South Korea Regulatory News

The National Institute of Environmental Research (NIER) in South Korea provides a summary for the Approval application documents based on the updates on disinfectant and preservatives for humidifiers ...

The National Institute of Environmental Research (NIER) in South Korea provides a summary for the Approval application documents based on the updates on disinfectant and preservatives for humidifiers on April 10^th, 2023. This is based on the updated classification on product type based on diversified disinfectant and preservatives for humidifiers under the ‘Regulations on the Approval for Consumer Chemical Products Subject to Safety Verification’ on December 12, 2022.

According to the summary, the Approval application documents for the antimicrobial and preservatives for humidifiers remains the same, but some of the Approval application documents for the preservation treatment product for humidifiers can be exempted. The provided summary for the Approval application documents is as below:

• The scope of document submission of standard and test method review

• The scope of document submission of stability & effectiveness review

○: Mandatory documents to be submitted

△: Documents that may be exempted

-: Documents that don’t need to be submitted

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Cosmetic Act on March 22nd, 2023. The Cosmetic Act prohibits advertisements that might mislead the pu...

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Cosmetic Act on March 22^nd, 2023. The Cosmetic Act prohibits advertisements that might mislead the public for cosmetics as medicines, functional cosmetics, natural cosmetics or organic cosmetics. This amendment is to clarify the scope of the prohibited subject related to the misleading advertisement.

The main amendments are:

If you have any opinion on this draft amendment, please write your opinion in the provided format and submit it to Korea Cosmetic Association.

The deadline for this consultation is April 14^th, 2023.

Ministry of Employment and Labor (MOEL) in South Korea updates the Standards for Classification and Labeling of Chemical Substances and Material Safety Data Sheets (MSDS) on Feb 16th, 2023. This is to...

Ministry of Employment and Labor (MOEL) in South Korea updates the Standards for Classification and Labeling of Chemical Substances and Material Safety Data Sheets (MSDS) on Feb 16^th, 2023. This is to improve the problems that occurred while implementing preliminary review for alternative contents of MSDS.

The main updates are:

• Addition of the definition of manufacturer: A person who directly plans (performance/function, designing raw material composition, etc) a chemical substance or mixture, and consigning it to another manufacturer to produce it under their name for the purpose of direct use or transfer/provision
• If the consignor submits MSDS or applies for non-disclosure approval, and is notified of the result, the submitted MSDS or the notified result of the non-disclosure approval should be provided to the consignee.

The National Institute of Environmental Research (NIER) in South Korea publishes the user guidelines for the effectiveness testing of wood preservatives regarding the approval of biocidal substance an...

The National Institute of Environmental Research (NIER) in South Korea publishes the user guidelines for the effectiveness testing of wood preservatives regarding the approval of biocidal substance and biocidal products on March 28^th, 2023. This guideline is based on the Korean Standards ‘KS M 1701:2018/Annex B/(Regulation) methods for effectiveness testing of wood preservatives’ to help field users understanding. It includes remarks of performing effectiveness testing, testing process, validation of effectiveness testing. The Korean Standards ‘KS M 1701’ is available from http://standard.go.kr.

The National Institute of Environmental Research (NIER) in South Korea notifies new approval application submission deadline for daily use consumer chemical product subject to safety verification and ...

The National Institute of Environmental Research (NIER) in South Korea notifies new approval application submission deadline for daily use consumer chemical product subject to safety verification and approval under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on March 16^th, 2023.

This is for the companies manufacture or import biocidal products subject to 2024 approval deferment among daily use consumer chemical product subject to safety verification. New approval application submission deadline for daily use consumer chemical product subject to safety verification and approval is June 30th, 2023, and companies should submit via Chemical product management system (chemp.me.go.kr). Please note that the system would be closed for the new approval application submission after the deadline.

If you have any questions regarding this notification, you can contact NIER (1800-1253).

The Ministry of Environment (MoE) in South Korea consults on a draft amendment of ‘the Designation of Consumer Chemical Products and Standards for Labelling and Safety’ on February 27th, 2023. The...

The Ministry of Environment (MoE) in South Korea consults on a draft amendment of ‘the Designation of Consumer Chemical Products and Standards for Labelling and Safety’ on February 27^th, 2023. There has been a request from the industry, and this is to allow some substances as a preservation material in spray types of products that has been confirmed as safe to use through risk assessment. 70 substances have been allowed to be used as a preservation material in products.

If you have any opinion on this amendment, please write your opinion and submit it to the MOE.

The deadline for this consultation is March 20^th, 2023.

The Ministry of Food and Drug Safety (MFDS) in South Korea updates the Regulations on Safety Standards for Cosmetics under the Cosmetic Act on Feb 21st, 2023. This is to strengthen safety management o...

The Ministry of Food and Drug Safety (MFDS) in South Korea updates the Regulations on Safety Standards for Cosmetics under the Cosmetic Act on Feb 21^st, 2023. This is to strengthen safety management of cosmetics and protect public health by designating raw materials that cannot be used in cosmetics, considering the results of risk assessment and overseas regulatory trends.

The main updates are as follow:

Change some of hair dye ingredients from the restricted list of cosmetics to the prohibited list of cosmetics.

• Add O-aminophenol, M-phenylenediamine, and Hydrochloric acid M-phenylenediamine to the prohibited list
• Change from Catechol (Pyrocatechol) (exception for a hair dye component of a mixture based on to the usage or capacity of oxidation hair dye, below 1.5%) to Catechol (Pyrocatechol)
• Change from Pyrogallol (exception for a hair dye component of a mixture based on to the usage or capacity of hair dye, below 2%) to Pyrogallol
• Update hair dye ingredient in Annex 2

The amendment came into effect in 6 months from the published date.