South Korea Regulatory News

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.

The National Institute of Environmental Research (NIER) in South Korea updated the chemical substance classification and labelling list on July 12th, 2021. This list includes name of chemical subs...

The National Institute of Environmental Research (NIER) in South Korea updated the chemical substance classification and labelling list on July 12th, 2021. This list includes name of chemical substances, unique number, CAS number, hazard code, labelling code, M coefficient, and UN number. 

This update includes revising details of 38 toxic substances, 5 restricted substances and 5 accident preparedness substances and the addition of 19 toxic substances. 

The toxic substances revised are as follows: No. 97-1-9, No. 97-1-90, No. 97-1-11, No. 97-1-93, No. 97-1-111, No. 97-1-134, No. 97-1-139, No. 97-1-188, No. 97-1-208, No. 97-1-250, No. 97-1-281, No. 97-1-297, No. 97-1-299, No. 97-1-300, No. 97-1-309, No. 97-1-377, No. 97-1-416, No. 97-1-423, No. 97-1-457, No. 97-1-466, No. 2000-1-513, No. 2001-1-518, No. 2001-1-519, No. 2002-1-529, No. 2003-1-539, No. 2004-1-545 , No. 2009-1-595, No. 2010-1-613, No. 2011-1-617, No. 2013-1-667, No. 2014-1-687, No. 2014-1-696, No. 2014-1-697, No. 2014-1-698, No. 2017-1-762, No. 2017-1-795, No. 2019-1-912, No. 2020-1-982. 

The restricted substances revised are as follows: No. 06-5-4, No. 06-5-8, No. 06-5-9, No. 06-5-11, No. 06-5-12. 

The accident preparedness substances revised are: No. 9, No. 18, No. 39, No. 76, No. 83. 

The toxic substances newly added are as follows from No. 2021-1-1038 to No. 2021-1-1056. 

Classification and labelling of chemical substances are subject to this update which came into effect immediately. 

National Institute of Environmental Research (NIER) in South Korea updated the Toxic Chemical Substances List on June 22nd, 2021.  After the hazard assessment under K-REACH, 13 substances ...

National Institute of Environmental Research (NIER) in South Korea updated the Toxic Chemical Substances List on June 22nd, 2021. 

After the hazard assessment under K-REACH, 13 substances were revised, and 19 substances were newly added to the list. 

The revised substances are as follows: No. 97-1-9, No. 97-1-134, No. 97-1-250, No. 97-1-281, No. 97-1-297, No. 97-1-299, No. 97-1-309, No. 97-1-416, No. 97-1-423, No. 97-1-457, No. 97-1-466, No. 2002-1-529, No. 2017-1-762. 

The newly added substances are: from No. 2021-1-1038 to No. 2021-1-1056. 

Manufacturers or importers of these toxic chemical substances must identify and label them by January 1st, 2022. 

The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of the K-REACH enforcement decree and rule, which was published on June 3rd. The draft of decree amendment ma...

The Ministry of Environment (MoE) in South Korea is consulting on a draft amendment of the K-REACH enforcement decree and rule, which was published on June 3rd.

The draft of decree amendment mainly proposes revisions including removing the requirement for polymer submissions to include risk assessment data, designating substance subject to permission, and sharing information with the Office of Customs Administration.

The draft of rule amendment mainly includes submitting feedback on the results of substance hazardous assessments, exemption to data protection request, and data to be submitted when applying for registration of Nano materials.

The deadline of this consultation is July 13, 2021.

Update: 2021-06-28

The recent partial amendment to K-REACH has been approved by South Korea's parliament on 13 April, and it will be enforced on 14 October. This amendment outlines the culpability of downstream...

The recent partial amendment to K-REACH has been approved by South Korea's parliament on 13 April, and it will be enforced on 14 October. This amendment outlines the culpability of downstream users and resellers that employ unregistered substances. 

Chemical manufacturers and importers who use more than 100 kg of new substances every year, and more than 1 tonnes of existing substances every year obliged to register the substances before starting their business activities. Otherwise, they will face penalties or bans. 

The amendment included not only manufacturers and importers but also downstream users and sellers. In case of non-compliance, there may be risks of recall or ban. However, the detailed sanctions have not yet materialized. 

The amendment also enables the MoE to cooperate with other authorities such as the Customs Office so that the MoE can request import/export documentation concerning a specific substance.

Last Update: 2021-05-11

The Ministry of Environment (MoE) in South Korea updated the list of pre-registered substances, which in total becomes 17,096 substances. The list includes 1,800 substances that are manufactured ...

The Ministry of Environment (MoE) in South Korea updated the list of pre-registered substances, which in total becomes 17,096 substances. The list includes 1,800 substances that are manufactured and imported more than 1000 tpa and 78 CMR substances. The full registration deadline for these substances is by 31 December this year.

The MoE indicates no extension to the 2021 registration deadline though there was three months extension for 510 Priority Existing Chemicals (PEC) registration in 2018. 

Companies shall aim to complete full registration at least three months before the deadline as it might take some time to get a registration certificate due to a compliance check. The MoE regularly monitors pre-registration status e.g. tonnage band so that the companies can meet the deadline. 

Last update: 2021-05-11