TSCA Compliance Software: Chemical Declarations¶
The US Toxic Substances Control Act (TSCA) imposes some of the most stringent chemical reporting obligations in the world. Companies importing, manufacturing, or processing chemical substances in the United States must navigate inventory listings, Significant New Use Rules (SNURs), Section 5 premanufacture notifications, and the rapidly evolving PFAS reporting framework under TSCA 8(a)(7). Without the right infrastructure, compliance becomes a drain on regulatory teams — and a serious liability risk.
The Problem: Manual TSCA Compliance Is Unsustainable¶
Chemical compliance teams at importers, manufacturers, and distributors face a common bottleneck: gathering, verifying, and submitting chemical declarations across thousands of SKUs and supplier relationships. Each product carries raw materials, intermediates, and additives that must be checked against the TSCA Inventory, evaluated for SNUR applicability, and screened for PFAS substances. Spreadsheets, email chains, and static PDF forms create version-control nightmares and leave companies exposed to EPA enforcement actions, import holds, and customer audit failures.
Consider a mid-sized specialty chemical importer bringing in 200 products from 50 suppliers across Asia and Europe. Each product requires substance-level declarations from every upstream manufacturer. Doing this manually — requesting data, chasing responses, cross-referencing CAS numbers, checking inventory status — consumes hundreds of hours per quarter and introduces error at every handoff. One missed SNUR or an unregistered substance can trigger an EPA notice of violation with penalties reaching $50,000 per day. The cost of non-compliance far exceeds the investment in proper software, but many teams continue to rely on manual processes simply because they are unaware of the automation options available.
The Hidden Cost of Manual Processes¶
Manual chemical compliance carries costs beyond direct EPA penalties. Customs delays at US ports can hold shipments for days or weeks while inspectors verify TSCA compliance documentation. Customer audits — especially from large OEMs and retailers — increasingly demand digital, traceable declarations that spreadsheets cannot provide. Internal regulatory teams spend 60–70% of their time on data collection and reconciliation rather than analysis and risk management. Every hour spent chasing supplier declarations or manually checking CAS numbers is an hour not spent on strategic compliance planning.
The Scale Problem¶
As a company grows, manual TSCA compliance does not scale linearly — each new product adds multiplicative complexity as supplier networks expand and regulatory obligations compound. A company with 50 products and 20 suppliers manages 1,000 potential declaration relationships. At 200 products and 50 suppliers, that figure jumps to 10,000. No manual process can maintain accuracy at that scale.
What TSCA Compliance Actually Requires¶
Understanding what software must cover starts with the regulatory framework. TSCA compliance breaks down into four core obligations that every importer and manufacturer must address.
TSCA Inventory Compliance¶
The TSCA Inventory lists every chemical substance allowed for manufacture, import, or processing in the US. As of 2026, the inventory contains roughly 86,000 substances, but the list is not static — EPA adds and removes substances through rulemaking. Any substance not on the inventory requires a Premanufacture Notification (PMN) under Section 5 — a process that can take months and thousands of dollars in EPA review fees. Compliance software must verify each CAS number against the current inventory in real time and flag non-inventory substances before they reach customs.
Significant New Use Rules (SNURs)¶
Even when a substance appears on the inventory, a SNUR may designate a particular use as a "significant new use," triggering a mandatory 90-day notice to the EPA. As of early 2026, EPA has finalized dozens of SNURs covering nanomaterials, halogenated solvents, and numerous PFAS categories. Automating SNUR screening against use codes and application categories catches exposures that manual review routinely misses — especially when the same substance may carry different SNUR statuses depending on end use.
PFAS Reporting (TSCA 8(a)(7))¶
The EPA's final rule under TSCA 8(a)(7) requires one-time reporting on PFAS manufactured or imported since 2011. The scope covers roughly 1,400 PFAS substances. The data fields are extensive: production volumes, industrial use categories, environmental release data, disposal methods, and byproduct profiles. Submissions must be certified by a responsible company official. Software that does not handle the full 8(a)(7) data set is incomplete for any company with PFAS in its supply chain.
Section 5 Premanufacture Notifications¶
For any chemical not on the inventory — or any new use of an existing chemical — a PMN under Section 5 is mandatory. The EPA review period runs 90 days minimum, and the associated data requirements include test data on health and environmental effects, production volume estimates, and exposure information. Early detection through automated substance screening is critical to avoid supply-chain delays. A substance flagged at customs triggers import holds that can stop entire shipments.
What TSCA Compliance Software Automates¶
Modern TSCA compliance platforms replace manual workflows with structured, auditable processes that reduce regulatory risk and free up team capacity.
- Chemical inventory screening — real-time verification of every substance against the TSCA Inventory, with CAS number validation, EPA Substance Registry Services lookups, and flagging of non-inventory entries. Results are captured per declaration and persisted for audit.
- SNUR and consent-order matching — automated cross-reference of substance identifiers and use descriptors against active SNURs and Section 5 orders issued by the EPA. The system flags matches with the applicable regulatory citation and the action required.
