Change after 20 years? DSM seeks US-FDA approval for sunscreen active ingredient
18 Oct 2022 --- DSM is pushing to achieve US approval for Bemotrizinol (BEMT) – a photostable broad-spectrum filter that provides UVA and UVB protection even at low concentrations. If approved, the company says the ingredient will be the first UV filter to be authorized in over 20 years.
The sunscreen active ingredient BEMT has been used globally as a UV filter for many years but is currently not available in the US. In the US, 16 UV filters are presently approved compared to 27 in the EU.
“At DSM, we believe that it is crucial for consumers in the US to be able to benefit from the broad-spectrum UV protection and sensory properties that modern filters such as BEMT can provide,” the company states.
“Access to UV filters such as BEMT helps protect skin health and prevent skin cancer, which is on the rise in the US. We are therefore sponsoring BEMT for inclusion under the Sunscreen Innovation Act at a maximum concentration of 6%.”
BEMT is the first new sunscreen active ingredient to be tested under the FDA’s new guidelines.
DSM provides BEMT under the trade name of PARSOL Shield as a UV light absorber for sunscreens and personal care cosmetic products since 2016. The company says it is easy to use and compatible with organic and inorganic UV filters.
FDA regulatory updates
In the US, sunscreens are regulated as over-the-counter (OTC) drugs by the Food and Drug Administration (FDA) and must be GRASE (generally recognized as safe and effective) approved before they can be used in sun protection products.
BEMT is the first new sunscreen active ingredient to be tested under the FDA’s new testing guidelines.
In 1999, Sunscreen Monograph was released for non-prescription OTC sunscreen drug products. This described the conditions under which OTC Sunscreen Monograph products would be GRASE.
On 21 February 2019, the FDA issued a proposed rule (the tentative final Sunscreen Monograph) with updated regulatory requirements for OTC sunscreen ingredients. However, until the FDA’s 2021 proposed order is finalized, all OTC sunscreen products are subject to the FDA 1999 sunscreen final rule and must comply with the 2011 regulations.
Additionally, the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 resulted in the FDA reforming the OTC drug approval process and issuing a new proposed order for sunscreens.
Under the FDA’s Proposed Tentative Final Sunscreen Monograph, zinc oxide and titanium oxide are two of sixteen active ingredients currently used in sunscreen products that are now recognized as GRASE. Further data is required for the remaining active ingredients to attain GRASE status. Those that fail will be eliminated from use in the US market.
Edited by Radhika Sikaria
