Reason for Amendment

• With the amendment of the Act on Registration, Evaluation, etc. of Chemicals (Amendment No. 20232, February 6, 2024, effective August 7, 2025), which includes the removal of the definition of toxic substances and the introduction of new definitions such as acute human toxicity substances, chronic human toxicity substances, ecological toxicity substances, and substances whose toxicity is not confirmed, the amendment is aimed at establishing necessary regulations and details on matters delegated by the law. This includes setting the criteria for substances whose toxicity is not confirmed.
  
  

Key Points
a. Establishment of Criteria for Substances Whose Toxicity is Not Confirmed (Article 2-2 and Appendix 1-2)

• As the definition of substances whose toxicity is not confirmed is newly introduced in Article 2(10) of the law, the specific criteria for these substances are established.
  
  

b. Change of the Designated Institution for New Chemical Substance Reporting to Korea Environment Corporation

• The delegation of new chemical substance reporting tasks to Korea Environment Corporation is reflected in the relevant regulations. The scope of materials that can be submitted during reporting is expanded to include both owned and verified data.

• Amendments are made to the requirements for reporting changes when substances no longer meet the criteria for toxicity confirmation.

• A new regulation on the review method for the adequacy of submitted data and subsequent notification to relevant authorities is included under Article 19-3.
  
  

c. Reflection of Terminology Changes Due to the Amendment (Articles 25, 34, 35, 38, and 40)

• Definitions for toxic substances are removed, and new definitions for acute human toxicity substances, chronic human toxicity substances, and ecological toxicity substances are introduced. The terminology for these changes is reflected in the regulations.
  
  

d. Information Provision and Disclosure of Chemical Substance Information According to Legal Amendments (Articles 35, 37, 51, and New Article 51-2)

• With the addition of substances whose toxicity is not confirmed to the target group for information provision under Article 29(1)3, the provision and disclosure of information for such substances are regulated.

• The scope of chemical substance information disclosure and the procedures for modifying and supplementing disclosed information are specified, with new forms introduced.
  
  

e. Adjustment of New Chemical Substance Registration and Reporting Standards

• Amendments are made to the method of submitting test data and related forms, reflecting changes in the law such as the introduction of the definition of substances whose toxicity is not confirmed (Appendix 1, Appendix 4, 5-3, 5-4, 5-5, 12, 16, 17, 25, 26).
  
  

f. Removal of Importer Information Section in Forms for Registration/Reporting

• Since importer information is already submitted during chemical substance registration and reporting and is managed through change notifications, the section for the importer's details is removed from the forms when requesting data protection or extension of the protection period (Appendix 37).
  
  

g. Consolidation of Reporting Authority for Appointment or Dismissal under Article 38(2)

• The authority to receive reports on the appointment or dismissal of personnel will be centralized under the Korea Environment Corporation, reflecting changes from various other bodies (Article 49).
  
  

h. Change in Inspection and Access Authorities for Business Operators under Article 43

• The authority for inspections and access will be amended to grant this responsibility to the Minister of Environment and local environmental offices, instead of various agencies such as the National Institute of Environmental Research (Article 52).