TSCA in the United States
TSCA Introduction
TSCA in the United States is the Toxic Substances Control Act of the United States. It was enacted by the U.S. Congress in 1976 and took effect in 1977. The U.S. Environmental Protection Agency (EPA) is responsible for its implementation. The Act 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 several revisions, TSCA has become an important regulation for the effective management of chemical substances in the United States. For companies whose products exported to the United States fall into the TSCA regulatory category, TSCA compliance is a prerequisite for normal trade. The updated inventory in February 2021 contains 86,557 chemicals, of which 41,864 are active chemicals.
TSCA in the United States
Scope of control
TSCA applies to chemical substances themselves, chemical substances in mixtures, and chemical substances intentionally released in articles that are produced by natural and chemical reactions. It should be noted that chemical substances defined by TSCA also include microorganisms. However, the following categories of chemicals are subject to other federal laws and are not regulated by TSCA: tobacco and tobacco products, nuclear materials, munitions, food, food additives, drugs, cosmetics, and substances used only as pesticides.
TSCA Control Scope
How to determine whethe~r the TSCA catalog contains the substance
The TSCA catalog is a dynamic catalog that includes approximately 85,000 chemical substances, divided into public and confidential parts. Substances listed in the TSCA catalog are existing substances, and those not listed are new substances. U.S. manufacturers and importers of existing and new substances must fulfill the corresponding regulatory obligations.
Submitters with TSCA verification requirements can provide EPA with specific chemical identification data, including:
· Chemical Abstract Index Name (appropriate CA Index Name can be obtained from the Inventory Expert Service of Chemical Abstract Service);
· Information about the manufacture or import of the substance;
· Support Letter if the supplier withheld certain information (such as specific chemical identity) from the submitter:
· Proof of intent to manufacture or import the substance for commercial purposes;
· All other information required to support the notification.
EPA will review the information submitted in a true notification and, if the agency believes that the submitter has demonstrated a true intent to manufacture or import, will search the complete TSCA inventory master file and provide the submitter with a written determination of the TSCA inventory status of the chemical. TSCA official website: https://www.epa.gov/tsca-inventory
How to test the points
(1) Only non-metallic materials need to be tested, metal, glass, magnetic core and ceramic are not selected.
(2) For components on PCB, select PCB and electrolytic capacitors.
(3) Except for components, the remaining parts are roughly tested with reference to the non-metallic parts of RoHS.
(4) If splitting is involved after mixed testing, another quotation is required, and raw materials are not allowed to be mixed.
Purpose of Control
The TSCA Act was originally established for three main purposes:
(1) to evaluate and manage the safety of new chemicals or their commercial products before they enter the market;
(2) to give priority to the management of chemicals that "pose unreasonable risks to human health and the environment" among existing chemicals in 1976;
(3) to regulate the spread and use of the above chemicals.
TSCA mainly evaluates and restricts the short-term and long-term environmental and health risks of industrial chemicals and their related products before and after entering the market.
TSCA Compliance Recommendations
TSCA regulations apply to branches of Chinese companies in the United States, as well as to American companies that import chemicals from China. For companies whose products exported to the United States fall into the TSCA regulatory category, TSCA compliance is a prerequisite for normal trade. The compliance points are as follows:
1. The enterprise must determine whethe~r the product falls within the scope of TSCA supervision and whethe~r the substance in the product is a new substance;
2. If it is a new substance and meets the corresponding exemption conditions, it can be directly exempted or a pre-production (PMN) exemption declaration can be made. If it is not exempted, a pre-production declaration (PMN) must be submitted;
3. If it is an existing substance and the annual export tonnage is more than 25,000 pounds (about 11.3 tons), the importer must be reminded to submit the CDR on time;
4. If it is a general existing chemical substance, a TSCA active substance declaration and a TSCA compliance or exemption statement must be completed;
5. If it involves TSCA focus substances, further measures need to be taken.
Latest developments
On January 6, 2021, the U.S. Environmental Protection Agency (EPA) issued the final rule on the control of hazardous substances. The rule puts forward control requirements for the five substances of decabromodiphenyl ethe~r, phenol, isopropyl phosphate, 2,4,6-TTBP)TTBP, HCBD, and PCTP, and the products and articles containing the substances.
Commercial activities that produce, process and distribute the above five substances are prohibited, restricted and controlled by the EPA. For example, if a company uses DecaBDE to produce or process wires or cables, this business behavior will be prohibited by the EPA from January 6, 2023. After March 8, 2021, manufacturers or processors that engage in this business activity will need to provide certain trade information and compliance statements. Submit compliance documents to the EPA within 30 days when requested by the EPA.
Five toxic substances detected by TSCA in the United States
The five controlled substances and their common uses are as follows:
Decabromodiphenyl ethe~r (DecaBDE): Flame retardant in plastic casings of wires and cables for televisions, computers, audio and video equipment, textiles and upholstered items, communications and electronic equipment, and other applications;
Phenol, isopropyl phosphate (3:1) (PIP (3:1)): Plasticizer, flame retardant, anti-wear additive or anti-compression additive in hydraulic fluids, lubricating oils, lubricants and greases, various industrial coatings, adhesives, sealants and plastic products;
2,4,6-tri(tert-butyl)phenol (2,4,6-TTBP): Processing intermediate/reactant, incorporated into formulations for fuels and fuel-related additives;
Hexachlorobutadiene (HCBD): A chemical used as a halogenated aliphatic hydrocarbon, produced as a by-product in the production of chlorinated hydrocarbons; and
Pentachlorobenzene (PCTP): A chemical used to make rubber softer in industrial applications.
