South Korea Regulatory News

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. 

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.

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."  

On September 26, 2023, the Ministry of Employment and Labor (MoEL) announced the names, hazards, and risks of 55 new chemical substances manufactured and imported in the third quarter of 2023, as well...

On September 26, 2023, the Ministry of Employment and Labor (MoEL) announced the names, hazards, and risks of 55 new chemical substances manufactured and imported in the third quarter of 2023, as well as measures to prevent workers’ health problems related to these substances. 

Manufacturers and importers of new chemicals must submit a Hazard and Risk Investigation Report to the Ministry of Employment and Labor (MoEL) 30 days before the date of manufacture or import of the new chemical, and the MoEL regularly announces the name, hazards, and risks of the new chemicals. 

20 of the 55 new chemicals announced this time, are classified as either acutely toxic, skin and eye irritating, skin sensitising, or hazardous to the aquatic environment including (S)-Nornicotine and diphenylphosphine. 

Accordingly, the Ministry of Employment and Labor notified employers who manufacture or import the substance of measures to prevent health problems among workers who handle harmful or dangerous chemicals. 

Choi Tae-ho, director of the Industrial Accident Prevention and Supervision Policy Bureau, said, "It should not stop at knowing the harmfulness and risks of new chemicals and measures to protect workers". He emphasized, "It is important for employers to install local exhaust systems and provide and wear personal protective equipment such as respiratory protection, protective gloves, and safety glasses, while implementing basic safety and health rules, such as thoroughly wearing personal protective equipment when handling chemicals." 

On October 6, 2023, the National Institute of Environmental Research (NIER) of South Korea published guidance on product labelling when submitting the approval documents for biocidal products under K...

On October 6, 2023, the National Institute of Environmental Research (NIER) of South Korea published guidance on product labelling when submitting the approval documents for biocidal products under K-BPR. 

A person who intends to obtain approval for a biocidal product shall prepare the correct label (labels) for each product in accordance with the relevant labelling laws and regulations and shall indicate the label claim that has been finally approved in accordance with the announced standards on the product. Accordingly, the National Institute of Environmental Research has prepared this guide so that applicants for approval can prepare approval application data smoothly by providing standards for writing biocidal product label claims and introducing cases. 

On the 16th of October 2023, the Cosmetics Policy Division of the Ministry of Food and Drug Safety announced that it is considering a pilot project to provide electronic information subject to labelin...

On the 16th of October 2023, the Cosmetics Policy Division of the Ministry of Food and Drug Safety announced that it is considering a pilot project to provide electronic information subject to labeling under the Cosmetics Act. This initiative aims to make it easier for consumers to check information on products, reduce social costs such as the generation of packaging waste, and make it easier for companies to introduce different types of packaging containers.

The information about the pilot project is listed below.

• (Business Purpose) To review the feasibility of introducing an electronic information provision method (e-label) in the cosmetics sector.

* Verification by evaluation index, such as enhancing consumer information readability, reducing costs associated with packaging material disposal, and lowering carbon emissions during the project period, will be conducted.

• (Contents) All information under Article 10 of the Cosmetics Act and sub-regulations should be displayed.

• (Project period) January 2024 – December 2025 (it can be extended)

• (Method of provision) Display some information on the containers and packaging of cosmetics and display all information on the e-label to be provided electronically.

* In the case of QR codes, etc., the display medium and the method of operation (link to the homepage, etc.) will be chosen autonomously by the company