South Korea Regulatory News

On July 15, 2024, Rep. Lim I-ja of the People Power Party introduced a bill to amend the ‘Act on the Registration and Evaluation of Chemical Substances’ (K-REACH). This bill aims to allow the use ...

On July 15, 2024, Rep. Lim I-ja of the People Power Party introduced a bill to amend the ‘Act on the Registration and Evaluation of Chemical Substances’ (K-REACH). This bill aims to allow the use of organoids - artificial organs made from stem cells – in place of animals in experiments. The bill includes provisions for the development and verification of these methods, the establishment of verification and training centres, and the promotion of international cooperation with the OECD. 

Impact on the Biotechnology Industry 

The biotechnology industry is optimistic about the bill and expects it to boost the market for organoids, which are seen as the next generation of bio-industrial technology. The global organoid market is projected to grow significantly, from $1.42 billion in 2023 to $4.38 billion by 2028, with a CAGR of 25.2%. Key players in Korea include CHA Biotech, Cytogen, Gradient, Aligned, JW Shinyak, and T&R Biofab. 

Key Points: 

• Organoids as Animal Substitutes: The bill proposes the use of organoids in place of animals for testing. 

• International Standards: Establishes centres for verification and training to meet international standards. 

• Market Growth: Expected to significantly boost the organoid market, both domestically and globally. 

This bill is poised to create a new ecosystem for the high-tech chemical testing industry, fostering international cooperation and market growth. 

On June 28, 2024, the National Institute of Chemical Safety (NICS) in South Korea disclosed the results of the hazard assessment of registered chemicals in accordance with Article 42 (Disclosure of ...

On June 28, 2024, the National Institute of Chemical Safety (NICS) in South Korea disclosed the results of the hazard assessment of registered chemicals in accordance with Article 42 (Disclosure of Chemical Information) of the Act on the Registration and Evaluation of Chemical Substances (K-REACH) and Article 51 (Disclosure of Chemical Information) of the Enforcement Rules of the Act. 

Disclosure Targets 

1. Disclosure of information on registered substances for which the hazard assessment has been completed 

- New chemical substances: 37 chemicals that were assessed for hazard between September and November 2023 

- Existing chemical substances: 20 chemicals that were assessed for hazard between January and March 2023 

 
2. Change of information according to additional data such as registration of changes, etc. Re-disclosure of necessary substances 

- 32 new substances  

- 36 existing substances (35 substances reflecting the unique number of toxic substances) 

The list of the results can be found here. 

On July 15, 2024, the Chemical Information Management Support Group in South Korea disclosed the results of pre-registered existing chemical substances in accordance with Article 42 (Disclosure of Che...

On July 15, 2024, the Chemical Information Management Support Group in South Korea disclosed the results of pre-registered existing chemical substances in accordance with Article 42 (Disclosure of Chemical Information) of the Act on the Registration and Evaluation of Chemical Substances (K-REACH) and Article 51 (Disclosure of Chemical Information) of the Enforcement Rules of the Act. 

A total of 17,484 chemical substances have been pre-registered. The contents disclosed are the results of the pre-registration by substance submitted by companies. This data will be used to organize and operate a joint registration consortium in the future. 

 Key Points: 

• The Chemical Information Management Support Group will periodically update and disclose the results of the (change) pre-registration in the future. 

• The list of pre-registered substances can be accessed here. 

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.