The Toxic Substances Control Act (TSCA) was enacted by the US Congress in 1976 and went into effect in 1977, with the US Environmental Protection Agency (EPA) responsible for implementation. The purpose of the Act is to consider the environmental, economic and social impacts of chemical substances circulating in the United States and to prevent &ldquo risks to human health and the environment. Unreasonable risk” . After numerous revisions, TSCA has become an important regulation for the effective management of chemical substances in the United States. For companies whose imports into the United States fall under the TSCA regulatory category, TSCA compliance is a prerequisite for normal trade. TSCA final rules for hazardous substances put forward control requirements for the products of many enterprises. TSCA is the entry threshold for products to enter the United States. Enterprises need to understand the control requirements of regulations as soon as possible, and determine the conformity of products through testing or supply chain investigation. CTI can provide targeted service solutions to help enterprises timely respond to regulatory control requirements, reduce export risks, help products achieve full compliance, and win the US market. The purpose of the TSCA Act is to comprehensively consider the environmental, economic, and social impacts of chemical substances circulating in the United States and to prevent &ldquo risks to human health and the environment. Unreasonable risk” . After numerous revisions, TSCA has become an important regulation for the effective management of chemical substances in the United States.

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

2, triphenyl isopropyl phosphonate (PIP (3:1)) CAS No. 68937-41-7

3, 2,4,6 tert-butylphenol (2,4,6-TTBP) CAS No. 732-26-3

4, Pentachlorothiophenol (PCTP) CAS No. 133-49-3 ⑤ Hexachlorobutadiene (HCBD) CAS No. 87-68-3

Note: Manufacturers are obliged to bring substances under control from March 8, 2021, and distributors will be under control from January 6, 2022.

The Toxic Substances Control Act (TSCA) does not, as the name suggests, classify substances as “ Toxic substances ” And “ Non-toxic substances ” Instead, it classifies matter as “ Existing substance ” And “ New substance ” To manage, whether belong to “ New chemicals ” Subject to whether the substance is included in the US TSCA list. Food, pesticides, drugs, tobacco and other substances are governed by other U.S. regulations and are exempt from U.S. TSCA declarations.

The U.S. TSCA List is a dynamic list of more than 85,000 chemical substances, divided into public and confidential sections. Substances listed in the U.S. TSCA list are existing substances, and those not listed are new substances. Producers and importers of existing and new substances in the United States are required to meet the corresponding legal obligations.

For new substances, companies submit PMN to EPA through the e-PMN online system at least 90 days prior to production or import.

  In addition to PMN notification prior to the production of new substances, there are other types of declarations or exemptions for the management of new substances under TSCA:

R& D Exemption: applies only to a small number of new substances for research and development purposes. The entity is not required to report materials to EPA, but the entity must have a responsible person to confirm the safe use of the product and be responsible for the safe use of the product;

Low release/Exposure exemptions: New substances that meet the appropriate criteria are required to submit a declaration to EPA within 30 days prior to production or use;

Test Marketing Exemption: For pre-manufactured new substances distributed to specific customers to open up the market, a declaration must be submitted to EPA within 45 days prior to production

Polymer Exemption: New polymers with no chemical activity or biological effects are exempt from PMN filing, and entities are not required to submit relevant materials to EPA, but are required to file supporting materials for review;

Minor exemption: Annual production or import & < 10 tons of new substances can be submitted to EPA within 30 days prior to production, import or use.

For a substance listed in the U.S. TSCA, that is, an existing substance, the manufacturer or importer of the substance must verify that the substance and the corresponding use comply with the Significant New Use Rule (SNUR) and Chemical Data Reporting (CDR) requirements. Products that fall within the scope of U.S. TSCA regulation or exemption must provide a U.S. TSCA compliance or exemption declaration at the time of product entry.

TSCA targets producers, processors, importers, and traders in the United States. The so-called United States, mainly the United States mainland, the District of Columbia, Puerto Rico.

TSCA has different regulatory requirements for existing substances and new substances, distinguishing between new substances and existing substances, mainly through the management of the list, as of February 2022, there are 68,576 published existing substances, in addition to 18,055 existing substances listed in the confidential list. To access the confidential list, a U.S. company must file a bona fide intent with the EPA.

There is also a distinction between active and inactive substances in the U.S. TSCA list, which currently has 42,435 active substances and 44,196 inactive substances. If an enterprise wants to produce or import an inactive substance, it must first submit a form B to the EPA and change the status of the substance to an active substance before it can be produced, imported or used.