On February 22, 2022, the Ministry of Environment of South Korea issued draft “Regulations on Designation of Substances Subject to Authorization” which sets forth criteria for selecting and disclosing candidate substances for substances subject to authorization. In the draft, the selection criteria for the candidate substances includes toxicity, volume of distribution, range of users (general persons, establishments, etc.), and regulatory status outside South Korea, and for the selected candidate substances, such information will be made public in advance and a public comment period will be conducted. In South Korea, anyone who manufactures, imports, or uses a chemical substance designated as a substance subject to authorization is required to submit relevant documents to the Ministry of Environment in advance and obtain authorization. However, as of March 15, 2022, there are no chemical substances designated as substances subject to authorization.
The original text of the draft Regulations can be viewed at the following URL (in Korean).
The main provisions of the Regulations on Designation of Substances Subject to Authorization are as follows.
- Candidate substances for substances subject to authorization shall be selected according to an evaluation score given to each chemical substance based on toxicity, volume of distribution, range of users (general persons, establishments, etc.), and regulatory status outside the country.
- For each selected candidate substance, information such as the name of the substance, scale of distribution volume, and regulatory status outside the country will be made public in advance. In addition, hazardous properties of the candidate substance will be examined separately, and the results will be also made public to solicit opinions on issues such as hazardous properties, specific uses, and alternative substances of the substance concerned.
- After soliciting opinions, the Ministry of Environment will determine the substances subject to authorization to be designated with priority, and after discussions with business operators that manufacture, import, or use the substances, will set the requirements for exemption from authorization and the grace period for authorization.
- Thereafter, a plan for the designation of substances subject to authorization will be formulated and publicly announced, and after deliberation by the Chemical Substance Evaluation Committee, the substances subject to authorization will be officially notified.
The solicitation of comments on this draft will continue until March 14, 2022. If the draft is officially finalized after deliberation by the National Diet, it is scheduled to go into effect on October 15, 2022.