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 November 22nd, 2022. This is to notify substance name, hazard information, classification and etc as the hazard reviews are completed for registered substances.

The draft amendment mainly proposes revisions including:

• Notification of the results of hazard review of registered chemical substances
  • 58 new substances
  • 30 existing substances
• Revision of notified substances
  • New substances
    • 5 new substances: update substance name
    • 36 new substances: update hazard information
  • Existing substances
    • 3 existing substances: update unique number
    • 7 existing substances: update toxic substance unique number
    • 12 existing substances: update hazard information
• Deletion of notified substances
  • 1 New substance

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

The deadline for this consultation is Dec 12th, 2022.

The Ministry of Environment (MoE) in South Korea consults on a draft amendment of ‘the Designation of restricted and prohibited substances’ under the Act on Registration and Evaluation of Chemical...

The Ministry of Environment (MoE) in South Korea consults on a draft amendment of ‘the Designation of restricted and prohibited substances’ under the Act on Registration and Evaluation of Chemicals (K-REACH) on November 14th, 2022. This is to extend the grace period for 2 years, in order to give the industry enough time to adapt handling restrictions occurred due to the restricted substance designation.

The draft amendment mainly proposes revisions including:

• Extend the grace period of manufacture, import, sale, storage, transport and use of ‘Strontium chromate’ among “Chromium (6+) compounds and mixtures containing 0.1% or more” to January 1^st, 2025.
  • Restriction for the manufacture & import: Jan 1^st, 2023 → Jan 1^st, 2025
  • Restriction for the sale, storage, transport & use: July 1^st, 2023 → Jan 1^st, 2025

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

The deadline for this consultation is Dec 4th, 2022.

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea consults on a draft of ‘the Guidelines for submitting a functional cosmetics report’ under the Enforcement Rule of the ...

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea consults on a draft of ‘the Guidelines for submitting a functional cosmetics report’ under the Enforcement Rule of the Cosmetic Act on November 21^st, 2022. According to the Cosmetic Act, functional cosmetics should be assessed unless it meets certain criteria to submit a report instead. This guideline is to provide clear guidelines to prepare and submit a report for functional cosmetics subject to submit a report.

This guideline mainly includes

• Report submission process
• Common categories for all reports for functional cosmetics type 1-3
• Details of the report for functional cosmetics type 1
• Details of the report for functional cosmetics type 2
• Details of the report for functional cosmetics type 3

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

The deadline for this consultation is Nov 24th, 2022.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the Regulation on the subject and methods of risk assessment for the consumer chemical produc...

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the Regulation on the subject and methods of risk assessment for the consumer chemical products’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on November 8th, 2022. This is to expand the subject of risk assessment based on diversified users and uses of the consumer chemical products. This makes it necessary to provide updated algorithm in order to enhance the utilization of the exposure algorithm.

The draft amendment mainly proposes revisions including:

• Add professional users to the subject of risk assessment
• Add exposure scenario by formulation to the current exposure calculation formula categorized by inhalation route and exposure route
• Update the current exposure calculation formula to enhance the utilization of the exposure algorithm
• Add general exposure factor and product exposure factor based on expanded subject of risk assessment

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

The deadline for this consultation is Nov 18th, 2022.

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) on Nov 4^th, 2022. This update is mainly on new substance.

The updates on chemical substance names are of the following 347 substances:

