South Korea Regulatory News

The National Institute of Chemical Safety in South Korea has announced the development of an advanced ultrasonic detector that can detect high-pressure gas leaks within 0.5 seconds. This innovative t...

The National Institute of Chemical Safety in South Korea has announced the development of an advanced ultrasonic detector that can detect high-pressure gas leaks within 0.5 seconds. This innovative technology overcomes the limitations of current electrochemical detectors, which are slower and less accurate. The ultrasonic sensor is expected to significantly reduce the damage caused by chemical accidents by quickly calculating and reporting the amount of leakage. 

State-Owned Patent and Industry Collaboration 

The National Institute of Chemical Safety has applied for a state-owned patent and partnered with SM Instruments Co., Ltd. to complete the prototype. Next year, they will collaborate with semiconductor companies to test its field applicability and begin mass production. This innovation marks a new paradigm in sensor technology and aims to enhance chemical safety in the semiconductor and display industries. 

On November 12, 2024, the Ministry of Environment announced an amendment to the "Regulations on the Specified Quantities of Toxic Substances, Restricted Substances, Prohibited Substances, and Permitte...

On November 12, 2024, the Ministry of Environment announced an amendment to the "Regulations on the Specified Quantities of Toxic Substances, Restricted Substances, Prohibited Substances, and Permitted Substances." The purpose of this amendment is to inform the public of the reasons and main contents of the amendment and to gather public opinions in accordance with Article 46 of the Administrative Procedures Act. 

1. Reason for Amendment 

Following the amendment of the "Designation Notice of Toxic Substances" (Chemical Safety Agency Notice No. 2024-34) on August 30, 2024, it is necessary to establish the specified quantities for newly designated toxic substances in order to distinguish the submission targets for chemical accident prevention management plans. 

2. Main Contents of the Amendment 

• Designation of Specified Quantities for New Toxic Substances: Specified quantities will be set for 10 newly designated toxic substances, including upper and lower limits. 

• Reflecting Changes in Existing Toxic Substances: Changes to the names and CAS numbers of 2 existing toxic substances will be reflected. 

• Resetting the Review Period: The review period for the regulations will be reset. 

3. Submission of Opinions 

Institutions, organizations, or individuals with opinions on this amendment are requested to review the amendment on the website of the Ministry of Environment (www.me.go.kr) and submit their opinions to the Minister of Environment (Director of Chemical Safety Division) by December 2, 2024. 

On November 20, 2024, South Korea’s National Institute of Chemical Safety (NICS) published an administrative notice of Partial Revision of Regulations on the Classification and Labelling of Chemic...

On November 20, 2024, South Korea’s National Institute of Chemical Safety (NICS) published an administrative notice of Partial Revision of Regulations on the Classification and Labelling of Chemical Substances in accordance with the Act on the Registration and Evaluation of Chemical Substances (K-REACH). 

Following the hazard assessment conducted under K-REACH, new classifications for toxic substances have been designated. This includes notifications and amendments related to the classification and labeling of existing hazardous chemicals that have undergone hazard evaluations. 

Main Contents 

1. Hazard Assessments: 

• Conducted on new and existing chemicals in accordance with Article 18 of K-REACH. 

• New hazard classification marks were established for newly designated toxic substances. 

• Identification numbers "2024-1-1223" to "2024-1-1248" were assigned for the classification and labeling of 26 types of toxic substances, including "1-octene". 

• Revised classification and labeling for existing hazardous chemicals requiring updates based on additional data. 

• Revision of hazardous ingredients and labeling for one toxic substance (unique number "2019-1-956"). 

2. Interim Measures: 

• Compliance deadlines for those required to display hazardous chemicals under the Chemical Substances Control Act (Article 16). 

Submission of Comments 

Individuals and organizations are invited to submit their comments on this notice by December 10, 2024. Please include: 

• Specific comments on the notice (whether it should be revised and why). 

• Name, address, and telephone number (for organizations, please include the name and representative). 

Contact: 

• Chemical Registration and Evaluation Team 

• Tel: 032-560-7218 

• Fax: 032-568-2038 

For detailed results, refer to the "Administrative Notice" on the Chemical Safety Agency website: www.kreach.me.go.kr. 

On November 20, 2024, South Korea’s National Institute of Chemical Safety (NICS) announced updates to its toxic substance regulations with the publication of the administrative notice of Partial R...

On November 20, 2024, South Korea’s National Institute of Chemical Safety (NICS) announced updates to its toxic substance regulations with the publication of the administrative notice of Partial Revision of the Designated Notice of Toxic Substances. The revision is in accordance with the "Act on the Registration and Evaluation of Chemical Substances (K-REACH).  

Reason for Revision 

In accordance with the Act on the Registration and Evaluation of Chemical Substances (K-REACH), substances that have been assessed as high hazard are to be designated as new toxic substances. 

Key Updates in the Revision 

1. Hazard Assessments: 

• Conducted on new and existing chemical substances per Article 18 of K-REACH. 

