South Korea Regulatory News

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

The Ministry of Environment (MoE) in South Korea introduced 'Designation and Management of Substance Subject to Permission System' in 2015. This is to designate chemical substances with a...

The Ministry of Environment (MoE) in South Korea introduced 'Designation and Management of Substance Subject to Permission System' in 2015. This is to designate chemical substances with a risk of harm as substance subject to permission, and to give permission to manufacture, import, or use those substances.

A pilot project is being carried out to specify the procedures and methods for selecting, disclosing, and collecting opinions on candidate substances.

For the pilot project, 10 candidate substances subject to permission were selected as follows:

If you have any opinion on candidate substances, please write your opinion and submit to yuhae@kcma.or.kr.

The deadline is January 20th, 2022.

Last Update: 2022-01-13

National Institute of Environmental Research (NIER) in South Korea updated the list of low-risk biocidal substances, which can be exempted from K-BPR, on Sep 27th. There are 4 low-risk biocidal s...

National Institute of Environmental Research (NIER) in South Korea updated the list of low-risk biocidal substances, which can be exempted from K-BPR, on Sep 27th. There are 4 low-risk biocidal substances added to the list: CAS 56-81-5, CAS 144-55-8, CAS 471-34-1, CAS 7647-14-5. With this update, there are 23 low-risk biocidal substances to be exempted from K-BPR.

This update came into effect immediately.

Attahced is the list of low-risk biocidal substances (Source: NIER).