Regulatory Sponsored by
The Continued Implementation of the Dermal Sensitization Quantitative Risk Assessment (QRA) for Fragrance Ingredients
Anne Marie Api—Research Institute for Fragrance Materials, Inc., Woodcliff Lake, NJ (www.rifm.org)
Matthias Vey—International Fragrance Association, Brussels, Belgium (www.ifraorg.org)
Significant developments have recently been incorporated in the way dermal sensitization risk assessments are conducted for fragrance ingredients. This, in turn, will have a substantial impact on the way that International Fragrance Association (IFRA) ingredient use restrictions based on dermal sensitization are implemented in the future. For more than a year an expert group, which included representatives from the fragrance and consumer products industries and Research Institute for Fragrance Materials, Inc. (RIFM), worked on refining this risk assessment methodology for fragrance ingredients. Details about the method for use with fragrance ingredients can be found on RIFM’s and IFRA’s Web sites (www.rifm.org/pub/publications.asp and www.ifraorg.org/news.asp).
This new methodology is a major improvement over the former approach because it specifically addresses the elements of exposure-based risk assessment that are unique to the induction of dermal sensitization, while being consistent with the principles of general toxicology risk assessment. The risk management strategies used in the past by IFRA for fragrance ingredients identified as allergens limited the use of the fragrance ingredient to the same concentration across all product types that involved skin contact. In the new QRA approach there are 10 different product categories for skin contact products. Category 11 is designated for non-skin or incidental skin contact products. Since exposure is a key element of category determination, this enables maintenance of relevant exposure and therefore safety, while providing greater flexibility to the perfumer because the limit is no longer the same across all skin contact applications. This means that, in some product applications, a higher fragrance ingredient concentration will be possible, while in others, a lower level may be specified, compared to what has been used in the past.