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In today’s tightly regulated landscape, compliance isn’t just a legal obligation—it’s a competitive advantage. The Toxic Substances Control Act (TSCA), administered by the U.S. Environmental Protection Agency (EPA), governs the full lifecycle of chemical substances in the U.S.—from manufacturing and Chemical Import Compliance to distribution and disposal.
The bar has been raised since the pivotal 2016 Frank R. Lautenberg amendments. Chemical companies are now held to higher transparency, safety, and accountability standards—especially when introducing new substances to the market. Understanding and aligning with TSCA’s evolving requirements isn’t just about avoiding penalties; it’s about unlocking long-term operational resilience and market trust.
TSCA at a Glance
Key Compliance Area | What Does It Mean for You? |
| TSCA Chemical Inventory & Registration | All chemicals must be listed on the TSCA Inventory list or go through EPA pre-approval. |
| TSCA Risk Evaluation | Substances are labeled High or Low Priority; high-priority ones face deeper reviews. |
| TSCA Reporting Requirements & Obligations | Companies must submit detailed usage and exposure data under the CDR rule. |
| Restrictions & Bans | Hazardous substances can be limited, phased out, or completely banned. |
| Import Certification | Imports require TSCA compliance declarations to clear customs. |
| Fees & Cost Impact | TSCA filings come with EPA fees and testing costs that must be budgeted for. |
TSCA Compliance Flow – New Chemical Approval
- Start with a new chemical substance
- Check the TSCA Inventory
- If the chemical is listed, you can proceed to manufacture or import.
- If the chemical is not listed, move to Step 3.
- The PMN Submission process includes submitting a Pre-Manufacture Notice (PMN) to the EPA
- Must be submitted at least 90 days before manufacturing or importing.
- EPA reviews the PMN
- Conducts a 90-day risk assessment to evaluate health and environmental risks.
- EPA decision
- If approved, proceed to manufacture or import under any specified conditions.
- If not approved, you may need to:
- Provide additional data or testing results
- Modify the substance or its intended use
- Implement risk management measures
- Comply with any EPA-imposed restrictions before market launch.
Recent TSCA Enforcement Examples
Substance | TSCA Action |
| Asbestos | Phased out in most applications |
| PFAS Restrictions | Usage is restricted in multiple formulations |
| Methylene Chloride | Banned in consumer paint strippers |
| NMP | Limited in household cleaning products |
TSCA Compliance: Risks and Rewards
Failure to comply with TSCA can result in:
- Customs detentions and product delays
- Civil penalties and Regulatory action
- Reputational and operational risks
However, compliance also brings strategic benefits, such as smoother market access, better investor confidence, and leadership in sustainability.
Conclusion
TSCA compliance can be complex, but it doesn’t have to be overwhelming. Freyr supports chemical manufacturers and importers with TSCA compliance services which include:
- TSCA registrations and Pre-Manufacture Notices
- Risk assessment documentation
- Data reporting and audit preparation
Whether you’re launching a new product or reassessing existing substances, we help you stay compliant—and competitive.
Navigate TSCA regulations. Unlock opportunity.Contact Freyr to simplify your TSCA journey →