• "2015-4", "2015-16", "2015-17", "2015-33", "2015-35", "2015-36", "2015-37", "2015-40", "2015-76", "2015-89", "2015-93", "2015-96", "2015-101", "2016-7", "2016-12", "2016-13", "2016-21", "2016-22", "2016-34", "2016-38", "2016-41", "2016-47", "2016-59", "2016-63", "2016-67", "2016-73", "2016-78", "2016-80", "2016-81", "2016-85", "2016-103", "2016-104", "2016-106", "2016-108", "2016-109", "2016-114", "2016-116", "2016-117", "2016-118", "2016-121", "2016-122", "2016-123", "2016-124", "2016-132", "2016-143", "2016-144", "2016-145", "2016-146", "2016-147", "2016-149", "2016-151", "2016-152", "2016-153", "2016-154", "2016-155", "2016-157", "2016-158", "2016-159", "2016-163", "2016-168", "2016-175", "2016-182", "2016-183", "2016-185", "2016-190", "2016-191", "2016-195", "2016-197", "2016-201", "2016-204", "2016-208", "2016-229", "2016-233", "2016-236", "2016-242", "2016-243", "2016-244", "2016-247", "2016-251", "2016-253", "2016-254", "2016-255", "2016-256", "2016-257", "2016-258", "2016-264", "2016-265", "2016-266", "2016-267", "2016-268", "2016-270", "2016-277", "2016-280", "2016-281", "2016-286", "2016-287", "2016-289", "2016-290", "2016-292", "2016-296", "2016-297", "2016-298", "2016-299", "2016-309", "2016-313", "2016-314", "2016-315", "2016-317", "2016-319", "2016-320", "2016-328", "2016-329", "2016-338", "2016-339", "2016-350", "2016-360", "2016-361", "2016-364", "2016-367", "2016-368", "2016-372", "2016-373", "2016-378", "2016-379", "2016-380", "2016-381", "2016-382", "2016-383", "2016-384", "2016-385", "2016-386", "2016-388", "2016-389", "2016-391", "2016-393", "2016-395", "2016-396", "2016-398", "2016-399", "2016-400", "2016-401", "2016-402", "2016-403", "2016-406", "2016-407", "2016-408", "2016-409", "2016-416", "2016-421", "2016-422", "2016-424", "2016-425", "2016-432", "2016-433", "2016-435", "2016-436", "2016-437", "2016-442", "2016-443", "2016-444", "2016-446", "2016-453", "2016-455", "2016-461", "2016-463", "2016-464", "2016-469", "2016-471", "2016-478", "2016-479", "2016-481", "2016-485", "2016-488", "2016-499", "2016-502", "2016-505", "2016-520", "2016-522", "2016-523", "2016-525", "2016-526", "2016-527", "2016-529", "2016-531", "2016-538", "2016-540", "2016-544", "2016-546", "2016-547", "2016-568", "2016-574", "2016-588", "2016-600", "2016-601", "2016-615", "2016-623", "2016-625", "2016-631", "2016-634", "2016-635", "2016-640", "2016-641", "2016-642", "2016-643", "2016-644", "2016-645", "2016-666", "2016-671", "2016-698", "2016-700", "2016-740", "2016-748", "2016-754", "2016-755", "2016-759", "2016-760", "2016-764", "2016-765", "2016-782", "2016-785", "2016-789", "2016-797", "2016-807", "2016-840", "2016-871", "2016-873", "2016-874", "2016-875", "2016-876", "2016-947", "2016-948", "2016-1018", "2016-1075", "2016-1103", "2016-1104", "2016-1105", "2016-1112", "2016-1113", "2016-1129", "2017-16", "2017-19", "2017-24", "2017-26", "2017-28", "2017-29", "2017-30", "2017-38", "2017-40", "2017-41", "2017-42", "2017-43", "2017-44", "2017-48", "2017-51", "2017-52", "2017-54", "2017-59", "2017-60", "2017-62", "2017-63", "2017-70", "2017-72", "2017-73", "2017-76", "2017-77", "2017-103", "2017-104", "2017-110", "2017-111", "2017-130", "2017-132", "2017-135", "2017-137", "2017-139", "2017-140", "2017-141", "2017-157", "2017-163", "2017-165", "2017-166", "2017-195", "2017-208", "2017-214", "2017-223", "2017-230", "2017-231", "2017-232", "2017-233", "2017-236", "2017-243", "2017-255", "2017-256", "2017-257", "2017-259", "2017-261", "2017-263", "2017-268", "2017-272", "2017-279", "2017-290", "2017-291", "2017-298", "2017-300", "2017-320", "2017-321", "2017-322", "2017-325", "2017-326", "2017-328", "2017-364", "2017-369", "2017-370", "2017-376", "2017-385", "2017-395", "2017-404", "2017-410", "2017-411", "2017-412", "2017-413", "2017-415", "2017-416", "2017-417", "2017-418", "2017-419", "2017-439", "2017-443", "2017-455", "2017-463", "2017-467", "2017-470", "2017-472", "2017-474", "2017-483", "2017-489", "2017-491", "2017-495", "2017-498", "2017-519", "2017-529", "2017-537", "2017-547", "2017-559", "2017-562", "2017-589", "2017-590", "2017-591"

The amendment came into effect immediately.

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the Regulations on the approval for consumer chemical products subject to safety verification...

The National Institute of Environmental Research (NIER) in South Korea consults on a draft amendment of ‘the Regulations on the approval for consumer chemical products subject to safety verification’ under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR) on November 1^st, 2022. This is to provide updated classification on product type based on diversified and new antimicrobial and disinfectant for humidifiers. Also, this is to rationalize approval application data by specifying the approval application data.

The draft amendment mainly proposes revisions including:

• Segmentation of products such as antimicrobial and disinfectant for humidifiers
• Clarification of the submission requirements for approval application data
• Establishment of numbering standards as the expansion of approved products
• Clarification of interim measures for preservative treatment products for humidifiers

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

The deadline for this consultation is Nov 21st, 2022.

The Ministry of Food and Drug Safety (MFDS) in South Korea consults on a draft amendment of ‘Standards for Appliances, Containers and Packaging’ under Food Sanitation Act on October 14th, 2022. It...

The Ministry of Food and Drug Safety (MFDS) in South Korea consults on a draft amendment of ‘Standards for Appliances, Containers and Packaging’ under Food Sanitation Act on October 14^th, 2022. It is expected that the approval for using recycled materials as raw materials for utensils, containers and packaging would be published in the near future. And this draft amendment is to specify data to be submitted when applying for the approval. In addition to this, this draft amendment is to improve some issues of the current standards that industry is facing to pursue the sustainable society.

The draft amendment mainly proposes revisions including:

• Update the standard of recycled materials made of synthetic resins
• New standard for polybutylene adipate terephthalate (PBAT)
• Update the test method

Please note that one article for the standard of recycled materials made of synthetic resins in the draft is based on the draft Enforcement Rule of the Food Sanitation Act, so it may change according to the final Enforcement Rule.

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

The deadline for this consultation is Dec 13th, 2022.