South Korea Regulatory News

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Regulations on quasi-drug classification numbers on May 9th, 2023. This is to improve the efficiency ...

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Regulations on quasi-drug classification numbers on May 9th, 2023. This is to improve the efficiency of quasi-drug product approval (report) by updating the quasi-drug classification numbers.

The main amendments are:

• Assign quasi-drug classification numbers to ‘products used for sanitary treatment of bleeding and lochia (postpartum vaginal discharge) after childbirth’ that are newly designated as quasi-drugs: Quasi-drug classification number 3510, 3520, 3530, and 3600
• Remove the quasi-drug classification number of items converted to biocides, according to the Consumer Chemical Products and Biocides Safety Control Act (K-BPR): Quasi-drug classification number 4300, 4310, 4910, 5100, 5110, 5120, 5200, 5210, and 5220

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

The deadline for this consultation is May 29th, 2023.

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Regulations on Safety Standards for Cosmetics on May 4th, 2023. This is to reinforce cosmetic safety...

The Ministry of Food and Drug Safety (MFDS) in South Korea consults for the draft amendment of the Regulations on Safety Standards for Cosmetics on May 4th, 2023. This is to reinforce cosmetic safety management and protect human health by adding some hair dye ingredients to the prohibited list of cosmetics, considering the results of risk assessment and overseas regulatory trends.

The main amendments are:

• Add 7 hair dye ingredients to the prohibited list of cosmetics
• Lower concentrations upper limits for 2 hair dye ingredients

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

The deadline for this consultation is July 4th, 2023.

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.