FDA has issued a solicitation related to a proposal for a quantitative risk assessment analysis of 26 fragrance ingredients. Additionally, FDA is interested in using quantitative risk assessment (QRA) to quantify estimates of the safe use levels of these 26 fragrance ingredients. QRA is a tool to translate the probability and impact of a risk into a measurable quantity and hence it can be used to evaluate the risk of skin sensitization from dermal exposure to these 26 fragrance ingredients.
The objective is to gain a better understanding of quantitative estimates of risk associated with the use of products containing the above 26 fragrance ingredients. The model will assist FDA in understanding the risks associated with these ingredients to induce fragrance contact allergy and identifying the acceptable risk levels of these allergens in cosmetic products.
The Contractor shall provide a methodology for dermal sensitization to determine acceptable allergic risk levels of these 26 fragrance ingredients in cosmetic products by conducting a quantitative risk assessment model. The exposure to each of these allergens in different cosmetic products should be below the acceptable allergic risk levels identified by the Contractor. The Contractor shall validate the model by introducing a strategy of validation.
Responses are due by August 1, 2018.
