South Korea Regulatory News

On 29 July 2024, the South Korean Ministry of Food and Drug Safety (MFDS) published a notice regarding the use of salicylic acid in cosmetics. Salicylic acid is commonly used as a preservative in gene...

On 29 July 2024, the South Korean Ministry of Food and Drug Safety (MFDS) published a notice regarding the use of salicylic acid in cosmetics. Salicylic acid is commonly used as a preservative in general cosmetics, but in some cosmetics, it has been inappropriately advertised as an exfoliating and sebum-controlling ingredient.

Regulatory Guidance

The MFDS emphasized that the labeling and promotion of general cosmetics containing salicylic acid for purposes other than preservation is prohibited.
While extracts containing salicylic acid can be advertised for their role in general cosmetics, such as exfoliation control, the salicylic acid component itself cannot be promoted for these purposes.

Salicylic Acid Concentration in Cosmetics

The concentration limits for salicylic acid and its salts as a preservative, categorized by product type are listed below:

Deadlines for Compliance

The published notice clarifies the labeling requirements for cosmetics containing salicylic acid. Companies that have already marketed products containing salicylic acid will be given a grace period to make corrections. The advertisement corrections must be made by January 2025 and labeling corrections by July 2025. The MFDS will also oversee the labeling and advertising of cosmetic products containing salicylic acid.

On August 27, 2024, the National Institute of Chemical Safety (NICS) published Hazard Assessment Results under K-REACH.     Announcement of Hazard Assessment Results  In accordance with t...

On August 27, 2024, the National Institute of Chemical Safety (NICS) published Hazard Assessment Results under K-REACH. 

Announcement of Hazard Assessment Results 

In accordance with the Act on the Registration and Evaluation of Chemical Substances, the results of the “Hazard Assessment of Chemical Substances” are published to gather public feedback. This notice is issued in accordance with Article 46 of the Administrative Procedure Act. 

Reason for Revision 

The hazard assessment for registered chemical substances has been completed. The results, including the names, hazards, and toxicity status of these substances, are published. 

Main Content 

A. Notification of Hazard Assessment Results for Registered Chemical Substances 

• New Substances: Examined Substances (Dec 2023 - Mar 2024) - 32 substances, Korean CAS No. 2024-38 to 2024-69 

• Existing Substances: Examined Substances (Apr 2023 - Sep 2023) - 59 substances, Korean CAS No. 2024-463 to 2024-521 

Note: New substances registered between Jun 2023 and Aug 2023. 

This public announcement is made including chemical substances that have secured additional data, such as change registration, and substances that require further review within the same period.

B. Revision of Previously Announced Chemical Substances 

• New Substances: 25 substances were revised for toxicity, name corrections, and hazard information. 

• Existing Substances: 2 substances were revised for hazard information and correction of misinformation. 

Submission of Opinions 

Individuals and organizations are invited to submit their opinions on this Notice by September 19, 2024. Please include: 

• Itemized opinions on the Notice (modifications and reasons). 

• Name, address, and telephone number (for organizations, include the representative’s name). 

Submit to the Director General of the Chemical Safety Agency (Chemical Registration and Evaluation Team) via: 

• Phone: 032-560-7219 / 8493 

• Fax: 032-568-2038 

On September 3, 2024, Representative Paik Jong-heon proposed a bill to amend the Cosmetics Act. The amendment aims to abolish the current government-led certification system and promote a private self...

On September 3, 2024, Representative Paik Jong-heon proposed a bill to amend the Cosmetics Act. The amendment aims to abolish the current government-led certification system and promote a private self-certification system. The goal is to provide more diverse information on natural and organic cosmetics and to align product selection with consumer demand. 

Reason for Revision 

The existing law allows the government to certify natural and organic cosmetics. Internationally, however, such certification systems are typically managed by the private sector. To align with global standards, Korea needs to move to a market-oriented certification system. As the cosmetics industry evolves and consumer values diversify, the government is seeking to abolish the current certification system to better meet consumer demand for natural and organic products. 

Call for Public Input 

If you have an opinion, please fill in the form and send it to jmhan@kcia.or.kr by September 10, 2024. 

The Ministry of Environment, in cooperation with civil society organizations, has announced the selection of 11 new “Excellent Chemical Reduction Products” for 2024. These products, including dete...

The Ministry of Environment, in cooperation with civil society organizations, has announced the selection of 11 new “Excellent Chemical Reduction Products” for 2024. These products, including detergents and other household items, are recognized for reducing or replacing hazardous substances. They are chosen based on a thorough evaluation process, including document reviews, on-site inspections, and final assessments by a judging committee. 

This year, a new mark has been introduced to help consumers easily identify these safer products. The mark features a roof symbolizing protection and hands representing consumer safety, with the phrase “safer choice”. 

The newly selected products include: 

• LG Household & Health Care’s “Oxygen Clean Plus” 

• Mugunghwa’s “Barun Detergent Research Institute Baking Soda” 

• Bullsone’s “Step 1 Thick Blemish Restoration Compound” 

• Aekyung Industry’s “Mom’s Choice Baking Soda” 

This brings the total number of excellent chemical reduction products to 72. Since 2017, the Ministry has been committed to promoting transparency and safety in household chemicals, encouraging companies to disclose all ingredients and prioritize consumer safety. 

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.