Alcohol and Alcohol Denat.

What Is It?

Ethanol or ethyl alcohol, sometimes just called Alcohol, is the alcohol found in alcoholic beverages. 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), ethanol 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 denaturant to the ethyl alcohol to make it taste bad, thus creating ethyl 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 ethyl alcohol be denatured.Denatured alcohol is generally identified as Alcohol Denat. or Specially Denatured (SD) Alcohol.

Why is it used in cosmetics and personal care products?

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 agent, cosmetic astringent, solvent, and viscosity decreasing agent.

Safety Information:

U.S. Cosmetic Ingredient Review (CIR)

The safety of the alcohol denaturants Denatonium Benzoate, t-Butyl Alcohol, Diethyl Phthalate, and Methyl Alcohol were reviewed by the Cosmetic Ingredient Review (CIR) Expert Panel in 2008. The Expert Panel concluded that all are safe when used under current conditions of use and concentration. Likewise, because they are denatured with the above denaturants, SD Alcohols 3-A, 30, 39-B, 39-C, 40-B and 40-C were all considered safe as used in cosmetic formulations.

The 2008 CIR Expert Panel also evaluated the scientific data for the denaturants Quassin, Brucine, and/or Brucine Sulfate and concluded the data were not sufficient to support the safety of those denaturants.

Several earlier CIR reviews also supported the safety of the following ingredients when used in cosmetic products for purposes other than as denaturants 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)

More safety Information:

The 2008 CIR Expert Panel was not concerned with the safety of ethyl alcohol as used in cosmetics and personal care products because relative to intake of ethyl alcohol in alcoholic beverages, dermal application or inhalation of cosmetic products containing ethyl 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).

Alcohol may also be used as an indirect food additive. For example, it may be used as a component of adhesives in contact with food.

On September 6, 2016, the FDA issued a final rule on the ‘Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.’ In the final rule, FDA noted it did not receive any new information since the 2013 Consumer Wash Proposed Rule demonstrating that alcohol (ethyl alcohol) was eligible for evaluation under the OTC Drug Review for use as a consumer antiseptic wash. Consequently, drug products containing alcohol (ethyl alcohol) as an active ingredient are considered new drugs that will require FDA approval. The FDA concluded that manufacturers had not adequately demonstrated products containing these ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Prior to the FDA ruling, some manufacturers had already started removing these ingredients from their 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.