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US TSCA Certification
US TSCA Certification




TSCA testing refers to the Toxic Substances Control Act, which aims to comprehensively consider the environmental, economic, and social impacts of chemical substances circulating in the United States and prevent "unreasonable risks" to human health and the environment. After multiple revisions, TSCA has become an important regulation for effectively managing chemical substances in the U.S. For enterprises whose products exported to the U.S. fall under TSCA-regulated categories, TSCA compliance is a prerequisite for normal trade.


TSCA certification applies to naturally occurring and chemically produced substances, chemical substances in mixtures, and intentionally released chemical substances in articles. It should be noted that the chemical substances defined by TSCA also include microorganisms.


However, the following categories of chemicals are regulated by other federal laws and are not subject to TSCA:


Tobacco and tobacco products, nuclear materials, firearms, food, food additives, pharmaceuticals, cosmetics, and substances used solely as pesticides.

Introduction to TSCA Restricted Substances:


The U.S. Environmental Protection Agency (EPA) is responsible for implementing TSCA's control over chemicals.


On January 6, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register for five persistent, bioaccumulative, and toxic (PBT) substances under TSCA.

The five substances in TSCA testing are:


DecaBDE (Decabromodiphenyl ether), PIP (Isopropylated phenyl phosphates), PCTP (Pentachlorothiophenol), HCBD (Hexachlorobutadiene), 2,4,6-TTBP (2,4,6-Tris(tert-butyl)phenol). These requirements took effect on February 5, 2021, and will be implemented gradually from March 8.


Substance Category

Prohibition Time

Limit Requirement

Product Scope

Decabromodiphenyl ether (DecaBDE)
CAS No. 1163-19-5

From March 8, 2021

Prohibited (must not contain)

All products (exempting recycled materials)

Phenol, isopropylated phosphate (3:1) [PIP (3:1)]
CAS No. 68937-41-7

From March 8, 2021

Prohibited (must not contain)

All products

2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP)
CAS No. 732-26-3

From January 6, 2026

0.3%

Products less than 55 gallons, and oil and lubricant additives

Pentachlorothiophenol (PCTP)
CAS No. 133-49-3

From March 8, 2021

1%

All products

Hexachlorobutadiene (HCBD)
CAS No. 87-68-3

From March 8, 2021

Prohibited (must not contain)

All products


1. What is the testing period for TSCA's 5 PBT substances and 10 substances that have completed risk assessments?


Typically 5-7 working days.


2. What is the scope of TSCA regulation?


Substances, mixtures, and articles placed on the U.S. market are within its scope.


3. What products are within the scope of TSCA regulation?


Tobacco, nuclear materials, firearms, food, food additives, pharmaceuticals, cosmetics, and pesticides are exempted. All others are within the scope, such as electronic and electrical products.


4. What is the future trend of TSCA regulation?


For existing chemicals, TSCA requires the EPA to conduct chemical assessments to determine whether substances are "high" priority or "low" priority. For "high" priority substances, the EPA must complete chemical risk assessments, and for substances determined to pose significant risks, the EPA must take final risk management measures within two years (extendable to four years if necessary). Therefore, the number of substances controlled by TSCA is gradually increasing, similar to the EU's REACH regulation. Enterprises need to enhance their awareness of controlling product risks and strengthen control over their production processes to adapt to regulatory changes and requirements at any time.


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