DSM strives to obtain GRASE status for UV-filters

The company has used Avobenzone, a UVA-protective sunscreen filter, to showcase a model which, if adopted by the FDA, would accelerate sunscreen safety assessment.

FDA proposal for new sunscreen regulation​

In February of this year the Food and Drug Administration (FDA) issued a proposal that would update regulatory requirements in the US that prompted consumer uncertainty about sunscreen safety.

The FDA says it wants to bring nonprescription and over-the-counter sunscreens up-to-date with the latest science as a means og enhancing consumer protection for preventative sun care products.

The announcement led to a flurry of media articles about the proposed ruling, with the New York Times and Allure Magazine, among others, warning consumers to closely scrutinize the labeling of SPF products.

Only two sunscreen ingredients make the mark​

In the proposed new rule, which goes into effect November 2019, only two of the 16 currently approved OTC active ingredients will be recognized by the FDA as “Generally Regarded as Safe and Effective” (GRASE) – zinc oxide and titanium dioxide oxide.

Any other ingredients will have to be backed by comprehensive data to attain GRASE status, or face being eliminated from the US market.

Sunscreen ingredient manufacturers are concerned that to establish data to prove the safety of the other 14 ingredients could take years.

In response, the DSM team says it is proposing an alternative, accelerated approach for testing UV filters that could significantly shorten the time for the remaining filters to attain GRASE status – and used Avobenzone as a model.

FDA approval for all avobenzone ingredients​

Company executives have stressed that while the hoped for FDA approval of Avobenzone as GRASE PARSOL 1789 would be beneficial to DSM (since the company is one of the leading global suppliers of the ingredient under the tradename PARSOL 1789), the efforts benefit the industry as a whole since all Avobenzone ingredients would also receive the designation.

Furthermore, the approach taken to prove Avobenzone safety recommended by the company also aims to serve as a model to fast-track the GRASE approval of all outstanding Category 3 filters.

The company also says it wants to acknowledge that it used FDA data as a basis for its test, enabling the safety assessment testing to be completed and make the final proposal.