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Rules & Revelations: Fragrance Regulations Demystified

By: Carl Geffken
Posted: February 20, 2007

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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.