South Korea Regulatory News

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.

The National Institute of Environmental Research (NIER) in South Korea updates the ‘Regulations on the Approval for Consumer Chemical Products Subject to Safety Verification’ under the Consumer Ch...

The National Institute of Environmental Research (NIER) in South Korea updates the ‘Regulations on the Approval for Consumer Chemical Products Subject to Safety Verification’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on December 12, 2022. This is to provide updated classification on product type based on diversified antimicrobial and disinfectant for humidifiers. Also, this is to update approval application data by specifying the approval application data.

The main updates are:

• Change the product type from ‘antimicrobial and disinfectant for humidifiers’ to ‘disinfectant and preservatives for humidifiers’
• Provide definition of ‘preservation treatment product for humidifiers’
• Clarification of the submission requirements for approval application data on ‘disinfectant and preservatives for humidifiers’ and ‘preservation treatment product for humidifiers’
• Establishment of numbering standards as the expansion of approved products

The amendment came into effect immediately.

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

The National Institute of Environmental Research (NIER) in South Korea updates ‘the Designation of toxic substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH) and Chemical Control Act (CCA) on December 7^th, 2022.

The main updates are:

• Revision of chemical substance name: substances with unique number “97-1-91”, “97-1-92”, “97-1-271”, “97-1-311”, “97-1-315”, “97-1-334”, “97-1-345”, “97-1-436”, “97-1-451”, “97-1-472”, “99-1-499”, “2000-1-509”, “2001-1-515”, “2001-1-516” and “2008-1-577”
• Addition of chemical substances: substances with unique number from “2022-1-1096” to “2022-1-1109”

The amendment will come into effect in a month. However, ‘Handling standards of hazardous chemicals’ and ‘Preparation and submission of chemical accident prevention management plan’ under the Chemicals Control Act will be implemented in 3 months. In addition to this, ‘Arrangement, installation and management standards of handling facilities’ and ‘Hazardous chemical business license’ under the Chemicals Control Act will be implemented from January 1^st, 2025.

The National Institute of Environmental Research (NIER) in South Korea updated the ‘Regulation on chemical substance classification and labelling’ under the Act on Registration and Evaluation of C...

The National Institute of Environmental Research (NIER) in South Korea updated the ‘Regulation on chemical substance classification and labelling’ under the Act on Registration and Evaluation of Chemicals (K-REACH) and the Chemicals Control Act (CCA) on December 7^th, 2022.

The main updates are:

• Revision of toxic substances: substances with unique number “97-1-91”, “97-1-92”, “97-1-271”, “97-1-311”, “97-1-315”, “97-1-334”, “97-1-345”, “97-1-436”, “97-1-451”, “97-1-472”, “99-1-499”, “2000-1-509”, “2001-1-515”, “2001-1-516” and “2008-1-577”
• Addition of toxic substances: substances with unique number from “2022-1-1096” to “2022-1-1109”
• Revision of restricted substances: substances with unique number “06-5-5”, “06-5-6” and “06-5-10”
• Revision of substances requiring preparation for accidents: substances with unique number “1”

The amendment came into effect immediately.

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea provides a Guideline to prepare functional cosmetics report submission under the Enforcement Rule of the Cosmetic Act on De...

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea provides a Guideline to prepare functional cosmetics report submission under the Enforcement Rule of the Cosmetic Act on December 1^st, 2022. This guideline is to provide details of report submission and requirement.

This guideline mainly includes:

• Report submission process
• Common categories for all reports for functional cosmetics type 1-3
• Details of the report for functional cosmetics type 1
• Details of the report for functional cosmetics type 2
• Details of the report for functional cosmetics type 3

If you are planning to prepare and submit functional cosmetics report, please refer to the guideline for the details.

The Ministry of Environment (MoE) in South Korea updated the ‘Enforcement Decree of the Chemical Control Act (CCA)’ on November 15th, 2022. This update is mainly on import reporting procedures for...

The Ministry of Environment (MoE) in South Korea updated the ‘Enforcement Decree of the Chemical Control Act (CCA)’ on November 15^th, 2022. This update is mainly on import reporting procedures for substances categorized as both restricted substances and toxic substances.

Before the update, if a substance categorized as both restricted substances and toxic substances, importers of the substance should get import permit for restricted substances (based on CCA Article 20-1) and import reporting for toxic substances (based on CCA Article 20-2), respectively. After the amendment, if importers get import permit for restricted substances, it can be exempted from import reporting for toxic substances. This is to reduce the burden on chemical importers from dual import procedure.

The amendment came into effect immediately.

The Ministry of Environment (MoE) in South Korea plans for the public consultation on the draft list of substances subject to permission under the Act on Registration and Evaluation of Chemicals (K-RE...

The Ministry of Environment (MoE) in South Korea plans 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.

This public consultation opens from Dec 15^th, 2022 to Feb 13^th, 2023.