South Korea Regulatory News

On May 19, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the “Special Act on Imported Food Safety Control” aimed at strengthening consumer safety by regul...

On May 19, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the “Special Act on Imported Food Safety Control” aimed at strengthening consumer safety by regulating the use of recycled materials in imported food-contact items such as utensils and packaging. Although Korea’s Food Sanitation Act already regulates the use of recycled materials in domestically produced food-contact items, there are currently no safety standards for recycled materials used in imported items. This gap poses a potential health risk torec consumers. The proposed amendment introduces a system to ensure that recycled materials used in imported utensils, containers, and packaging comply with Korean food safety standards. 

Key Provisions 

1. Mandatory Safety Certification for Recycled Materials (Article 10-3) 

• Importers of food-contact products made with recycled materials must obtain prior approval from the Ministry of Food and Drug Safety (MFDS) to verify that the materials meet the safety criteria under the Food Sanitation Act. 

• Importers must submit the required documentation and may be asked to provide additional safety data. 

• If approved, the MFDS will issue an official certification. 

• Certifications obtained through false or misleading means will be revoked. 

2. Ban on Non-Certified Recycled Material Imports (Article 10-4) 

• It is strictly prohibited to import or sell any food-contact articles made with recycled materials that have not received official MFDS approval. 

3. Enforcement and Penalties (Article 42 Amendment) 

• Violators who import or distribute non-certified recycled products will be subject to regulatory penalties under the revised Article 42. 

On May 16, 2025, South Korea launched the construction of the nation’s first dedicated animal-free testing facility, with the aim of promoting ethical scientific practices and improving chemical saf...

On May 16, 2025, South Korea launched the construction of the nation’s first dedicated animal-free testing facility, with the aim of promoting ethical scientific practices and improving chemical safety assessments. The facility is being built at the headquarters of the Korea Environment Corporation (K-ECO) in Incheon and is scheduled for completion in October 2026. 

This project supports the global shift towards alternatives to animal testing, aligning with similar moves by the EU and the United States. It will also contribute to South Korea’s national goal of replacing over 60% of toxicity testing with alternative methods by 2030. 

Key Contents  

1. Facility Overview: 

• Size: 7,499㎡, with 4 floors above ground and 1 basement level. 

• Budget: ₩33.4 billion (approximately $24 million). 

• Focus: Testing using human cells, artificial organs, 3D models, and AI simulations. 

2. Functions and Services: 

• Perform non-animal toxicity assessments. 

• Operate a training center for researchers. 

• Host international conferences and workshops. 

• Support certification and provide technical guidance for private testing labs. 

 3. Legal and Policy Support: 

• Based on Korea’s Chemical Substances Control Act. 

• Government policy promotes animal alternatives as a first option. 

Awareness and Engagement Activities  

To coincide with the launch, the Ministry designated May 16–23 as "Animal-Free Testing Awareness Week". Activities include: 

• May 16: Government–industry roundtable on alternative testing. 

• May 20: Expert workshop in Seoul covering: 

• Current government strategies. 

• Case studies from private labs. 

• Research updates and mental health support for animal researchers. 

This facility is expected to reduce dependence on animal testing, lower costs, and improve the accuracy and speed of testing. South Korea aims to become a global leader in ethical, science-driven toxicology and chemical safety. 

On May 9, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the "Regulation on the Permission, Notification, Review, etc of Medical Devices”. The revision aims ...

On May 9, 2025, South Korea notified the World Trade Organization (WTO) of proposed amendments to the "Regulation on the Permission, Notification, Review, etc of Medical Devices”. The revision aims to clarify cybersecurity documentation requirements for medical devices that use wired or wireless communication. It also aligns clinical trial data requirements with international standards and addresses administrative inefficiencies identified during prior regulatory operations. 

Key Contents  

1. Procedures for Deferral of New Health Technology Assessment 

The regulations now establish clear steps for applying for approval or certification to defer new health technology evaluations. This includes adding clinical evaluation data as a new type of clinical trial documentation and providing detailed guidance on how to prepare each section. 

2. Unified Oversight for Class II Medical Device Certification 

Applicants seeking confirmation for products equivalent to already-certified Class II devices must now submit documentation to the Ministry of Food and Drug Safety (MFDS) which centralizes the process. 

3. Clarification of Manufacturing and Import Filing Procedures 

Following the amendment to the Medical Device Act Enforcement Rules, the procedure for reviewing manufacturing and import reports has been clearly defined to enhance transparency. 

4. Cybersecurity Requirements for Medical Devices 

The amendment introduces a formal definition of cybersecurity for medical devices and requires that detailed cybersecurity information be included in approval applications. Multiple related provisions and documentation templates have been updated accordingly. 

5. Support Measures for Innovative Medical Devices 

Newly developed medical devices are now eligible for expedited review. However, the exemption from submitting clinical trial data based on equivalence during post-market surveillance is restricted to ensure safety. 

6. Expanded Scope for Technical Documentation 

Examples of situations requiring the submission of clinical data are now included to help clarify when such data is necessary, thereby improving predictability and compliance. 

Public comments 

Individuals or organizations with feedback on the draft amendment may submit written comments by May 20, 2025. 

On March 27, 2025, South Korea’s Ministry of Employment and Labor (MOEL) released a list of 72 new chemical substances that were manufactured or imported into the country during the first quarter (Q...

