South Korea Regulatory News

On July 18, 2024, the Ministry of Food and Drug Safety (MFDS) published an administrative notice of a partial amendment to the Standards for Manufacturing and Quality Control of Excellent Cosmetics. ...

On July 18, 2024, the Ministry of Food and Drug Safety (MFDS) published an administrative notice of a partial amendment to the Standards for Manufacturing and Quality Control of Excellent Cosmetics. 

The amendment aims to harmonize domestic Good Manufacturing Practice (GMP) standards for cosmetics with the international standard (ISO 22716). This alignment is expected to improve work efficiency and international competitiveness. 

By referring to international standards, it has improved terminology by unifying it and has allowed manufacturers to set rework targets and criteria in line with international practices. 

Public opinions on the partial revision will be collected until July 31, 2024. 

On July 12, the Ministry of Environment and the Korea Consumer Agency signed a Memorandum of Understanding (MOU) with home appliance companies to establish an autonomous safety management system for b...

On July 12, the Ministry of Environment and the Korea Consumer Agency signed a Memorandum of Understanding (MOU) with home appliance companies to establish an autonomous safety management system for biocides used in home appliances.  

Regulations and Industry Goals 

Starting in 2028, the home appliance industry will be required to use only approved biocidal products and label processed products under the Consumer Chemical Products and Biocides Safety Control Act. The consumer electronics industry aims to reduce the use of biocides and eliminate exaggerated claims, such as “99% antibacterial power”, associated with biocidal products.  

Cooperation and Support 

The Korea Consumer Agency will collaborate with the home appliance industry to create a safer market environment. The Ministry of Environment will support the implementation of chemical-related systems and improve safety management capabilities throughout the supply chain. Vice Minister of Environment Lee Byung-hwa expressed gratitude for the industry’s efforts to improve safety and reduce the hype about antibacterial effects. Yoon So-hyun, head of the Korea Consumer Agency, emphasized the agency’s commitment to eliminating the hype surrounding biocidal products and improving the product use environment for consumers. 

On July 2, 2024, the Korean Ministry of Environment approved a partial revision of the Enforcement Decree of the Act on the Registration and Evaluation of Chemical Substances. From October 10, 2024, c...

On July 2, 2024, the Korean Ministry of Environment approved a partial revision of the Enforcement Decree of the Act on the Registration and Evaluation of Chemical Substances. From October 10, 2024, chemicals produced by recycling waste will be exempt from registration. This revision aims to eliminate legal uncertainty regarding the registration of recycled chemicals. 

Conditions for Exemptions 

Previously, the recycling industry faced challenges in proving that a manufactured chemical was identical to a chemical already registered in the same supply chain before it became waste. The amendment now includes waste recycled chemicals in the list of exemptions, provided certain conditions are met: 

- Three-Year Gap: The substance must have been registered at least three years ago. 

- Weight Range: It must fall within the weight range of the previously registered chemical. 

- Data Submission: If the previously registered substance is categorized as an intermediate and data submission was omitted, the exemption applies. 

Applicants seeking exemption can submit their confirmation to the Korea Environment Corporation through the Chemical Information Processing System. 

Additional Clarifications and Industry Impact 

Additionally, the revision clarifies the fee collection for the use of hazard test data and aims to reduce the registration burden for the recycling industry. Hwang Kye-young, director of the Environmental Health Department, emphasized the importance of proper waste recycling and chemical safety management. 

On June 14, 2024, the Korean Ministry of Food and Drug Safety (MFDS) announced a partial revision of the regulations on the reporting of production and import results and the list of cosmetic raw mate...

On June 14, 2024, the Korean Ministry of Food and Drug Safety (MFDS) announced a partial revision of the regulations on the reporting of production and import results and the list of cosmetic raw materials. The purpose of this update is to improve the reporting method for listing ingredients in customized cosmetics. Key points include: 

1. Reporting of Customized Cosmetics: Sellers of customized cosmetics must now report the raw materials used in their products. 

2. Collective Reporting: Collective reporting is allowed for products created by combining ingredients from other cosmetics or raw materials. 

