BASF AG contends that several tests FDA is requiring to establish UV filters as generally regarded as safe and effective for inclusion in the sunscreen monograph are “not scientifically or legally justified.”
BASF Asks FDA To Weigh Whole Sunscreen TEAs, Not Separate Parts
The firm’s representatives maintain a “weight-of-evidence” approach comprising repeated dose toxicity, photo-genotoxicity, dermal carcinogenicity and photo-carcinogenicity studies is adequate to establish safety. In public meetings required by the Sunscreen Innovation Act, FDA officials say BASF needs to provide more study data.
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