01 Understanding TSCA Regulations
TSCA (Toxic Substances Control Act) categorizes chemical substances in the United States into "existing substances" and "new substances" for management. The US TSCA inventory is a dynamic list containing approximately 86,862 chemical substances (as of July 2025), with 42,578 listed as "active" substances. Substances not included in the TSCA inventory are considered "new substances," and their manufacturers or importers typically need to submit PMN (Premanufacture Notice) declarations unless exempt.
TSCA Scope of Application: Organic substances, inorganic substances, polymers, UVCB substances, microorganisms, and mixtures.
TSCA Exemptions: Pesticides, food and food additives, pharmaceuticals, cosmetics, tobacco, and nuclear materials.
02 Understanding the Five PBT Substances and Their Control Requirements
The TSCA regulations focus on the following five PBT substances (Persistent, Bioaccumulative, and Toxic), which are strictly controlled due to their persistence, bioaccumulation, and toxicity.
| Substance Name (Chinese/English) | CAS Number | Common Applications | Control Requirements |
|---|---|---|---|
|
十溴二苯醚 (DecaBDE) |
1163-19-5 | Flame retardant for wires, cables, textiles, electronic equipment housings, etc. | Prohibited, except for unintentional addition with content <0.1% |
|
六氯丁二 烯 (HCBD) |
87-68-3 | Rubber manufacturing, solvent | Prohibited |
|
五氯苯硫酚 (PCTP) |
133-49-3 | Rubber industry | Limit ≤1% |
|
异丙基化磷酸三苯酯 (PIP (3:1)) |
68937-41-7 | Flame retardant, plasticizer, lubricant, hydraulic oil, etc. | Prohibited, except for unintentional addition with content <0.1% |
|
2,4,6-三叔丁基苯酚 (2,4,6-TTBP) |
732-26-3 | Fuel additive, antioxidant in engine oil and lubricants, additive | Limit ≤0.3% |
03 Recent Important Revisions
On November 19, 2024, the US EPA issued revised rules for DecaBDE and PIP (3:1), which took effect on January 21, 2025. The main revisions include:
Regarding DecaBDE (Decabromodiphenyl ether):
- Allows unintentionally added DecaBDE content in products to be less than 0.1% (by weight).
- Specifies workplace safety protection measures (such as using personal protective equipment PPE) and prohibits discharge into water.
- Clarifies phased prohibition requirements for wires and cable insulation materials containing DecaBDE in nuclear power generation facilities.
Regarding PIP (3:1) (Isopropylated phosphate triaryl ester):
- Allows unintentionally added PIP (3:1) content in products to be less than 0.1% (by weight).
- Clarifies exemptions for specific uses and phased elimination plans, such as for wire harnesses and circuit boards, lubricants, motor vehicle and aerospace parts, etc. (with corresponding exemptions or extended compliance dates).
- Specifies requirements for workplace safety protection measures (such as using personal protective equipment PPE).
04 Enterprise Export Compliance Strategies
In response to TSCA compliance requirements, enterprises can adopt the following strategies:
Supply Chain Transparency Investigation:
Enterprises need to strengthen compliance inquiries with raw material and component suppliers, requiring them to provide material declarations or certificates of conformity to ensure supply chain transparency.
Product Testing and Risk Assessment:
Systematic testing of high-risk materials and finished products is a key step to ensure compliance. This is particularly important for materials such as plastics, rubber, coatings, and electronic components. Enterprises should choose professional laboratories with qualifications such as CMA and CNAS for testing.
Close Attention to Regulatory Updates:
TSCA is a dynamically updated regulatory system, and the EPA continuously evaluates and updates the list of chemical substances and restrictions. Enterprises should regularly check the EPA official website or use information from professional service agencies to ensure timely understanding of the latest regulatory developments.
Preparation of Compliance Declarations and Documents:
TSCA itself does not require a special "certificate," but during product customs clearance, US Customs may require enterprises to provide TSC compliance declarations (similar to self-declarations) and supporting test reports and other documents. Enterprises must keep relevant test reports and certificates of conformity for at least 3-5 years for EPA verification.
05 GRGTEST TSCA Five PBT Substances Testing Services
To assist enterprises in meeting US market access requirements, GRGTEST provides testing and consulting services for TSCA five PBT substances, offering one-stop solutions for TSCA regulatory consulting, raw material testing, and complete machine and component product testing.