South Korea Regulatory News

On July 15, 2024, the Korean Ministry of Food and Drug Safety (MFDS) announced revised guidelines for alternative animal testing methods for cosmetics. The move aims to improve the international compe...

On July 15, 2024, the Korean Ministry of Food and Drug Safety (MFDS) announced revised guidelines for alternative animal testing methods for cosmetics. The move aims to improve the international competitiveness of the cosmetics industry and non-clinical trial organizations in terms of toxicity tests. The updated guideline includes the OECD TG422E test method (in vitro skin sensitization: genomic allergen rapid detection for assessment of skin sensitizers). 

The guidelines can be found on the website of the Ministry of Food and Drug Safety (www.mfds.go.kr). 

On June 4, 2024, the Korean Environmental Corporation (K-ECO) announced that chemical substances that are wholly exported to foreign countries and fall under Article 11, Clause 1 of the Decree (Confir...

On June 4, 2024, the Korean Environmental Corporation (K-ECO) announced that chemical substances that are wholly exported to foreign countries and fall under Article 11, Clause 1 of the Decree (Confirmation of Exemption from Registration and Reporting) will be exempted from registration and reporting. 

The Decree was due to enter into force on August 7, 2025, but the implementation date has been brought forward to May 28, 2024. This is due to the immediate application of Article 11, Clause 1, Number 3 of the Act and is part of an initiative by the Ministry of Environment to improve the active administration system. It will no longer be necessary to submit documents to prove the exporting country and the export volume. 

Relevant Legal Text 

※ Article 11, Clause 3 of the Act on the Registration and Evaluation of Chemical Substances: A person who intends to manufacture or import other chemical substances prescribed by Presidential Decree, such as a chemical substance manufactured or imported to export the whole quantity thereof, in which case he or she has obtained confirmation of exemption from registration or reporting (hereinafter referred to as "confirmation of exemption from registration, etc.") from the Minister of Environment. 

In such cases, the number of goods registered pursuant to Article 10 (1) and (5) or reported pursuant to paragraph (4) of the same Article shall be excluded from the calculation of the quantity for which registration, etc. has been exempted. 

On April 17, 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...

On April 17, 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 and Article 51 (Disclosure of Chemical Information) of the Enforcement Rules of the Act.

The disclosed contents are the results of the pre-registration by substance submitted by the company, and they can be used to organize and operate a joint registration consortium in the future.

• 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 found here.

On May 27, the Korea Cosmetic Association updated the Guidelines for Prohibited Substances in Cosmetics for Analysis and released two new guidelines: ‘Analytical Methods of Cosmetic Ingredients in C...

On May 27, the Korea Cosmetic Association updated the Guidelines for Prohibited Substances in Cosmetics for Analysis and released two new guidelines: ‘Analytical Methods of Cosmetic Ingredients in Cosmetic Products’ and ‘Guidelines for Testing and Safety Evaluation of European SCCS Cosmetic Ingredients.’

These documents aim to enhance safety management in the cosmetics industry and facilitate exports. They provide valuable information on the analysis of cosmetic ingredients present in cosmetic products. The analytical methods described in these documents have been validated through research funded by the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea. Before implementing these methods based on the specific type of cosmetic product, it is advisable to validate them by appropriate procedures. If changes are made to the analytical methods, the revised approaches should undergo thorough evaluation with appropriate validation procedures.

On May 30, 2024, the National Institute of Chemical Safety (NICS) in South Korea issued an administrative notice regarding the partial revision of the Notice of Designation of Toxic Substances. Here a...

On May 30, 2024, the National Institute of Chemical Safety (NICS) in South Korea issued an administrative notice regarding the partial revision of the Notice of Designation of Toxic Substances. Here are the key details: 

1. Reasons for Revision: 

• The revision is in accordance with the Act on the Registration and Evaluation of Chemical Substances (K-REACH). 

• The goal is to designate highly hazardous substances as new toxic substances. 

2. Key Details: 

• Hazard assessments were conducted on new and existing chemicals under the Act on the Registration and Evaluation of Chemical Substances. 

• Eleven substances were added (columns “2024-1-1213” to “2024-1-1223”). 

• These substances meet the criteria for toxic designation: 

• Acute oral toxicity (Category A): 2024-1-1214, 2024-1-11219, and 2024-1-11223. 

• Strong acute inhalation toxicity (Category C): 2024-1-1213, 2024-1-11215, 2024-11216, 2024-1-221, and 2024-1-1-1222. 

