South Korea Regulatory News

On August 30, 2024, the Korea Environment Corporation (K-eco) announced an important update regarding the registration of chemical substances. When registering a chemical substance in accordance wit...

On August 30, 2024, the Korea Environment Corporation (K-eco) announced an important update regarding the registration of chemical substances. When registering a chemical substance in accordance with Article 13 (5) of the Enforcement Decree of the Act on the Registration and Evaluation of Chemical Substances (K-REACH), certain data submissions may be omitted.  

Key Point of the Update 

The key points to note are: 

1. Criteria for Data Omission: When a chemical substance is registered under the provisory clause to Article 14(1) of the Act on the Registration and Evaluation of Chemical Substances and Article 13(5) of the Enforcement Decree of the same Act, part of the registration application may be omitted. 

2. Proof of Similarity Requirement: Previously, under Article 5(1)5 of the Enforcement Regulations of the same Act, companies were required to submit the following data as evidence: 

• Proof of similarity between the substance to be registered and similar chemicals. 

• Test data for similar chemicals. 

3. Reduced Redundancy: The Ministry of Environment announced that if the test data has been submitted previously, the same company can omit to submit it again when registering chemical substances under Article 13(5) of the Enforcement Decree of the Act on the Registration and Evaluation of Chemical Substances. This was implemented immediately per the active administrative decision dated August 23, 2024. 

Legal Basis for Data Omission in Chemical Registrations  

The provisory clause to Article 14(1) of the Act on the Registration and Evaluation of Chemical Substances: In the case of a phase-in substance or non-phase-in substance prescribed by Presidential Decree, he or she need not submit some of the relevant data, as prescribed by Ordinance of the Ministry of Environment.  

Article 13 (5) of the Enforcement Decree of the Act on the Registration and Evaluation of Chemical Substances: A chemical substance whose human health or environmental hazards may be determined based on the results obtained from a chemical substance with similar structure or similar physical and chemical properties, such as metallic compounds containing same metals. 

On October 10, 2024, the Korea Environment Corporation (K-eco) announced an important update regarding the registration status of existing chemical substances used in waste recycling. According to Art...

On October 10, 2024, the Korea Environment Corporation (K-eco) announced an important update regarding the registration status of existing chemical substances used in waste recycling. According to Article 11, Paragraph 1, and Paragraph 9 of the Enforcement Decree of The Act on Registration and Evaluation of Chemical Substances, if a chemical substance produced from recycled waste has already been registered, it can now be exempted from re-registration. 

Key Points: 

• Amendment to the Enforcement Decree: This amendment allows the manufacture or import of waste-recycling chemicals with a confirmed exemption from registration. 

• Data Disclosure: The K-eco discloses data that can confirm the registration status of the same chemical substance as the waste recycling chemical (if 3 years have passed since the date of registration). This data can be used to confirm the exemption from registration. (attachment) 

• Inquiry Process: For substances not listed in the attachment, please check the registration status through the chemical information processing system. You can request an inquiry and fill out a new confirmation application form to understand the current status of the process. 

On October 15, 2024, the Chemical Information Management Support Group in South Korea disclosed the results of the pre-registration of existing chemical substances under K-REACH. This disclosure is in...

On October 15, 2024, the Chemical Information Management Support Group in South Korea disclosed the results of the pre-registration of existing chemical substances under K-REACH. This disclosure is 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.  

Details of pre-registration results 

A total of 17,502 chemical substances have been pre-registered. The information disclosed results from 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 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.