South Korea Regulatory News

On June 1st, 2023, the National Institute of Environmental Research (NIER) in South Korea revised the regulation on chemical classification and labeling, including pictograms, hazard statements and pr...

On June 1st, 2023, the National Institute of Environmental Research (NIER) in South Korea revised the regulation on chemical classification and labeling, including pictograms, hazard statements and precautionary statements, and classification mark lists, and enforced it on the same date. 

Earlier this year, NIER consulted on a draft amendment of this matter, and this was to notify the classification and labeling of newly designated toxic substances, as well as existing hazardous chemicals for which hazard reviews have been completed. 

• New classification and labeling for newly designated toxic substances 

- 6 substances including 3,5-difluorophenol. 

- CAS 2713-34-01 and mixtures containing more than 5%, CAS 872-93-5 and mixtures containing more than 25%, CAS 91742-16-4 and mixtures containing more than 25%, CAS 79-00-5 and mixtures containing more than 25%, CAS 1976005-08-9 and mixtures containing it more than 1%, and CAS 84988-61-4 and mixtures containing it more than 5%. 

• Revise classification and labeling for existing hazardous chemicals 

1) 28 toxic substances 

2) 2 substances requiring preparation for accidents. 

On 17 May 2023, the Chemical Materials Research Division of the National Institute of Environmental Research uploaded its plans to conduct evaluations of biocidal substances submitted for approval un...

On 17 May 2023, the Chemical Materials Research Division of the National Institute of Environmental Research uploaded its plans to conduct evaluations of biocidal substances submitted for approval under the "Act on the Safety Management of Household Chemical Products and Biocides." 

In relation to this, the authority has provided guidance regarding the exemption of efficacy test data for biocidal substances (wood preservatives). 

The Exemption Guidelines for Test Data on Efficacy and Effectiveness of Biocidal Substances (Wood Preservatives) are as follows: 

 
For wood preservatives listed under the Korean standard on wood preservatives and similar substances, the submission of test data on efficacy and effectiveness may be exempted according to the Industrial Standardization Act. KSM 1701 is a standard number issued by the government agency, the Korea Agency for Technology and Standards (KATS), to designate wood preservatives. 

 
Seven out of the 40 existing wood preservatives are subject to deferred approval in 2024. When applying for approval of these confirmed biocidal substances and their representative example products, the submission of test data on efficacy and effectiveness is exempted. 
However, general data on the efficacy and effectiveness of the biocidal substances (such as their functions, control methods, mechanisms of action, limitations, etc.) should still be submitted. 
The exemption for test data on efficacy and effectiveness only applies to wood preservatives and does not extend to other types of biocidal products. The exemption for test data on efficacy and effectiveness of wood preservatives is independent of the designation of existing biocidal substances and internationally approved evaluated substances. Changes in the inclusion or removal of substances under KSM 1701 may result in modifications to the eligibility for exemption from test data on efficacy and effectiveness. 

 
For wood preservatives that are not included under KSM 1701, test data on efficacy and effectiveness should be submitted when applying for their approval. If the efficacy and effectiveness of the biocidal substance are not sufficiently proven or if individual testing is not feasible, evaluation of the representative example product can be used to demonstrate the efficacy and effectiveness of the biocidal substance. As wood preservatives fall under the category of preservatives used in biocidal treatment products, test data demonstrating the desired efficacy and effectiveness in treated biocidal products using the representative example product should be submitted. Both domestic and internationally recognized test methods can be used for evaluating the efficacy and effectiveness of wood preservatives. Refer to the information provided in the Chemical Products Management System.  

Please note that the information provided is based on the referenced guidelines and regulations. It is advisable to consult the official regulatory authorities or seek legal guidance for precise and up-to-date information regarding the exemption of test data on efficacy and effectiveness for wood preservatives. 

On May 24, 2023, the Chemical Materials Research Division of the National Institute of Environmental Research published an article regarding guidelines for changing the format of the application for p...

On May 24, 2023, the Chemical Materials Research Division of the National Institute of Environmental Research published an article regarding guidelines for changing the format of the application for pesticide approval. 

According to Article 12 and Article 20 of the "Act on the Safety Management of Household Chemical Products and Biocides," a law in Korea aimed at ensuring the safe use and management of household chemical products and biocides, anyone intending to manufacture or import biocidal products must obtain approval for the respective biocidal products. 

In relation to the above, the South Korean authority has informed that there has been a change in the format for submitting documentation for the approval of biocidal products. The change involves the addition of additional composition information per product. For the previously submitted format (ver 1.0), no changes are required for the review process. However, for new submissions or revised documents, the updated format must be used. 

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 May 9th, 2023. 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: 37 new substances
• Revision of notified substances: 30 new substances

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

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 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