What Is It?
t-Butyl Hydroquinone, also called TBHQ, is a white to light tan crystalline solid. In cosmetics and personal care products, TBHQ is used in the formulation of lipsticks, colognes, moisturizers and other makeup products.
Why Is It Used?
TBHQ prevents or slows deterioration of cosmetics and personal care products caused by chemical reactions with oxygen.
In addition to its use in cosmetics and personal care products, TBHQ is used in fats, oils, and meat products to prevent oxidative rancidity.
The Food and Drug Administration (FDA) reviewed the safety of TBHQ and approved its use as a direct food additive for use as a food Ingredients that prevent or retard bacterial growth, and thus protect cosmetic products from spoilage.. The safety of t-Butyl Hydroquinone has been assessed by the The 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 TBHQ may be safely used as a cosmetic ingredient at concentrations not to exceed 0.1%. In 2007, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on TBHQ and reaffirmed the above conclusion.
CIR Safety Review: Data indicated that TBHQ was slightly toxic in oral feeding studies. The results from subchronic, chronic and developmental toxicity studies of TBHQ and hair dyes containing this ingredient were unremarkable. In clinical studies, TBHQ was not an irritant or sensitizer when tested at 0.14%. TBHQ was a weak skin depigmenter at 1.0 and 5.0% but not at 0.1%.
Although a threshold for depigmentation was not established, the dose-response relationship was adequate to conclude that TBHQ at concentrations of use of 0.1% and less was not a human skin depigmenter. Other data indicated that this ingredient was not a phototoxic agent. The CIR Expert Panel concluded TBHQ was safe as a cosmetic ingredient at concentrations not to exceed 0.1%.
Link to FDA Code of Federal Regulations for TBHQ
TBHQ may be used in cosmetics and personal care products marketed in Europe according to the Under 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:
Health Canada permits the use of TBHQ in cosmetics and personal care products at concentrations equal to or less than 0.1%.
More Scientific Information
TBHQ is an aromatic A compound that contains carbon and hydrogen and usually other elements such as nitrogen, sulfur and oxygen.. In cosmetics and personal care products, TBHQ functions as an Ingredients that prevent or slow deterioration due to chemical reaction with oxygen..
Find out more about the regulation of Food Additives by the Food and Drug Administration
Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…
Substances Generally Recognized As Safe (“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/