Denatonium Benzoate
What Is It?
Ethanol or ethyl alcoholAlcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages., sometimes just called Alcohol, is the alcohol found in alcoholic beverages. In the United States alcoholic beverages (liquor, wine, beer, etc.) are heavily taxed. In order to avoid paying beverage taxes on alcohol that is not meant to be consumed (e.g., for use in cosmetic and personal care products), the alcohol must be denatured per specific formulations given by the U.S. Government’s Alcohol and Tobacco Tax and Trade Bureau (TTB). The process adds a small amount of a denaturantIngredients added to ethyl alcohol (grain alcohol) to make it unsuitable for drinking, usually by imparting an intensely bitter taste. In the United States, the use of denaturants are controlled by the Alcohol and Tobacco Tax and Trade Bureau in the Department of Treasury. to the alcohol to make it taste bad, thus creating alcohol that is not suitable for drinking, but is otherwise similar for other purposes. When used in products that are not food, beverages or oral drugs, many other countries, like the U.S., also require that alcohol be denatured.
Denatured alcohol is generally identified as Alcohol Denat. or specially Denatured (SD) Alcohol.
Denatonium Benzoate, t-Butyl Alcohol, Diethyl Phthalate, Methyl Alcohol, Salicylic Acid, Sodium Salicylate, and Methyl Salicylate are examples of denaturants permitted for use by the TTB and concluded to be safe for use in cosmetics. Other countries have different rules on allowed denaturants so when formulating you should check with local regulations. Specific denatured alcohols containing these denaturants that are permitted for use in U.S. cosmetics and personal care products are SD Alcohol 3-A, SD Alcohol 30, SD Alcohol 39-B, SD Alcohol 39-C, SD Alcohol 40-B and SD Alcohol 40-C.
Why Is It Used?
Denatured Alcohol is used in many personal care product types including makeup, lotions, fragrance, shaving, oral care, skin care and hair care products where it functions as an antifoaming agentIngredients that reduce the tendency of finished products to generate foam when shaken., cosmetic astringentIngredients that induce a tightening or tingling sensation of the skin., solventSubstances, usually liquids, that are used to dissolve other substances. and viscosity decreasing agentSubstances that decrease the thickness of liquid cosmetic products. In OTC antimicrobial drug products, Alcohol also functions as an antimicrobial agentIngredients that kill microorganisms, or prevent or inhibit their growth and reproduction. In the United States, antimicrobial agents are regulated as Over-The-Counter (OTC) drug ingredients.
to kill germs.
Safety Information
U.S. CIR
The safety of the alcohol denaturants Denatonium Benzoate, t-Butyl Alcohol, Diethyl Phthalate, and Methyl Alcohol were reviewed 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. Expert Panel (CIR) in 2008 and found to be safe as used. Likewise, because they are denatured with the above denaturants, SD Alcohols 3-A, 30, 39-B, 39-C, 40-B and 40-C all were considered safe as used in cosmetic formulations.
The 2008 CIR Expert Panel report also evaluated the scientific data for the denaturants Quassin, Brucine, and/or Brucine Sulfate and concluded that the data were not sufficient to support the safety of those denaturants.
Several earlier CIR reviews also supported the safety of these and a few additional alcohol denaturants. Specific CIR conclusions were:
- t-Butyl Alcohol—safe as used (CIR 2005)
- Diethyl Phthalate—safe for topical application in the present practices of use and concentration (CIR 1985) and reaffirmed safe for use in the present practices of use and concentration (CIR 2005)
- Methyl Alcohol—safe as used (CIR 2001)
- Salicylic Acid, Sodium Salicylate, and Methyl Salicylate—safe as used when formulated to avoid irritation and when formulated to avoid increasing sun sensitivity, or, when increased sun sensitivity would be expected, directions for use should include the daily use of sun protection (CIR 2003)
The 2008 CIR Expert Panel was not concerned with the safety of Alcohol as used in cosmetics and personal care products because relative to intake of Alcohol in alcoholic beverages, dermal application or inhalation of cosmetic products containing Alcohol would not produce significant systemic exposure to ethanol.
FDA
FDA includes Alcohol (ethanol) on its list of direct food 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.).
Alcohol may also 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.. For example, it may be used as a component of adhesives in contact with food.
The FDA has also approved Alcohol for use in Over-the-Counter (OTC) antimicrobial drug products.
Other Countries
In Europe, Alcohol Denat is Alcohol denatured with one or more denaturing agents in accordance with the national legislation of each European Union (EU) country. All EU Member states recognize denaturing methods applied by any of the other EU nations. Brucine is not permitted to be used in cosmetics and personal care products marketed in Europe.
In Canada, ingredient limits are specified in the Health Canada cosmetic ingredient hotlist.