South Korea Regulatory News

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.

The National Institute of Chemical Safety (NICS) has launched an initiative to distribute an “Information Book for Chemical Accident Site Response” to relevant organizations such as firefighting u...

The National Institute of Chemical Safety (NICS) has launched an initiative to distribute an “Information Book for Chemical Accident Site Response” to relevant organizations such as firefighting units, local governments, and police departments from April 9.

The book contains specialized information needed for on-site response in the event of chemical accidents.

Expanded Material Information and Comprehensive Coverage

Originally containing 97 types of material information, the book has now been expanded to 150 types.

These 150 types of material information are selected based on chemical substances that have caused accidents in Korea over the past 10 years. They include substances such as hydrochloric acid (hydrogen chloride), ammonia, and sulfuric acid.

The book provides details on chemical characteristics, risks, countermeasures, personal protective equipment, detection equipment, evacuation distances, acceptable exposure standards, and emergency measures. To facilitate understanding, key response information is presented using pictograms and photos.

Use of Technology and Future Plans

An “accident situation sharing app” operated by the Korea Chemical Safety Institute provides real-time material information to responders. The app significantly reduces the time required to provide material information, ensuring optimal response time.

The full text of the material information book will be available as a PDF on the Korea Chemical Safety Institute’s website.

The Institute plans to create 150 types of material information each year, with a total of 900 types by 2028. The aim is to help emergency responders take prompt initial action in the event of a chemical accident.

Park Bong-kyun, head of the Ministry of Environment’s Chemical Safety Institute, emphasized the importance of providing accurate information to effectively respond to chemical accidents.

On March 26, 2024, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of its decision to designate certain consumer chemical products subject to safety verifica...

On March 26, 2024, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of its decision to designate certain consumer chemical products subject to safety verification and to establish standards for their safety and labeling.

Reason for the Revision

The reason for the revision is that in the case of products with ambiguous judgment as to whether they are food misunderstood or confused, it is necessary to prepare devices such as a committee to finally determine whether they meet safety standards, and if the weight and capacity of living chemicals decrease while the price of consumer chemical products remains the same, consumers cannot easily know the change.

The partial amendment includes the following:

- Establishment of a Committee to assess consumer chemical products that are mistaken for food

- Indication of changes in product weight and capacity, etc.

Timeline

The amendment is open for comments until April 16, 2024. The proposed date for adaptation of the amendment is May 31, 2024, and the enforcement date of the amendment is January 1, 2025.

On January 9, 2024, the South Korean Ministry of Environment announced that five environmental bills had been passed by the National Assembly. These bills aim to improve the registration and managemen...

On January 9, 2024, the South Korean Ministry of Environment announced that five environmental bills had been passed by the National Assembly. These bills aim to improve the registration and management of chemicals and adjust the trading of greenhouse gas emission rights. The main contents are as follows: 

1. Act on Registration and Evaluation of Chemical Substances (K-REACH) and Chemical Substances Control Act (CCA): 

• Adjusted the registration standards for new chemical substances to international levels and reformed the toxic substance designation system to rationalize chemical management. 

• Raised the registration threshold for new chemical substances from 0.1 tonnes per year to 1 tonne, and substances without toxicity information are presumed to be harmful, thereby strengthening management responsibility. 

• Classified toxic substances into acute human toxicity, chronic human toxicity, and ecological toxicity for management. 

2. Act on the Allocation and Trading of Greenhouse Gas Emissions Permits: 

• Set the ratio of emission permits to be allocated free of charge, considering the conditions for reduction of greenhouse gases in sectors and industries and established the grounds for the gradual expansion of the ratio of paid allocation. 

• Introduced measures to activate the market for emission rights trading and encourage corporate investment in greenhouse gas reduction. 

3. Act On Water Management and Residents Support in the Nakdong River Basin: 

• Clearly defined in the Act the types of resident support projects to be funded by the Water System Fund, including the installation of housing infrastructure and medical facilities. 

4. Administrative Legal System Innovation Act for the Geum River Basin Water Management and Resident Support: 

• Improved the conciseness and uniformity of the administrative legal system and promoted citizen-centered administrative law operations by aligning various presumptions of approval and objections to dispositions with the Basic Administrative Law. 

The Ministry of Environment will make every effort to prepare subordinate legislation and provide advance guidance to ensure timely implementation of these bills. These bills are expected to contribute to the safe management of chemicals, the reduction of greenhouse gases, the resolution of environmental policy conflicts, and to reflect the voices of industry.