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Fragrance Regulations Demystified

By: Carl Geffken
Posted: August 28, 2008

During a recent visit to Sephora, I reconfirmed that the fragrance playing field continues to offer broad opportunities for new products, although a host of well-known brands remain as historically respected favorites. Activity at both the women’s and men’s fragrance counters was constant and in fact, it rivaled shoppers’ interest in other cosmetic products throughout the store. Most of those who sprayed and sampled the many fragranced products were undoubtedly unaware of the technical details and required controls provided by fragrance manufacturers. The following is an explanation or update on some of those controls.

Product definitions: In the broad sense, fragranced products are defined under numerous categories. Many cosmetics are designed and scented to provide a characteristic aroma, while others may simply carry an aroma intended to mask the undesirable notes from certain required ingredients in a formulation. While there are no specific guidelines, some companies classify fine fragrances according to their concentration of fragrance oils, such as cologne (3–7%), toilet water or eau de toilette (6–12%), eau de parfum (above 12%) and perfume (20% or more).

Labeling: Package labeling for fragranced cosmetic products is regulated under the various sections of 21 CFR Parts 701 and 740, as well as the Fair Packaging and Labeling Act. In addition to the standard requirements for product identity and net contents declaration, any warnings, name and address of manufacturer or distributor and ingredient disclosure must be provided on the unit of sale. The U.S. and Canadian regulations allow for grouping of all fragrance materials by stating “Fragrance” in the listing. For Europe and Canada “Fragrance/Parfum” would be the appropriate designation. The Seventh Amendment to the European Cosmetic Directive also has mandated the disclosure of 26 fragrance allergens in the ingredient listing and these are identified in Annex III-Part 1 of the regulation. Consideration has been provided for different disclosure for “leave-on” versus “rinse-off” products. Typical allergens listed include ingredients such as linalool, coumarin, hexyl cinnamaldehyde, eugenol and limonene.

While the fragrance allergen regulation is only promulgated for the European market, it is interesting that fully half of the fine fragrance products I audited during a recent product survey have disclosed these potential allergens as a benefit for all their customers.

Alcohol, denatured: In the U.S., ethyl alcohol, also known as ethanol or grain alcohol, is used in fine fragrances and it must be denatured to ensure a very bitter and unpleasant taste, to deter potential consumption and taxation as an alcoholic beverage by the federal government. In Europe, the actual fragrance oils are considered to be the effective deterrent to potability.