South Korea Regulatory News

The National Institute of Environmental Research (NIER) in South Korea updated the regulation on the scope and methods of biocidal substances and biocidal product approval application data under the C...

The National Institute of Environmental Research (NIER) in South Korea updated the regulation on the scope and methods of biocidal substances and biocidal product approval application data under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on April 8th, 2022.

The scope include:

The Ministry of Environment (MoE) in South Korea pre-announced the legislation to update K-REACH. This is aimed at simplifying K-REACH data submission for new substances under 1 TPA (Tonnes per Annu...

The Ministry of Environment (MoE) in South Korea pre-announced the legislation to update K-REACH. This is aimed at simplifying K-REACH data submission for new substances under 1 TPA (Tonnes per Annum) and easing exemption requirement on new substance reports for Research & Development purposes.

Environmental hazard data (acute toxicity to fish, acute toxicity to daphnia, biodegradability) can be omitted when registering new substances that are manufactured or imported under 1 TPA and when any of the following applies:

·       With water solubility less than 1㎎/ℓ

·       For intermediates use or process regulators use

Also, if an overseas manufacturer/producer does not provide the name and identification number of a substance to be imported due to trade secrets, Material Safety Data Sheet (MSDS) can be submitted instead.

In February 2022, the Ministry of Food and Drug Safety (MFDS) in South Korea proposed amendments to the ‘Regulation on Safety Standards, etc. of Cosmetics’. This is the cosmetics policy enacted...

In February 2022, the Ministry of Food and Drug Safety (MFDS) in South Korea proposed amendments to the ‘Regulation on Safety Standards, etc. of Cosmetics’. This is the cosmetics policy enacted in 2015 to guide the manufacture and import of cosmetics and their safety control, it provides a framework for determining the raw materials that can not be used in cosmetics.

The Ministry proposes that persistent pollutants, some components of perfluorinated compounds and 1, 2, 4-trihydroxybenzene should be added to the list of prohibited ingredients while benzalkonium chloride should be prohibited from use as a preservative in spray-type products. It also proposes the maximum limit concentration of ingredients used as hair dye.

Furthermore, some prohibited ingredients are to be established as new exceptions. There are proposed management standards for CBD and THC and radioactive materials and fluorescent brightener 367 have new permissible limits.

The final date to comment on this notification is April 28, 2022. 

National Institute of Environmental Research (NIER) in South Korea updated and announced the results of hazard review of chemical substances under K-REACH on February 11th, 2022.The updates are as f...

National Institute of Environmental Research (NIER) in South Korea updated and announced the results of hazard review of chemical substances under K-REACH on February 11th, 2022.

The updates are as follows:

·         Update the hazard information of substances with the unique no. “2020-032”, “2020-034”, “2020-041” and “2020-050”

·         Create the hazard information of substances with the unique no. from “2022-170” to “2022-199”

This update came into effect immediately.

The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of Designation of Substances Subject to Intensive Control under Enforcement Decree of the Act on Registration and ...

The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of Designation of Substances Subject to Intensive Control under Enforcement Decree of the Act on Registration and Evaluation of Chemicals (K-REACH), which was published on Jan. 28th, 2022.

The draft amendment mainly proposes revisions including:

• Designating 54 types of substances (162 in detailed list) that have been confirmed harmful in the criteria of endocrine system disorders, persistence/bioaccumulation/toxicity, and high persistence/ high bioaccumulation by foreign governments or international organizations
• Deleting 4 types of substances that are Prohibited Substance
• Combining current Appendix 1 and Appendix 2, and grouping substances with similar or identical structures or functional group with specific list under the group

If you have any opinion on this amendment, please write your opinion and submit to the MoE by post.

The deadline of this consultation is Feb 17th, 2022.

Updated Enforcement Rule of The Consumer Chemical Products and Biocides Safety Control Act (K-BPR) came into effect on December 31st, 2021.This updated Enforcement Rule reflects matters mandated by ...

Updated Enforcement Rule of The Consumer Chemical Products and Biocides Safety Control Act (K-BPR) came into effect on December 31st, 2021.

This updated Enforcement Rule reflects matters mandated by the ‘Belief System for Biocidal Product Victims’ in K-BPR. ‘Belief System for Biocidal Product Victims’ is a system to pay relief promptly to biocidal product victims with health damage, and to impose and collect contributions on responsible manufacturers and importers of such biocidal products.

The major updates are as follows:

• Composition and operation of a biocidal product damage investigation team
• Details of requested data
•  Establishment of effective period for decision to pay relief
• Operation of the relief account, and composition and operation of the relief account management committee
• Procedures for imposing and collecting contributions for biocidal product victims, etc

The Ministry of Environment (MoE) in South Korea published and distributed a guide to serious civic accidents caused by raw materials and products under the Serious Accidents Punishment Act (SAPA). ...

The Ministry of Environment (MoE) in South Korea published and distributed a guide to serious civic accidents caused by raw materials and products under the Serious Accidents Punishment Act (SAPA).

The SAPA regulates the punishment of business owners, chief executives, public officials, and corporations who cause casualties by violating their duty to take safety and health measures while operating business or workplace, public facilities, and public transportation, or handling raw materials or products harmful to the human body. This is to prevent serious accidents and protect citizens and workers.

The guideline is to help companies understand and support the establishment of a safety and health management system on serious civic accidents caused by raw materials and products. It includes an overview of the SAPA, the definition of raw materials and products, and the duty of chief executives to establish safety and health management systems, secure safety and health, among others. The guide can be accessed here.

Last Update: 2022-01-28