South Korea Regulatory News

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 October 6^th, 2022. This is to disclose chemical substance name due to the cancellation of data protection.

The draft amendment mainly proposes revisions including:

• Information disclosed based on the results of hazard review: 347 of new substances
• Information disclosed due to the termination of data protection period

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

The deadline for this consultation is Oct 26^th, 2022.

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.

National Institute of Environmental Research (NIER) in South Korea provides a guideline to prepare biocidal product approval submissions. Under the Consumer Chemical Products and Biocides Safety Contr...

National Institute of Environmental Research (NIER) in South Korea provides a guideline to prepare biocidal product approval submissions. Under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR), manufacturers and importers of biocidal substances and biocidal products must get approval.

This guide provides details of preparation methods and submission requirement regarding ‘Comprehensive safety data (comprehensive evaluation data)’ in under Article 6 (1) of the .

The contents are as follows:

1. Application for biocidal product approval

          a. Preliminary stage of application for biocidal product approval

          b. Preparation for biocidal product approval application data

2. Preparation for comprehensive evaluation data

          a. Summary and evaluation results

          b. Evaluation results on biocidal product information and safety

          c. Comprehensive data results on safety

If you are planning to prepare biocidal product approval submissions, please refer to the guideline for the details.

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea consults on a draft on Cosmetics Preservation Test Guidelines on September 26th, 2022. This is to strengthen the quality an...

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea consults on a draft on Cosmetics Preservation Test Guidelines on September 26th, 2022. This is to strengthen the quality and safety management of distributed cosmetics.

The cosmetic preservation test is a test that evaluates the cosmetic preservation in a general manufacturing environment or consumer’s product usage environment by inoculating microorganisms into cosmetics and examining growth, survival and death of the tested microorganisms. And this guideline includes test method formation, procedure and performance, and precautions.

If you have any opinion on this draft, please write your opinion in the provided format and submit it to Korea Cosmetic Association.

The deadline for this consultation is Sep 29th, 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 Ministry of Food and Drug Safety (MFDS) in South Korea consults on a draft amendment of ‘Regulation on Safety Standards of Cosmetics’ under the Cosmetic Act on September 5th, 2022. This is to ...

The Ministry of Food and Drug Safety (MFDS) in South Korea consults on a draft amendment of ‘Regulation on Safety Standards of Cosmetics’ under the Cosmetic Act on September 5th, 2022. This is to strengthen the safety management of cosmetics and protect public health by regulating some raw materials that may not be used or restricted to use in cosmetics.

The main updates include:

• Remove some raw materials of hair dye from the restricted list and add it banned list

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

The deadline for this consultation is Sep 19th, 2022.

The Ministry of Environment (MoE) in South Korea provides a guide to implement biocide management system for manufacturers and importers of consumer chemical products subject to safety verification. U...

The Ministry of Environment (MoE) in South Korea provides a guide to implement biocide management system for manufacturers and importers of consumer chemical products subject to safety verification. Under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR), manufacturers and importers of biocidal substances and biocidal products must get approval from the MoE (The National Institute of Environmental Research (NIER)).

Scope of the biocidal products are as following:

• 10 biocidal product types: sterilizers, algicides, antibacterial disinfectants for cleaning humidifiers, disinfectants to prevent infectious disease, repellents, insecticides for public health, repellents for public health, insecticides to prevent infectious disease, rodenticides to prevent infectious disease, and wood preservatives
• Products whose main purpose is a biocidal function

Deadlines are as following:

• Biocidal products (except for wood preservatives)

-Biocidal products containing biocidal substances approved within 2022: 2024.12.31

-Biocidal products containing biocidal substances not approved within 2022: 2023.12.31

• Wood preservatives

-Biocidal products containing biocidal substances approved within 2024: 2026.12.31

-Biocidal products containing biocidal substances not approved within 2024: 2025.12.31

Approval of biocidal substances can take more than 1 year and 9 months for evaluation (excluding data revision and supplementation period), and approval of biocidal products can take more than 1 year and 3 months for evaluation (excluding data revision and supplementation period).

As it takes so long time for the evaluation, it should be taken into consideration to get approval within the deadline. In case of non-approval, manufacturing, import, sale, and distribution after the above deadline are prohibited.