Accelerated GRASE status proposal

DSM’s Personal Care & Aroma Ingredients business unit has proposed an accelerated scientific approach to confirm GRASE status for most UV-filter products in the United States.

On 21 February 2019, The U.S. Food and Drug Administration (FDA) issued a proposed rule (tentative final monograph) that would update regulatory requirements for most sunscreen products in the United States. This government pronouncement has led to consumer uncertainty around sunscreen safety 

In the proposed rule, of the 16 currently approved OTC active ingredients for sunscreens, only two – zinc oxide and titanium oxide, will be recognised by the FDA as “Generally Regarded as Safe and Effective” (GRASE) as of November 2019. The others will be required to have further data generated to attain GRASE status or will be eliminated from use in the US market. 

While the desire from the industry is that the most widely used UV-filters attain GRASE status, the timeline to complete the current testing proposed by the FDA will take years. Consumers have also unfortunately equated the additional testing required as proof that if an ingredient is not GRASE, it is not safe. DSM suggests an alternative, accelerated approach to UV-filters and sunscreen products safety assessment and presented its finding to FDA with the example of its Avobenzone UVA Filter (Parsol 1789). 

Carl D’Ruiz, Sr . regulatory manager for DSM’s Personal Care’s North American division, said: “… FDA should not discount other potential categories of valid scientific and global epidemiological evidence, including real world evidence and post-market surveillance data. Use of such information would meaningfully reduce the time that it will take for the agency to issue a final rule on the sunscreen ingredients… and provide more certainty to the public.”