South Korea Regulatory News

The National Institute of Environmental Research (NIER) in South Korea updates ‘the Regulations on preparation methods for registration application dossier and hazard review methods’ under the Act...

The National Institute of Environmental Research (NIER) in South Korea updates ‘the Regulations on preparation methods for registration application dossier and hazard review methods’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on September 30^th, 2022.

The main updates on new substances are as follows:

• Addition of definitions of hazard review methods: In vivo somatic chromosome aberration test, In vitro chromosome aberration test, Non-test data, Read-across, WoE (Weight of Evidence)
• Addition of non-test data and its requirements: QSAR data, Read-across, WoE
• Addition of methods to submit opinions to the president of the NIER if a person who received the result of hazard review disagrees with it (Article 35)
• Addition and specification of exemption conditions for each test category

The amendment came into effect immediately. However, the amendment of the Article 35 will come into effect from October 15^th, 2022.

The Ministry of Environment (MoE) in South Korea updates the ‘Regulations on Emissions Survey and Calculation Factors of Chemical Substances’ under the Chemical Substances Control Act. The scop...

The Ministry of Environment (MoE) in South Korea updates the ‘Regulations on Emissions Survey and Calculation Factors of Chemical Substances’ under the Chemical Substances Control Act.

The scope for emission survey is based on the Annex 1, which is categorized according to the Korea Standard of Industry Classification. For point pollution sources, the facilities subject to the emission survey are the ones with the permission to have emission facilities, but it can be exempted based on substance category and tonnage band. Also, nonpoint pollution sources can be included for the emission survey if necessary.

The chemical substances subject to emission survey are listed in Annex 2, and it should fall under any of the followings:

1. Chemical substances and products produced at facilities
2. Raw materials and additives used at facilities
3. Process auxiliary substances used at facilities
4. Chemical substances kept and stored at facilities
5. Wastes processed at waste treatment plants
6. Chemical substances used in other facilities (for example, chemical substances used for wastewater treatment, and maintenance and repair of facilities and equipment)

The validity of this regulation will be reviewed every three years from January 1, 2023.

The amendment came into effect immediately.

The National Institute of Environmental Research (NIER) in South Korea updates ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-RE...

The National Institute of Environmental Research (NIER) in South Korea updates ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH). This update is mainly on new substances.

The main updates on new substances are as follows:

1) Updates on chemical substance name, etc: “2019-144", “2019-178", “2019-179", “2020-203" and “2022-21"

2) Updates on hazard information, etc: “2016-32", “2016-210", “2016-337", “2016-498", “2016-877", “2016-1126", “2017-33", “2017-286", “2017-311", “2017-414", “2017-548", “2017-589", “2017-812", “2018-523", “2018-699", “2019-148", “2019-200", “2019-257", “2019-315", “2019-452", “2019-466", “2019-821", “2020-47", “2020-230", “2021-26", “2021-27", “2021-38", “2021-78", “2021-84", “2021-178", “2022-102" and “2022-114"

2) Addition of 52 substances and their hazard information: from "2022-172" to "2022-223"

The amendment came into effect immediately.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘Regulation on preparation methods for registration application dossier and hazard review meth...

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘Regulation on preparation methods for registration application dossier and hazard review methods’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on August 25th, 2022.

This is to minimize the use of vertebrates for the chemical registration and hazard review by regulating hazard review method to use non-test data.

The main updates include:

• Addition of hazard view method based on non-test data definition and type (QSAR, correlation method, evidence method, etc.)
• Addition and specification of exemption conditions for each test category based on chemical substance properties or non-test data
• Addition of methods to submit opinions to the president of the NIER if a person who received the result of hazard review disagrees with it

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

The deadline for this consultation is Sep 14th, 2022.

The Ministry of Environment (MoE) in South Korea updates the Enforcement Rules of the Act on Registration and Evaluation of Chemicals (K-REACH). The main updates include: Requirement on hazar...

The Ministry of Environment (MoE) in South Korea updates the Enforcement Rules of the Act on Registration and Evaluation of Chemicals (K-REACH).

The main updates include:

• Requirement on hazard reviews including hazards, use, exposure and etc to designate substances subject to permission
• Omission on the Environmental hazard data for registration if water solubility is less than 1㎎/ℓ, or if the use is intermediate or process regulators
• Simplification on report exemption requirements for new chemical substances to be imported less than 0.1 tpa for research and development use

The amendment came into effect immediately.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the results of hazard review of chemical substances’ under the Act on Registration and Eval...

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH).

The draft amendment mainly proposes revisions including:

• Notification of the results of hazard review of registered chemical substances
  • Addition of 52 new substances from “2022-172” to “2022-223”
• Revision of 37 notified new substances by adding additional information
• Notification of information on classified substances: the name of chemical substances, CAS no., toxic substance designation, main hazard, classification and labeling, etc

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

The deadline for this consultation is Aug 11th, 2022.

The National Institute of Environmental Research (NIER) in South Korea updates ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-R...

The National Institute of Environmental Research (NIER) in South Korea updates ‘the results of hazard review of chemical substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH).

The main updates are as follows:

• New substances

1) Updates on hazard information: "2017-297 (CAS 12078-25-0)", "2017-1034 (CAS 22029-36-3)", "2018-113 (CAS 34140-91-5)", "2018-654 (CAS 1431957-88-8)", "2021-55 (CAS 85508-44-7)", "2021-116 (CAS 94994-62-4)", "2021-144" and "2021-200 (CAS 27288-07-9)".

2) Addition of 48 substances and their hazard information: from "2022-124" to "2022-171".

• Existing substances

1) Updates on hazard information: "2020-012 (CAS 10043-35-3, CAS 11113-50-1)", "2020-043 (CAS 8001-58-9)", "2021-063 (CAS 85535-85-9)", "2021-133 (CAS 3236-71-3)", "2021-144 (CAS 13360-57-1)", "2021-158 (CAS 75-59-2)", "2021-159 (CAS 75-57-0)".

2) Addition of 88 substances and their hazard information: from "2022-224" to "2022-311".

The amendment came into effect immediately.