 mg Sodium Bromate or 50 mg Potassium Bromate must carry a warning label “to be kept out of the reach of children, and in case of accidental ingestion, a Poison Control Centre or physician is to be contacted immediately.” Products containing these ingredients must also be packaged in a child-resistant package.

Link to the Health Canada website: 
http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…