South Korea Regulatory News

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.

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.