South Korea Regulatory News

The Ministry of Environment (MoE) in South Korea consults on a draft amendment of ‘the Rules on Approval of Chemical Safety Information Exception’ under the Act on Registration and Evaluation of C...

The Ministry of Environment (MoE) in South Korea consults on a draft amendment of ‘the Rules on Approval of Chemical Safety Information Exception’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on October 18th, 2022. Currently, there is a risk that trade secret approved for non-disclosure under other regulations may be exposed through the K-REACH registration number (or report number), since K-REACH registration number (or report number) is not subject to non-disclosure. Therefore, this amendment aims to protect trade secret by including K-REACH registration number (or report number) as non-disclosure.

The draft amendment mainly proposes revisions including:

• In case of approval for non-disclosure under other act, K-REACH registration number (or report number) is included as non-disclosure
  • The information on whether a substance is registered or reported will be still marked to show its compliance under K-REACH

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

The deadline for this consultation is Nov 7th, 2022.

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea consults on a draft amendment on the Guidelines for Clinical trials on cosmetics that alleviate hair loss symptoms on Octob...

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea consults on a draft amendment on the Guidelines for Clinical trials on cosmetics that alleviate hair loss symptoms on October 14th, 2022. This is to clarify required fields to be included in the clinical trial report.

The guidelines mentions that the clinical trial report should follow the “Regulations on the demonstration of cosmetic labeling and advertising”. The clinical trial report is recommended to include the following criteria:

• Title of the test
• Testing institute information
• Test and control substance information
• Subject control and test method
• Test results
• Methods of synthesizing results
• Data reliability
• Side effect and measurement details

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 Oct 20th, 2022.

The National Institute of Environmental Research (NIER) in South Korea updates ‘the Designation of toxic substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on October ...

The National Institute of Environmental Research (NIER) in South Korea updates ‘the Designation of toxic substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on October 6^th, 2022.

The main updates are:

• Revision of chemical substance name: substances with unique number “97-1-5”, “97-1-21”, “97-1-45”, “97-1-46”, “97-1-80”, “97-1-96”, “97-1-119”, “97-1-132”, “97-1-163”, “97-1-182”, “97-1-198”, “97-1-209”, “97-1-212”, “97-1-218”, “97-1-240”, “97-1-268”, “97-1-277”, “97-1-278”, “97-1-376”, “97-1-410”, “97-1-411”, “97-1-432”, “2010-1-611”, “2010-1-646” and “2012-1-688”
• Addition of chemical substances: substances with unique number from “2022-1-1085” to “2022-1-1095”

The amendment will come into effect in a month. However, for 1) handling standards of hazardous chemicals, 2) preparation and submission of chemical accident prevention management plan, 3) arrangement, installation and management standards of handling facilities, and 4) hazardous chemical business license under the Chemicals Control Act, it will be implemented in 3 months.

The National Institute of Environmental Research (NIER) in South Korea updated the Regulation on chemical substance classification and labelling under the Act on Registration and Evaluation of Chemica...

The National Institute of Environmental Research (NIER) in South Korea updated the Regulation on chemical substance classification and labelling under the Act on Registration and Evaluation of Chemicals (K-REACH) and the Chemicals Control Act on October 6^th, 2022.

The main updates are:

• Revision of toxic substances: substances with unique number “97-1-5”, “97-1-21”, “97-1-45”, “97-1-46”, “97-1-80”, “97-1-94”, “97-1-96”, “97-1-114”, “97-1-119”, “97-1-132”, “97-1-136”, “97-1-137”, “97-1-139”, “97-1-145”, “97-1-148”, “97-1-163”, “97-1-165”, “97-1-167”, “97-1-182”, “97-1-183”, “97-1-198”, “97-1-200”, “97-1-203”, “97-1-209”, “97-1-218”, “97-1-240”, ““97-1-274”, “97-1-277”, “97-1-313”, “97-1-359”, “97-1-376”, “97-1-381”, “97-1-382”, “97-1-384”, “97-1-405”, “97-1-406”, “97-1-407”, “97-1-409”, “97-1-410”, “97-1-411”, “97-1-432”, “98-1-479”, “99-1-492”, “99-1-506”, “2001-1-520”, “2001-1-525”, “2006-1-556”, “2010-1-604”, “2010-1-610”, “2010-1-611”, “2012-1-640”, “2012-1-644”, “2012-1-645”, “2012-1-646”, “2013-1-666”, “2013-1-668”, “2014-1-685”, “2014-1-688”, “2014-1-700”, “2018-1-824” and “2020-1-982”
• Addition of toxic substances: substances with unique number from “2022-1-1085” to “2022-1-1095”
• Revision of restricted substances: substances with unique number “06-5-4” and “06-5-13”
• Revision of substances requiring preparation for accidents: substances with unique number “3”, “4”, “11”, “26”, “35”, “40”, “42”, “43”, “45”, “47”, “49”, “52”, “54”, “62”, “65”, “66” and “73”

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 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.