Regulatory Developments

K-REACH Amendments Expected to Be Promulgated Shortly and Be Enforced January 2019

March 16, 2018

The South Korean Ministry of Environment (MOE) announced on March 14, 2018, that amendments to the Act for the Registration and Evaluation of Chemicals (K-REACH) will be promulgated on March 20, 2018, and be enforced beginning January 1, 2019. As reported in our January 4, 2018, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” MOE proposed changes at the end of 2016 that would drastically alter the current legislation and require all substances imported over one ton per year to pre-register and eventually register substances regardless of inventory status.

As initially enacted, K-REACH would have designated priority existing chemicals (PEC) in three batches for registration. MOE announced the first batch of PECs on July 1, 2015, and PECs imported above one ton per year must be registered by June 30, 2018. This registration deadline is unchanged by the amendments. The amendments will apply a phase-in registration mechanism for the remaining existing chemical substances manufactured or imported in volumes greater than or equal to one ton per year, however. The amendments include the following registration deadlines, based on hazard and tonnage band:

  • 2018: 510 PECs;
     
  • 2021: Registration deadline for all substances used in volumes of over 1,000 tons per year and substances that are carcinogenic, mutagenic, or toxic to reproduction (CMR) used in volumes of one ton or more per year;
     
  • 2024: Registration deadline for substances used in volumes of 100 to 1,000 tons per year;
     
  • 2027: Registration deadline for substances used in volumes of ten to 100 tons per year; and
     
  • 2030: Registration deadline for substances used in volumes of one to ten tons per year.
     

To help MOE identify and manage potential registrants, and improve joint registration, companies will be required to report information such as the name of the company and the estimated volume of manufacture or import before beginning manufacture or import. Under the amendments, the registration periods based on volume will apply only to companies that pre-register.

MOE will strictly manage substances and products that contact substances that are designated “critically controlled substances.” Critically controlled substances can include the following categories: CMR substances; highly toxic substances; products that contain high amounts of residual substances (i.e., >0.1 percent and imported above one ton); and substances that cause harm to specific organs such as the lungs and liver.

The amendments will also implement a fine system intended to recover illegal economic benefits obtained by manufacturing or importing chemical substances without registering them. MOE states that it plans to implement the changes by communicating with stakeholders such as industry and non-governmental organizations.

For further assistance, please e-mail or call Karin F. Baron, MSPH, at kbaron@actagroup.com or (202) 266-5022.


 
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