South Korea Regulatory News

On November 15, 2024, the South Korean Ministry of Food and Drug Safety (MFDS) notified the World Trade Organization (WTO) of a proposed amendment to the “Regulation on Labelling and Description of ...

On November 15, 2024, the South Korean Ministry of Food and Drug Safety (MFDS) notified the World Trade Organization (WTO) of a proposed amendment to the “Regulation on Labelling and Description of Medical Devices". The purpose of the amendment is to increase efficiency and reduce burdens on the industry by allowing manufacturers to include only the primary contact or visit address on the container or package of medical devices.  

Key Updates 

A. Improvements to the writing of the address on the container or package (Article 6):  

Based on the manufacturing/import business license, an address that can be contacted or visited at any time can be selected as the primary address on the label.   

B. Changes in terminology to reflect current regulations (Articles 8 and 9): 

Reflects names of websites where one can check matters related to permission, certification, and reporting (Medical Device Electronic Civil Service System) and code for video conversion of voice and sign language, and sign language terms. 

Public Consultation and Enforcement Timeline 

The amendment will be open for comments for 60 days from the date of notification. The proposed date for adoption and enforcement of the amendment will be announced at a later date.  

On November 14, 2024, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of the new designation of lead compounds and methylene Chloride as restricted substance...

On November 14, 2024, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of the new designation of lead compounds and methylene Chloride as restricted substances. The purpose of the amendment is to newly designate substances that are of high concern for hazards in certain uses as restricted substances. 

Key Changes 

1, Expansion of Lead Restrictions 

The lead identification number 06-5-8 is expanded to include lead and its compounds.  

• Prohibited uses: The manufacture, import, sale, and use of lead and its compounds for painting purposes.  

• Exemptions: Aerospace, and defense applications (e.g., maintenance and repair of aircraft or weapons). 

2, New Restriction on Methylene Chloride 

Methylene chloride and mixtures containing more than 0.1% of it are newly designated as restricted substances. The new identification number is 06-05-15. 

• Prohibited uses: Methylene chloride and mixtures containing more than 0.1% cannot be used for paint removal for household, construction, and furniture purposes.  

Public Consultation and Enforcement Timeline 

The amendment will be open for comments for 60 days from the date of notification. The proposed date for adaptation and enforcement of the amendment is January 2026.  

On November 6, 2024, South Korea’s Chemical Safety Agency completed the hazard assessment for registered chemical substances in accordance with the “Act on the Registration and Evaluation of Chemi...

On November 6, 2024, South Korea’s Chemical Safety Agency completed the hazard assessment for registered chemical substances in accordance with the “Act on the Registration and Evaluation of Chemical Substances, etc.,”  

The results, including the names of the chemical substances, their hazards, and whether they are classified as toxic substances, are disclosed to inform the public and gather their opinions. 

Main Contents 

1. Notification of Hazard Assessment Results for Registered Chemical Substances 

• Schedule No. 1 (New Chemical Substances): Substances Examined (April - July 2024): 53 Types, KE Numbers 2024-70 to 2024-122 

• Schedule No. 2 (Existing Chemicals): Audited Substances (October 2023 - January 2024): 33 Types, KE Numbers 2024-522 to 2024-554 

• Additional Data: Includes substances registered from September to December 2023 and those requiring additional review. 

2. Revisions to Secure Additional Data 

• Schedule No. 1 (New Chemical Substances): Revisions based on securing hazard information, including changes to generic names and toxicity status. 

• Schedule No. 2 (Existing Chemicals): Not applicable. 

3. Details of Completed Hazard Assessments 

• Names of chemical substances (CAS No.), notification of toxic substances, major hazards, etc. 

Submission of Comments 

Individuals, organizations, and associations interested in commenting on this revision are invited to submit a written comment by November 26, 2024.  

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