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TSCA RESTRICTIONS OF 5 PBT SUBSTANCES IN PRODUCTS

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This TSCA restrictions guide also answers common questions about TSCA PBT substances, supplier declarations, restricted substances in products, and how companies can document compliance for the U.S. market.

The U.S. Toxic Substances Control Act (TSCA) regulates hazardous chemicals in substances, mixtures, and articles/products. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (2016) modernized TSCA, strengthening chemical evaluations to better protect human health and the environment. Under these reforms, the U.S. Environmental Protection Agency (EPA) has implemented restrictions on certain persistent, bioaccumulative, and toxic (PBT) substances in articles, including actions taken under TSCA Section 6(h).

TSCA-PBT

What Action is the EPA Taking?

First, the Frank R. Lautenberg Chemical Safety for the 21st Century Act has initiated the US Toxic Substances Control Act (TSCA) reform. 

According to this reform, the federal Environmental Protection Agency (EPA) must take action on particular chemical substances identified as persistent, bioaccumulative, and toxic (PBT). 

As a result, after a thorough Federal TSCA Work Plan for Chemical Assessments, the EPA has decided to restrict the use of the following five substances in products (ref. 40 CFR Part 751):

TSCA PBT substances
  • PIP (3:1), or Phenol, Isopropylated Phosphate (3:1);
  • DecaBDE, or Decabromodiphenyl Ether. DecaBDE is also one of the PBDEs restricted under RoHS;
  • PCTP, or Pentachlorothiophenol;
  • 2,4,6-TTBP, or 2,4,6-tris(tert-butyl)phenol;
  • HCBD, or Hexachlorobutadiene. The EU Persistent Organic Pollutants (POP) regulation also rules HCBD.

These substances are either restricted or merely prohibited from specific applications. Recordkeeping may also apply, with various effective dates.

More regulated substances are likely to be added to this list over the years, similarly to the EU REACH regulation. Furthermore, the EU RoHS and EU Halogen-free /  POP also restrict some of these PBTs, such as DecaBDE and HCBD.

TSCA Reform and In-scope Articles

TSCA products in scope

A wide range of articles, or products, are potentially affected by these new restrictions or prohibitions. They include products placed into the American market with:

  • PVC plastics;
  • Cables;
  • Electronic equipment;
  • Rubber items;
  • Etc.

Medical devices, regulated under the US Food and Drug Administration (FDA), are excluded from the TSCA’s scope.

The TSCA Restrictions of Substances in Products

The following table portrays substances currently regulated by the US EPA, under the TSCA:

Substance Name (Short Form)CAS_RN_#_Where Used (Examples)Restriction in Products (Simplified)Effective Dates (Simplified)*
PIP (3:1)68937-41-7
  • Plasticizer and flame retardant in plastics (PVC and others), and resins
  • In adhesives and sealants
  • Functional fluids in aircraft and industrial machinery
  • Restriction of the manufacture in products and articles (0.1% w/w) (including import) and processing;
  • Exemptions apply to the general prohibition. For example in circuit boards and wire harnesses, lubricants and greases for aerospace use and turbine engines, some recycled plastics, or some aerospace, automotive, or military applications (see the next section for more details);
  • Obligation to inform customers via Safety Data Sheet (SDS) or labeling;
  • Five-year recordkeeping requirements.

October 31, 2024.

However, different compliance dates apply to exemptions (see the next section for more details).

 
DecaBDE1163-19-5

Flame retardant in:

  • Wires, cables,  and rubber casings
  • Electronic equipment casings
  • Building and construction materials
  • Restriction of the manufacture in products and articles (0.1% w/w) (including import) and processing;
  • Some exemptions to the prohibition apply, for example to recycled plastics;
  • Five-year recordkeeping requirements.

March 8, 2021.

However, different compliance dates apply to exemptions.

 
PCTP133-49-3Rubber products
  • Concentration limit of 1% w/w in articles;
  • Recordkeeping of products and articles containing PCTP.
March 8, 2021 
2,4,6-TTBP732-26-3
  • Fuel, oil, and lubricant additive
  • Fuel injector cleaner
  • Concentration limit of 0.3% w/w:
  • in any containers below 35 gallons;
  • as an oil or lubricant additive in any container size.
January 6, 2026  
HCBD87-68-3Production of solvents
  • Prohibition of the manufacture  in products and articles (including import) and processing;
  • Possible exemptions to unintentional production of HCBD as a byproduct;
  • Recordkeeping requirements.
March 8, 2021 
 *Reference: 89 FR 91486
 

Revisions to PBT Rules for DecaBDE and PIP (3:1) Under the TSCA Restrictions

The 2024 amended rule introduces several important changes impacting the electronics industry. Key updates include:

  • The prohibitions of PIP (3:1) and DecaBDE no longer apply to products or articles containing these substances at concentrations below 0.1% by weight, as long as the substances were not intentionally added.
  • Distribution of PIP (3:1)-containing articles: While the use and processing of PIP (3:1) are banned as of October 31, 2024, distribution of articles containing PIP (3:1) is allowed until October 31, 2026.
  • Permanent exclusion for PIP (3:1) in circuit boards and wire harnesses: This exemption includes items like:
    • cable sleeves
    • casings
    • connectors
    • fuse covers
    • tapes, and
    • terminal.

