The US Food and Drug Administration intends to build on previous contracted work related to cosmetic hazard and risk assessment by focusing on ingredients that may need special consideration.
The agency issued a request for quotes in late July to help the FDA improve its approach to evaluating the safety of cosmetic product ingredients.
Specifically, the FDA is interested in acquiring a hazard and risk assessment protocol that takes into account:
unique biological characteristics which may have an impact in the evaluation of ingredients in cosmetic products used by subpopulations such as infants and children, the elderly, people of color, and immunosuppressed individuals;
unique physiochemical characteristics which may have an impact in the evaluation of certain ingredients such as engineered nanomaterials used in cosmetic products.
Additionally, the contractor will be expected to update and improve the FDA’s existing hazard and risk assessment protocol.
The agency is targeting one year – 1 September 2021-31 August, 2022 – for completion of the above tasks.
The RFQ also outlines an option for an additional year of work to refine an existing framework for assessing aggregate risks posed by cosmetic ingredients. (FDA Solicits Protocol For Assessing Cosmetic Ingredient Aggregate Exposure Risks)
That will involve “incorporating updated scientific approaches/methods and demonstrat[ing] the practicality of the protocol by providing examples of aggregate risk assessment for a single ingredient used in multiple cosmetic products as well as via multiple routes of exposure,” the agency says.
Finally, the contracted party will be asked to update the FDA’s education and training program for cosmetic ingredient safety assessment.
According to the agency's solicitation, hazard and risk assessment protocol development will require the contractor to consult with recognized subject matter experts in the clinical field, as well as experts in the formulation and manufacturing of cosmetic products and their ingredients.
Further, the contractor should be prepared to identify published toxicological and clinical endpoints and studies relevant to ingredients used in FDA-regulated products and published exposure estimates for subpopulations under consideration as well as ingredients with unique physicochemical attributes. (Cosmetic Brands And Animals Have Growing Problem In Europe Commissions Nanomaterials Report)
Contractor quotes were due to the FDA on 9 August.