BHA

What Is It?

Butylated Hydroxyanisole, known as BHA, is a waxy solid that can be found in a variety of cosmetics and personal care products, particularly in lipstick and eye shadow. Butylated Hydroxyanisole should not be confused with a class of cosmetic ingredients, Beta Hydroxy Acids, which may also be abbreviated BHA.

Why Is It Used?

BHA functions as an antioxidantIngredients that prevent or slow deterioration due to chemical reaction with oxygen..

Scientific Facts

Due to its antioxidant properties, BHA is used in cosmetic and personal care products, as well as in edible fats and oils, waxes, and vitamin A preparations. BHA is also used as a food preservative and as an ingredient in some Over-the-Counter (OTC) medicines.

Safety Information

The Food and Drug Administration (FDA) includes BHA on its list of substances considered Generally Recognized As Safe (GRAS“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.) as a preservativeIngredients that prevent or retard bacterial growth, and thus protect cosmetic products from spoilage. for food. It may be used in food at concentrations not to exceed 0.02% of the total fat or oil content of a particular food.The safety of BHA 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 BHA was safe as a cosmetic ingredient. In 2003, the CIR Expert Panel considered available new data on this ingredient and reaffirmed the above conclusion.

CIR Safety Review: At concentrations used in cosmetics and personal care products, BHA is not an eye irritant, nor it is a dermal irritant or sensitizer. Laboratory studies indicate that BHA is not a reproductive toxicant. BHA can inhbit the mutagenic and carcinogenic activity of some compounds. Following oral exposure, some studies indicate that high doses caused forestomach tumors in rodents.

As humans do not have forestomachs, these tumors were not considered relevant to humans. The CIR Expert Panel concluded that BHA was safe for use in cosmetic products.

FDA: Link to the Code of Federal Regulations for Butylated Hydroxyanisole

BHA 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…

The Joint FAO/WHO Expert Committee on Food Additives has established an estimate of the Acceptable Daily Intake at 0-0.5 mg/kg body weight for BHA, BHT, TBHQ, or the sum of the three compounds.
http://www.inchem.org/documents/jecfa/jecmono/v15je04.htm

More Scientific Information

BHA is a mixture of isomers of tertiary butyl-substituted 4-methoxyphenols that is used as an antioxidant. Antioxidants are ingredients employed in cosmetics to prevent or retard product spoilage from rancidity (or deterioration from reaction with oxygen).Antioxidants play a vital role in maintaining the quality, integrity, and safety of cosmetic products.

Resources

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): 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/