• Criteria have been established for the designation of 26 new toxic substances, with unique numbers ranging from "2024-1-1223" to "2024-1-1248". 

• Aquatic Environment Hazards: 2024-1-1223 to 2024-1-1247. 

• Strong Toxicity from Repeated Exposure: 2024-1-1248. 

2. Revised Data: 

• The unique number "97-1-91" has been updated to reflect the name of the chemical substance. 

• "Zinc carbonate" (97-1-91) has been excluded due to its high hazard to water, but it meets the criteria for designation as a toxic substance. 

3. Interim Measures: 

• Deadlines for compliance with the Chemicals Control Act for those handling newly designated toxic substances, including import declarations, business licenses, and labeling standards. 

Opportunity for Stakeholder Input 

Stakeholders are invited to submit their opinions on the announcement by December 10, 2024. Submissions should include: 

• Specific opinions on the notice (whether it should be revised and why). 

• Name, address, and telephone number (for organizations, include the name and representative). 

Contact Information: 

• Chemical Registration and Evaluation Team 

• Tel: 032-560-7218 

• Fax: 032-568-2038 

For detailed results, refer to the "Notification of Hazard Assessment Results of Chemical Substances" on the Chemical Safety Agency website: www.kreach.me.go.kr. 

On November 15, 2024, the South Korean Ministry of Food and Drug Safety (MFDS) notified the World Trade Organization (WTO) of a proposed amendment to the “Regulation on Labelling and Description of ...

On November 15, 2024, the South Korean Ministry of Food and Drug Safety (MFDS) notified the World Trade Organization (WTO) of a proposed amendment to the “Regulation on Labelling and Description of Medical Devices". The purpose of the amendment is to increase efficiency and reduce burdens on the industry by allowing manufacturers to include only the primary contact or visit address on the container or package of medical devices.  

Key Updates 

A. Improvements to the writing of the address on the container or package (Article 6):  

Based on the manufacturing/import business license, an address that can be contacted or visited at any time can be selected as the primary address on the label.   

B. Changes in terminology to reflect current regulations (Articles 8 and 9): 

Reflects names of websites where one can check matters related to permission, certification, and reporting (Medical Device Electronic Civil Service System) and code for video conversion of voice and sign language, and sign language terms. 

Public Consultation and Enforcement Timeline 

The amendment will be open for comments for 60 days from the date of notification. The proposed date for adoption and enforcement of the amendment will be announced at a later date.  

On November 14, 2024, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of the new designation of lead compounds and methylene Chloride as restricted substance...

On November 14, 2024, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of the new designation of lead compounds and methylene Chloride as restricted substances. The purpose of the amendment is to newly designate substances that are of high concern for hazards in certain uses as restricted substances. 

Key Changes 

1, Expansion of Lead Restrictions 

The lead identification number 06-5-8 is expanded to include lead and its compounds.  

• Prohibited uses: The manufacture, import, sale, and use of lead and its compounds for painting purposes.  

• Exemptions: Aerospace, and defense applications (e.g., maintenance and repair of aircraft or weapons). 

2, New Restriction on Methylene Chloride 

Methylene chloride and mixtures containing more than 0.1% of it are newly designated as restricted substances. The new identification number is 06-05-15. 

• Prohibited uses: Methylene chloride and mixtures containing more than 0.1% cannot be used for paint removal for household, construction, and furniture purposes.  

Public Consultation and Enforcement Timeline 

The amendment will be open for comments for 60 days from the date of notification. The proposed date for adaptation and enforcement of the amendment is January 2026.  

On November 6, 2024, South Korea’s Chemical Safety Agency completed the hazard assessment for registered chemical substances in accordance with the “Act on the Registration and Evaluation of Chemi...

On November 6, 2024, South Korea’s Chemical Safety Agency completed the hazard assessment for registered chemical substances in accordance with the “Act on the Registration and Evaluation of Chemical Substances, etc.,”  

The results, including the names of the chemical substances, their hazards, and whether they are classified as toxic substances, are disclosed to inform the public and gather their opinions. 

Main Contents 

1. Notification of Hazard Assessment Results for Registered Chemical Substances 

• Schedule No. 1 (New Chemical Substances): Substances Examined (April - July 2024): 53 Types, KE Numbers 2024-70 to 2024-122 

• Schedule No. 2 (Existing Chemicals): Audited Substances (October 2023 - January 2024): 33 Types, KE Numbers 2024-522 to 2024-554 

• Additional Data: Includes substances registered from September to December 2023 and those requiring additional review. 

2. Revisions to Secure Additional Data 

• Schedule No. 1 (New Chemical Substances): Revisions based on securing hazard information, including changes to generic names and toxicity status. 

• Schedule No. 2 (Existing Chemicals): Not applicable. 

3. Details of Completed Hazard Assessments 

• Names of chemical substances (CAS No.), notification of toxic substances, major hazards, etc. 

Submission of Comments 

Individuals, organizations, and associations interested in commenting on this revision are invited to submit a written comment by November 26, 2024.