South Korea Regulatory News

On May 30, 2024, the National Institute of Chemical Safety (NICS) in South Korea issued an administrative notice regarding the partial revision of the Notice of Designation of Toxic Substances. Here a...

On May 30, 2024, the National Institute of Chemical Safety (NICS) in South Korea issued an administrative notice regarding the partial revision of the Notice of Designation of Toxic Substances. Here are the key details: 

1. Reasons for Revision: 

• The revision is in accordance with the Act on the Registration and Evaluation of Chemical Substances (K-REACH). 

• The goal is to designate highly hazardous substances as new toxic substances. 

2. Key Details: 

• Hazard assessments were conducted on new and existing chemicals under the Act on the Registration and Evaluation of Chemical Substances. 

• Eleven substances were added (columns “2024-1-1213” to “2024-1-1223”). 

• These substances meet the criteria for toxic designation: 

• Acute oral toxicity (Category A): 2024-1-1214, 2024-1-11219, and 2024-1-11223. 

• Strong acute inhalation toxicity (Category C): 2024-1-1213, 2024-1-11215, 2024-11216, 2024-1-221, and 2024-1-1-1222. 

• Highly corrosive (Category D): 2024-1-1217, 2024-1-1218, and 2024-1-1220. 

• Refer to the detailed value results in the Result of Hazard Assessment of Chemical Substances. 

3. Revisions and CAS Numbers: 

• KE numbers “2017-1-762” and “2022-1-1095” require additional CAS numbers. 

• Specify CAS numbers for sub-isomers of existing and new chemicals corresponding to toxic substances. 

4. Transitional Measures: 

• Provide deadlines for implementing obligations under the Chemical Substances Control Act for handling newly designated toxic substances. 

5. Submission of Comments: 

• Individuals, institutions, and organizations can submit opinions by June 19, 2024. 

• Include opinions, name (or organization), address, and phone number. 

• The full amendment is available on the National Institute of Chemical Safety's website. 

On May 27, the Korea Cosmetic Association updated the Guidelines for Prohibited Substances in Cosmetics for Analysis and released two new guidelines: ‘Analytical Methods of Cosmetic Ingredients in C...

On May 27, the Korea Cosmetic Association updated the Guidelines for Prohibited Substances in Cosmetics for Analysis and released two new guidelines: ‘Analytical Methods of Cosmetic Ingredients in Cosmetic Products’ and ‘Guidelines for Testing and Safety Evaluation of European SCCS Cosmetic Ingredients.’

These documents aim to enhance safety management in the cosmetics industry and facilitate exports. They provide valuable information on the analysis of cosmetic ingredients present in cosmetic products. The analytical methods described in these documents have been validated through research funded by the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea. Before implementing these methods based on the specific type of cosmetic product, it is advisable to validate them by appropriate procedures. If changes are made to the analytical methods, the revised approaches should undergo thorough evaluation with appropriate validation procedures.

On May 30, 2024, the National Institute of Chemical Safety (NICS) in South Korea issued an administrative notice regarding the partial revision of the Regulations on Classification and Labeling of Che...

On May 30, 2024, the National Institute of Chemical Safety (NICS) in South Korea issued an administrative notice regarding the partial revision of the Regulations on Classification and Labeling of Chemical Substances. Here are the key details:

1. New Hazard Classification and Labeling for Toxic Substances:

As a result of hazard studies conducted under the Act on Registration and Evaluation of Chemical Substances, new hazard classification and labeling were established for both new and existing toxic substances.

Specifically, 11 types of toxic substances, including “phosphorus trifluoride”, will be newly classified and labeled with unique numbers ranging from “2024-1-1213” to “2024-1-1223.”

2. Revised Classification and Labeling for Existing Hazardous Chemicals:

Existing hazardous chemicals that require changes based on additional data will have their classification and labeling revised.

This includes:

Revision of the classification and labeling for three toxic substances (KE numbers “2017-1-785”, “2018-1-837” and “2021-1-1068”).

Addition of pictograms (GHS 9) corresponding to hazard to the aquatic environment for one type of toxic substance (KE number “97-1-145”).

Specific indication of the CAS number for sub-isomers of two toxic substances (KE numbers “2017-1-762” and “2022-1-1095”).

* The KE number refers to a unique identifier assigned to existing chemical substances in South Korea.

3. Implementation Obligations:

Individuals and organizations required to label hazardous chemicals must comply with the revised regulations under the Chemical Substances Control Act (as specified in Article 16 of the Act).

4. Submission of Comments:

Stakeholders interested in commenting on this notice can submit written feedback to the Director of the National Institute of Chemical Safety (Chemical Registration Evaluation Team) no later than June 19, 2024.

The submission should include:

A. Opinions on whether or not the notice should be revised and the rationale for the position.

B. Name (or name of organization and representative), address, and phone number.

C. The full text of relevant amendments to the “Regulations on Classification and Labeling of Chemical Substances” can be submitted via the Chemical Substances Safety Board website.

