South Korea Regulatory News

The Ministry of Food and Drug Safety (MFDS) in South Korea updates the designation of usage standards of cosmetic raw materials, especially on UV protection ingredients, under the Cosmetic Act on May ...

The Ministry of Food and Drug Safety (MFDS) in South Korea updates the designation of usage standards of cosmetic raw materials, especially on UV protection ingredients, under the Cosmetic Act on May 4^th, 2023. This is to notify the list of cosmetic raw materials and its usage standard based on the screening results.

The main update is as follow:

• UV protection ingredients

The National Institute of Environmental Research (NIER) in South Korea is consulting on a draft amendment of Designation of Toxic Substances under the Act on Registration and Evaluation of Chemicals (...

The National Institute of Environmental Research (NIER) in South Korea is consulting on a draft amendment of Designation of Toxic Substances under the Act on Registration and Evaluation of Chemicals (K-REACH).

The draft amendment mainly proposes revisions including:

• New designation of toxic substances for which hazard reviews has been completed: from 2023-1-1110 to 2023-1-1115
• Revise the name of toxic substances: 97-1-41, 97-1-68, 97-1-71, 97-1-1134, 97-1-213, 98-1-480, 2014-1-692
• Regulate newly designated toxic substances on import declaration & business license under Chemical Control Act (CCA), labeling hazardous chemicals, and transitional measures for handling

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

The deadline of this consultation is May 15th, 2023.

The National Institute of Environmental Research (NIER) in South Korea is consulting on a draft amendment of the Regulation on chemical substance classification and labelling under the Act on Registra...

The National Institute of Environmental Research (NIER) in South Korea is consulting on a draft amendment of the Regulation on chemical substance classification and labelling under the Act on Registration and Evaluation of Chemicals (K-REACH). This is to notify classification and labelling of newly designated toxic substances, as well as existing hazardous chemicals for which hazard reviews has been completed.

The draft amendment mainly proposes revisions including:

• New classification and labelling for newly designated toxic substances
  • 6 substances including 3,5-difluorophenol
  • From 2023-1-1110 to 2023-1-1115
• Revise classification and labelling for existing hazardous chemicals
  • 28 toxic substances
  • 2 substances requiring preparing for accidents

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

The deadline of this consultation is May 15th, 2023.

The National Institute of Environmental Research (NIER) in South Korea is consulting on a draft amendment of the Regulation on test methods for chemical substances under the Act on Registration and Ev...

The National Institute of Environmental Research (NIER) in South Korea is consulting on a draft amendment of the Regulation on test methods for chemical substances under the Act on Registration and Evaluation of Chemicals (K-REACH). This is to update the regulation based on updated international chemical regulations including OECD’s animal alternative test methods.

The draft amendment mainly proposes revisions including:

• Add 2 categories in the test on human health part: OECD TG 497, OECD TG 498
• Revise 9 categories in the test on human health part: OECD TG 405, OECD TG 406, OECD TG417, OECD TG 439, OECD TG 429, OECD TG 442A, OECD TG 442C, OECD TG 455, OECD TG 494

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

The deadline of this consultation is May 8th, 2023.

The National Institute of Environmental Research (NIER) in South Korea plans to evaluate biocidal products for the approval of biocidal substance and biocidal products under the Consumer Chemical Prod...

The National Institute of Environmental Research (NIER) in South Korea plans to evaluate biocidal products for the approval of biocidal substance and biocidal products under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR). Regarding this evaluation, an update on test methods for determining the shelf life of biocidal products was provided on April 12^th, 2023.

Applicants for the approval must submit complete physical and chemical stability test data proving that the quality (content, effect, efficacy, etc.) of the biocidal product is stable during the shelf life. Long-term storage test, acceleration storage test, and low-temperature stability test (liquid) are mandatory, but it can be exempted under certain conditions.

New case with the stability test

• Testing Institute: Recommended to submit data produced by testing institutes that comply with international standards. Example: ISO 9001, ISO/IEC 17025, GLP, etc.

• Test data: Long-term storage test and acceleration storage test data that conform to the shelf life of biocidal products must be submitted, but test data can be selectively submitted depending on the shelf life and storage temperature & conditions.

Submitting existing test data

• Scope: Limited to products that have been approved by submitting stability test data as daily use consumer chemical product subject to safety verification and approval.

• Approval: Resubmit the stability test data that was submitted and got approval as the daily use consumer chemical product subject to safety verification and approval, and the shelf life given at the time of approval would be accepted.

The National Institute of Environmental Research (NIER) in South Korea provides a summary for the Approval application documents based on the updates on disinfectant and preservatives for humidifiers ...

The National Institute of Environmental Research (NIER) in South Korea provides a summary for the Approval application documents based on the updates on disinfectant and preservatives for humidifiers on April 10^th, 2023. This is based on the updated classification on product type based on diversified disinfectant and preservatives for humidifiers under the ‘Regulations on the Approval for Consumer Chemical Products Subject to Safety Verification’ on December 12, 2022.

According to the summary, the Approval application documents for the antimicrobial and preservatives for humidifiers remains the same, but some of the Approval application documents for the preservation treatment product for humidifiers can be exempted. The provided summary for the Approval application documents is as below:

• The scope of document submission of standard and test method review

• The scope of document submission of stability & effectiveness review

○: Mandatory documents to be submitted

△: Documents that may be exempted

-: Documents that don’t need to be submitted

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Cosmetic Act on March 22nd, 2023. The Cosmetic Act prohibits advertisements that might mislead the pu...

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Cosmetic Act on March 22^nd, 2023. The Cosmetic Act prohibits advertisements that might mislead the public for cosmetics as medicines, functional cosmetics, natural cosmetics or organic cosmetics. This amendment is to clarify the scope of the prohibited subject related to the misleading advertisement.

The main amendments are:

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

The deadline for this consultation is April 14^th, 2023.