FLUKE
Kimball Electronics
Tolomatic
Industrial Scientific
AHEAD
roboception
FLUKE
Kimball Electronics
Tolomatic
Industrial Scientific
AHEAD
roboception
By Deepa Shetty | Thu Jun 6 2024 | 2 min read

Table of Contents

Companies manufacturing or selling products in the European Union (EU) or the United States (U.S.) must navigate two critical chemical regulations: the Toxic Substances Control Act (TSCA) and the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation. These frameworks serve as regulatory gatekeepers, ensuring that substances used in manufacturing comply with environmental and health standards. While both regulations share the goal of protecting human health and the environment, their distinct requirements mean that compliance with one does not automatically ensure compliance with the other.

Understanding the Similarities Between TSCA and REACH

Both TSCA and REACH regulate the use of chemical substances that pose risks to human health and the environment. Companies manufacturing, importing, or selling products in the U.S. or EU must disclose information about regulated substances and ensure compliance with established safety standards. Non-compliance with either regulation can result in significant fines, enforcement actions, and restrictions on market access.

Key Differences Between TSCA and REACH

One of the most frequently asked questions about these regulations is whether their substance lists are identical. The answer is no. TSCA and REACH take different approaches to chemical regulation.

The TSCA framework maintains a single list that categorizes substances as either approved or restricted. There are no intermediate tiers or phased-out substances; chemicals are either permitted or banned outright. In contrast, REACH operates under a tiered system that includes three distinct lists:

Businesses that fall under both TSCA and REACH must monitor substances across all these lists and ensure that their supply chains remain compliant.

Registering New Substances Under TSCA and REACH

Companies dealing with new substances must understand the registration processes for both TSCA and REACH. Under TSCA, any product containing a new substance or involving a Significant New Use (SNU) requires registration with the U.S. Environmental Protection Agency (EPA) before approval. REACH, on the other hand, mandates that manufacturers or importers handling SVHCs in quantities exceeding one metric ton annually register with the European Chemicals Agency (ECHA). Additionally, suppliers must disclose the presence of any regulated substances to their clients to support compliance efforts down the supply chain.

Comparing TSCA and REACH highlights why companies need structured REACH compliance management to handle global chemical compliance efficiently.

Keeping Up With Regulatory Updates

Both TSCA and REACH are dynamic regulations, with their restricted substance lists continuously evolving. Under TSCA, the EPA prioritizes chemicals for evaluation on a rolling basis, ensuring a constant pipeline of substances under review. REACH follows a similar process through the Community Rolling Action Plan (CORAP), which is updated annually based on emerging health and environmental risks.

To stay ahead of regulatory changes, businesses should implement proactive compliance strategies. A best practice is to adopt standardized processes such as IEC 63000, which outlines methods for collecting and organizing materials data. Keeping detailed product technical files and ensuring real-time monitoring of regulatory updates can help companies maintain compliance and avoid costly disruptions.

How Acquis Simplifies TSCA and REACH Compliance

Navigating TSCA and REACH compliance can be complex, but Acquis streamlines the process with automated tools that enhance supply chain visibility and regulatory adherence. Our solutions help businesses:

  • Automate Data Collection – Seamlessly gather and validate materials and substance data from suppliers.
  • Ensure Accurate Documentation – Maintain up-to-date compliance records aligned with IEC 63000 standards.
  • Manage Regulatory Updates – Receive real-time alerts on changes to TSCA and REACH requirements.
  • Improve Supply Chain Transparency – Gain insights into potential compliance risks before they become liabilities.

Taking Action for Compliance Success

For businesses selling in the U.S. and EU markets, understanding and complying with TSCA and REACH is essential for maintaining market access. Implementing proactive compliance strategies and leveraging automation tools can reduce regulatory risks and build a sustainable, transparent supply chain.

Want to ensure full compliance with TSCA and REACH? Download our free compliance checklist to streamline your regulatory strategy and stay ahead of changing requirements.

[[Download Now] or Contact Us Today to learn how Acquis can help.](https://www.acquiscompliance.com/)

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TSCA vs. REACH: Key Compliance Insights for U.S. and EU Markets

TSCA , managed by the U.S. EPA, uses a single inventory system, chemicals are either allowed or banned. REACH , managed by ECHA in the EU, uses a tiered system ( Candidate List , Authorization List, Restrictions List) with phased restrictions.
TSCA covers existing and new chemicals listed on the EPA’s TSCA Inventory (~82,000+) , and requires pre‑notification (PMN) for new chemicals. REACH mandates registration for all substances produced/imported in the EU at 1 t/year or more, expanding to detailed dossiers at higher tonnages.
Not exactly. REACH enforces mandatory risk assessments and data submission , including chemical safety reports for ≥10 t/year. TSCA relies on EPA-mandated tests or voluntary data submissions , especially under its Section 8(d) rule.
No. Approval in one jurisdiction doesn’t guarantee another . A substance legal under TSCA must still be registered under EU REACH to be used in Europe, and vice versa.
TSCA allows companies to protect confidential business information (CBI) , often hiding volume, identity, and use . REACH emphasizes public transparency , requiring safety data, SVHC listings, and registered volumes to be accessible
In the U.S., the EPA conducts rolling prioritization and enforces Section 6 bans/restrictions . In the EU, ECHA and the European Commission update REACH via processes like CORAP, candidate and authorization lists, and restrictions
TSCA considers unlisted chemicals as “new” and requires a Premanufacture Notice (PMN) 90 days before manufacture. In REACH, any substance in the EU not registered at ≥1 t/year must be registered before first placing on the market.