On March 27, 2025, South Korea’s Ministry of Employment and Labor (MOEL) released a list of 72 new chemical substances that were manufactured or imported into the country during the first quarter (Q1) of 2025. The announcement is part of Korea’s continued effort to ensure chemical safety in workplaces under the Korea Occupational Safety and Health Act (KOSHA). Consequently, employers are urged to review the published list, implement the recommended safety measures, and educate all workers, especially foreign employees, on the proper chemical handling practices. 

Key Contents 

• Total Substances Announced: 72 new chemical substances registered in Q1 2025. 

• Hazardous Substances Identified: 32 substances, including 2-methylpiperazine, found to pose risks such as: 

• Acute toxicity 

• Reproductive toxicity 

• Skin corrosion/irritation 

 Compliance Requirements for Manufacturers and Importers 

• Pre-Notification Obligation: Manufacturers and importers must submit a hazard and risk assessment report to the MOEL 30 days before production/import. 

• Safety Measures for Employers: 

• Provide personal protective equipment (PPE) 

• Install local exhaust ventilation 

• Maintain and display Material Safety Data Sheets (MSDS) 

• Use proper hazard warning labels 

Foreign Worker Safety 

• To improve chemical safety for foreign employees, MOEL has published MSDS and label training materials in 17 languages, including English, Vietnamese, Chinese, and more. These materials help workers recognize hazard symbols and understand key safety instructions. 

On 28 March 2025, the South Korean Ministry of Environment published a draft amendment to the Enforcement Rules of Consumer Chemical Products and Biocides Safety Control Act. The proposed changes aim ...

On 28 March 2025, the South Korean Ministry of Environment published a draft amendment to the Enforcement Rules of Consumer Chemical Products and Biocides Safety Control Act. The proposed changes aim to align with recent amendments to the Act on Registration and Evaluation of Chemicals (K-REACH) and to improve regulatory efficiency and transparency. 

Key Objectives of the Amendment 

• Legal Alignment: Reflect changes from the revised K-REACH, which take effect on August 7, 2025, particularly the removal of the definition of “hazardous chemicals.” Related legal references are updated accordingly. 

• Simplified Document Submission: Companies modifying previously approved biocidal products or household chemical products will no longer be required to resubmit documents already held by the authorities from previous applications. However, this exemption does not apply to changes involving the transfer of rights or obligations. 

• Enhanced Public Disclosure: To ensure clarity and transparency, information on the location of manufacturing facilities will now be included in the publicly disclosed information about approved biocidal substances and products. 

Public Comment Period 

The MoE is accepting feedback from individuals and organizations until May 7, 2025. Comments should include the submitter’s position (support or opposition) and reasoning, along with their contact details. 

On March 28, 2025, the National Institute of Chemical Safety in South Korea announced a partial revision of the Standards for Installation and Management of Hazardous Chemical Transport Facilities. Th...

On March 28, 2025, the National Institute of Chemical Safety in South Korea announced a partial revision of the Standards for Installation and Management of Hazardous Chemical Transport Facilities. This revision aims to clarify and specify the standards for vehicle transport facilities to reduce confusion in the file and enhance the chemical safety of transport facilities.  

Specifically, the current regulations for vehicle-mounted tanks require a minimum steel plate thickness of 3.2 mm or equivalent materials for all substances, but this approach is impractical for corrosive substances, leading to increased vehicle weight and reduced steel lifespan. To address this, the regulations have been revised to allow materials tailored to the specific needs of corrosive substances. However, existing guidelines for lining materials and methods are unclear, resulting in frequent accidents despite the use of linings. 

Key Content 

• Target audience: Operators of hazardous chemical vehicle transport facilities, specifically those transporting corrosive substances. 

• Stakeholders: The public, especially those impacted by the transportation of hazardous chemicals. 

• Key change: The revised standards specify that when transporting corrosive substances, the selection of appropriate corrosion-resistant lining materials must be clearly defined. This includes providing practical guidance on how to inspect and apply the correct lining materials. 

Submission of Comments  

Individuals, organizations, and associations wishing to provide feedback on the proposed revisions to the "Standards for Installation and Management of Hazardous Chemical Transport Facilities" must submit their comments by April 18, 2025. Feedback can be submitted online through the National Legislative Center website, or by email with the necessary contact details. 

On April 8, 2025, South Korea issued a notice of administrative announcement on a partial revision on the result of chemical hazard evaluation. This revision is based on the completion of toxicity eva...

On April 8, 2025, South Korea issued a notice of administrative announcement on a partial revision on the result of chemical hazard evaluation. This revision is based on the completion of toxicity evaluations for existing chemicals under the K-REACH Act. The revised notice includes details on the chemical substance names, hazard information, whether substances are hazardous, and other relevant results. Additionally, the notice includes the publication of the names of newly evaluated chemical substances after the expiration of their data protection periods. 

Key Changes 

1. Expiration of Data Protection: 

• Following the expiration of the data protection (2023), chemical substance names that were previously protected will now be made public. This includes four substances, with corrections to one item. 

2. Hazard Evaluation of Existing Substances: 

• The hazard evaluation results for 29 substances, conducted between February and June 2024, will be included in Annex 2.  

3. Additional Data for Previously Announced Chemicals: 

• Four additional substances will have their data updated, and 20 substances will be assigned unique identifiers based on toxicity status. 

4. Chemical Substance Details: 

• The notice will include comprehensive details such as CAS numbers, hazard status, and key hazard characteristics for substances that have been evaluated. 

Submission of Comments 

Interested individuals, institutions, and associations are invited to submit their feedback on the proposed changes by April 28, 2025. Comments should be addressed to NICS and should include details such as the subject of the feedback, contact information, and the reasons for any suggested revisions.