South Korea Regulatory News

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 March 14, 2024, the Ministry of Environment (MoE) in South Korea published the Administrative Notice of Partial Revision of Regulations on prescribed quantities of toxic substances, restricted sub...

On March 14, 2024, the Ministry of Environment (MoE) in South Korea published the Administrative Notice of Partial Revision of Regulations on prescribed quantities of toxic substances, restricted substances, prohibited substances, and permitted substances. 

Content of the Notice 

The notice aims to establish the prescribed quantity for each substance to classify the subject of submitting a chemical accident prevention management plan (first group, second group, exemption) for toxic substances additionally designated by the revision of the "Description of Toxic Substances (National Institute of Environmental Research, January 10, 2024)”. 

For new toxic substances (39 types in total), the upper and lower prescribed quantities have been specified.  

Stakeholder Feedback 

Organizations, institutions, or individuals who have opinions on this amendment should review the amendment on the website of the Ministry of Environment  by April 2, 2024, and submit a written opinion to the Minister of Environment (Director of Chemical Safety) stating the following: 

1. Whether you agree or disagree with the notice (give reasons if you disagree) 

- Revision (draft) 

- Correction (draft) 

- Reasons for correction 

2. Name (for an institution or organization, the name of the institution or organization, and the name of its representative), address, and phone number 

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. 

On January 10, 2024, the National Institute of Environmental Research (NIER) in South Korea published a partial amendment to the Notice of Designation of Toxic Substances. The amendment will come into...

On January 10, 2024, the National Institute of Environmental Research (NIER) in South Korea published a partial amendment to the Notice of Designation of Toxic Substances. The amendment will come into force on April 11, 2024. 

Regulatory Overview: 

• The Ministry of Environment designates hazardous chemicals as toxic substances based on the hazard assessment. 

• Companies that manufacture, sell, store, transport, and use toxic substances need a business licence. 

• Companies that wish to import toxic substances, must report them to the Minister of the Environment. 

Summary of changes: 

Change in content: 3 substances. 

New: 42 substances. 

On March 14, 2024, the South Korean National Institute of Food and Drug Safety Evaluation published a draft of the ‘Guidelines for Alternatives to Animal Testing Methods’ to help improve the inter...

On March 14, 2024, the South Korean National Institute of Food and Drug Safety Evaluation published a draft of the ‘Guidelines for Alternatives to Animal Testing Methods’ to help improve the international competitiveness of the domestic cosmetics industry and non-clinical testing institutions related to toxicity tests. The draft contains the guidelines for the two test methods as follows. 

• Guidelines for Test No. 498: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test method Skin phototoxicity for Cosmetics, etc. 

• Guidelines for ARE-Nrf2 Luciferase Keratinocyte Activation Test Method (OECD 442D) KeretinoSens TM for skin sensitization for Cosmetics, etc. 

Companies that have an opinion on the draft guideline, please reply to our association (email: jenko@kcia.or.kr ) by March 18, 2024.