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.”

 

 

 

 

 

Other news

Upcoming Events

QC Micro Summit 2019

Charleston, SC
24-26 September 2019

California SCC - Suppliers' Day 2019

Long Beach Convention Center
2 - 3 October 2019

Cosmetorium 2019

Palau de Congressos de Barcelona Hall 5, Fira de Barcelona Recinto de Montjuïc Av. Reina Maria Cristina s/n 08004 Barcelona Spain
23rd and 24th October 2019

in-cosmetics North America 2019

Jacob K. Javits Convention Center, New York
23 - 24 October 2019

SEPAWA Congress 2019

Estrel Hotel, Berlin, Germany
23 - 25 October 2019

Latest Issue

Personal Care Asia Pacific

Personal Care Asia Pacific

Sep 2019

Carotolino –Blue Light Protection and a Vivid Look

Register now to apply for regular copies of Personal Care Asia Pacific and free access to premium content, as well as our regular newsletters.

Personal Care Europe

Personal Care Europe

Jun 2019

Energizing the skin and awakening radiance

Register now to apply for regular copies of Personal Care Europe and free access to premium content, as well as our regular newsletters.

Personal Care Extras

Personal Care Extras

Jun 2019

피부 안에서부터 시작되는 재생

Register now to apply for regular copies of Personal Care Extras and free access to premium content, as well as our regular newsletters.

Little Book

Little Book

Apr 2019

Register now to apply for regular copies of Little Book and free access to premium content, as well as our regular newsletters.