South Korea Regulatory News

The National Institute of Environmental Research (NIER) in South Korea publishes the Guidelines for the Approval of Biocidal Polymers in December 2022. In accordance with the enforcement of the Consum...

The National Institute of Environmental Research (NIER) in South Korea publishes the Guidelines for the Approval of Biocidal Polymers in December 2022. In accordance with the enforcement of the Consumer Chemical Products and Biocides Safety Control Act (K-BPR), biocidal substances or products manufactured or imported to South Korea should get approval before its sales or release in Korean market. This guideline explains data preparation method and data requirement for the approval of biocidal polymers, regarding the comprehensive safety data under the Regulation on the Scope and Preparation Methods for the Approval of Biocidal Substances and Products.

This guideline has two chapters as below:

Chapter 1. Approval of biocidal substances and products: Regulation on the approval of biocidal substances, approval process, data requirement

Chapter 2. Application for the approval of polymer compounds: Information on polymer compounds, considerations when applying for the approval of polymer compounds, requirements for application for approval of polymer compounds

If you are planning to apply for the approval of biocidal polymers, please refer to the guideline for the details.

The National Institute of Environmental Research (NIER) in South Korea publishes the Guidelines for the Approval of Natural Biocidal Compounds in December 2022. In accordance with the enforcement of t...

The National Institute of Environmental Research (NIER) in South Korea publishes the Guidelines for the Approval of Natural Biocidal Compounds in December 2022. In accordance with the enforcement of the Consumer Chemical Products and Biocides Safety Control Act (K-BPR), biocidal substances or products manufactured or imported to South Korea should get approval before its sales or release in Korean market. This guideline explains data preparation method and data requirement for the approval of natural biocidal compounds, regarding the comprehensive safety data under the Regulation on the Scope and Preparation Methods for the Approval of Biocidal Substances and Products.

This guideline has two chapters as below:

Chapter 1. Approval of biocidal substances and products: Regulation on the approval of biocidal substances, approval process, data requirement

Chapter 2. Application for the approval of polymer compounds: Information on natural biocidal compounds, considerations when applying for the approval of natural biocidal compounds, requirements for application for approval of natural biocidal compounds

If you are planning to apply for the approval of natural biocidal compounds, please refer to the guideline for the details.

The Ministry of Environment (MoE) in South Korea extends the deadline for the public consultation on the draft list of substances subject to permission under the Act on Registration and Evaluation of ...

The Ministry of Environment (MoE) in South Korea extends the deadline for the public consultation on the draft list of substances subject to permission under the Act on Registration and Evaluation of Chemicals (K-REACH). The MOE published 11 potential substances subject to permission on Novebmer 23^rd, 2022.

These substances subject to permission are:

Additionally, they are going to publish hazard information and other relevant data on December 12^th, 2022. This would include 1) hazard information, 2) main use and exposure information, 3) distribution volume in Korea, 4) types of people who may be exposed in the process of handling chemicals and etc.

If you have any opinion on this draft, please write your opinion and submit it via www.chemnavi.or.kr.

The deadline for the public consultation opens is Feb 28^th, 2023.

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) on Dec 21^st, 2022.

The updates on chemical substance names are of the following 347 substances:

The main updates on new substances are as follow:

1) Updates on chemical substance name, etc: "2015-84", "2016-15", "2016-284", "2017-169", and "2021-87"

2) Removal of chemical substance: "2015-45"

3) Updates on hazard information: "2016-87", "2016-153", "2016-196", "2016-235", "2016-502", "2016-540", "2016-668", "2016-990", "2017-245", "2017-448", "2017-450", "2017-490", "2017-952", "2018-175", "2018-260", "2018-533", "2018-694", "2019-107", "2019-348", "2019-889", "2020-170", "2020-176", "2020-223", "2020-229", "2021-19", "2021-61", "2021-161", "2022-43", "2022-122", "2022-131", "2022-134", "2022-149", "2022-161", and "2022-162"

4) Addition of chemical substances: from "2022-224" to "2022-279"

The main updates on existing substances are as follow:

1) Updates on unique number: "2020-020", "2021-058", and "2021-166"

2) Updates on toxic substance unique number: "2022-207", "2022-208", "2022-209", "2022-210", "2022-211", "2022-212", "2022-213", "2022-214", "2022-215", "2022-216", "2022-218", "2022-219", "2022-220", "2022-221", and "2022-222"

3) Updates on hazard information: "2021-051", "2021-052", "2021-053", "2021-054", "2021-069", "2021-088", "2021-094", "2021-115", "2022-203", "2022-204", "2022-205", and "2022-207"

4) Addition of chemical substances: from "2022-312" to "2022-338"

The amendment came into effect immediately.