- PFAS 8(a)(7) data collection — guided data entry for all 42 required data fields, including chemical identifiers, industrial processing and use categories, production volumes, environmental release data, disposal methods, and company certification. The workflow matches EPA's reporting format.
- Supplier declaration management — request, collect, and reconcile chemical declarations from upstream suppliers in a structured digital format, eliminating manual follow-up cycles and email-based data collection.
- Public output and audit trails — generate a verifiable declaration page for each product with a permanent URL, timestamped history, supporting evidence, and certification records. Maintain complete records for EPA inspection.
- Multi-regulation cross-checks — flag substances that may trigger obligations under other US regulations (Proposition 65, FIFRA, RCRA) alongside TSCA findings in a single declaration view.
Benefits of Automation¶
Teams that switch from manual to automated TSCA compliance report declaration cycle times reduced from weeks to hours, supplier response rates above 90%, and zero customs holds related to missing or incorrect chemical declarations. The structured data format also enables reuse across downstream customers, frameworks, and regulatory programs — each declaration serves as a building block for broader product compliance.
How Sustalium Fits Into Your Workflow¶
Sustalium integrates as a lightweight layer between your product data and your compliance obligations. Define a product, invite suppliers, and review declaration results in a single dashboard. The platform handles substance screening, regulatory cross-referencing, and output generation so your team can focus on certification and sign-off rather than data chasing and manual verification.
TSCA Compliance Checklist¶
Evaluate any TSCA compliance software against these capabilities:
- Verify CAS numbers against the current TSCA Inventory in real time.
- Flag non-inventory substances and identify potential Section 5 PMN requirements.
- Cross-reference all substances against active SNURs by CAS number and use descriptor.
- Collect and reconcile supplier declarations through a structured digital portal.
- Support the full 42-field PFAS 8(a)(7) data set.
- Generate a verifiable, publicly shareable declaration page per product.
- Maintain timestamped audit trails for every data change and certification.
- Track regulatory database updates and re-screen declarations automatically.
- Integrate with existing ERP and PLM systems via CSV or API.
- Provide transparent, per-document pricing with no long-term commitments.
Risk and Enforcement Landscape¶
EPA enforcement under TSCA has intensified significantly. The agency's 2024–2027 enforcement plan prioritizes chemical reporting violations, with specific focus on import certification, SNUR compliance, and PFAS reporting. Civil penalties under TSCA can reach $50,000 per violation per day. In 2025, EPA levied over $12 million in TSCA-related penalties, with several cases involving importers who failed to certify TSCA compliance at entry. Automated compliance software provides the documented, auditable trail that EPA inspectors and US Customs and Border Protection increasingly expect.
Common Compliance Gaps¶
The most frequent TSCA violations include failure to submit import certifications, incorrect chemical identity declarations, and improper SNUR determinations. Many of these gaps stem from the same root cause: reliance on manual data collection and outdated reference materials. Software eliminates these gaps by enforcing structured data collection, maintaining current regulatory databases, and providing automated cross-checks that manual processes cannot replicate at scale.
Use Cases Across Industries¶
Chemical manufacturers use TSCA compliance software to screen raw materials and finished products against the inventory before distribution. Electronics and semiconductor companies rely on automated declarations to verify that imported components and sub-assemblies contain only TSCA-compliant substances. Automotive suppliers manage tier-1 through tier-n declaration chains, ensuring that every material entering a vehicle platform meets US regulatory requirements. Consumer goods importers screen finished goods formulations against SNURs and PFAS reporting obligations before products reach retail shelves.
Comparison: Sustalium vs ERA vs Cority vs Sphera¶
The TSCA compliance software market includes several established players, but the scope and delivery model vary significantly. The table below outlines how Sustalium compares against the three most frequently evaluated alternatives.
| Feature | Sustalium | ERA | Cority | Sphera |
|---|---|---|---|---|
| TSCA Inventory screening | Automated, real-time | Manual upload batches | Requires module add-on | Partial, module-based |
| SNUR matching | Built-in, auto-updated | Manual review | Additional license | Limited scope |
| PFAS 8(a)(7) reporting | Dedicated workflow, full data set | Basic templates | Not yet supported | Roadmap only |
| Supplier declaration portal | Yes, structured forms | No | Limited | Email-based only |
| Public output page | Included per declaration | Not available | Not available | Not available |
| Pricing per document/month | €10 | €25+ | €35+ | Custom only |
| Time to first declaration | Same day | 2–4 weeks | 4–8 weeks | 3–6 months |
ERA requires manual batch uploads and lacks a supplier portal, making it impractical for companies with large supplier networks. Cority offers broader EHS functionality but treats TSCA as an add-on module with limited PFAS and SNUR coverage. Sphera targets enterprise chemical management but requires custom scoping and extended implementation timelines. Sustalium is purpose-built for TSCA declarations with a per-document pricing model that scales linearly with declaration volume and requires zero implementation lead time.