This limits the TSCA PIP (3:1) restriction to PCB and cable assemblies. However, enclosures, fasteners, motors, pumps, and other non-PCB components remain within scope.

The Grace Periods for PIP (3:1) in Electronics

From 2024:

  • Consumer electronics replacement parts: a 7-year grace period.
  • Exemptions for new manufacturing equipment: a 10-year phase-in exemption applies to new parts in:
    • Semiconductor manufacturing,
    • HVAC,
    • Refrigeration,
    • Water heating,
    • Power generation, and
    • Laboratory and commercial electronics.
    • Additionally, replacement parts with PIP (3:1) are permitted for the full-service life of these products or up to 25 years.
  • Lubricants and grease exclusions narrowed: PIP (3:1) in lubricants and grease is now only exempt when used in aerospace and turbine applications, with a 15-year grace period for other uses.

PIP (3:1) for the Automotive and Aeropace Industries

Also from 2024:

  • Changes to motor vehicle parts exemption: The previous exclusion has been replaced with a non-permanent exemption, lasting 15 years for parts in new vehicles (including heavy motorized machinery) and 30 years for replacement parts.
  • Aerospace manufacturing exemption: The prior exclusion has been replaced with a 30-year exemption for parts in new aerospace vehicles. However, aerospace manufacturers may benefit from longer grace periods for replacement parts due to the industry’s long product life cycles.

How to Comply with TSCA PBT?

These amendments impact industries worldwide. To comply with the American laws, the manufacturers and importer will have to make sure that their supply chain is aware of these obligations and meets the TSCA requirements, on top of the California Prop. 65 obligations.

To do so, you are welcome to use the free Enviropass EPEC form. Ask your suppliers to fill in the Supplier’s information and TSCA tabs.

Enviropass is here to help you grasp the TSCA reform, verify the technical documentation with your supply chain and assess your products. We will audit the medium to high-risk suppliers and provide recommendations via a gap analysis.

TSCA PBT FAQ

Which substances are restricted under TSCA?

Under the U.S. Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) can restrict chemicals that present risks to human health or the environment. For product compliance, companies often focus on the TSCA Section 6 restrictions, including persistent, bioaccumulative, and toxic substances.

Examples of restricted substances include:

  • Decabromodiphenyl ether (DecaBDE);
  • Phenol, isopropylated phosphate (3:1), also known as PIP (3:1);
  • 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP);
  • Hexachlorobutadiene (HCBD);
  • Pentachlorothiophenol (PCTP).

These substances may be prohibited, restricted, or subject to specific conditions depending on the chemical, concentration, use, article type, and applicable compliance dates. EPA revised the rules for DecaBDE and PIP (3:1) in 2024, including provisions for products and articles.

Under TSCA, EPA issued restrictions for five “PBT” chemicals commonly referenced as: PIP (3:1), decaBDE, PCTP, 2,4,6-TTBP, and HCBD. These rules restrict certain manufacturing/processing/distribution uses to reduce exposure and environmental release.

Often, yes. Several TSCA-PBT rules apply not only to substances/mixtures but also to processing and distribution in commerce for use in articles, meaning products and components can be in scope depending on the rule and use-case.

Yes. TSCA can apply to electronic products when they contain restricted chemical substances or articles regulated under TSCA. This is especially relevant for electrical and electronic equipment that may contain substances such as flame retardants, plasticizers, lubricants, rubber additives, or other chemical additives.

For example, PIP (3:1) may be relevant to electronics because it has been used as a flame retardant, plasticizer, and anti-wear additive, while DecaBDE has been used as a flame retardant. Therefore, companies placing electronic products on the U.S. market may need to verify whether restricted TSCA substances are present in components, materials, or supplier parts.

A TSCA assessment for electronics may include supplier declarations, material reviews, substance screening, and documentation showing that restricted substances are absent, below applicable thresholds, or otherwise compliant with the relevant TSCA requirements.

.

PIP (3:1) has had phased compliance dates and specific restrictions for different uses. A widely cited milestone is the October 31, 2024 compliance deadline related to processing/distribution for use in articles and PIP (3:1)-containing articles, with additional longer-term deadlines for certain sectors/uses. Always confirm which paragraph applies to your use.

EPA finalized revisions to the decaBDE and PIP (3:1) rules to address implementation issues and clarify compliance pathways for certain applications (including considerations discussed publicly by EPA).

TSCA violations can lead to significant civil penalties (inflation-adjusted). EPA publishes updated statutory penalty maximums under 40 CFR 19.4 (TSCA is one of the statutes listed).

Want to know more about TSCA or other American regulations? Contact Enviropass!