South Korea Regulatory News

On November 10, 2023, the head of the National Institute for Environmental Research (NIER, Director Geum Han-Seung) under the Ministry of Environment (MoE) announced that it would urgently approve eig...

On November 10, 2023, the head of the National Institute for Environmental Research (NIER, Director Geum Han-Seung) under the Ministry of Environment (MoE) announced that it would urgently approve eight products in the neonicotinoid family of insecticides (DinoTepuran) so that they can be used to control bedbugs. DinoTepuran is an insecticide that has already been registered and approved in the United States and Europe and has already registered in Korea for mosquitoes, flies, and cockroaches in Korea. 

Domestic and international studies have shown that bedbugs that have recently emerged are resistant to Piresloid-based pesticides and are less effective. 

NIER held discussions with experts on November 7 to review the possibility of emergency approval for the neonicotinoid family of pesticides, and a meeting with product producers was held on November 9 to confirm the intent to participate, manufacturing, and supply and demand of raw materials and emergency approval. 

The emergency approval of the neonicotinoid family of insecticides is based on the fact that they are registered and used for the control of mosquitoes, flies, and cockroaches, and that, in addition to the effectiveness of the insecticide against bedbugs, their safety for humans and the environment has already been verified during the registration process. 

All eight urgently approved products are only approved for controlled use by professional quarantine workers, and household (health) pesticides were excluded from the emergency approval. 

However, the National Institute of Environmental Research immediately initiated follow-up approval procedures such as safety verification, so that neonicotinoid-based pesticides can be used for household use and plans to quickly identify other pesticides that are less resistant. 

Chemical control of pests can inevitably cause resistance problems and affect the human body and the environment, said the head of the NIER. "Physical control such as steam, high temperature treatment, and vacuum cleaning should be prioritized, and chemical control (use of insecticides) should be used only where necessary taking into account the use, capacity and precautions to prevent exposure to the human body." 

On October 4, 2023, the Chemical Safety Management Team of the Ministry of Environment (MoE) published a “Notice of Revision of the Subordinate Laws of the Chemical Substances Control Act”.  T...

On October 4, 2023, the Chemical Safety Management Team of the Ministry of Environment (MoE) published a “Notice of Revision of the Subordinate Laws of the Chemical Substances Control Act”. 

The Enforcement Decree and the subordinate laws of the same Act have been partially revised as follows. 

➊ Technical manpower: Extension of validity based on technical manpower in workplaces with less than 30 employees (2023 → 2028) 

➋ Qualifications for managers and technical personnel: Added certification qualifications such as surface treatment and chemical analysis (12 types added, 37 types in total) 

➌ Training for handling personnel: 16 hours before handling or 8 hours each before/after handling 

➍ Chemical Substance Management ledger: Check "Purchase Purpose" when selling hazardous chemicals and record them in the ledger 

It came into force on October 4, 2023, however, training part for handling personnel will be implemented from January 1st, 2025, taking into account the development of educational material. 

The South Korean Ministry of Food and Drug Safety (MFDS) announced a new guideline for animal testing on October 18, 2023, entitled Guideline of Alternative Animal Testing Methods for Cosmetics: Eye I...

The South Korean Ministry of Food and Drug Safety (MFDS) announced a new guideline for animal testing on October 18, 2023, entitled Guideline of Alternative Animal Testing Methods for Cosmetics: Eye Irritation (Acute Eye Damage or Irritation) Test using Reconstructed Human Cornea-like Epithelium (RhCE).

Animal testing

Many countries prohibit animal testing. Since 2013, South Korea has also been a pioneer in the protection of animal rights. According to the South Korean Cosmetics Act, no cosmetics or cosmetic materials that have been tested on animals may be supplied in the country. The ban on animal testing also applies to imported cosmetics.

The MFDS has previously issued twenty-nine recommendations previously on alternative animal testing methods to help cosmetic companies conduct safety tests efficiently.

RhCE model

The reconstructed human corneal-like epithelial model (RhCE) is a model created by culturing immortalized human-derived corneal epithelial cells that have a lamellar structure and a highly differentiated squamous epithelium. It consists of at least four living cell layers and measures survival after topical exposure to a test substance. RhCE tissue viability measures the extent to which the bioluminescent dye MTT is converted to formazan dye by living cells and predicts the overall ocular damage/irritation response to chemicals.

Guidelines

The recently published guidelines explain alternative testing methods for eye irritation in cosmetics using the RhCE model. It describes the position of the Food and Drug Administration (FDA) and is based on scientific evidence and laws in effect as of October 18, 2023. It may be applied differently depending on recent amendments.

"Eye damage or irritation" refers to adverse effects such as damage or irritation caused by the test chemical coming into contact with the eyes. The RhCE eye irritation test technique is anticipated to assist companies in developing safer cosmetic products without the use of animal testing.

This test guideline applies to single substances, mixtures, solids, liquids, semi-solids, and waxes. It is applicable to water-soluble or water-insoluble liquids and highly soluble or insoluble solids. It is not appropriate to apply this guideline to gases and aerosols, and scientifically meaningful results should be considered when testing difficult-to-test substances or mixtures not covered by this guideline.

