The Food and Drug Administration (FDA) reviewed the safety of 2-Bromo-2-Nitropropane-1,3-Diol and approved its use as an indirect food additive as component of paper and paperboard for incidental contact with food. The safety of 2-Bromo-2-Nitropropane-1,3-Diol has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel.

The CIR Expert Panel reviewed the scientific data and concluded that 2-Bromo-2-Nitropropane-1,3-Diol was safe as a cosmetic ingredient with limitations. In 2003, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on 2-Bromo-2-Nitropropane-1,3-Diol and reaffirmed the above conclusion.

CIR Safety Review: 2-Bromo-2-Nitropropane-1,3-Diol has been evaluated several times by the CIR Expert Panel and it has been determined to be safe with limitations. In 1979, the CIREP reviewed the available data and noted that 2-Bromo-2-Nitropropane-1,3-Diol produces minimal contact allergy and/or contact irritation in both animals and humans at concentrations below 0.1%. Unformulated 2-Bromo-2-Nitropropane-1,3-Diol at concentrations of 1% or greater was an irritant. 2-Bromo-2-Nitropropane-1,3-Diol is moderately toxic when administered orally. 2-Bromo-2-Nitropropane-1,3-Diol had no effect on reproduction, did not cause developmental or embryotoxic effects. It was not a mutagen by the standard dominant lethal test or by the bacterial reverse mutant system.

The CIR Expert Panel concluded that 2-Bromo-2-Nitropropane-1,3-Diol was safe as a cosmetic ingredient at concentrations up to and including 0.1% except under circumstances where its action with amines or amides can result in the formation of nitrosamines or nitrosamides. In 1984, the CIR Expert Panel evaluated test data that were available since the 1979 report on 2-Bromo-2-Nitropropane-1,3-Diol.

The earlier conclusion that 2-Bromo-2-Nitropropane-1,3-Diol was safe as a cosmetic ingredient at concentrations up to 0.1% except under circumstances where its action with amines or amides can result in the formation of nitrosamines or nitrosamides was reaffirmed. The CIR Expert Panel noted that 2-Bromo-2-Nitropropane-1,3-Diol is a known N-nitrosating agent for secondary and tertiary amines, and if improperly formulated, 2-Bromo-2-Nitropropane-1,3-Diol can react with amines or amides to form potentially carcinogenic nitrosamines or nitrosamides. Manufacturers of personal care products are therefore instructed by regulatory authorities to “avoid the formation of nitrosamines” which means removing amines or amides from the formulation or using nitrosamine inhibitors and monitoring formulations to make sure they stay free of nitrosamines.

More information about nitrosamines.

FDA: Link to Code of Federal Regulations for 2-Bromo-2-Nitropropane-1,3-Diol http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

2-Bromo-2-Nitropropane-1,3-Diol is allowed to be used in cosmetic and personal care products marketed in Europe as a preservative at a maximum concentration of 0.1% (See Annex VI). The Cosmetics Directive notes that products containing 2-Bromo-2-Nitropropane-1,3-Diol must be prepared to avoid nitrosamine formation.

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

In Canada, 2-Bromo-2-nitropropane-1,3-diol is on the cosmetic ingredient hotlist. 2-Bromo-2-nitropropane-1,3-diol is permitted at concentrations equal to or less than 0.1%. It is not permitted in formulations that contain amines or amides.

Please check the Health Canada website at http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_hot-list-cri…
for updates and additional information about this list.