FDA proposes first new sunscreen molecule since 1996

FDA proposes the first new sunscreen molecule in decades: bemotrizinol

A proposal released Dec. 11 by the US Food and Drug Administration would bring a new sunscreen molecule, an ultraviolet (UV) filter, to the country for the first time since 1996.

Specifically, the agency would add bemotrizinol (BEMT) to a list of molecules that it considers generally recognized as safe and effective, a move often referred to as a GRASE designation.

BEMT has been available in the European Union and most other parts of the world since 2000, and its FDA approval would be granted partially by considering that long history of safe use. The FDA has had the authority to use such data since 2002 but has resisted repeated urging to do so from public health advocates, consumer product makers, ingredient suppliers, and Congress.

Carl D’Ruiz, a regulatory affairs manager at the ingredient maker DSM-Firmenich who has worked on BEMT for 23 years, calls the development “a sure win for American public health and skin cancer prevention.”

BEMT is a particularly good UV filter, proponents say, because it blocks both major types of UV radiation and its high molecular weight prevents it from absorbing through the skin into the bloodstream. Though only this ingredient is on the table for now, policy experts think that approval of BEMT could smooth the way for more molecules already used in other countries to be approved in the US in the near future.

The agency is accepting public comment on the proposal, which could bring BEMT sunscreens to US consumers as early as the fall of 2026.

—Craig Bettenhausen

US House passes defense bill barring work with biotech companies ‘of concern’

On Dec. 10, the US House of Representatives narrowly passed a reconciled version of the annual defense policy bill, which would authorize roughly $900 billion in national security spending along with various other measures. The final draft of the National Defense Authorization Act (NDAA) includes a Senate-proposed amendment (PDF) that would bar federal agencies from procuring equipment or services from “biotechnology companies of concern.”

The amendment, known as the Biosecure Act, doesn’t name specific companies but states that these companies are ones affiliated with “a foreign adversary’s military, internal security forces, or intelligence agencies,” particularly China’s. According to Science, some science policy experts believe that the measure could harm academic collaborations with China, as well as negatively affect US pharmaceutical supply chains.

Notably, one measure that didn’t make it into the final bill, which reconciles the House and Senate versions of the NDAA, was the House-proposed SAFE Research Act, which many in the academic and scientific communities have spoken out against in recent months (PDF). Like the Biosecure Act—but far more expansive—the SAFE Research Act would have prohibited federal agencies from funding any researcher who is either affiliated with or collaborating with anyone who is affiliated with what was broadly defined as a “hostile foreign entity.”

Another provision that is included the final fiscal year (FY) 2026 NDAA would prevent the US Department of Defense from altering indirect cost rates for the research grants it provides prior to consulting “the extramural research community,” which comprises universities, independent research institutes, and private foundations.

Back in June, the DOD announced the implementation of a 15% indirect cost cap, similar to caps other federal agencies had announced, which was subsequently struck down by a federal judge in October.

The bill is now headed to the Senate, which is expected to vote on the FY 2026 NDAA by the end of December. If the Senate also passes the bill, it will then go to the president to be signed into law.

—Krystal Vasquez

50 US chemical plants are exempt from a regulation for toxic air pollution, report says

Some 50 US chemical manufacturing plants have a 2-year exemption from certain requirements under the Clean Air Act, says a report published Tuesday from the Union of Concerned Scientists (UCS). The plants are among 188 industrial facilities that have been granted such exemptions by the White House.

“For people across the country, these exemptions translate directly into higher toxic air pollution exposure and cancer risks,” says Darya Minovi, a senior analyst at the UCS and a coauthor of the report. The UCS says almost 4.6 million people live within 3.2 km (2 miles) of at least one of 546 facilities that are eligible for an exemption.

President Donald J. Trumped in March offered a 2-year exemption from nine hazardous air pollution regulations to 546 industrial facilities. Trump invoked part of the Clean Air Act that allows such exemptions if the president determines that technology to implement a toxic air pollution limit isn’t available and if issuing an exemption is in the national security interests of the US.

Of the 50 chemical plants exempted from a 2024 regulation for controlling pollutants that are known or suspected to cause cancer in humans, 18 are in Louisiana and 17 are in Texas, the report says. The 2024 regulation, strongly opposed by the chemical industry, was expected to slash ethylene oxide and chloroprene emissions from chemical manufacturing facilities by up to 80%.

Another 167 chemical manufacturing plants are also eligible for the exemption, the report says.

Facilities in other industries have also sought and have been granted exemptions from hazardous-air-pollutant regulations. Seventy coal-fired power plants are exempt from a regulation to limit their mercury emissions, according to the report. In addition, 39 commercial sterilizers are operating exempt from a regulation that would control their release of ethylene oxide.

Though an email address at the US Environmental Protection Agency receives the applications for exemptions, they are forwarded to the White House, which makes determinations, an agency spokesperson tells C&EN.

Meanwhile, the EPA is reconsidering whether it will change or withdraw regulations for the nine toxic air pollutants.

—Cheryl Hogue, special to C&EN

EU plans to replace fossil fuels with biological matter

The European Commission last month announced a new bioeconomy strategy that aims to increasingly use organic matter that can grow back to replace fossil fuels in producing materials such as plastics and other chemicals.

The EU’s bioeconomy, estimated in 2023 at €2.7 trillion (about $3.2 trillion), already employs over 17 million people, accounting for 8% of jobs in the region. The plan aims to create even more jobs, as well as reduce resource dependence on individual countries or regions, while supporting activities that “provide sustainable practical solutions and alternatives to critical raw materials.”

The EU policy, launched on Nov. 27, would involve implementing measures to boost biobased innovations in sectors such as agriculture, forestry, aquaculture, and biotechnology through soliciting public and private investments, streamlining regulations and approvals, and creating a “bioeconomy investment deployment group” to scale up private financing.

The move could accelerate shifts in the packaging industry from plastics—amid the current impasse on treaty talks to end plastic pollution—to biobased materials. Other sectors might also be encouraged to replace fossil-fuel-derived chemicals: for example, pharmaceuticals and personal care items could use biobased chemicals such as algae, while microorganisms may be used in the production of fertilizers.

But environmental groups worry that the strategy doesn’t go far enough with regard to protecting ecosystems, particularly when crops are used to produce biofuels such as ethanol to substitute for fossil fuels. Many groups judge such practices as unsustainable and a threat to food security.

The European Environmental Bureau, the region’s largest network of environmental civil society organizations, warns in a statement that “while focusing on scattered product innovation efforts instead of tackling the root causes of nature, pollution, and climate crises, the [European] Commission has missed a crucial opportunity.”

The European Biogas Association, meanwhile, has welcomed the strategy. “Recognising biogases and their co-products in the EU Bioeconomy Strategy highlights one of the most practical and immediate ways to deliver a circular, low-carbon, and competitive bioeconomy,” Harmen Dekker, the association’s CEO, says in a statement.

—Paula Dupraz-Dobias, special to C&EN