On July 8, 2025, the National Institute of Chemical Safety (NICS) of South Korea announced a draft revision to the Notice on the Designation of Toxic Substances. This revision is proposed in order to respond to the amended Chemicals Control Act, which will take effect on August 7, 2025. The draft revision aims to improve chemical substance regulation by classifying and distinguishing substances based on different types of risk (hazard). Until now, these substances have been collectively regulated as “toxic substances.” Specifically, the draft amendment classifies chemicals into the following three types according to their hazardous characteristics:
- Substances with acute hazard to human health (e.g., substances that adversely affect human health upon short-term exposure)
- Substances with chronic hazard to human health (e.g., substances that adversely affect human health upon repeated exposure)
- Substances with ecological hazard (e.g., substances that adversely affect ecosystems upon short-term or long-term exposure)
These three types of substances are collectively defined as “substances hazardous to human health or ecosystems” and will be controlled separately according to their respective hazard types.
The key details of the proposed revision are as follows:
- The regulation will be renamed from “Notice on the Designation of Toxic Substances” to “Notice on the Designation of Substances with Acute Hazard to Human Health, Substances with Chronic Hazard to Human Health, and Substances with Ecological Hazard.”
- The existing toxic substance list, as stipulated in Appendix to the Notice on the Designation of Toxic Substances, will be revised. The revised list will include substances 97-1-1 to No. 2025-1-1248, and will classify substances in three different types, with updated concentration thresholds specified for each type. Substances that do not meet the criteria for these three substance types will be removed from the list.
- Fifteen chemical substances (No. 2025-1-1249 to 2025-1-1263), identified from among “existing or new chemical substances” that have undergone hazard assessment under Article 18 of the Act on Registration, Evaluation, etc. of Chemicals (K-REACH), will be newly designated as substances with hazard to human health or ecosystems.
- Seventeen chemical substances (No. 2025-1-1264 to 2025-1-1280), selected from among accident preparedness substances and prohibited substances, will also be newly designated as substances with hazard to human health or ecosystems based on the results of hazard assessments.
Example of the revised list
For example, the following substance will be classified as a substance with acute or chronic hazard to human health, depending on its concentration.
Current version | Revised version | |||||
---|---|---|---|---|---|---|
No. | Substance name | Substance name | Threshold for acute hazard to human | Threshold for chronic hazard to human | Ecological hazard | Type |
97-1-12 | Nitrobenzene; 98-95-3 and mixture containing 0.3% or more of this substance | Nitrobenzene; 98-95-3 | 25% | 0.3% | – | Substance with acute / chronic hazard to human |
Transitional Measures provided:
With the reclassification under the draft amendment, where new substances have been designated or the concentration thresholds of existing substances have been revised, businesses already handling such substances will be granted a grace period to comply with the obligations set forth under the Chemicals Control Act, such as labeling requirements, import notification, business licensing, and handling standards. The duration of the grace period will vary depending on the specific provision.
The NICS is accepting public comments on this proposed amendment until July 28, 2025.
The original text of the Notice on the Designation of Substances with Acute Hazard to Human Health, Substances with Chronic Hazard to Human Health, and Substances with Ecological Hazard can be accessed by using search box on the NICS website:
https://nics.me.go.kr/boardView.do.
Preliminary Notice of Partial Amendment to the Public Notice on the Designation of Toxic Substances (in Korean)
https://opinion.lawmaking.go.kr/gcom/admpp/45350?announceType=TYPE6&mappingAdmRulSeq=2000000318820