December 18, 2025

Managing chemical compliance across global markets is a complex and ongoing responsibility for manufacturers, importers, and distributors. Two of the most widely recognized chemical regulatory frameworks worldwide are:

  • REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) – European Union
  • TSCA (Toxic Substances Control Act) – United States

While both aim to safeguard public health and the environment, they differ significantly in scope, registration obligations, data requirements, risk evaluation, and compliance responsibilities. Understanding these differences is crucial for ensuring smooth market access, reducing supply chain risks, and maintaining long-term regulatory compliance.

1. Scope and Coverage

Regulation

Region

Scope Focus

Coverage Includes

REACH

European Union

Life-cycle chemical safety

Substances in products, mixtures, and articles

TSCA

United States

Industrial chemical oversight

New chemicals and new uses of existing chemicals

REACH covers all substances manufactured or imported into the EU at ≥1 tonne/year, including those in formulations, mixtures, and final articles.

TSCA focuses primarily on industrial chemicals, excluding pharmaceuticals, pesticides, food, cosmetics, and biological products.

2. Registration Requirements

REACH (ECHA)

  • Companies must register substances with the European Chemicals Agency (ECHA) before placing them on the EU market.
  • Requires comprehensive technical dossiers, including:
    • Toxicological & eco-toxicological data
    • Exposure and use scenarios
    • Risk management recommendations
  • Operates under the principle “No Data, No Market.”

TSCA (EPA)

  • Companies must submit a Pre-Manufacture Notice (PMN) to the U.S. Environmental Protection Agency (EPA) at least 90 days before producing or importing a new substance.
  • EPA conducts a risk-based evaluation and may:
    • Approve
    • Restrict usage
    • Request additional testing
    • Deny market entry

3. Chemical Risk Assessment and Testing

Aspect

REACH

TSCA

Risk Responsibility

On the company

On the EPA

Testing Requirements

Mandatory based on tonnage

Requested based on EPA evaluation

Data Transparency

Public safety data mandatory

Reporting varies and may remain confidential

REACH demands proactive safety demonstration, while TSCA often requests testing only when risk is uncertain or elevated.

4. Substance Restrictions and Enforcement

REACH Enforcement

  • Managed by ECHA, enforced by individual EU member states
  • Includes:
    • Candidate List (SVHCs)
    • Authorisation List (Annex XIV)
    • Restrictions List (Annex XVII)

TSCA Enforcement

  • Managed and enforced centrally by the EPA
  • Uses the TSCA Inventory as the baseline list
  • Restrictions added case-by-case following risk review

5. Supply Chain Obligations

Requirement

REACH

TSCA

Safety Documentation

Safety Data Sheets + Poison Centre Notification

Compliance certification + recordkeeping

Representation

Non-EU companies must appoint an Only Representative (OR)

No OR required, but importer certification is mandatory

Record Retention

Safety data must be continuously updated

Records must be retained for minimum 5 years

Global Compliance Strategy Insight

Since REACH is more data-intensive and industry-driven, many organizations choose to meet REACH-level compliance first, using it as a foundation for TSCA and other global chemical frameworks. This reduces rework, improves global readiness, and supports cross-market commercialization.

How Maven Regulatory Solutions Supports Compliance

Maven Regulatory Solutions provides end-to-end regulatory support, including:

  • REACH Registration & Technical Dossier Preparation
  • SVHC Identification & Authorisation Application Support
  • TSCA PMN Preparation & EPA Submission Management
  • Supply Chain & Only Representative (OR) Management
  • SDS, Labelling, CLP & GHS Compliance
  • Global Chemical Regulatory Intelligence & Monitoring

Our approach ensures strategic, efficient, and risk-aware compliance across markets.