South Korea Regulatory News

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. 

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 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. 

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. 

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.