Rules & Revelations: Fragrance Regulations Demystified

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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.

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.

California bound: When products are intended for sale in California, and certain other states, the manufacturer must assure that appropriate VOC limits are controlled for each product category as formulated. Periodic regulatory changes are inevitable, so it’s imperative to know and comply with the latest directives in force. Product surveys and product filings must be submitted to stay in compliance with these regulations, which may soon be a part of Canadian law as well.

Beyond REACH
The major fragrance supply houses work diligently to inform and provide technical support to the industry. Major challenges include support for fragrance allergen disclosure for their products; no easy task with the mix of natural ingredients and the variability of certain constituent ingredients based upon the material source and even growing conditions. With the inevitable advent of the European REACH program, as well as periodic challenges from non-governmental organizations, suppliers are routinely pressed to support their clients with more and better technical assistance and documentation.

Some of the required support comes from various well-respected technical associations and organizations. For example, the Research Institute for Fragrance Materials (RIFM) evaluates and distributes data on the safety assessment of fragrance materials used in virtually all fragranced product categories. It boasts the most comprehensive toxicology database of fragrance and flavor materials worldwide and provides safety evaluation literature and supporting information.

The International Fragrance Association (IFRA) was founded in 1973 and represents the collective interests of the worldwide fragrance industry. It publishes and provides specifications and standards for fragrance materials and develops test methodology for the industry to establish a code of practice. While both organizations have extensive support mechanisms, links on their Web sites will identify a broad network of industry resources.

Additionally, the Cosmetic Ingredient Review has evaluated numerous fragrance materials and has provided monographs to support its well-respected scientific conclusions.
For centuries, fragrances have been revered and admired for their stature and the pleasure they bring. In the current culture, these same aromatic pleasures have created a multi-billion dollar industry with a degree of sophistication and obligatory control not easily recognized by the casual consumer.

General References
•    The US Code of Federal Regulations: 21 CFR, Parts 701 and 740
•    Commission Directive: 2003/83/EC and amendments to Annex III—Part 1 (for 26 fragrance allergens)
• (for Bureau of Alcohol, Tobacco, Firearms and Explosives)
• (for CARB VOC regulations)
• (for RIFM)
• (for IFRA)

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