On October 31, 2023, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of the draft partial amendment to the Enforcement Rule of the Act on Registration and Ev...

On October 31, 2023, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of the draft partial amendment to the Enforcement Rule of the Act on Registration and Evaluation of Chemical Substances. The amendment aims to reduce trade barriers and facilitate trade. 

The amendment is open for comments for 60 days from the date of notification. The proposed date for adaptation and enforcement of the amendments is January 30, 2024. The partial amendment contains the following: 

For the chemical substances under Article 11(1) of the Act on Registration and Evaluation of Chemical Substances (hereinafter referred to as "the Act"), it is allowed to waive some of the data required for chemical registration under Article 10 of the Act, the Ministry of Environment requests to submit the reason of waiving and the evidence data under Article 5 of the Enforcement Rule of the Act.  However, at present, the MoE requests the submission of the evidence data even when it is possible to justify waiving some data based on the hazard evaluation results of overseas governments, etc. Therefore, this partial amendment aims to specify the cases in which the submission of evidence data is not required. 

On October 31, 2023, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of a draft partial amendment to the Enforcement Decree of the Act on Registration and Ev...

On October 31, 2023, the South Korean Ministry of Environment (MoE) notified the World Trade Organization (WTO) of a draft partial amendment to the Enforcement Decree of the Act on Registration and Evaluation of Chemical Substances. The amendment covers both phase-in and non-phase-in substances, and it aims to reduce trade barriers and facilitate trade. 

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 30, 2024. The partial amendment includes the following: 

Currently, the registration obligation under Article 10 of the Act on Registration and Evaluation of Chemical Substances also applies to chemical substances produced by recycling waste. However, in the EU which has a chemical registration instrument like that of Korea, the registration obligation is exempted for chemical substances produced by recycling wastes if other business operators have already completed the registration of the same chemical substance. Therefore, Korea will allow an exemption from the registration of chemical substances produced by recycling wastes if the chemical substance has already been registered by other business operators. 

Companies in South Korea that manufacture or import 10 to 100 tonnes of chemicals per year are required to submit their Material Safety Data Sheets (MSDSs) to the MSDS portal before the grace period e...

Companies in South Korea that manufacture or import 10 to 100 tonnes of chemicals per year are required to submit their Material Safety Data Sheets (MSDSs) to the MSDS portal before the grace period ends on January 16, 2024. 

This mandatory submission is part of the country’s efforts to ensure the safety and health of workers handling these chemicals. The MSDS provides detailed information on the physical and chemical properties of these substances, including potential hazards and instructions for safe handling. 

In cases where the MSDS contains trade secrets, workplaces must undergo a non-disclosure approval review with the Occupational Safety and Health Agency (OSHA). This process allows for alternative names and content to be entered, protecting proprietary information while still ensuring safety compliance. 

Failure to meet this deadline could result in penalties, so companies are encouraged to start preparing their MSDS submissions as soon as possible. 

Grace periods for submitting MSDSs 

From 16 January 2021, Korean authorities require manufacturers, importers, or Only Representatives (ORs) appointed by non-Korean manufacturers to submit an MSDS before manufacturing or importing chemical substances. The MSDS must be submitted in Korean Language and follow the fourth revision of the UN GHS. If a chemical substance has been placed on the Korean market and an MSDS has been prepared before 16 January 2021, there are grace periods for submitting MSDSs based on the tonnage bands as listed in the table below. The grace periods for the tonnage bands above 1000 tonnes per annum (TPA) and 100-1000 TPA have expired.  

The Ministry of Employment and Labor (MoEL) announced the results of the "Monitoring of the Implementation Status of Material Safety Data Sheet (MSDS) in 2023" (220 locations, from July 10 to August 3...

The Ministry of Employment and Labor (MoEL) announced the results of the "Monitoring of the Implementation Status of Material Safety Data Sheet (MSDS) in 2023" (220 locations, from July 10 to August 31) for chemical handling sites.  

A total of 223 violations of the system were discovered at nearly half of the monitored workplaces (97 locations, 44%) including the following:  

• No warning signs (46 sites, 85 cases) 

• No material safety and health data education (31 sites, 33 cases) 

• No material safety and health data posted (21 sites, 37 cases)  

Compared to the 2022 monitoring results, the posting of material safety and health data newly introduced in 2021 decreased compared to the previous year, while posting warning signs and conducting worker education was still insufficient. 

In addition to the Material Safety Data Sheet (MSDS) system, 33 workplaces (36 cases) were found to have inadequate measures to protect the health of workers, such as failing to conduct special health checkups, which are the employer’s obligation to take safety and health measures or failing to install local exhaust ventilation systems to remove harmful substances in the workplace. Violations were subjected to legal action (4 cases) and fines (254 cases, KRW 185 million), and immediate corrective action was taken.   

Choi Tae-ho, Supervisory Policy Officer of the Industrial Accident Prevention, said, "A basic business owner must faithfully prepare, submit and post material safety data sheets and clarify warning signs on containers". He further emphasized, "It is also a key point to prevent accidents to fully educate workers about the dangers, hazards, and handling of chemicals before work."