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Updates: On July 29, 2022, South Korea's Ministry of Environment (MoE) published MoE Ordinance No.997 to announce the adoption of Article 34(2) into the K-REACH Enforcement Rules, which clarifies the criteria for the designation of candidate substances subject to authorization. It will come into force on October 15, 2022. However, the supporting Regulation on Designation, etc. of Substances subject to Authorization, which was drafted in line with the Article 34(2) in February 2022 hasn't been finalized.
Besides the addition of the Article 34(2), other proposed amendments to K-REACH Enforcement Rules as per the MoE Announcement No. 2022-90 were adopted as well. For details about 'examption confirmation', please refer to South Korea Simplifies Data Requirements for Exemption Confirmation for Non-hazardous R&D Substances
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The concept of 'substances subject to authorization' has been proposed in K-REACH since 2015, however, there's no regulations promulged to specify how to designate and manage them. A new Article 34(2) was proposed to be added into the K-REACH Enforcement Rules on February 18, 2022 by MoE Announcement No. 2022-90 to clarify the criteria for the designation of candidate substances subject to authorization. In line with the Article 34(2), the MoE notified WTO on February 18, 2022 the draft Regulation on Designation, etc. of Substances subject to Authorization (hereinafter referred to as Regulation) and then issued it on February 22, 2022 by the MoE Announcement No. 2022-91 for public comments.
The draft Regulation contains 13 articles and 2 annexes (Annex 1 Criteria for the Priorities and Approval of the Selection of Candidate Substances; Annex 2 Main Contents when Submitting Opinions on the Candidate Substances). MoE will review the Regulation and make improvements every three years counting from January 1, 2023.
As per the draft Regulation, the main procedures of designating substances subject to authorization are summarized as below.
Step 1 Designation of candidate substances
A candidate substance subject to authorization will be designated considering the following criteria stipulated in the Article 34(2) of the draft amendments to K-REACH Enforcement Rules:
Hazards (equivalent to that presented by a priority management substance);
Total circulation amount in South Korea;
Users of the substance exposed to (only workers or general consumers); and
International regulations on the substance
Step 2 Public consultation on each candidate substance
The MoE publishes the list of candidate substances subject to authorization with the following information, including chemical name, circulation amount, relevant overseas regulations, and the schedule for soliciting public comments on each candidate substance, etc. According to the schedule, the MoE conducts detailed surveys on the distribution of each candidate substance, reviews its risks, makes the results public to all, and carries out a consultation regarding the hazards, specific uses, alternatives substances and technologies, etc.
Step 3 Discussion with stakeholders (manufacturers, importers, downstream users, etc.)
The MoE prioritizes candidate substances based on feedbacks of the public consultation. Then, the MoE will discuss with the stakeholders regarding uses that can be exempted from authorization, the grace period, the content threshold for mixtures subject to authorization, etc.
* It should be noted that the MoE prohibits stakeholders who participate in the discussion to disclose confidential business information (CBI) that may be obtained when reviewing the submitted data in the process of designation of candidate substances.
Step 4 Designation and public announcement of the substances subject to authorization
After deliberation by the Chemicals Evaluation Committee, the MoE designates and publicly announces the substances subject to authorization (with the information that has been discussed in Step 3).
Other Amendments to K-REACH Enforcement Rules
Besides the addition of the new article-Article 34(2), there are some other amendments to the K-REACH Rules as per the MoE Announcement No. 2022-90. Including:
1. Data requirements for registration will be simplified (some environmental hazard test data will not be required) if a new substance is manufactured or imported between 0.1t/y and 1 t/y and falls into any of the following conditions:
Water solubility is < 1mg/liter; or
Be manufactured/imported only for intermediates and process regulators purposes.
2. Importers in South Korea can apply for the exemption confirmation (exempted from providing chemical name and CAS No.) if the substance meets the following conditions:
Imported<0.1 t/y for R&D purposes;
Non-hazardous; and
Overseas suppliers who have CBI concerns are unwilling to provide chemical name and CAS No., but the corresponding MSDS is provided.
The draft amendments to K-REACH Enforcement Rules and the draft Regulation are under consultation until March 30, 2022. Once approved, both will come into force on October 15, 2022.
The official documents can be downloaded here:
Draft amendments to K-REACH Enforcement Rules
Draft Regulation on Designation, etc. of Substances subject to Authorization
