South Korea Regulatory News

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).

National Institute of Environmental Research (NIER) in South Korea published a guide to the classification of biocidal product types on Aug 18th, 2021. This is to help industry to examine different ty...

National Institute of Environmental Research (NIER) in South Korea published a guide to the classification of biocidal product types on Aug 18th, 2021. This is to help industry to examine different types of biocidal products under K-BPR.

There are 15 biocidal product types under 4 categories as follow:

1. Disinfectants: Disinfectants, Algaecides
2. Pest control: Rodenticides, Control of other vertebrates, Insecticides, Control of other invertebrates, Repellents
3. Preservatives: Preservatives for product, Film preservatives, Fiber and leather preservatives, Wood preservatives, Construction material preservatives, Material and equipment preservatives, Embalming and taxidermist fluid
4. Others: Antifouling products for vessels and underwater facilities

The guide includes 15 biocidal product types, explanations and different usage based on users. It also provides comparison of product types between K-BPR and EU-BPR, and classification of usage.

The Ministry of Environment (MoE) in South Korea updated K-REACH to simplify data submission for duplicate data requirements. According to K-REACH enforcement rule article 36, chemical substance sa...

The Ministry of Environment (MoE) in South Korea updated K-REACH to simplify data submission for duplicate data requirements.

According to K-REACH enforcement rule article 36, chemical substance safety information shall be provided. Especially, when it is required to prepare and provide MSDS (Material Safety Data Sheet), chemical substance safety information (risk information) shall be provided in the form of appendix 26. However, through this update, the chemical substance safety information can be omitted and MSDS can be submitted instad, if any of the following applies:

1. Hazardous substances that have not yet been registered as existing substances, but within the registration grace period
2. Substances registered or reported without risk data (tonnage band: below 10 tpa)

South Korea enacted the Act on Risk Assessment of on July 27, 2021. This Act aims to protect and promote public health by evaluating risk assessment of products applied to the human body and regulatin...

South Korea enacted the Act on Risk Assessment of on July 27, 2021. This Act aims to protect and promote public health by evaluating risk assessment of products applied to the human body and regulating matters of safety management.

The Ministry of Food and Drug Safety (MFDS) will examine risk assessment of various products and channels to understand the overall impacts and risk factors of products applied to the human body. MFDS will also establish and implement a master plan on risk assessment of products applied to the human body every five years, following deliberation by the risk assessment policy committee, to manage risk assessment systematically and effectively.

Products applied to the human body include 11 categories as follows:

• Foods, food additives, equipment, container and packaging defined in ˹Food Sanitation Act˼
• Agricultural and marine products and processed foods defined in ˹Agricultural and Fishery Products Quality Control Act˼
• Livestock defined in ˹Livestock Products Sanitary Control Act˼
• Liquors defined in ˹Liquor Tax Act˼
• Health Functional Foods defined in ˹Health Functional Foods Act˼
• Medicine, herbal medicine, ingredients of herbal medicine and quasi-drugs defined in ˹Pharmaceutical Affairs Act˼
• Narcotics defined in ˹Narcotics Control Act˼
• Cosmetics defined in ˹Cosmetic Act˼
• Medical Devices defined in ˹Medical Devices Act˼
• Hygiene Products defined in ˹Hygiene Products Control Act˼
• Other products controlled by the Minister of Food and Drug Safety based on Presidential Decree

This comes into effect from January 28th, 2022.

The Ministry of Environment (MoE) in South Korea added the provision to expand the definition of existing substances on Aug 12th, 2021. According to K-REACH, existing substances are those listed in...

The Ministry of Environment (MoE) in South Korea added the provision to expand the definition of existing substances on Aug 12th, 2021.

According to K-REACH, existing substances are those listed in the inventory. The definition of existing substances has been expanded to include various forms of substances including: 

• hydrate or anhydrous of existing substances
• reaction products consisting of two or more existing substances
• Isomers of an existing substance

It also includes those chemical substances mentioned in the attachment (in Korean). 

This expansion is due to the definition of existing substances now includes existing chemicals' reaction products and isomers. Registrants are recommended to check if their substances are considered as existing substances after the expansion of the definitions under K-REACH. This update came into effect immediately.