South Korea Regulatory News

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. 

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.