South Korea Regulatory News

On September 12, 2023, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a notification to classify 'permanent wave products for eyelashes' as cosmetics in order to handle them securel...

On September 12, 2023, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a notification to classify 'permanent wave products for eyelashes' as cosmetics in order to handle them securely and methodically. In the second half of this year, the Ministry will begin work on revising related regulations.

Cosmetic products for the eyes are popular because they improve the overall appearance of the eyes, but it is important to consider their adverse effects on the human body before using them. There have been reports of eye and cornea damage as a result of customers using 'permanent wave treatments for eyelashes' incorrectly, highlighting the need for improved safety management.

The MFDS expects users to have a proper understanding of how to use 'Permanent Wave Product for Eyelashes' in order to use it safely and avoid any negative effects caused by improper usage. Since June 2023, the Ministry of Food and Drug Safety has been discussing with experts about 'permanent wave products for eyelashes' as cosmetics. The government has also discussed required labelling, monitoring of side effects, and the necessity to ensure the safety of raw materials.

To regulate 'permanent wave products for eyelashes' as cosmetics, the Ministry of Food and Drug Safety will promote the revision of related laws such as the "Enforcement Rules of the Cosmetics Act" and the "Regulations on Precautions for Using Cosmetics and Labelling of Allergenic Ingredients" beginning in the second quarter of 2023.

On August 3, 2023, the Ministry of Environment (MOE) in South Korea announced that it will issue a preliminary legislative notice of draft partial amendments to the Enforcement Decree and Enforceme...

On August 3, 2023, the Ministry of Environment (MOE) in South Korea announced that it will issue a preliminary legislative notice of draft partial amendments to the Enforcement Decree and Enforcement Rule on the Wastes Control Act and its implementing regulations. The MOE will hold a legislative preview for the amendments from August 4, 2023, to September 15, 2023.  

These amendments aim to rationalize regulations and unify the procedures for the collection, transportation, and disposal of waste, including hazardous chemicals, will be unified under the Waste Control Act. Related standards will be reorganized to prevent gaps in safety management, and related regulations such as electric vehicle waste batteries and carbon dioxide collection will be improved to reflect the improvement and supplementation requirements raised in the system operation process. This includes revitalizing the circulation of waste resources and expanding the use of new technologies. 

It is intended to unify the management system by including restricted substances, licensed substances, prohibited substances, and substances requiring preparation for accidents among hazardous chemicals in the waste classification system, and to clearly define that human secretion themselves are included in general medical waste. 

On August 31, 2023, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of the draft partial amendment of the Enforcement Decree and Enforcement Rule of the Act ...

On August 31, 2023, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of the draft partial amendment of the Enforcement Decree and Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances. The amendment will affect new and existing chemical substances, polymers, nanomaterials, and substances subject to intensive control.

Both amendments are open for comments for 60 days from the notification date. The proposed date for adaptation and enforcement of the amendments is January 4, 2024. The partial amendment contains the following:

1. Enforcement Decree:

Name of Law: "Draft partial amendment of the Enforcement Decree of the Act on Registration and Evaluation of Chemical Substances"

- Major Contents:

A. Delegation of Authority and Entrustment of Affairs etc (Articles 21, 22, and 31)

1) ORs are enabled for the tasks of reporting changes in substances subject to intensive control contained in the product and the newly amended duty

2) The tasks of reporting changes in substances subject to intensive control contained in the product and the newly amended duty could be done via the online system operated by the government.

3) Reporting changes of substances subject to intensive control contained in a product should be submitted to the heads of regional environmental offices

B. Criteria for Imposition of Administrative Fine (Attachment 6)

1) Depending on how many times a person has failed to report the changes of substances subject to intensive control contained in the product and the newly amended duty, a maximum of 10,000,000 KRW fine will be given.

2. Enforcement Rule:

Name of Law: "Draft partial amendment of the Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances"

- Major Contents:

A. Simplification of provision of information on chemical substances (Article 36)

1) For any substances that have been registered without CSR, instead of registered numbers, whether registered could be written on MSDS for provision of information.

B. Criteria for reporting changes in substances subject to intensive control contained in the product (Article 43)

1) When the number of substances subject to intensive control contained in a product changes more than 50%, the substance needs to be reported for changes.

