South Korea Regulatory News

On March 18, 2025, the South Korean Ministry of Food and Drug Safety (MFDS) notified the World Trade Organization (WTO) of a proposed amendment to the Enforcement Rule of the Special Act on Imported F...

On March 18, 2025, the South Korean Ministry of Food and Drug Safety (MFDS) notified the World Trade Organization (WTO) of a proposed amendment to the Enforcement Rule of the Special Act on Imported Food Safety Control.  

The purpose of the amendment is to enhance efficiency by expanding the circumstances under which importers can request a change in the purpose of raw materials. It also aims to establish a legal framework for the issuance of electronic export health certificates for food products.  

Key Updates 

• Raw material sourcing during crisis: Allows businesses to purchase raw materials from other manufacturers if domestic supply is disrupted due to global crises such as wars, pandemics, or natural disasters. 

• Exemption of registration change fee: Exempts businesses from registration change fees if the change is due to administrative district reorganization, and the applicant is not responsible for the change. 

• Business Registration: New requirements for businesses to include mobile numbers and email addresses on registration forms. 

• Import Declaration: Clear guidelines for submitting photos with import declarations, including specific labeling and packaging details. 

• Export Hygiene Certificates: Introduction of electronic formats for export food hygiene certificates and updated document templates. 

Public Feedback 

MFDS invites public feedback on the proposed changes until April 21, 2025. For more information and to submit comments, visit the Food and Drug Safety Administration (FDA) website. 

On March 20, 2025, the South Korean Ministry of Environment (MoE) notified a partial revision to the Regulations on the Quantity Specifications for Toxic Substances, Restricted Substances, Prohibited ...

On March 20, 2025, the South Korean Ministry of Environment (MoE) notified a partial revision to the Regulations on the Quantity Specifications for Toxic Substances, Restricted Substances, Prohibited Substances, and Permitted Substances. This revision aims to provide clearer guidelines on the submission requirements for chemical accident prevention management plans and to reflect the recent changes in the designation of certain substances. 

Key Amendments 

1. Introduction of New Quantity Specifications for 26 Newly Designated Toxic Substances 

• Following the revision of the Toxic Substance Designation Notice (Chemical Safety Agency Notice No. 2025-2, January 24, 2025), 26 newly designated toxic substances will now have specific upper and lower quantity limits for the submission of chemical accident prevention plans. 

2. Chrysotile Moved from Restricted to Prohibited Substances 

• The restricted substance Chrysotile (asbestos) is now removed from the restricted list. 

• The substance Chrysotile is added to the list of prohibited substances. 

3. Adjustments to the Reevaluation Timeline  

• The revision includes the resetting of the re-evaluation period for certain substances to ensure ongoing compliance with safety standards. 

Feedback Submission 

Individuals or organizations wishing to submit comments on the proposed revision may do so until April 11, 2025. Comments must be submitted via post, direct mail, or fax to the Chemical Safety Division of the MoE. 

Submission Details: 

• Online: www.me.go.kr (Public Participation → Electronic Public Hearing) 

• Mail: Ministry of Environment, Chemical Safety Division, Sejong-si Hanuri-daero 499 

• E-mail: hongsyong@korea.kr 

• Fax: (044) 201 - 6830 

On February 12, 2025, South Korea’s National Institute of Chemical Safety (NICS) announced a partial revision of the classification and labelling of certain chemical substances. The revision include...

On February 12, 2025, South Korea’s National Institute of Chemical Safety (NICS) announced a partial revision of the classification and labelling of certain chemical substances. The revision includes reclassification of specific restricted substances and some regulatory changes. The purpose of this partial revision is to comply with the recent amendment of Article 27 of K-REACH regarding restricted substances.  

Key Updates 

1. Substance Reclassification 

• Chrysotile will be reclassified from a restricted substance to a banned substance in accordance with the Ministry of Environment’s announcement (no. 2024-253). 

        2. Regulatory Changes 

• The entry for for Chrysotile as a restricted substance (no. 06-5-7) will be removed and it will be listed as a banned substance (no. 06-4-27). 

• Only the designation of the substance will change - no further changes to hazard classification or labeling requirements. 

Public Feedback 

A public consultation was held on this revision allowing stakeholders to submit  comments on the amendments and any suggested revisions to NICS until March 4, 2025.  

The South Korean Ministry of Environment (MoE), in collaboration with the Ministry of Justice (MoJ), has launched an 8-month voluntary reporting period, starting from February 28, 2025. This initiativ...

The South Korean Ministry of Environment (MoE), in collaboration with the Ministry of Justice (MoJ), has launched an 8-month voluntary reporting period, starting from February 28, 2025. This initiative is aimed at companies that have failed to meet the registration, change registration, or prior notification requirements under K-REACH. 

