South Korea Regulatory News

On February 5, 2025, a group of 13 congressmen in South Korea proposed amendments to the Act on Registration and Evaluation of Chemical Substances (also known as K-REACH). The purpose of this new prop...

On February 5, 2025, a group of 13 congressmen in South Korea proposed amendments to the Act on Registration and Evaluation of Chemical Substances (also known as K-REACH). The purpose of this new proposal is, first, to improve the transparency of the chemical registration process, especially in the process of joint submission and its cost sharing. Secondly, it aims to enhance the efficiency of the Only Representative (OR) appointment system by addressing gaps related to the transfer of responsibilities when the OR is changed.  

Key Amendments and Changes 

1. Fair and Transparent Cost Allocation for Joint Registration: 

• The amendments propose a clear and fair framework for cost sharing for joint registrations of chemicals. 

• Costs will be allocated based on objective criteria, taking into account the interests of each party and the specific manufacturing or import volumes. 

• The proposal ensures transparency by requiring clear and verifiable evidence for all cost allocations. 

2. Dispute Resolution for Registration Conflicts: 

• If disputes arise during the joint registration process the parties will be able to seek mediation from the Ministry of Environment. 

• This will ensure that disputes over shared registration materials or costs are resolved in a fair and transparent manner. 

3. Protection for Latecomer Registrants: 

• To protect the interests of latecomer registrants, the amendments propose a formal process to resolve issues that cannot be settled through negotiation. 

• This protection will ensure that latecomer registrants who joined the joint submission at a late stage are not unfairly burdened with excessive fees or delays in the registration process. 

4. Clarification of the OR System for Foreign Manufacturers: 

• The amendments will address gaps in the law by providing clarity regarding the transfer of responsibilities when a foreign manufacturer changes their Only Representative. 

• The responsibilities of the previous OR, including completed registrations, will be transferred to the new OR to ensure continuity in the registration process. 

• Foreign manufacturers must report the change to the Ministry within one month. 

Public Feedback and Status of the Proposal  

• Public feedback was accepted from  February 7 to February 21, 2025.  

• The proposal is still under committee review. When there are further updates regarding this amendment, GPC will continue to update the 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 

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 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. 

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.