When to Choose Each Platform¶
Sustalium fits teams that need fast deployment, transparent pricing, and purpose-built TSCA declaration capabilities without investing in broad EHS suites. ERA may suit organizations already on their platform for other compliance workflows, though the lack of SNUR automation and supplier portal remains a limitation. Cority works for enterprises that need a unified EHS platform and are willing to pay for module add-ons. Sphera is appropriate for large-scale chemical management programs with dedicated implementation budgets and custom scoping requirements.
Pricing¶
TSCA compliance software should be accessible at any scale. Sustalium charges €10 per document per month — a flat, predictable fee that covers TSCA Inventory screening, SNUR matching, PFAS 8(a)(7) data collection, supplier declaration management, and the public output page for that document.
There are no setup fees, no annual commitments, and no per-user licensing. Enterprise volume discounts are available for declarations exceeding 500 documents per month. You can add, pause, or remove declarations on a monthly basis with no penalty. For a company with 50 product declarations, the monthly cost is €500 — less than the hourly rate of a single regulatory consultant.
Pricing Comparison by Declaration Volume¶
| Volume | Sustalium | ERA | Cority | Sphera |
|---|---|---|---|---|
| 50 documents | €500/mo | €1,250+ | €1,750+ | Custom |
| 200 documents | €2,000/mo | €5,000+ | €7,000+ | Custom |
| 500 documents | €5,000/mo | €12,500+ | €17,500+ | Custom |
All Sustalium plans include the full feature set — no tiered feature gating by price level.
Implementation and Getting Started¶
Setting up TSCA compliance declarations on Sustalium takes minutes, not months. Create an account, define your first product or substance, and invite suppliers to complete their declarations through the structured portal. The platform screens each substance against the TSCA Inventory and active SNURs as declarations are submitted. Most teams complete their first declaration within hours. There are no training requirements, no dedicated IT projects, and no data migration needed. Data can be imported via CSV or API for bulk declaration setup, and the output page provides a structured data feed that integrates with downstream compliance and procurement systems.
Frequently Asked Questions¶
What is TSCA compliance software? TSCA compliance software automates the process of verifying chemical substances against the TSCA Inventory, screening for Significant New Use Rules, collecting supplier declarations, and generating EPA-ready reports for regulatory submissions.
Who needs TSCA compliance software? Importers, manufacturers, distributors, and contract processors of chemical substances into the United States — specifically regulatory affairs, product compliance, and supply-chain quality teams responsible for EPA reporting obligations.
Does Sustalium submit data to the EPA on my behalf? No. Sustalium provides the structured framework and public output page for your TSCA declarations. Your organization owns the data accuracy, certification, and sign-off. We generate the declarable framework; you own the compliance decision.
Can Sustalium handle PFAS 8(a)(7) reporting? Yes. Sustalium acts as the Generator for TSCA Compliance Declaration and the Verifier for TSCA PFAS 8(a)(7). The platform guides collection of all EPA-mandated data fields, integrates supplier responses, and produces an auditable declaration page.
What substances are covered? The platform covers organic and inorganic chemicals, polymers, UVCB substances, and PFAS classes listed under the TSCA Inventory and EPA's 8(a)(7) reporting scope. CAS number validation, EPA substance registry checks, and SNUR cross-references are included.
How does the €10 per document per month pricing work? Each product or substance declaration counts as one document. You pay €10 per month per active declaration. Declarations can be added, paused, or removed at any time. There are no long-term contracts — you scale up or down month to month.
What happens if a substance is not on the TSCA Inventory? The platform flags the substance immediately and provides guidance on next steps, including whether a Section 5 PMN may be required. Sustalium does not file PMNs but gives you the data framework to proceed with EPA submissions.
How do suppliers submit their chemical data? Suppliers receive a secure link to a structured declaration form. They fill in substance identifiers, CAS numbers, concentration ranges, and functional use information. The data flows directly into the product declaration with full audit traceability.
Is Sustalium compatible with existing ERP and PLM systems? Data can be imported via CSV or API for bulk declaration setup. The output page provides a structured data feed that can integrate with downstream compliance and procurement systems.
Does Sustalium track regulatory changes? Yes. The TSCA Inventory and SNUR databases are updated in the platform as EPA publishes changes. Declarations are re-screened automatically when regulatory data changes, and flagged updates are surfaced in the dashboard.
What happens during an EPA audit? Your Sustalium declarations serve as the structured evidence trail. Each declaration includes a timestamped history, supplier responses, screening results, and certification records — all accessible through a permanent URL.
Get Compliant Today¶
Manual TSCA compliance introduces risk at every step — from inventory misclassification to missed SNUR obligations and incomplete PFAS reporting. Sustalium gives your team a structured, auditable framework to handle US chemical declarations without the overhead of traditional compliance software. No module licensing, no multi-month implementations, no surprises.
Get started now — €10 per document per month, no setup fees, no minimum term.
Want to learn more? Read the full breakdown at Sustalium US TSCA Chemical Declaration.