South Korea Regulatory News

On 24 September 2024, the Ministry of Food and Drug Administration of South Korea published a partial revision of the Enforcement Rules of the Cosmetic Act. The notice was issued under Article 41 of t...

On 24 September 2024, the Ministry of Food and Drug Administration of South Korea published a partial revision of the Enforcement Rules of the Cosmetic Act. The notice was issued under Article 41 of the Administrative Procedure Act and is open for public comment until 4 November 2024.

Key Amendments to the Cosmetic Act:

The Cosmetics Act will be amended to improve labeling on cosmetic packaging, set standards for detailed descriptions, and prepare procedures for changing raw material designations.

The amendment also introduces electronic certificates for business registration and strengthens compliance standards. The amendment addresses consumer safety concerns about the unsafe use of labeling and advertising and promotes the safe use of cosmetics by the public.

The draft schedule outlines procedures for examining undesignated raw materials in cosmetics, preparing detailed standards for marking outer packaging, and strengthening advertising compliance standards.

Strengthening Compliance and Safety

The procedure includes the creation of procedures, forms, and fee regulations for manufacturers to remove prohibited ingredients or apply for change. When writing 'Precautions for Use' for hair dye and hair removal products, only essential information should be displayed on the outer packaging, while additional details can be provided in an attached document.

 Additionally, the set packaging should include a control number for checking manufacturing numbers and a statement indicating the period of use after opening.

The guidelines are intended to prevent misleading advertising and administrative penalties for violations.

Submitting Public Feedback

Opinions can be submitted by email to  sunmilee@korea.kr  or by regular mail to Zip code 28159) 187, Osong Life Insurance 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Korea

The Ministry of Environment has issued a 20-day administrative notice starting September 26 to revise the ‘Designation of Restricted Substances and Prohibited Substances’ notice. Key changes inclu...

The Ministry of Environment has issued a 20-day administrative notice starting September 26 to revise the ‘Designation of Restricted Substances and Prohibited Substances’ notice. Key changes include:

• Lead Compounds in Paint: Newly designated as a restricted substance. Usage in paints is now limited to 0.009%.
• Methylene Chloride in Paint Removers: Also newly designated as a restricted substance. Usage is restricted to 0.1% for home, construction, and furniture paint removal.
• White Asbestos: Previously restricted for certain uses, now completely prohibited.

These changes aim to enhance public safety by limiting exposure to these hazardous chemicals. The impact on the industry is expected to be minimal as companies have already been adapting to international safety standards.

The Ministry of Environment has identified 69 products purchased directly from overseas that do not meet domestic safety standards. These products include: 20 Household Chemicals: Items such as ...

The Ministry of Environment has identified 69 products purchased directly from overseas that do not meet domestic safety standards. These products include:

• 20 Household Chemicals: Items such as air fresheners and coatings found to contain hazardous substances like MIT, CMIT, tetrachloroethylene, toluene, benzalkonium chloride, formaldehyde, and lead.
• 49 Metal Jewelry Products: Items such as earrings and necklaces found to contain lead and cadmium.

The Ministry has requested the Korea Customs Service to block the import of these products to protect public health. The products were identified through a safety investigation of 558 items purchased from online distributors AliExpress and Temu. The Ministry will continue to monitor and prevent the resale of these unsafe products.

On  August 2, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea announced a proposed amendment to its ‘Regulations on Cosmetic Safety Standards’, which aims to strengthen public he...

On  August 2, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea announced a proposed amendment to its ‘Regulations on Cosmetic Safety Standards’, which aims to strengthen public health by revising safety standards for cosmetic ingredients. The MFDS is seeking public comments on these amendments until October 3, 2024, and the revised regulations will come into effect six months after their announcement.

Updates and New Ingredient Limits

The amended regulations remove a combination of lawson and dihydroxyacetone from the list of UV-blocking ingredients and introduce a new UV-blocking ingredient, tris-biphenyl triazine, with specific limits on its use in aerosol products and requirements for particle size and purity. The amendment also specifies new or revised limits for several raw materials. This amendment reflects ongoing efforts to enhance cosmetic safety, particularly concerning UV-blocking agents and raw materials with potential health risks.

Proposed Amendment

The proposed amendment to the "Regulation on Safety Standards etc. of Cosmetics" is as follows:

1) Impose restrictions on some cosmetic substances

• 2,6-Dihydroxyethylaminotoluene (hair dye substance):

  • No restrictions up to 1.0%.

  • Not to be used with nitrosating agents.

  • Total nitrosamine content must not exceed 50 ppb.

• Nonoxynol-9: No restrictions up to17.2%.

• Butylphenyl Methylpropional: No restrictions up to 0.14%.

• Cyclotetrasiloxane: No restrictions up to 8.7%.

• Cyclopentasiloxane: No restrictions up to 19.7%.

2) Changes to restrictions on maximum concentration of UV filters in cosmetics

• Addition: Tris-biphenyl triazine

  •  Permitted up to 10%.

  • Not to be used in aerosols.

  • If used in nanoparticles the particle size must be greater than 80 nm and the purity must be at least 98%.

• Deletion: Compounds of lawsone and dihydroxyacetone

• Reduction of allowable concentrations for benzophenone-3(oxybenzone):

  • Allowed up to 2.4% for general use

  • Allowed up to 5% in the face, hand, and lip products)

A partial amendment notice has been sent to the Ministry of Food and Drug Safety seeking feedback on the use of six chemicals in cosmetics, including benzophenone-3. The notification asks for an opinion for or against the use the substances, along with the organization or group's name, address, and phone number. The notice also mentions the addition of one UV-blocking component to the list of raw ingredients that require limits on cosmetics use.

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 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. 

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