South Korea Regulatory News

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 December 7, 2023, the Ministry of Food and Drug Safety (MFDS, Director Oh Yoo-kyung) announced that 1,2,4-trihydroxybenzenes (THB) will be designated as a prohibited raw material for use in cosmeti...

On December 7, 2023, the Ministry of Food and Drug Safety (MFDS, Director Oh Yoo-kyung) announced that 1,2,4-trihydroxybenzenes (THB) will be designated as a prohibited raw material for use in cosmetics and that the regulation on cosmetic safety standards will be revised to include it in the prohibited list. 

The measure is based on the results of the safety verification conducted by the Cosmetic Raw Materials Safety Verification Committee in accordance with the recommendation for improvement made by the previous Regulatory Reform Committee. 

As a result of a comprehensive review of domestic and foreign toxicity data on THB, data submitted by the Ministry of Food and Drug Safety, and data submitted by the company, the verification committee concluded that the possibility of genetic toxicity of THB could not be excluded and submitted a stability verification report to the Ministry of Food and Drug Safety.

Accordingly, the MFDS plans to announce an administrative notice on the revision of regulations on cosmetic safety standards, etc., and revise the notice after a regulatory review by the Regulatory Reform Committee, to add THB to the list of banned ingredients as a precautionary measure according to the potential genetic toxicity of THB. 

After the revision of the notice, THB cannot be used in the manufacture of cosmetics, but products already manufactured before the revision can be sold until October 1, 2024. 

The prohibition on the production and import of cosmetic items containing 1,2,4-THB will go into force on April 9, 2024.

On November 11, 2023, the Ministry of Environment (Minister Han Hwa-jin) announced that it will implement a ‘Chemical-Safe Car Management’ initiative as part of the 4th Chemical Safety Week. The a...

On November 11, 2023, the Ministry of Environment (Minister Han Hwa-jin) announced that it will implement a ‘Chemical-Safe Car Management’ initiative as part of the 4th Chemical Safety Week. The announcement was made at a ceremony held at Seoul Dragon City (located in Yongsan-gu, Seoul), and attended by five domestic car manufacturers, Hyundai Motor Company, Kia, GM Technical Center Korea, Renault Korea Motors, and Keiji (KG) Mobility. 

The ceremony was also attended by the Korea Consumer Agency and the Korea Automobile Mobility Industry Association, who pledged to cooperate with the Ministry of Environment and the car manufacturers to  

• Only use safe biocides in cars that contain various biocidal products,  

• Reduce the use of chemical substances,  

• Eliminate misleading claims such as antibacterial, and  

• Conduct voluntary regulation and continuous communication and mutual cooperation. 

The ‘Biocidal Products Safety Management Guideline for Automobiles’ was jointly developed by the Ministry of Environment and the domestic car industry, in preparation for the upcoming enforcement of the Act on the Safety Management of Household Chemicals and Biocidal Products, which will require the car industry to use approved biocidal products for biocidal products and to properly label and advertise them. 

The use of approved biocidal products for biocidal products and the labeling and advertising obligations for processed products will be enforced from January 1, 2027. 

Minister of Environment Han Hwa-jin said at the ceremony: “We hope that the environmental management of cars will be expanded to include not only the control of air pollutant emissions but also the safety of chemicals that may be exposed during the production and use of cars.” 

Yoon so-hyun, head of the Korea Consumer Agency, said: “We have created the first guideline for the car sector that uses various biocides as components, so that we can improve the chemical management system in cras and effectively protect consumer safety.” 

The Ministry of Environment and the Korea Consumer Agency will also use the Business Periodic Consultative Body to establish a self-management system and competitiveness in the distribution network, focusing on items closely related to daily life, and providing consumers with safe chemical products that they can trust. 

A consultative body established and operated by the Korea Consumer Agency, consisting of 13 companies in 146 industries, including cars, home appliances, and distribution, to carry out various activities such as pre-emptive response to consumer safety issues and risk prevention. 

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 “Notice of Designation of Toxic Substances.” This amendment will ...

On November 17, 2023, the National Institute for Environmental Research (NIER) in South Korea published a partial amendment to the “Notice of Designation of Toxic Substances.” This amendment will take effect from February 2024, three months after the date of notification. 

The key changes in this partial amendment include: 

1. Revision of the Chemical Name: 

• The chemical name of the substance 2017-1-758 has been updated. Specifically, 2064323-02-8 has been added to the end of the chemical name. 

• The substance is described as Triphenylsulfonium salt with 2,3-bis (2,2,2-trifluoroethyl) 5-sulfobicyclo [2.2.1] heptane-2,3-dicarboxylate (1:1) 2064323-02-8, and it includes mixtures containing 25% or more of this substance. 

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. 

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.  

On 7th November 2023, the South Korean Ministry of Food and Drug Safety (MFDS) released a notification regarding the partial revision of the Regulations on Safety Standards for Cosmetics, etc. In acco...

On 7th November 2023, the South Korean Ministry of Food and Drug Safety (MFDS) released a notification regarding the partial revision of the Regulations on Safety Standards for Cosmetics, etc. In accordance with Article 46 of the Administrative Procedure Act, the MFDS issued a notice entitled "Regulations on Cosmetic Safety Standards" in advance to inform the public about the revision's grounds and key contents. 

Objective of revision 

The chemical identification number (Cas No.) and chemical name of raw materials that cannot be used in cosmetics and raw materials that require restrictions on use have been added to improve the convenience of raw material identification. and one sunscreen ingredient has been added in accordance with "Regulations on Designation and Change of Standards for Use of Cosmetic Ingredients (Ministry of Food and Drug Safety Notice) 

New points added to the standard 

• The addition of chemical names and chemical identification numbers (CAS No.) for raw materials whose use is restricted or cannot be used in cosmetics (Appendix 1, Appendix 2) 

• In accordance with the Regulations on Designation and Change of Standards for Use of Cosmetic Ingredients (Ministry of Food and Drug Safety Notice) one type of UV ray-blocking component has been added to the list of raw materials with limits on use (Appendix 2). As a result, the UV protection component 'Methoxypropylaminocyclohexynylideneethoxyethylcyanoacetate' was introduced. 

Opinion submission 

Organizations, institutions, or individuals that have comments on this Partial Revision Notice (draft) are asked to submit a written comment to the Director General of the Ministry of Food and Drug Safety (Reference: Cosmetics Policy Division) by 27th November 2023. 

The written comments must contain: 

1. Opinion in favor or against the notice 

2. The name, address, and contact details of the institutions, organizations, or individuals. 

3. Other notes 

Comments can be submitted to mfdscos@korea.kr.