DSM’s Personal Care & Aroma Ingredients business unit, one of the industry’s leading suppliers to the personal care, home care and fine fragrance markets, proposes an accelerated scientific approach to confirm GRASE status for most UV-filter products in the United States. The company has used Avobenzone, the most protective sunscreen active on the market against UVA damage, marketed by the company as PARSOL® 1789 to showcase the model it believes will accelerate sunscreen safety assessment.
FDA’s announcement causes concern among industry and consumers
On 21st of 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 consumers uncertainty around sunscreen safety.
Per the FDA press release issued earlier this year on this matter, this action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens “up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options.” This announced triggered a flurry of concern in the consumer sphere with media headlines such as The New York Times “How Safe is Sunscreen?” and Allure Magazine warning consumers that it’s “time to double-check the ingredient list on your favorite SPF.”
In the proposed rule, of the 16 currently approved OTC active ingredients for sunscreens, only two – Zinc Oxide and Titanium Oxide, will be recognized 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.
DSM proposes an accelerated safety evaluation approach to achieve GRASE status
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 to complete. Furthermore, despite the FDA stating that most of these sunscreens will continue to be allowed for use in consumer products during the testing period, consumers have 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, and 20 year veteran of the sunscreen industry, commented: “Skin cancer is a significant and largely preventable public health concern, and every day that consumers are actively avoiding sunscreens due to misplaced concerns regarding their safety puts them further at risk.” In the company’s comments to the FDA submitted last month, D’Ruiz stated “…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 around safe sun practices.”
Avobenzone is a critical ingredient for UVA protection. It has the highest UVA absorbance and is the only dedicated UVA absorber approved in the US, making its use necessary to achieve well formulated products with high UVA protection.
DSM proposed an alternative scientific approach – a quantitative risk assessment using “real world” empirical human use data attained from FDA’s recently published Maximal Usage Trials (MUsT studies), which demonstrates that the use of Avobenzone in sunscreens should be considered safe – even up to 5% - a higher use level than the currently allowed 3% in the US - broadening the protection of consumers. In addition, the company advocated that if the ingredient is determined by the FDA as GRASE, then it should also be allowed to be used in combination with all other GRASE sunscreen active ingredients (i.e. zinc oxide and titanium dioxide) without limitation under the current sunscreen monograph.
Per D’Ruiz “the allowance of this combination is especially important for babies (over 6 months old), children and adults with skin disorders to fully protect skin from UVB and UVA radiation as their delicate skin is even more susceptible to damage.”
DSM has unparalleled expertise in selecting UV-filters, formulating them to provide optimum UV protection, and developing sensory modifiers to make sun care products feel light and pleasant on the skin. DSM hopes to take a big step towards reducing the number of people living with these preventable cancers by continuingly innovating and bringing the latest sunscreen technologies on the market as well as raising awareness of the importance of regular sun protection under its “Safer under the sun” program.
DSM’s entire submission can be found on the FDA’s Regulations.Gov website.