The Ministry of Environment (MoE) in South Korea updates the Act on Registration and Evaluation of Chemicals (K-REACH) on Jan 3rd, 2023. This is to clarify requirement of the notification of changes f...

The Ministry of Environment (MoE) in South Korea updates the Act on Registration and Evaluation of Chemicals (K-REACH) on Jan 3^rd, 2023. This is to clarify requirement of the notification of changes for the substances subject to intensive control, and regulate succession of rights and duties for reported substances subject to intensive control.

The main updates are:

• Notification of changes for the substances subject to intensive control before Jan 31^st of the following year of the occurrence if any of the following changes:
  • Newly manufactured or imported product with the content of substances subject to intensive control over 0.1 weight percent per product
  • Weight percent
  • Exposure information of substances subject to intensive control
  • Use of substances subject to intensive control
  • Content of substances subject to intensive control
  • Other matters specified by the MoE
• Report succession of rights and duties for reported substances subject to intensive control within one month for the following cases:
  • A person made report/ registration/ exemption dies or transfers the business
  • A corporate merger of manufacturer and importer

The amendment will come into effect from Jan 4^th, 2024.

The National Institute of Environmental Research (NIER) in South Korea notifies conditions for submission of hazard data for 31 biocidal substances that have been evaluated internationally. This is to...

The National Institute of Environmental Research (NIER) in South Korea notifies conditions for submission of hazard data for 31 biocidal substances that have been evaluated internationally. This is to maintain reliable biocide approval system by clarifying the management methods of hazard information of biocidal substances that have been evaluated internationally. This will enable efficient implementation of the biocide approval system for existing biocidal substances subject to get the approval by 2024.

Scope:

- 31 biocidal substances that have been evaluated internationally among existing biocidal substances subject to get the approval by 2024

- exclusion: 15 substances under evaluation or unable to confirm evaluation information

Conditions for data submission:

① Prioritizing the substances that completed 2^nd international evaluation: For the same biocidal substance, if the hazardous data submission condition for the first evaluation and second evaluation is different, the data submitted for the second evaluation will be prioritized.

② Additional data submission: Test data (CMR, PBT, EDCs, etc.) of major approval category (approval criteria, determination of valid date, etc.) may be required additionally during the approval evaluation to enhance the reliability of the data.

③ Submission of retained data: For the substances that completed 2^nd international evaluation, it is possible to submit retained data to enhance the reliability of the data. If it is a reliable data, the data submitted by an applicant will be prioritized (only applicable for individual submission).

④ Risk Assessment: Applicants should confirm risks index and submit risk assessment result including risk reduction plan.

⑤ Ensuring completeness: Completed data with substance manufacturer certificate (including manufacturing site), component analysis report (including impurities), representative product sample, etc should be submitted (till June 2023).

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the Designation of Existing Biocidal Substances for Approval Deferment’ under the Consumer ...

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the Designation of Existing Biocidal Substances for Approval Deferment’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on December 13th, 2022. This is to designate additional existing biocidal substances for approval deferment based on hazard and risk of the substances, as well as to cancel the designation of existing biocidal substances for approval deferment due to the cancellation of reporting.

The draft amendment mainly proposes revisions including:

• Addition of biocidal product type for the designated biocidal substances: 5 substances
• Designation cancellation of existing biocidal substances for approval deferment: 110 substances
• Designation cancellation of biocidal product type of existing biocidal substances for approval deferment: 106 substances
• Additional designation of existing biocidal substances for approval deferment: 12 substances

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

The deadline for this consultation is Dec 23rd, 2022.