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FDA Contracting Out Research On 25 Cosmetic Ingredients’ Allergenicity

 
• By Ryan Nelson

Agency is accepting contractor proposals through August 11 for a scientific literature survey and data analysis to determine whether 25 cosmetic ingredients/mixtures warrant identification as “sensitizers” or “allergens,” according to definitions being developed separately. Preservatives dominate the list.

FDA is soliciting proposals for contract research to assess the allergenicity and sensitization potential of 25 cosmetic ingredients/mixtures – mostly preservatives – based on published scientific data and consensus-backed definitions.

“In order to develop a regulatory position that is based on the most relevant scientific literature, the FDA needs a review and an evaluation of the existing published data that supports the safety (or lack thereof) of these cosmetic ingredients/mixtures, in particular when exposure is via the dermal and inhalation routes,” the agency says in a July 13

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