South Korea Regulatory News

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.

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea updates the Guidelines on analysis methods for cosmetic ingredients with restricted uses on October 31st, 2022. This is for...

National Institute of Food and Drug Safety Evaluation (NIFDS) in South Korea updates the Guidelines on analysis methods for cosmetic ingredients with restricted uses on October 31^st, 2022. This is for the quality improvement and safety management of cosmetics.

The main updates are:

• Addition of analysis methods applicable to products regarding 10 types of colorants that can be used in cosmetics based on “Cosmetic colorant types, standard and test methods”
  • Green No. 204, Yellow No. 4, Red No. 2, Green No 2
  • Red No. 102, Red No. 40, Yellow No. 202 (1), Red No. 103 (1), Orange No. 205, Violet No. 401

The Ministry of Environment (MoE) in South Korea added the provision to expand the definition of existing substances on Aug 12th, 2021. Based on the updated definition of existing substances, South Ko...

The Ministry of Environment (MoE) in South Korea added the provision to expand the definition of existing substances on Aug 12th, 2021. Based on the updated definition of existing substances, South Korea updates K-REACH registration procedure for existing substances.

The updates are as below:

For example, if an existing substance is "Mixture (reaction mass) of X+Y+(…Z)", pre-register with the existing substance X, and create new CICO with the name "Mixture (reaction mass) of X+Y+(…Z)". Also, it is necessary to put the reason as “got the approval as an existing substance from the NIER”.

*The definition of existing substances added are as follows:

• hydrate or anhydrous of existing substances
• reaction products consisting of two or more existing substances
• Isomers of an existing substance
• Other chemical substances mentioned in the attachment

On 27 September 2022 South Korea’s Ministry of Environment (MoE) published a notification on updating the requirements for two Persistent Organic Pollutants (POPs). The requirements are added to the...

On 27 September 2022 South Korea’s Ministry of Environment (MoE) published a notification on updating the requirements for two Persistent Organic Pollutants (POPs). The requirements are added to the rules for chemical compounds exported on prior informed permission of the Chemical Control Act (CCA). The new requirements are up for consultation under South Korea’s Ministry of Environment (MoE) until 17 October 2022. 

The Consumer Chemical Products and Biocides Safety Act (K-BPR) regulates both  compounds listed in the recent notification. The two POPs are:  

• decabromodiphenyl ether (decaBDE) which is used as a flame retardant in a variety of products, including thermoset resin plastics, textiles, and adhesives. 

• perfluorooctanoic acid (PFOA) and its salts and related compounds. PFOA and its salts are widely used as processing aids in the production of fluoro-elastomers and fluoropolymers, with Polytetrafluoroethylene (PTFE) being an important fluoropolymer. PFOA-related compounds are used as surfactants and for the manufacture of side-chain fluorinated polymers. Due to the surfactant properties of both PFOA and its related non-polymeric surfactants, applications exist for the use of these substances, e.g., fire-fighting foams, wetting agents, and cleaners. 

According to the proposed regulations, companies planning to export these chemicals would need to get permission from the MoE and submit an export notification to the ministry in English before proceeding. 

Companies exporting the compounds would also need to supply handlers in importing nations with safety data sheet (SDS) information as well as mark hazardous information on the packaging or containers of the substance.  

The recommendation comes after the UN’s decision to include these two compounds in the Rotterdam Convention in June 2022. The countries receiving products containing these chemicals must be informed of their import and have the option to reject them under the Prior Informed Consent (PIC) procedure of the Convention. 

Both compounds are included in the Stockholm Convention's list, which obliges nations to stop using and producing them. Nevertheless, some particular uses are still momentarily permitted.