Author’s note: When I write this column, I usually cover a recent change to regulations somewhere in the world. I also keep a backlog of subjects; some so old they may no longer be of value or interest. Finally, I review recent e-mails and calls I have received, which are the sources for this column’s topic. I selected alcohol because it is a complex regulatory issue that confuses many chemists and marketers, as well as regulatory experts, as to the permitted grades, required uses and proper labeling—which vary by country. This confusion can lead to use of the wrong denaturants and levels, custom holds on imports and exports, and consumer misuse. The regulation of alcohol rarely changes but these problems remain.
The first problem with alcohol is the International Nomenclature Cosmetic Ingredient (INCI) name. There are many different ways to label what is commonly called alcohol. Alcohol is the INCI name for the chemical known as ethanol or ethyl alcohol. It is a simple, two-carbon chemical with a terminal hydroxyl group at the end. It has the CAS number of 64-17-5 and an ELINCS number of 200-578-6. The INCI Monograph ID 65 refers to the use and definition of alcohol as follows: “In the United States, alcohol may be used as an active ingredient in OTC drug products. See ‘Regulatory and Ingredient Use Information,’ regarding the labeling names for US OTC Drug Ingredients in Volume 1, Introduction, Part A. When used as an active drug ingredient, the established drug name is alcohol.”
When searching for the definition of denatured alcohol, one is directed to alcohol denat., which is defined by the INCI Dictionary1 as “ethyl alcohol that is denatured with one or more denaturing agents in accordance with the national legislation of each European Community (EU) country. All EU Member States recognize denaturing methods applied by any of the other EU Member States. This INCI name may also be used in the United States for ethyl alcohol denatured in accordance with the regulations of the Alcohol and Tobacco Tax and Trade Bureau (ATF), US Department of the Treasury, as found in 27CFR20 and 27CFR21.” Note that the Alcohol, Tobacco and Firearms (ATF) Bureau has been replaced by the Alcohol and Tobacco Tax and Trade Bureau (TTB).
So what is denatured alcohol? It is alcohol that has chemicals added to it to make it unfit to drink. Ideally the additives are difficult to remove, even by distillation. Some additives are poisonous and others taste bad so that users will not swallow it; since it cannot be consumed, denatured alcohol is therefore not subject to the same taxes as drinkable alcohol, i.e., booze. In the United States, the federal tax can be as high as $27 per gallon while state taxes can be as high as an additional $18/gallon. These are commonly referred to as “sin taxes” and are used to discourage consumption and raise revenues. As most taxes on alcohol are excise taxes, they are added to the price at production, not consumption. So using undenatured alcohol in a cosmetic reflects these taxes and is much more expensive than denatured alcohol.
Permissible Denatured Alcohols
The FDA’s Frequency of Use report for 2011, based on the voluntary registration program, indicated that 3,095 entries included alcohol denatured, where the denaturant or grade was not registered. There are, in comparison, 2,366 reports for alcohol. Table 1">Table 1 lists the permitted grades allowed in cosmetics and alerts issued for some common denaturants. In addition, methanol is now on California’s Proposition 65, so the use of it as a denaturant now may trigger warnings.
The most commonly used denatured alcohols are as follows:
SD Alcohol 39-C: Up to 100 gallons of alcohol to which 1 gallon of diethyl phthalate is added; note that these do not support “phthalate-free” claims;
SD Alcohol 40: Up to 100 gallons of alcohol with 1/8 gallon of tert- butyl alcohol, and one and one-half avoirdupois ounces of either: 1) brucine alkaloid, 2) brucine sulfate, N.F. IX, 3) quassin, or 4) any combination of two or of three of these denaturants; and
SD Alcohol 40-B: Up to 100 gallons of alcohol with 1/16 avoirdupois ounce of denatonium benzoate, N.F., and 1/8 gallon of tert- butyl alcohol.
It is important to note that each country sets its own specifications for denatured alcohol. Since the denaturant is added as an ingredient, a product including alcohol denat. on the label should also include the denaturants in the ingredient listing, although labeling it by the SD designation would not require the naming of the denaturant. However, this labeling of the denaturant is rarely followed by the industry.
