Regulatory Review—Labeling Alcohol, Alcohol Denat. and Booze

Sep 1, 2012 | Contact Author | By: David C. Steinberg, Steinberg & Associates
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Title: Regulatory Review—Labeling Alcohol, Alcohol Denat. and Booze
alcoholx gradesx labelingx denaturantsx
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Keywords: alcohol | grades | labeling | denaturants

Abstract: Alcohol 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.

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DC Steinberg, Regulatory review—Labeling alcohol, alcohol denat. and booze, Cosm & Toil 127(9) 614-619 (Sep 2012)

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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.

Definition

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.” This column explores and defines the variants of alcohol and specifies labeling guidelines.

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Biography: David C. Steinberg, Steinberg & Associates

David C. Steinberg founded Steinberg & Associates, a consulting firm based in Plainsboro, NJ, USA, in 1995. Co-founder of the graduate program in cosmetic sciences at Fairleigh Dickinson University, where he lectured for 18 years on cosmetic chemistry, Steinberg has more than 35 years of experience in marketing, technical service and regulatory affairs in the personal care industry. In addition, he was president of the Society of Cosmetic Chemists in 1991. Steinberg is a frequent speaker worldwide on cosmetic regulations and preservation as well as sunscreen and cosmetic ingredient chemistry. In 2009, he was honored as the first regulatory expert in personal care to be granted fellow status by the Regulatory Affairs Professional Society. He wrote the Alluredbook, Preservatives for Cosmetics, Third Edition. 

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