TSCA Requirements for Importing Chemicals
What are TSCA Import Certification Requirements?
It is mandatory for importers of any chemical substance, chemical mixtures, or articles that contain a chemical substance to follow the Toxic Substances Control Act (TSCA) to be a part of the U. S. market. Importers need to certify that the chemicals are in compilation with TSCA positive certification. Chemical-free products do not require TSCA positive certification for being a part of the U. S. market. The requirements to import in the U. S. are described in:-
• Section 13 in the Toxic Substances Control Act (TSCA) (15 U.S.C. 2612).
• Implementing regulations developed by the U.S. Customs and Border Protection (CBP),
• EPA, at 19 CFR 12.118 through 12.127.
• EPA, companion policy statement of chemical imports at 40 CFR 707.20 (PDF) (3 pp., 183 kb).
Import of New Chemicals and their uses:-
TSCA section 3(7) defines the word manufacture that is part of the import. This clarifies that section 5(a)(1)(B) require to submit a pre-manufacture notice (PMN) to EPA at least 90-days before commencing non-exempt commercial manufacture of a replacement chemical substance in the U. S. that is applied to the import of the latest chemicals, as does the section 5(a)(2) significant new use notice (SNUN) requirement. Therefore, the intended import of chemical substances can lead to the following provisions:
• Pre manufacture notice provisions for the new chemicals in sec. 40 CFR Part 720
• Provision for significant new use notice in 40 CFR Part 721
• Pre manufacture notice for exemptions in new chemicals in sec. 40 CFR Part 723
• Reporting requirements for inter-generic microorganisms in sec. 40 CFR Part 725
• Learn in detail about EPA's new chemicals program.
An importer's TSCA certification statement must certify either that the chemical shipment is:
Positive Certification Statement:
A positive certification means the chemical substance is in regulation with all applicable TSCA rules including:
• Section 5 for premanufacture notification rules.
• Section 5 for significant new use rules.
• Section 5(e) for orders.
• Section 5(f) for rules and orders.
• Section 6 for rules and orders
• Section 7 for judicial actions
• Title IV for rules and orders
For further understanding sections, 4 and 8 rules do not relate to section 13 of import certification requirements. Importers need to satisfy all applicable requirements of sections four and eight rules to comply with the above-mentioned provisions that are not associated with individual chemical shipments and thus don't affect import certification.
Negative Certification Statement: - It means that the chemical shipment is not subject to TSCA.
A negative certification is needed for the following products as they are not clearly identified as a chemical substances. Check the list below:-
• Any chemical pesticide.
• Any food, preservative additive, drug, cosmetic, and device.
• Source material, special nuclear material, and the by-product of any material.
• Firearms and ammunitions as mentioned in section 3 of TSCA.
There are possibilities that, these products could also be considered clearly identified once they are related to another relevant agency’s entry documentation or electronic entry filing requirements. It includes Notice of Arrival for pesticides or applicable entry documentation for FDA-regulated products.
No certification is required for tobacco and tobacco products as any presence of chemicals is a part of the end product. However few countries may require statement certification with the application of special rules under TSCA.