Alcohol is a Category I FDA-approved over-the-counter (OTC) drug for use as a first aid antiseptic at concentrations ranging from 48% to 95%. It is also allowed at 26.9% in combination with eucalyptol at 0.091%, menthol at 0.042%, methyl salicylate at 0.055%, and thymol at 0.063%. It is also a Category I-approved OTC drug as a health care antiseptic drug at 60% to 95% for hand washes, preoperative skin preparations and surgical hand scrub applications, frequently called instant hand sanitizers. This drug use of alcohol also causes confusion. The definition of a drug under the 1938 Food Drug and Cosmetic Act states that a drug must be recognized in the US Pharmacopeia (USP) or other references. The USP lists alcohol in these monographs:
Alcohol: Alcohol contains not less than 92.3% and not more than 93.8% w/w corresponding to not less than 94.9% and not more than 96.0% by volume, at 15.56°C, of C2H5OH.
Dehydrated alchol: Dehydrated alcohol contains not less than 99.2% w/w corresponding to not less than 99.5%, by volume, at 15.56°C of C2H5OH.
Rubbing alcohol: Rubbing alcohol and all preparations under the classification of Rubbing Alcohols are manufactured in accordance with the requirements of the ATF, Formula 23-H, using eight parts by volume of acetone, 1.5 parts by volume of methyl isobutyl ketone, and 100 parts by volume of ethyl alcohol. It contains no less than 68.5% and no more than 71.5% by volume of dehydrated alcohol, the remainder consisting of water and the denaturants, with or without color additives, and perfume oils.
Rubbing alcohol contains, in each 100 mL, no less than 355 mg of sucrose octa-acetate or 1.40 mg of denatonium benzoate. The preparation may be colored with one or more color additives listed by the FDA for use in drugs. A suitable stabilizer also may be added. Rubbing alcohol complies with the requirements of the ATF.
However, what do the OTC monographs say? In the Federal Register notice of 5/21/82, the requirements for topical application of alcohol as an active ingredient required it to be denatured under ATF regulations. It must be listed as alcohol by volume of the solution. A final monograph for this was never issued and topical applications were broken up into two different monographs. The first monograph to come out was on first aid antiseptics in a proposed rule in 1991. Here, the requirement of 1982 was stated again. The second, the Health Care Antiseptic Proposed Rule, came out in 1994 and also required the use of denatured alcohol. It is unusual that both tentative final monographs require the use of denatured alcohol but insist the active ingredient be labeled as alcohol, which the USP defines as being undenatured.
As this author finishes a highly relevant glass of Scotch whiskey, he considers the confusion caused by alcohol regulations. When one adds pure, undenatured alcohol to the product, “alcohol” is included in the ingredient listing. When adding alcohol denat. to a product, the denaturant(s) should be identified either in the ingredient list, or using the TTB designations of SD Alcohol and inserting the grade.
Imposing one country’s requirements for denaturants on others makes no sense. US-based companies cannot sell SD Alcohol 40 in the EU, as brucine is prohibited. The EU cannot sell an alcohol denatured with denatonium benzoate alone, commonly referred to by its trade name, Bitrex, as this does not meet TTB specifications. Maybe the International Cooperation on Cosmetic Regulation should consider how to harmonize these grades.
This author believes the FDA must clarify the labeling for topical OTC drugs by not using the word alcohol as the active. Alcohol also refers to a drink, and the industry does not want anyone drinking hand sanitizers. Further, the FDA clearly wants alcohol to be denatured. This can be made clear by requiring companies to simply state, under the active ingredient section, the term denatured alcohol, and require the denaturant to be listed in the inactive ingredient section.
Finally, this column would not be complete without comments regarding “alcohol-free” claims. As regular readers know, this author discourages negative advertising, through which products are sold based on what they do not contain versus what they do contain. Political ads are no exception. The marketers of “free-from” products are telling the public there is something wrong with an ingredient, which is why it was removed. The reality is, they probably never used it to start.
Claims of “alcohol-free” began appearing on mouthwashes, which has led to frequent recalls because the alcohol serves as a preservative in mouthwashes. Even if the product is free of contamination when it leaves the plant, many consumers use mouth rinse products straight from the bottle, resulting in consumer contamination. Maybe the FDA should require all oral rinse products that do not contain alcohol to include a warning of this danger.
One can’t help but chuckle when marketers get into trouble for claiming something is alcohol-free and someone complains about there being alcohol in the product; the most common “alcohol” being cetyl alcohol. Of course cosmetic chemists know they are not the same, but consumers …
As this column was written, the state of California added benzophenone, cocamide DEA and DEA to its Proposition 65 list for cancer, effective as of June 22, 2012. There were no safe harbor limits as of yet.
- INCI Dictionary, Personal Care Products Council, available at http://webdictionary. personalcarecouncil.org/jsp/Home.jsp (Accessed Jul 23, 2012)