South Korea Regulatory News

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.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘Regulation on preparation methods for registration application dossier and hazard review meth...

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘Regulation on preparation methods for registration application dossier and hazard review methods’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on August 25th, 2022.

This is to minimize the use of vertebrates for the chemical registration and hazard review by regulating hazard review method to use non-test data.

The main updates include:

• Addition of hazard view method based on non-test data definition and type (QSAR, correlation method, evidence method, etc.)
• Addition and specification of exemption conditions for each test category based on chemical substance properties or non-test data
• 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

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

The deadline for this consultation is Sep 14th, 2022.

South Korea enacts the ‘Regulation on Labeling and Advertising of Consumer Chemical Products’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on July 28th, 2022. This ...

South Korea enacts the ‘Regulation on Labeling and Advertising of Consumer Chemical Products’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on July 28th, 2022. This Regulation is to regulate phrases or expressions that manufacturers, importers, sellers or distributors of the consumer chemical products and biocides should not use when packaging or advertising the product. The regulation includes specific phrases restricted for labelling and advertising.

The main phrases restricted for labelling and advertising include:

•   Phrases that can be misunderstood as non-toxic
  • Example: Non-toxic, Toxic-zero
• Phrases that can be misunderstood as having no negative impact on environment and nature
  • Example: natural (exception: if the content is 100% natural), green, eco, care about environment, naturalism, pure, etc
• Phrases that can be misunderstood as having no harm and may lead to excessive use or incorrect use of the product
  • Example: no impact on human health, safe, no harmful substances, good, safe for children, etc
• Phrases that can be misunderstood as having no negative impact on human or animal
  • Example: well-being, care about human health, etc

This regulation will be reviewed and may be updated every three years.

This comes into effect from July 29th, 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). This update is mainly on new substances.

The main updates on new substances are as follows:

1) Updates on chemical substance name, etc: “2019-144", “2019-178", “2019-179", “2020-203" and “2022-21"

2) Updates on hazard information, etc: “2016-32", “2016-210", “2016-337", “2016-498", “2016-877", “2016-1126", “2017-33", “2017-286", “2017-311", “2017-414", “2017-548", “2017-589", “2017-812", “2018-523", “2018-699", “2019-148", “2019-200", “2019-257", “2019-315", “2019-452", “2019-466", “2019-821", “2020-47", “2020-230", “2021-26", “2021-27", “2021-38", “2021-78", “2021-84", “2021-178", “2022-102" and “2022-114"

2) Addition of 52 substances and their hazard information: from "2022-172" to "2022-223"

The amendment came into effect immediately.