South Korea Regulatory News

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. 

On December 31, 2024, the Korean Environment Corporation (K-ECO) notified an updated template of the Letter of Confirmation (LoC) for chemical substance verification.     Key Contents   ...

On December 31, 2024, the Korean Environment Corporation (K-ECO) notified an updated template of the Letter of Confirmation (LoC) for chemical substance verification.  

Key Contents  

• Based on Article 2 of the Enforcement Rule of K-CCA (Korea Chemical Control Act), manufacturers and importers must submit either a Chemical Substance Composition Statement or the LoC to the Ministry of Environment (MoE), for chemical substance verification.  

• According to the K-CCA amendment, the previous template of the LoC can only be used till August 6, 2025. After this date, only the new template will be accepted.  

• The deadline for acceptance of the previous LoC may be moved earlier. In that case, it will be notified through the Chemical Substance Information Management System. 

• As of January 1, 2025, the authority responsible for chemical substance verification has changed from the Korea Chemical Management Association (KMCA) to the Korea Environment Corporation (K-ECO). 

The new LoC template can be downloaded from the official website of Chemical Substance Information Management System (k-reach.me.go.kr). 

On January 14, 2025, the South Korean Ministry of Environment (MoE) reported that 86 additional products purchased from overseas do not meet local safety standards. This was discovered after the MoE e...

On January 14, 2025, the South Korean Ministry of Environment (MoE) reported that 86 additional products purchased from overseas do not meet local safety standards. This was discovered after the MoE expanded its investigation, which initially reviewed 558 products and later added 32 more items for review, as noted in our previous newsletter: South Korea Blocks Unsafe Overseas Purchases.  

Unsafe Products Identified 

The 86 products include 40 household chemical products, 38 metal accessories, and 8 asbestos-containing products. The MoE has requested the Korean Customs Service to block the import of these products to protect public health.  

Focus on Online Retailers 

The MoE will continue to monitor whether these products have been blocked by online distributors such as AliExpress and Temu. Additionally, the budget for safety investigations will be significantly increased in 2025 to examine the safety of more products purchased overseas.  

The Ministry of Employment and Labor, along with the National Fire Agency, has successfully unified the information on 565 of the 4,091 overlapping chemicals in their respective chemical information s...

The Ministry of Employment and Labor, along with the National Fire Agency, has successfully unified the information on 565 of the 4,091 overlapping chemicals in their respective chemical information systems, ensuring consistency in GHS (Globally Harmonized System) information. 

What is GHS?  GHS is an internationally standardized system for classifying and labeling chemical substances, providing crucial safety information. 

Background  The Ministry's Material Safety Data Sheet System and the National Fire Agency's National Integrated Dangerous Goods Information System previously provided information on 20,555 and 7,364 chemical substances, respectively. However, discrepancies in the information for the same chemicals led to user confusion. 

Collaboration and Completion  In collaboration with the Korea Occupational Safety and Health Agency (KOSHA) and the Korea Fire Institute (KFI), the unification of chemical information was completed by 2024. This includes matching GHS details such as pictograms, signal words, hazard phrases, and precautionary statements. 

Benefits 

• Public Safety: Ensures the public receives consistent and accurate information about chemical products. 

• Industry Clarity: Reduces confusion in the import, export, and handling of chemicals. 

• Government Response: Enhances the government's ability to respond swiftly and accurately to chemical accidents. 

On 2 January 2025, the Korean Cosmetic Association (KCA) announced that customized cosmetics must be reported before 28 February 2025.    Reporting of customized cosmetics material  The KC...

On 2 January 2025, the Korean Cosmetic Association (KCA) announced that customized cosmetics must be reported before 28 February 2025. 

Reporting of customized cosmetics material 

The KCA has issued a reminder of the annual reporting obligations for personalized cosmetics outlined in Article 5, Paragraph 6 of the Cosmetics Act, and Article 13 of its Enforcement Regulations.  

The Regulations on Reporting Import Performance and Ingredient List require companies to report a list of ingredients used in customized cosmetics sold in the previous year by the end of February each year.  

Companies must report the raw components used in their personalized cosmetics by 28 February 2025. The KCA recommends that companies follow the appropriate standards and submit their reports via the association's raw material list reporting system by the deadline.  

How to report

Companies can apply to report raw materials in cosmetics on the KCA website (www.kcia.or.kr) by submitting the raw material list at the end.  

Key Guidelines for Submission 

The KCA has issued specific instructions for companies submitting ingredient lists for personalized cosmetics, highlighting the need for standardized methods and timely reporting. These include: 

• Standardized Ingredient Names. 

• When filling out the "Ingredient Name" form, companies must use normal Korean names for their ingredients. 

• For combined materials, the constituent components must be identified. 

• The KCA's online cosmetic ingredient dictionary is provided as a source of standardized nomenclature. 

Marking Products for Export 

• Products intended for export should be labelled "EXP" in the "usage purpose" section. 

• If the product is not intended for export, leave this column blank. 

Product Name or Category Reporting Options 

• Companies can report components using individual product names or categories.  

• Customized cosmetics with identical ingredients may be grouped into one category, avoiding the need for recurrent reporting. 

Failure to meet this criterion may result in penalties or disruptions to business operations. Companies should move quickly to ensure correct and timely submissions.  

The Korea Occupational Safety and Health Agency (KOSHA) has updated the "Measures to Deal with Explosion and Fire" for 90 types of water-reactive substances. These updates, which came into effect on D...

The Korea Occupational Safety and Health Agency (KOSHA) has updated the "Measures to Deal with Explosion and Fire" for 90 types of water-reactive substances. These updates, which came into effect on December 23, 2024, are now available on the Chemical Information Site.  

Key Points: 

• Importance of Correct Fire Extinguishing Methods: Using the wrong methods to extinguish fires involving water-reactive substances can lead to greater damage. 

• Workplace Preparedness: Workplaces must update their Material Safety Data Sheets (MSDS) to reflect these revisions and ensure that workers receive appropriate MSDS training. 

For more information, click here. 

Since January 1, 2025, South Korea has been enforcing updated registration standards for new chemical substances under K-REACH. This update aligns with National Policy Task 68 (Safe Food, Healthy Livi...

Since January 1, 2025, South Korea has been enforcing updated registration standards for new chemical substances under K-REACH. This update aligns with National Policy Task 68 (Safe Food, Healthy Living Environment), which focuses on differentiated management based on the risk level and quantity of hazardous chemicals. 

Key Changes: 

• Registration Threshold: The threshold for manufacturing and importing these substances will increase from 0.1 to 1 tonne per year. 

• Hazard Categorization: The current definition of 'toxic substance' will be removed. Instead, substances will be categorized according to their hazardous characteristics, leading to a risk-based management system. Categories include: 

         - Acutely hazardous substances for humans 

         - Chronically hazardous substances for humans 

         - Substances harmful to ecology 

• Safety Enhancements:  

         - Expand disclosure of information on registered and reported chemical substances. 

         - Strengthen the reporting system. 

These changes aim to reduce the registration burden on companies while enhancing public safety and transparency. 

Policy Overview Highlights: 

• Revised registration standards for new chemical substances (from 0.1 tonne to 1 tonne per year). 

• New procedures for disclosure, reporting data adjustment, and adequacy review. 

• Defined management principles for substances with unidentified hazards. 

Effective Dates: 

January 1, 2025, and August 7, 2025.