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Fragrance Regulations Demystified

By: Carl Geffken
Posted: August 28, 2008

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The appropriate INCI designation for denatured alcohol in the U.S. and Europe is “Alcohol denat.,” which generically includes a number of permitted denaturants (referenced in 27 CFR). The most common denaturant, provided in a trace quantity, is Bitrex or denatonium benzoate and tertiary butyl alcohol, known as SD Alcohol 40B. Previously, diethyl phthalate was used safely (in SD Alcohol 39C), although erroneous association with other phthalates has now diminished its use.

Alcohol permits: From the manufacturer’s perspective, there are several requirements that ensure consumer protection and specifically address compliance with federal regulations. All fragrance compounding facilities using ethyl alcohol must file for and receive an alcohol use permit from the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), a division of the U.S. Treasury Department. Product formulations must be submitted to the ATF for review and issuance of an alcohol permit for a specific quantity of denatured alcohol to be used for the formulations intended. This process identifies the annual cosmetic usage, which is exempt from taxation as an alcoholic beverage.

Flammability warning: With the exception of pressurized containers, flammability warnings are not specifically required in the U.S. or Canada, and there is no single recommended statement when printed on the inner and outer package labeling for alcoholic cosmetic products. Despite this fact, nearly half of all current fragrances display a caution about keeping the product away from heat or an open flame. It’s unclear whether these warnings are primarily for consumer safety or to deter litigation, but the resulting benefit is positive.

Claim substantiation: Significant product claims should be substantiated, although there are relatively few products that delve into areas of aromatherapy and other specific holistic benefits. Some fragrance ingredients have been historically credited with therapeutic benefits including certain well-known essential oils such as rose, chamomile, lavender, neroli and ylang-ylang. Package stability: Stability and package component compatibility are important features of fragranced product development. Whether performed for establishing a reasonable shelf life or for assuring that bottles, pump components and gaskets won’t deteriorate over time, the documentation of formula performance is crucial, since certain fragrance ingredients can act in unpredictable ways that create marketplace disasters. This is where an ounce of prevention is a worthwhile investment.

Toxicity testing: Adequate safety testing should be performed to assure the absence of product irritation during use. Frequently, repeat insult patch testing is performed in an initial screening process. Clinical evaluations may then include phototoxicity and perhaps photoallergenicity, although this extended study is more costly.