• Highly corrosive (Category D): 2024-1-1217, 2024-1-1218, and 2024-1-1220. 

• Refer to the detailed value results in the Result of Hazard Assessment of Chemical Substances. 

3. Revisions and CAS Numbers: 

• KE numbers “2017-1-762” and “2022-1-1095” require additional CAS numbers. 

• Specify CAS numbers for sub-isomers of existing and new chemicals corresponding to toxic substances. 

4. Transitional Measures: 

• Provide deadlines for implementing obligations under the Chemical Substances Control Act for handling newly designated toxic substances. 

5. Submission of Comments: 

• Individuals, institutions, and organizations can submit opinions by June 19, 2024. 

• Include opinions, name (or organization), address, and phone number. 

• The full amendment is available on the National Institute of Chemical Safety's website. 

On May 30, 2024, the National Institute of Chemical Safety (NICS) in South Korea issued an administrative notice regarding the partial revision of the Regulations on Classification and Labeling of Che...

On May 30, 2024, the National Institute of Chemical Safety (NICS) in South Korea issued an administrative notice regarding the partial revision of the Regulations on Classification and Labeling of Chemical Substances. Here are the key details:

1. New Hazard Classification and Labeling for Toxic Substances:

As a result of hazard studies conducted under the Act on Registration and Evaluation of Chemical Substances, new hazard classification and labeling were established for both new and existing toxic substances.

Specifically, 11 types of toxic substances, including “phosphorus trifluoride”, will be newly classified and labeled with unique numbers ranging from “2024-1-1213” to “2024-1-1223.”

2. Revised Classification and Labeling for Existing Hazardous Chemicals:

Existing hazardous chemicals that require changes based on additional data will have their classification and labeling revised.

This includes:

Revision of the classification and labeling for three toxic substances (KE numbers “2017-1-785”, “2018-1-837” and “2021-1-1068”).

Addition of pictograms (GHS 9) corresponding to hazard to the aquatic environment for one type of toxic substance (KE number “97-1-145”).

Specific indication of the CAS number for sub-isomers of two toxic substances (KE numbers “2017-1-762” and “2022-1-1095”).

* The KE number refers to a unique identifier assigned to existing chemical substances in South Korea.

3. Implementation Obligations:

Individuals and organizations required to label hazardous chemicals must comply with the revised regulations under the Chemical Substances Control Act (as specified in Article 16 of the Act).

4. Submission of Comments:

Stakeholders interested in commenting on this notice can submit written feedback to the Director of the National Institute of Chemical Safety (Chemical Registration Evaluation Team) no later than June 19, 2024.

The submission should include:

A. Opinions on whether or not the notice should be revised and the rationale for the position.

B. Name (or name of organization and representative), address, and phone number.

C. The full text of relevant amendments to the “Regulations on Classification and Labeling of Chemical Substances” can be submitted via the Chemical Substances Safety Board website.

On May 28, 2024, the Ministry of Environment, led by Minister Han Hwa-jin, announced plans to sign an agreement with the Organization for Economic Cooperation and Development (OECD) to promote interna...

On May 28, 2024, the Ministry of Environment, led by Minister Han Hwa-jin, announced plans to sign an agreement with the Organization for Economic Cooperation and Development (OECD) to promote international cooperation projects for the development of a Korean version of the QSAR Toolbox, a computer program for predicting chemical toxicity.

Developed jointly by the Organization for Economic Cooperation and Development (OECD) and the European Union (EU), this program aims to minimize animal testing by predicting the toxicity of chemicals without the need for actual animal testing.

Key points about the QSAR Toolbox

• Purpose: To prepare for the demand for chemical testing following the implementation of the chemicals management system (REACH).
• Functionality: Predicts the toxicity of chemicals and provides test data or assists in the development of new substances required for chemical registration.
• Specifications: The QSAR Toolbox includes 70 profilers that identify chemical characteristics and 59 databases with information on chemical structures and physical and biological properties.
• Toxicity prediction: It can predict various toxicities, including acute toxicity, genetic toxicity, skin sensitivity, and aquatic toxicity.

Current Challenges and Future Goals

Until now, the Korean version of the program was not available, and companies had to use the English version. This posed challenges due to a lack of knowledge of English terminology and additional costs when seeking professional advice.

The Ministry of Environment aims to release the Korean version by 2027, following an agreement with the OECD. The aim is to reduce animal testing and improve animal welfare while ensuring accurate chemical registration. Detailed guidelines for each toxic category will also be provided for the convenience of the industry.