Purpose 

• The purpose of this voluntary reporting period is to collect data on chemical safety and enhance regulatory compliance, ensuring that companies align with K-REACH laws.  

• The ultimate goal is to protect public health and the environment from exposure to harmful chemicals. 

Key requirements 

• Companies that have manufactured or imported chemicals before February 27, 2025, without complying with K-REACH, are subject to the voluntary reporting. 

• To voluntarily report, companies must submit relevant documents (including manufacturing and import details) via the Chemical Substance Information Management System (kreach.me.go.kr). 

Benefits of voluntary reporting and future inspection 

• Companies that voluntarily report violations and take corrective actions will be exempt from severe penalties such as imprisonment of up to 5 years or a fine of up to 100 million KRW.  

• They will also not face surcharges based on sales, and ongoing investigations or prosecutions will be considered with more leniency. 

• The MoE will conduct thorough on-site inspections after the voluntary reporting period ends, and any violations found will be dealt with strictly in accordance with the regulations. 

From 2028, only approved biocidal products will be allowed in household appliances in South Korea and safety controls will be strengthened. In preparation for this, the Ministry of Environment (MoE), ...

From 2028, only approved biocidal products will be allowed in household appliances in South Korea and safety controls will be strengthened. In preparation for this, the Ministry of Environment (MoE), the Korea Consumer Agency, and the home appliance industry have released guidelines aimed at improving the safety management of biocidal products used in household devices. 

Key Features of the Guidelines for Biocidal Product Safety 

• Developed in advance of the upcoming regulations, the guidelines focus on creating a comprehensive safety management system that ensures the legal use of biocides in home appliances.  

• The guidelines promote transparency and safety by requiring information sharing throughout the manufacturing and supply chain. 

Pilot Project to Implement Safety System in Home Appliances 

• To facilitate the adoption of these guidelines, the MoE will launch a pilot project aimed at establishing a safety management system for biocidal product in the home appliance sector.  

• The initiative will include training and consultations for appliance manufacturers and suppliers to enhance their safety management capabilities. 

Expanding Safety Efforts to Other Sectors 

• This initiative follows similar efforts in the automobile industry, where the MoE previously set up a safety management system for auto parts suppliers.  

• In the future, the MoE, in collaboration with the Korea Consumer Agency, plans to expand these safety management systems to other sectors such as textiles and bedding. 

On January 21, 2025, South Korea's Ministry of Food and Drug Safety (MFDS) released updated regulations for advertising and labelling of cosmetics to prevent false or exaggerated claims and guide ...

On January 21, 2025, South Korea's Ministry of Food and Drug Safety (MFDS) released updated regulations for advertising and labelling of cosmetics to prevent false or exaggerated claims and guide the industry.

Objective of the amendment

The Ministry has found cases of misleading advertisements that give false or exaggerated advertising After analysing the violations, the MFDS has expanded the list of prohibited expressions. These changes aim to protect consumers and ensure cosmetics businesses follow proper advertising standards.

Key prohibited expressions:

• Prohibition on expression of designation/recommendation (e.g. for hospital use)
• Prohibition on expression of human-derived ingredients (e.g. exosomes)
• Prohibition on misleading product usage methods (e.g. microneedles)
• Prohibition on claims about reducing skin age (e.g. reduces skin age by n years)

The Ministry of Food and Drug Safety plans to provide specific guidance on cosmetics matters of concern and prohibited expressions, assisting cosmetics salespeople in labeling and advertising.

On December 20, 2024, the South Korean Ministry of Environment (MoE) announced the approval of the first 15 biocidal products under the Consumer Chemical Products and Biocides Safety Act (K-BPR).  ...

On December 20, 2024, the South Korean Ministry of Environment (MoE) announced the approval of the first 15 biocidal products under the Consumer Chemical Products and Biocides Safety Act (K-BPR). 

Background on the approval of biocidal substances and products

• The K-BPR requires all biocidal substances and products to be tested for safety, and effectiveness, before being placed on the Korean market.  

• To date, 56 biocidal substances have been approved and 15 biocidal products using these approved substances were approved for the first time, on December 20, 2024.  

Approval requirements for relevant products 

• In addition to these 15 biocidal products, products containing fungicides, pesticides, acaricides, and acaricide types must be approved as biocidal products by December 2025. 

• If they are not approved, they will be banned from distribution and sale from July 1, 2026. 

Sequential evaluation plans

• The MoE and National Institute of Chemical Safety (NICS) plan to sequentially evaluate the safety and efficacy of 10 types of biocidal substances and products based on the deadlines under the K-BPR Act.