U.S. Launches Full Life-Cycle Risk Evaluation for D4 – Global Ban Momentum Accelerates-Iota

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News > Dynamic industry > U.S. Launches Full Life-Cycle Risk Evaluation for D4 – Global Ban Momentum Accelerates

U.S. Launches Full Life-Cycle Risk Evaluation for D4 – Global Ban Momentum Accelerates

The U.S. Environmental Protection Agency (EPA) has recently released a draft risk evaluation for octamethylcyclotetrasiloxane (D4, CAS No. 556-67-2) under the framework of the Toxic Substances Control Act (TSCA), alongside the opening of a public consultation. This move was confirmed through a supplemental technical barriers to trade notification submitted to the World Trade Organization (WTO), marking a new stage of international coordination in regulating D4.

Evaluation Covers Full Life Cycle – Preliminary Finding: Dual Risks

The assessment, initiated at the request of manufacturers, focuses on the “conditions of use” (COUs) of D4, spanning the entire life cycle from production, processing, transport, and use to disposal. It considers details such as industrial operating practices and concentrations in consumer products. Based on the weight of available scientific evidence, the EPA has reached a preliminary conclusion that D4 may present an “unreasonable risk” to both human health and the environment.

This aligns with international research findings. Long-term toxicity studies published on PubMed show that high concentrations of D4 exposure may cause damage to the female reproductive system as well as liver and kidney abnormalities. The European Union has already classified D4 as “suspected of damaging fertility” and “very toxic to aquatic life with long-lasting effects,” listing it as a Substance of Very High Concern (SVHC). Notably, the EPA emphasized that it will no longer assume that personal protective equipment (PPE) is consistently used in occupational settings, instead applying stricter consideration of actual exposure risks.

Ten Key Issues Open for Comment – Transparency in the Regulatory Process

The draft evaluation is now publicly available on the U.S. government website (https://www.regulations.gov). The public may submit comments on ten core issues, including the use of pharmacokinetic models, the accuracy of hazard identification, the effectiveness of exposure control measures, and the completeness of bioaccumulation data. The EPA stated that public input will be an essential basis for refining the conclusions, and a peer review process will follow to ensure scientific rigor.

Global Regulation in Alignment – Pressure on Cosmetics and Other Industries

The U.S. action is not an isolated event but part of a broader tightening of global D4 regulation:

European Union: In 2024, the EU adopted a REACH regulation amendment banning D4 in cosmetics and other products at concentrations ≥0.1% starting in 2026, with the restriction expanding to nearly all consumer goods by 2027.
China: The National Institutes for Food and Drug Control recently proposed in a draft cosmetics standard to include D4 in the list of prohibited ingredients.
The EU had already banned D4 under the Cosmetics Regulation, and Chinese brand Florasis (花皙蔻) voluntarily removed D4 from its formulas as early as 2019—three years ahead of the EU ban.

“The persistence, bioaccumulation, and potential toxicity of D4 are the key drivers of stricter global regulation,” noted an industry analyst. D4 can travel long distances through the air, has been detected in remote regions such as the Arctic, and is resistant to natural degradation. As a result, industries such as chemicals and cosmetics have begun adopting alternatives, including Volasil 8100 from Innospec and DM 55 from IOTA, which can replicate D4’s functions while maintaining product performance.

Industry Advisory

Experts urge companies to closely monitor the EPA’s draft evaluation developments and the ban timelines across jurisdictions. Early substitution of raw materials and formulation adjustments will be essential to avoid cross-border compliance risks.

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