NAM&NAM | Overseas Chemical Regulations | US TSCA
US
TSCA
US Toxic
Substance
Control Act
  • Applicable law
    Toxic Substance Control Act
  • Effective date
    October 11, 1976
  • Purpose
    To regulate the chemicals posed an ‘unreasonable risk to health or to the environment’ in their distribution and use
  • Chemical substances not on the Inventory
    The chemicals below are not regulated under TSCA:
    • Pesticides
    • Tobacco and tobacco products
    • Nuclear materials
    • Munitions
    • Foods, food additives, Drugs, or Cosmetics
Existing
substances list
TSCA Inventory
  • US Environmental Protection Agency (EPA), Existing substances inventory is available for download online.
  • New substances, not listed on the Existing substance inventory
TSCA Active-Inactive Rule
  • Active
    Substance
    Its (manufacture/ import) activity in US is reported since 2006
    Form-B Notice is not needed.
  • Inactive
    Substance
    Its (manufacture/ import) activity in US is not reported since 2006
    Form-B Notice, it is necessary to submit at least 90 days prior to manufacture/ import.
Pre-Manufacture
Notice (PMN)
  • Pre-manufacture Notice (PMN) should be submitted and approved, before New substance is manufactured/ imported.
  • Person who should charge on submitting: Manufacturer/ importer in US
  • Main information required for PMN:
    • Person submitting notice, Technical contact
    • Chemical identity information: CASrN, molecular formula, impurities/ byproducts, MSDS etc.
    • Production, import, and use information
    • Physico-chemical properties, Environmental & health hazardous data (if possible)
    • Expected volume of manufacture/ import for 3 yrs after PMN
    • Exposure information in manufacture/ import for worker and environment.
Exemption from Pre-manufacturing Notice (PMN)
  • Division
    Type of exemption
    EPA examination period
  • Active
    Substance
    Type of exemption
    EPA examination period
    R&D exemption
    N/A
    Polymer exemption
    N/A
  • Inactive
    Substance
    Type of exemption
    EPA examination period
    TME; Test Marketing Exemption
    45 days
    LVE; Low Volume Exemption
    30 days
    LoREX; Low Release & Exposure Exemption
    30 days
Our service
  • Advice and/or education program on US TSCA
  • Service for TSCA inventory
  • Service for PMN, SNUN, PMN exemption
  • Review (data gap) of test data for TSCA
  • Test preparation of Physico-chemical properties and hazardous toxicity
Do you have further questions?
Please send us a quote request or inquiry. A person in charge of each department will help.
Overseas Chemical Regulations
+82-2-6714-1190
Overseas Chemical Regulations Weekdays 09:00 ~18:00
(not available on weekend/holidays)