Is It Time for the US to Consider a REACH-Like Program?
June 16, 2026 by Dr. John Hott
There was a time when the United States was the undisputed "first to market" destination for new chemistry. If you had an innovative substance, you launched it in the US.
Today, the landscape looks drastically different.
Increasingly, the US is finding itself last in line, often lagging significantly behind the EU and other global markets. While the 2016 Lautenberg amendments to the Toxic Substances Control Act (TSCA) were intended to create a more effective, science-based framework, the reality of post-Lautenberg TSCA implementation has left many chemical innovators frustrated.
What was supposed to be a streamlined process has become fraught with unpredictability, prolonged delays, and mounting complications. Companies are regularly facing unexpected demands for extra testing, additional labeling requirements, and conservative default modeling that mandates excessive Personal Protective Equipment (PPE) requirements.
Across the pond, the EU’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) system is undeniably stringent and demanding. But it has one massive advantage over the current state of TSCA: It is predictable.
This stark contrast begs a controversial but necessary question for our industry: Is it time for the US to abandon its current framework and consider adopting a REACH-like program?
Here is a look at some of the pros and cons of making such a monumental shift.
The Case FOR a REACH-Like System
Predictability and Certainty: REACH operates on a rigid "no data, no market" principle. While the upfront data requirements are heavier, the rules of the game are clearly defined by tonnage bands. You know exactly what is required to get to market, largely eliminating the regulatory limbo of open-ended agency reviews.
Global Harmonization: Aligning a US program with a REACH-style framework would simplify compliance for multinational companies. A more unified, globally accepted standard for safety data could reduce duplicative testing and streamline complex supply chains.
Clearing the Backlog: Under a REACH model, the responsibility sits squarely on the manufacturer to prove safety upfront via a comprehensive registration dossier, rather than relying on the EPA to model hypothetical risks and conditions of use from limited initial data. This structural shift could theoretically clear the agency's current new-chemical backlog.
The Case AGAINST a REACH-Like System
Upfront Costs: The financial burden of preparing a full REACH-style registration dossier is higher. This heavy upfront cost may disproportionately harm small-to-medium enterprises (SMEs) and can kill low-volume, highly specialized innovations before they ever leave the lab.
The Animal Welfare Setback: EU REACH has historically been criticized for requiring immense amounts of vertebrate animal testing to fulfill data endpoints. Conversely, the Lautenberg TSCA explicitly mandates the EPA to reduce and replace animal testing by prioritizing New Approach Methodologies (NAMs). Adopting a REACH-like system could severely undermine the progress the US has made toward eliminating animal testing.
Loss of Risk-Based Nuance: The US has historically prided itself on a risk-based approach (evaluating hazard combined with actual exposure). REACH leans heavily toward a hazard-based framework. A US REACH system could lead to severe restrictions on highly useful chemicals that pose no actual risk under realistic, real-world conditions of use.
Escaping the False Dichotomy: The Canadian Middle Ground
When we debate TSCA versus REACH, we often fall into a false dichotomy, ignoring that other effective models exist.
Take Canada’s New Substances Notification (NSN) under CEPA, for example. Many in the industry view Canada's system as the "Goldilocks" approach. It relies on a tiered system with clear data requirements (offering the predictability of REACH) but maintains a strong risk-based focus rather than a hazard-only approach. It provides a structured pathway to market without automatically defaulting to worst-case scenarios, though it is not without its own flaws, particularly regarding less public transparency (e.g., confidential masked chemical names), and heavy downstream tracking burdens like SNAc notices.
Where Do We Go From Here?
The current Section 5 new chemicals backlog under TSCA is actively stifling American innovation and driving R&D overseas. But is a sweeping, REACH-style overhaul the cure, or would the massive upfront costs simply create a different kind of barrier to entry?
Perhaps we don't need a new law at all. Many argue that the text of Lautenberg TSCA isn't the problem, the issue lies entirely in how the EPA is currently implementing it.
Have a Question?
Get in touch with our Dr. John Hott and our team using the form below.
Dr. John Hott | Client Solution Principal Consultant
Based in the United States, Dr. Hott brings more than 30 years of experience working with leading governmental authorities, including the EPA, FDA, and international regulators. He has helped shape regulatory policy, modernise compliance systems, and guide organisations through complex chemical and product safety frameworks.
Further reading
