South Korea Regulatory News

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.

The Ministry of Environment (MoE) in South Korea updates the designation of the consumer chemical products and standards for labelling and safety on November 16th, 2022.   The main updates are:...

The Ministry of Environment (MoE) in South Korea updates the designation of the consumer chemical products and standards for labelling and safety on November 16^th, 2022.

The main updates are:

• Addition of new management category for the consumer chemical products & establishment of safety and labelling standards
  • Finishing agent, hardener, hardening accelerator, cleaning polish for sporting goods
• Addition of new use for the existing management category & establishment of safety and labelling standards
  • Filter cleaner, paint remover, gloss coating agent for metal jewelry, special purpose coating agent for leather softening, disinfectant for filter
• Establishment of safety management regulations for containers, packaging and appearance misled as of food
• Improvement of reporting method of product weight, capacity, and number
• Improvement of the labelling method of the consumer chemical products per box
• Establishment of grounds for the voluntary application of child protective packaging labelling for the products that are not subject to child protective packaging
• Establishment of grounds for the voluntary application of allergenic substance labeling for the substances that are not subject to label
• Clarification of excepts for the categories
  • Lubricant, deodorant, disinfectant, etc

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) on November 22nd, 2022. This is to notify substance name, hazard information, classification and etc as the hazard reviews are completed for registered substances.

The draft amendment mainly proposes revisions including:

• Notification of the results of hazard review of registered chemical substances
  • 58 new substances
  • 30 existing substances
• Revision of notified substances
  • New substances
    • 5 new substances: update substance name
    • 36 new substances: update hazard information
  • Existing substances
    • 3 existing substances: update unique number
    • 7 existing substances: update toxic substance unique number
    • 12 existing substances: update hazard information
• Deletion of notified substances
  • 1 New substance

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 12th, 2022.

The Ministry of Environment (MoE) in South Korea consults on a draft amendment of ‘the Designation of restricted and prohibited substances’ under the Act on Registration and Evaluation of Chemical...

The Ministry of Environment (MoE) in South Korea consults on a draft amendment of ‘the Designation of restricted and prohibited substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on November 14th, 2022. This is to extend the grace period for 2 years, in order to give the industry enough time to adapt handling restrictions occurred due to the restricted substance designation.

The draft amendment mainly proposes revisions including:

• Extend the grace period of manufacture, import, sale, storage, transport and use of ‘Strontium chromate’ among “Chromium (6+) compounds and mixtures containing 0.1% or more” to January 1^st, 2025.
  • Restriction for the manufacture & import: Jan 1^st, 2023 → Jan 1^st, 2025
  • Restriction for the sale, storage, transport & use: July 1^st, 2023 → Jan 1^st, 2025

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

The deadline for this consultation is Dec 4th, 2022.

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea consults on a draft of ‘the Guidelines for submitting a functional cosmetics report’ under the Enforcement Rule of the ...

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea consults on a draft of ‘the Guidelines for submitting a functional cosmetics report’ under the Enforcement Rule of the Cosmetic Act on November 21^st, 2022. According to the Cosmetic Act, functional cosmetics should be assessed unless it meets certain criteria to submit a report instead. This guideline is to provide clear guidelines to prepare and submit a report for functional cosmetics subject to submit a report.

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 have any opinion on this amendment, please write your opinion and submit it to the Korea Cosmetic Association.

The deadline for this consultation is Nov 24th, 2022.