REACH-Verordnung
TSCA
Toxic Substances Control Act (TSCA): U.S. Chemicals Regulation – Market Approval, Risk Management & Compliance
TSCA – Legal Framework, EPA, and Chemical Regulation in the United States
Role of the EPA (Environmental Protection Agency) in the Regulatory System – Law, Regulations, and Requirements
The Toxic Substances Control Act (TSCA) is the central law governing chemical regulation in the United States. The EPA (Environmental Protection Agency) serves as the competent environmental authority and oversees the manufacture, processing, use, and disposal of chemicals (“substances”) and materials. The purpose of the Act is the control and reduction of toxicological risks to human health and the environment through a federal regulatory system with binding requirements, regulations, and rules across the U.S. states.
Scope: Chemicals, Substances/Materials, Mixtures, and Products
The TSCA applies to chemical substances, including both individual chemicals and mixtures, as well as certain products and articles. It covers both industrial chemicals and chemical products intended for end consumers, addressing their use, processing, intended applications, and potential impacts throughout their lifecycle.
TSCA Inventory & Lists – Existing Chemicals vs. New Chemicals (Inventory, Lists, Hazardous Substances List)
Entry into the TSCA Inventory: Data, Directory, Chemical List, Chemicals
The TSCA Inventory is a central registry of all chemicals and substances approved in the United States. This list serves as the basis for market authorization, risk assessment, and regulatory action by the EPA. Certain substances may be listed separately with higher priority to indicate additional regulatory requirements when an increased risk is identified.
Existing Chemicals and New Chemicals – Impact on Use & Distribution
TSCA distinguishes between existing chemicals (listed in the Inventory) and new chemicals. Stricter regulatory and testing requirements apply to new chemicals prior to their entry into the market. The classification affects the permitted use, distribution, and approval of chemicals in the United States.
Market Authorization of New Substances – PMN, Review & Conditions
PMN (Premanufacture Notice), Import & Manufacture – Process and Requirements
Before manufacturing or importing, companies must submit a PMN (Premanufacture Notice) to the EPA for new chemical substances. This procedure is mandatory for manufacturers and importers seeking to produce or bring chemicals into the United States and serves as the basis for regulatory review.
Risk Evaluation & Risk Management – Potential Risks to Human Health & the Environment
As part of the risk evaluation, the EPA analyzes potential risks to human health and the environment that may arise depending on exposure, use, and disposal. The risk evaluation serves to minimize hazards and enhance chemical safety.
Conditions, Restrictions, and Approval for Intended Use
Depending on the outcome, conditions, restrictions, or measures to limit specific uses may be imposed. Approval is often tied to a clearly defined intended use and may include product-specific regulatory requirements.
Restrictions & Prioritization – PBTs, Flame Retardants, Plasticizers, HCBD
PBT Substances: Risk Minimization, Regulations, and Implementation in Companies
Particularly concerning are PBT substances (persistent, bioaccumulative, toxic). Stricter regulations apply to these substances to minimize risks, which companies must actively implement as part of their due diligence obligations.
Substances with Specific Risks (HCBD, Flame Retardants, Plasticizers) – Implications for Products
Certain flame retardants, plasticizers, and substances such as hexachlorobutadiene (HCBD) are subject to specific restrictions. These restrictions can have significant impacts on product development and composition and require close coordination with suppliers and other supply chain stakeholders.
Obligations for Companies, Manufacturers & Supply Chain Actors
Due Diligence, Information & Data Management in the Supply Chain
TSCA obliges companies to exercise due diligence throughout the entire supply chain. Manufacturers and suppliers must provide relevant substance data, assess risks, and comply with chemical regulatory requirements.
Use / Processing Facilities: Compliance with Chemicals & Mixtures
Processing facilities must ensure that the use of chemicals, including both individual substances and mixtures, is TSCA-compliant. This includes internal processes for chemical safety, documentation, and regular review.
Obligations for Importers – Documentation, Reporting, and Responsibilities
Importers are responsible for ensuring TSCA-compliant market entry, reporting, and documentation to the EPA. Violations may result in sanctions and jeopardize market access.
Research & Development – Innovation under TSCA Requirements
Development of New Chemicals: Data Requirements, Testing, and Regulation
In research and development (R&D) of novel chemical products—including individual substances, mixtures, and formulations —TSCA requirements must be considered at an early stage. Data, testing, and regulatory assessments form the basis for subsequent market entry. A robust and comprehensive set of analytical data is essential for this purpose.
Impact of Regulation on Products, Companies, and Implementation
TSCA regulation influences innovation processes, product design, and strategic business decisions in multiple ways. Early implementation ensures planning certainty.
Testing and Documentation Support (Our Services for TSCA Compliance)
Analytics / Screening of Substances: PBTs, Flame Retardants, Plasticizers, Hydrocarbons
Analogous to our services for the analysis of SVHCs under EU REACH, we support market actors through tailored analytical screenings of TSCA-regulated substances, such as PBTs, flame retardants, plasticizers, and hydrocarbon-based compounds, to assess their TSCA relevance.
Sampling of Products and Mixtures, Document Reviews & Compliance Evidence
Our services include chemical testing of products, substances, and mixtures, as well as the review and evaluation of documents and compliance evidence for the EPA.
Support for PMN, Inventory Classification, Market Authorization, and Regulatory Conditions
We support companies in the preparation and submission of the Premanufacture Notice (PMN), the Notice of Commencement (NOC) for entry into the TSCA Inventory, market authorization, regulatory conditions, and ongoing monitoring.