TSCA in the United States
TSCA Introduction
TSCA in the United States is the Toxic Substances Control Act of the United States. It was enacted by the U.S. Congress in 1976 and took effect in 1977. The U.S. Environmental Protection Agency (EPA) is responsible for its implementation. The Act 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 several revisions, TSCA has become an important regulation for the effective management of chemical substances in the United States. For companies whose products exported to the United States fall into the TSCA regulatory category, TSCA compliance is a prerequisite for normal trade. The updated inventory in February 2021 contains 86,557 chemicals, of which 41,864 are active chemicals.
TSCA in the United States
Scope of control
TSCA applies to chemical substances themselves, chemical substances in mixtures, and chemical substances intentionally released in articles that are produced by natural and chemical reactions. It should be noted that chemical substances defined by TSCA also include microorganisms. However, the following categories of chemicals are subject to other federal laws and are not regulated by TSCA: tobacco and tobacco products, nuclear materials, munitions, food, food additives, drugs, cosmetics, and substances used only as pesticides.
TSCA Control Scope
How to determine whethe~r the TSCA catalog contains the substance
The TSCA catalog is a dynamic catalog that includes approximately 85,000 chemical substances, divided into public and confidential parts. Substances listed in the TSCA catalog are existing substances, and those not listed are new substances. U.S. manufacturers and importers of existing and new substances must fulfill the corresponding regulatory obligations.
Submitters with TSCA verification requirements can provide EPA with specific chemical identification data, including:
· Chemical Abstract Index Name (appropriate CA Index Name can be obtained from the Inventory Expert Service of Chemical Abstract Service);
· Information about the manufacture or import of the substance;
· Support Letter if the supplier withheld certain information (such as specific chemical identity) from the submitter:
· Proof of intent to manufacture or import the substance for commercial purposes;
· All other information required to support the notification.
EPA will review the information submitted in a true notification and, if the agency believes that the submitter has demonstrated a true intent to manufacture or import, will search the complete TSCA inventory master file and provide the submitter with a written determination of the TSCA inventory status of the chemical. TSCA official website: https://www.epa.gov/tsca-inventory
How to test the points
(1) Only non-metallic materials need to be tested, metal, glass, magnetic core and ceramic are not selected.
(2) For components on PCB, select PCB and electrolytic capacitors.
(3) Except for components, the remaining parts are roughly tested with reference to the non-metallic parts of RoHS.
(4) If splitting is involved after mixed testing, another quotation is required, and raw materials are not allowed to be mixed.
Purpose of Control
The TSCA Act was originally established for three main purposes:
(1) to evaluate and manage the safety of new chemicals or their commercial products before they enter the market;
(2) to give priority to the management of chemicals that "pose unreasonable risks to human health and the environment" among existing chemicals in 1976;
(3) to regulate the spread and use of the above chemicals.
TSCA mainly evaluates and restricts the short-term and long-term environmental and health risks of industrial chemicals and their related products before and after entering the market.
TSCA Compliance Recommendations
TSCA regulations apply to branches of Chinese companies in the United States, as well as to American companies that import chemicals from China. For companies whose products exported to the United States fall into the TSCA regulatory category, TSCA compliance is a prerequisite for normal trade. The compliance points are as follows:
1. The enterprise must determine whethe~r the product falls within the scope of TSCA supervision and whethe~r the substance in the product is a new substance;
2. If it is a new substance and meets the corresponding exemption conditions, it can be directly exempted or a pre-production (PMN) exemption declaration can be made. If it is not exempted, a pre-production declaration (PMN) must be submitted;
3. If it is an existing substance and the annual export tonnage is more than 25,000 pounds (about 11.3 tons), the importer must be reminded to submit the CDR on time;
4. If it is a general existing chemical substance, a TSCA active substance declaration and a TSCA compliance or exemption statement must be completed;
5. If it involves TSCA focus substances, further measures need to be taken.
Latest developments
On January 6, 2021, the U.S. Environmental Protection Agency (EPA) issued the final rule on the control of hazardous substances. The rule puts forward control requirements for the five substances of decabromodiphenyl ethe~r, phenol, isopropyl phosphate, 2,4,6-TTBP)TTBP, HCBD, and PCTP, and the products and articles containing the substances.
Commercial activities that produce, process and distribute the above five substances are prohibited, restricted and controlled by the EPA. For example, if a company uses DecaBDE to produce or process wires or cables, this business behavior will be prohibited by the EPA from January 6, 2023. After March 8, 2021, manufacturers or processors that engage in this business activity will need to provide certain trade information and compliance statements. Submit compliance documents to the EPA within 30 days when requested by the EPA.
Five toxic substances detected by TSCA in the United States
The five controlled substances and their common uses are as follows:
Decabromodiphenyl ethe~r (DecaBDE): Flame retardant in plastic casings of wires and cables for televisions, computers, audio and video equipment, textiles and upholstered items, communications and electronic equipment, and other applications;
Phenol, isopropyl phosphate (3:1) (PIP (3:1)): Plasticizer, flame retardant, anti-wear additive or anti-compression additive in hydraulic fluids, lubricating oils, lubricants and greases, various industrial coatings, adhesives, sealants and plastic products;
2,4,6-tri(tert-butyl)phenol (2,4,6-TTBP): Processing intermediate/reactant, incorporated into formulations for fuels and fuel-related additives;
Hexachlorobutadiene (HCBD): A chemical used as a halogenated aliphatic hydrocarbon, produced as a by-product in the production of chlorinated hydrocarbons; and
Pentachlorobenzene (PCTP): A chemical used to make rubber softer in industrial applications.