On May 28, 2024, the Ministry of Environment, led by Minister Han Hwa-jin, announced plans to sign an agreement with the Organization for Economic Cooperation and Development (OECD) to promote interna...

On May 28, 2024, the Ministry of Environment, led by Minister Han Hwa-jin, announced plans to sign an agreement with the Organization for Economic Cooperation and Development (OECD) to promote international cooperation projects for the development of a Korean version of the QSAR Toolbox, a computer program for predicting chemical toxicity.

Developed jointly by the Organization for Economic Cooperation and Development (OECD) and the European Union (EU), this program aims to minimize animal testing by predicting the toxicity of chemicals without the need for actual animal testing.

Key points about the QSAR Toolbox

• Purpose: To prepare for the demand for chemical testing following the implementation of the chemicals management system (REACH).
• Functionality: Predicts the toxicity of chemicals and provides test data or assists in the development of new substances required for chemical registration.
• Specifications: The QSAR Toolbox includes 70 profilers that identify chemical characteristics and 59 databases with information on chemical structures and physical and biological properties.
• Toxicity prediction: It can predict various toxicities, including acute toxicity, genetic toxicity, skin sensitivity, and aquatic toxicity.

Current Challenges and Future Goals

Until now, the Korean version of the program was not available, and companies had to use the English version. This posed challenges due to a lack of knowledge of English terminology and additional costs when seeking professional advice.

The Ministry of Environment aims to release the Korean version by 2027, following an agreement with the OECD. The aim is to reduce animal testing and improve animal welfare while ensuring accurate chemical registration. Detailed guidelines for each toxic category will also be provided for the convenience of the industry.

On May 23, 2024, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of a draft partial amendment to the Enforcement Decree of the Act on Registration and Evalua...

On May 23, 2024, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of a draft partial amendment to the Enforcement Decree of the Act on Registration and Evaluation of Chemical Substances. The amendment covers non-phase-in substances, and it aims to reduce trade barriers and facilitate trade.

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 1, 2025.

Key Content of the Amendment

The partial amendment includes the following:

A. Revised clauses related to the registration criteria of new substances amended by Article 10(1) of the Act on Registration and Evaluation of Chemical Substances (hereinafter referred to as "the Act") (Article 10(3), Article 13)

1. A chemical substance subject to registration pursuant to Article 10(5) of the Act will be designated for registration and publicly announced if its annual manufacture or import quantity nationwide is equal to or more than 10 tonnes per year.
2. Among the chemical substances subject to registration pursuant to Article 10(5) of the Act, the data requirements of new substance may be waived if its annual manufacturing or importing amount is less than 100 kg per year.

On March 28, 2024, the South Korean Ministry of Employment and Labor (MOEL) announced the names of 71 new chemical substances, their hazards and risks, annual production and import volumes, and measur...

On March 28, 2024, the South Korean Ministry of Employment and Labor (MOEL) announced the names of 71 new chemical substances, their hazards and risks, annual production and import volumes, and measures to be taken under Article 108(3) of the Occupational Safety and Health Act and Article 153 of the Enforcement Rules of the same Act.

Hazards and Risk Assessment

The hazards and risks associated with these 71 chemical substances are determined on the basis of toxicity data submitted by employers. Classification is based on the "Standards for Classification, Labeling, and Material Safety Data Sheets of Chemicals" (Ministry of Employment and Labor Notification No. 2023-9), using both domestic and foreign chemical information databases.

Continuous Risk Evaluation

New hazard/risk information may be identified through additional studies, such as toxicity tests.

Worker Protection Measures

The announcement provides basic measures that employers should take in case of short- and long-term exposure of workers handling new chemicals, even if specific hazards are not listed in the hazard and risk information section.

South Korea’s Ministry of Environment (MoE) has announced a reorganization that will take effect from April 30, 2024, transferring certain functions from the National Institute of Environmental Rese...

South Korea’s Ministry of Environment (MoE) has announced a reorganization that will take effect from April 30, 2024, transferring certain functions from the National Institute of Environmental Research (NIER) to the National Institute of Chemical Safety (NICS). The move, which was approved on April 23, 2024, aims to streamline chemical management by consolidating tasks under the Chemical Substances Control Act, the Act on Registration and Evaluation of Chemical Substances, and the Chemical Products Safety Act.

Streamlining Chemical Management

The NICS will be expanded to include more teams to manage hazardous substances and evaluate chemical registrations. This restructuring will address previous limitations in integrated management and policy support under the three chemical laws.

The National Institute of Chemical Safety will now oversee the entire lifecycle of chemical safety management, from registration to production and use. Meanwhile, the NIER will focus on strengthening its research capabilities in risk assessment and developing alternative testing methods.

Until now, companies have had to navigate separate processes for chemical registration and accident prevention plans. The unification of these functions is expected to simplify procedures for companies and improve the efficiency of chemical safety management and facility handling.

Integration for Improved Safety

Furthermore, the integration of information systems under the three chemical laws will enable the use of big data for personalized stakeholder information and improve the designation and management of hazardous chemicals and facilities. This reorganization promises a more cohesive approach to chemical safety in South Korea.