3. Streamlined Process: The amendment aims to improve the efficiency and accuracy of cosmetic ingredient reporting. 

On July 15, 2024, the Korean Ministry of Food and Drug Safety (MFDS) announced revised guidelines for alternative animal testing methods for cosmetics. The move aims to improve the international compe...

On July 15, 2024, the Korean Ministry of Food and Drug Safety (MFDS) announced revised guidelines for alternative animal testing methods for cosmetics. The move aims to improve the international competitiveness of the cosmetics industry and non-clinical trial organizations in terms of toxicity tests. The updated guideline includes the OECD TG422E test method (in vitro skin sensitization: genomic allergen rapid detection for assessment of skin sensitizers). 

The guidelines can be found on the website of the Ministry of Food and Drug Safety (www.mfds.go.kr). 

On June 4, 2024, the Korean Environmental Corporation (K-ECO) announced that chemical substances that are wholly exported to foreign countries and fall under Article 11, Clause 1 of the Decree (Confir...

On June 4, 2024, the Korean Environmental Corporation (K-ECO) announced that chemical substances that are wholly exported to foreign countries and fall under Article 11, Clause 1 of the Decree (Confirmation of Exemption from Registration and Reporting) will be exempted from registration and reporting. 

The Decree was due to enter into force on August 7, 2025, but the implementation date has been brought forward to May 28, 2024. This is due to the immediate application of Article 11, Clause 1, Number 3 of the Act and is part of an initiative by the Ministry of Environment to improve the active administration system. It will no longer be necessary to submit documents to prove the exporting country and the export volume. 

Relevant Legal Text 

※ Article 11, Clause 3 of the Act on the Registration and Evaluation of Chemical Substances: A person who intends to manufacture or import other chemical substances prescribed by Presidential Decree, such as a chemical substance manufactured or imported to export the whole quantity thereof, in which case he or she has obtained confirmation of exemption from registration or reporting (hereinafter referred to as "confirmation of exemption from registration, etc.") from the Minister of Environment. 

In such cases, the number of goods registered pursuant to Article 10 (1) and (5) or reported pursuant to paragraph (4) of the same Article shall be excluded from the calculation of the quantity for which registration, etc. has been exempted. 

On May 30, 2024, the National Institute of Chemical Safety (NICS) in South Korea issued an administrative notice regarding the partial revision of the Notice of Designation of Toxic Substances. Here a...

On May 30, 2024, the National Institute of Chemical Safety (NICS) in South Korea issued an administrative notice regarding the partial revision of the Notice of Designation of Toxic Substances. Here are the key details: 

1. Reasons for Revision: 

• The revision is in accordance with the Act on the Registration and Evaluation of Chemical Substances (K-REACH). 

• The goal is to designate highly hazardous substances as new toxic substances. 

2. Key Details: 

• Hazard assessments were conducted on new and existing chemicals under the Act on the Registration and Evaluation of Chemical Substances. 

• Eleven substances were added (columns “2024-1-1213” to “2024-1-1223”). 

• These substances meet the criteria for toxic designation: 

• Acute oral toxicity (Category A): 2024-1-1214, 2024-1-11219, and 2024-1-11223. 

• Strong acute inhalation toxicity (Category C): 2024-1-1213, 2024-1-11215, 2024-11216, 2024-1-221, and 2024-1-1-1222. 

• Highly corrosive (Category D): 2024-1-1217, 2024-1-1218, and 2024-1-1220. 

• Refer to the detailed value results in the Result of Hazard Assessment of Chemical Substances. 

3. Revisions and CAS Numbers: 

• KE numbers “2017-1-762” and “2022-1-1095” require additional CAS numbers. 

• Specify CAS numbers for sub-isomers of existing and new chemicals corresponding to toxic substances. 

4. Transitional Measures: 

• Provide deadlines for implementing obligations under the Chemical Substances Control Act for handling newly designated toxic substances. 

5. Submission of Comments: 

• Individuals, institutions, and organizations can submit opinions by June 19, 2024. 

• Include opinions, name (or organization), address, and phone number. 

• The full amendment is available on the National Institute of Chemical Safety's website.