South Korea Regulatory News

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.  

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. 

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.  

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). 

South Korea’s Ministry of Employment and Labor, in collaboration with the National Fire Agency, has successfully unified the information for 565 of the 4,091 overlapping chemicals in their respectiv...

South Korea’s Ministry of Employment and Labor, in collaboration with the National Fire Agency, has successfully unified the information for 565 of the 4,091 overlapping chemicals in their respective chemical information systems, ensuring consistency in GHS (Globally Harmonized System) information.

What is GHS? 

The UN Globally Harmonized System for Classification and Labelling of Chemicals (GHS) is an internationally standardized system for classifying and labelling chemical substances, designed to enhance safety by providing consistent hazard information.

GHS Background 

The Ministry's Material Safety Data Sheet System (covering 20,555 chemicals) and the National Fire Agency's National Integrated Dangerous Goods Information System (covering 7,364 chemical substances) contained discrepancies in overlapping information for 4,091 substances, causing confusion for users.

Collaboration and Completion 

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

Benefits Include

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

• Industry Clarity: Reduces confusion when importing, exporting, and handling 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.