South Korea Regulatory News

On March 14, 2024, the South Korean National Institute of Food and Drug Safety Evaluation published a draft of the ‘Guidelines for Alternatives to Animal Testing Methods’ to help improve the inter...

On March 14, 2024, the South Korean National Institute of Food and Drug Safety Evaluation published a draft of the ‘Guidelines for Alternatives to Animal Testing Methods’ to help improve the international competitiveness of the domestic cosmetics industry and non-clinical testing institutions related to toxicity tests. The draft contains the guidelines for the two test methods as follows. 

• Guidelines for Test No. 498: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test method Skin phototoxicity for Cosmetics, etc. 

• Guidelines for ARE-Nrf2 Luciferase Keratinocyte Activation Test Method (OECD 442D) KeretinoSens TM for skin sensitization for Cosmetics, etc. 

Companies that have an opinion on the draft guideline, please reply to our association (email: jenko@kcia.or.kr ) by March 18, 2024. 

According to the K-REACH database, there are currently no substances that have been added to the Authorisation List under K-REACH.  However, dibutyl phthalate (DBP; CAS No. 84-74-2), benzyl butyl ...

According to the K-REACH database, there are currently no substances that have been added to the Authorisation List under K-REACH. 

However, dibutyl phthalate (DBP; CAS No. 84-74-2), benzyl butyl phthalate (BBP; CAS No. 85-68-7), and di-(2-ethyl hexyl) phthalate (DEHP; CAS No. 117-81-7) have been proposed as the first three substances subject to authorization under K-REACH. These are phthalates that are classified as toxic to reproduction and are widely used as plasticizers in various products.  

The Ministry of Environment (MoE) invited stakeholders to submit their comments or information on these chemicals from October 6, 2023, to December 4, 2023. If adopted, the authorization requirement will apply to the manufacture, import, or use of these substances in South Korea, even if they have already completed registrations. This means that companies will need to obtain authorization from the MoE before using these substances or switch to safer alternatives. 

On December 28, 2023, the Risk Assessment Research Department of the National Institute of Environmental Research (NIER) announced that it will publish the risk assessments results of 10 chemicals, in...

On December 28, 2023, the Risk Assessment Research Department of the National Institute of Environmental Research (NIER) announced that it will publish the risk assessments results of 10 chemicals, including cyclohexane and 1,4-dichlorobenzene, on the K-REACH portal. 

From 2019 the National Institute of Environmental Research has been conducting risk assessments for chemicals manufactured and imported in quantities of 10 tonnes or more per year for chemical management purposes, and based on the results of the risk assessments, chemicals that are likely to be harmful will be identified as substances subject to control.  

In the future, the NIER will continue to publish the results of risk the assessment for chemicals with high circulation, and so far the risk assessment reports of 29 substances has been published on the K-REACH portal. 

The Korean Ministry of Environment and the Korea Environment Corporation are offering financial support to small and medium-sized enterprises (SMEs) that handle hazardous chemicals to upgrade their ag...

The Korean Ministry of Environment and the Korea Environment Corporation are offering financial support to small and medium-sized enterprises (SMEs) that handle hazardous chemicals to upgrade their ageing facilities and prevent chemical accidents. The support project, called the “Chemical Safety Workplace Creation Support Project”, will cover 70% of the improvement costs, up to 42 million won per company. The total budget for the project is 8 billion won. The application period is from January 22 to February 26, and the selected companies will be able to start improving their facilities in March. The project aims to promote safe chemical management and reduce the cost burden for SMEs. 

On January 9, 2024, the National Assembly of South Korea passed five laws related to the environment, including the “Chemical Substances Registration and Evaluation Act” and the “Chemical Substa...

On January 9, 2024, the National Assembly of South Korea passed five laws related to the environment, including the “Chemical Substances Registration and Evaluation Act” and the “Chemical Substances Control Act.” The purpose of these laws is to improve the rational management of chemicals based on their harmfulness by changing the registration criteria for new chemicals to meet international standards and reorganizing the current system for classifying toxic substances.  

The Ministry of Environment (MoE) said that the amendment to the Chemical Substances Registration and Evaluation Act, which currently requires new chemicals to be registered if they are produced or imported in quantities of more than 100 kg per year, will relax the registration requirement to 1 tonne per year. This is in response to the industry’s request to adjust the domestic criterion to the same as the EU or Japan.  

The amendment to the Chemical Substances Registration and Evaluation Act also added provisions for the disclosure of information on substances that are reported at less than 1 tonne per year and for the government to review their suitability. It also imposed a duty on business operators to ensure the safety of chemical substances by requiring that substances lacking hazard information be presumed to be harmful until their harmlessness is verified. At present, hazardous chemicals are defined as “toxic substances” and regulated uniformly, and substances that cause harm to humans through short-term exposure are classified as “acutely hazardous substances to the human body,” substances that cause harm to humans through repeated exposure or long-term accumulation are classified as “chronically hazardous substances to the human body,” and substances that cause harm to aquatic life are categorized as “ecologically hazardous substances.” 

The amendment to the Chemical Substances Control Act stipulated that permitted, restricted, and prohibited substances should be excluded from the definition of hazardous chemicals and that those used in very small quantities or with a low probability of accidents should be exempted from inspection and diagnosis. It also stipulated that if the handling of chemicals is very small or the risk is low, it should be changed from “authorization" to "notification.” The Ministry of Environment said that the revised bill was drafted after discussions at the Chemical Safety Policy Forum, which included various stakeholders such as civil society organizations and industry. 

On November 30, 2023, the South Korean Ministry of Food and Drug Safety (MFDS) issued a partial amendment to the Regulations on Cosmetics Safety Standards, etc., including the addition of some ingredi...

On November 30, 2023, the South Korean Ministry of Food and Drug Safety (MFDS) issued a partial amendment to the Regulations on Cosmetics Safety Standards, etc., including the addition of some ingredients of hair dye to the list of raw materials that cannot be used in cosmetics and the addition of the chemical substance identification number (CAS No.) to improve the convenience of identifying raw materials that cannot be used in cosmetics. 

The main content of the revision is as follows. 

• Added seven hair dye ingredients such as 2-amino-4-nitrophenol to the raw materials that cannot be used in cosmetics and lowering the concentration limit when two hair dye ingredients such as hydrochloric acid 2,4-diaminophenol are used in cosmetics. 

• Added the Chemical Identification Number (CAS No.) and the chemical name of raw materials that cannot be used as cosmetics ingredients and raw materials whose use need to be restricted. 

• "Methoxypropylaminocyclohexenylidene ethoxyethylcyanoacetate," which has been reviewed as a sunscreen, is added in accordance with the Regulations on Designation of Cosmetic Raw Materials and Review of Changes (notified by the Food and Drug Administration). 

On November 17, 2023, the National Institute for Environmental Research (NIER) in South Korea published a partial amendment to the “Regulations on Classification and Labelling of Chemicals...

On November 17, 2023, the National Institute for Environmental Research (NIER) in South Korea published a partial amendment to the “Regulations on Classification and Labelling of Chemicals.” This amendment will take effect from the date of notification. 

The key changes in this partial amendment include: 

1. Revised Toxic Substances: 

• 15 toxic substances, 2 restricted substances, and 6 substances requiring preparation for accidents have been updated. 

• The chemical names of these substances have been modified, and specific requirements regarding import declaration, business license, labeling of hazardous chemicals, and transitional measures have been established for the newly designated toxic substances. 

2. Addition of New Chemicals: 

• A total of 55 new chemicals have been added to the list. The chemicals are listed in the table below.