2) No need to report changes when the amount of change is less than 50%

C. Criteria for Fee (Attachment 11)

1) The reporting fee for the initial notification of SSICCP is set to be 20,000 KRW, reporting fee for the changes of the notification of SSICCP is set to be 15,000 KRW

The National Institute of Chemical Safety (Director Park Bong-kyun) formed a consortium for handling facility standards with experts, industries, and civil society to improve the standards of hazardou...

The National Institute of Chemical Safety (Director Park Bong-kyun) formed a consortium for handling facility standards with experts, industries, and civil society to improve the standards of hazardous chemical handling facilities and held a launching ceremony on August 18, 2023, at the National Institute of Chemical Safety. 

The expert consultative body was promoted to prepare for the revision of 15 types of handling facility standards, including the "Notification on the Installation and Management of Hazardous Chemicals Manufacturing and Use Facilities." 

Since early July, the National Institute of Chemical Safety has received recommendations for 10 participants in the expert consultative body from inspection agencies, academia, industry, and civil society. 

The consultative body consists of a total of 15 members, including 5 ex officio members, including the Ministry of Environment's Chemical Safety Division, 3 experts from inspection institutions, 3 experts recommended by industry, and 4 experts recommended by academia and civil society recommendations. 

The expert consultative body will operate until the end of 2024, and discussions will be held at least once a month to prepare standards for handling facilities considering the level of hazard and risk of chemicals. 

The consultative body will discuss technical standards that can minimize the occurrence and damage of chemical accidents, detailed items of facility standards according to acute, chronic, and ecological hazards, and handling facility standards according to physical risks. 

The first discussion, which followed the inauguration ceremony, had time to share the "direction of reorganization of toxic substance designation management system and handling facility standards" and the current status of implementation. 

Based on the discussion of the consultative body, the National Institute of Chemical Safety will prepare a standard notice for manufacturing, use, and storage facilities by December 2023 and announce it at the Chemical Safety Policy Forum. 

On August 1st, 2023, the National Institute of Environmental Research (NIER) in South Korea partially revised and notified the Notice of Designation of Toxic Substances, in accordance with Article 2(6...

On August 1st, 2023, the National Institute of Environmental Research (NIER) in South Korea partially revised and notified the Notice of Designation of Toxic Substances, in accordance with Article 2(6) and Article 20 of the 「Act on the Registration and Evaluation of Chemicals」 and Article 2(2) of the 「Chemical Substances Control Act」 and Article 2 of the Enforcement Decree of the same Act. 

Three highly hazardous chemicals (CAS 37348-84-8, CAS 932384-12-8, CAS 95-46-5) were added as toxic substances under K-REACH. 

The details of the substances are as follows: 

1. Cobalt manganese nickel oxide (CAS 37348-84-8) and mixtures containing 0.1% or more. 

2. Silica gel reaction products with chromium oxide (CrO3) and ethoxydiethylalumium (CAS 932384-12-8) and mixtures containing 10% or more of the same. 

3. 1-Bromo-2-methylbenzene (CAS 95-46-5) and mixtures containing at least 25% thereof. 

Starting this August, the Ministry of Environment in South Korea is introducing a preliminary review system to expedite the completeness review period conducted by the National Institute of Environmen...

Starting this August, the Ministry of Environment in South Korea is introducing a preliminary review system to expedite the completeness review period conducted by the National Institute of Environmental Research. 

1. This system is voluntary and not governed by the Chemical Product Safety Act. It is not included in the statutory review period and can be applied for voluntarily. 

2. The preliminary review period lasts a maximum of 5 days from the day after the request, with only one preliminary review allowed per application. 

3. After the preliminary review, the reviewed items must be confirmed, supplemented, and submitted to the Chemp system before the formal approval process can begin. 

4. The content of the preliminary review is limited to the completeness of the application and some of the required submissions. 

5. The preliminary review period is planned to remain in operation until further notice. However, it may be temporarily suspended in the event of a substantial influx of applications. 

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) takes part in the WNT (Working Group of the National Coordinators for the Test Guidelines Programme) meetin...

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) takes part in the WNT (Working Group of the National Coordinators for the Test Guidelines Programme) meeting that is held at the OECD headquarters in Paris, France from April 24 to 29. It participates in the deliberation and approval of OECD guidelines and presents the current status of the liver organoid-based toxicity assessment (complex collections of cells that are three-dimensional tissue cultures derived from stem cells or cells of organ origin. Organoids replicate the structure and function of real organs. They can be used in various areas such as safety evaluation, efficacy evaluation, and the development of treatment) methods developed in Korea.