South Korea Regulatory News

On March 14, 2024, the South Korean National Institute of Food and Drug Safety Evaluation published a draft of the ‘Guidelines for Alternatives to Animal Testing Methods’ to help improve the inter...

On March 14, 2024, the South Korean National Institute of Food and Drug Safety Evaluation published a draft of the ‘Guidelines for Alternatives to Animal Testing Methods’ to help improve the international competitiveness of the domestic cosmetics industry and non-clinical testing institutions related to toxicity tests. The draft contains the guidelines for the two test methods as follows. 

• Guidelines for Test No. 498: In vitro Phototoxicity - Reconstructed Human Epidermis Phototoxicity test method Skin phototoxicity for Cosmetics, etc. 

• Guidelines for ARE-Nrf2 Luciferase Keratinocyte Activation Test Method (OECD 442D) KeretinoSens TM for skin sensitization for Cosmetics, etc. 

Companies that have an opinion on the draft guideline, please reply to our association (email: jenko@kcia.or.kr ) by March 18, 2024. 

On January 10, 2024, the National Institute of Environmental Research (NIER) in South Korea published a partial amendment to the Notice of Designation of Toxic Substances. The amendment will come into...

On January 10, 2024, the National Institute of Environmental Research (NIER) in South Korea published a partial amendment to the Notice of Designation of Toxic Substances. The amendment will come into force on April 11, 2024. 

Regulatory Overview: 

• The Ministry of Environment designates hazardous chemicals as toxic substances based on the hazard assessment. 

• Companies that manufacture, sell, store, transport, and use toxic substances need a business licence. 

• Companies that wish to import toxic substances, must report them to the Minister of the Environment. 

Summary of changes: 

Change in content: 3 substances. 

New: 42 substances. 

On December 11, 2023, the Ministry of Environment (MoE) in South Korea issued a pre-announcement regarding the partial amendment of the Enforcement Regulations of the Act on the Promotion of Saving an...

On December 11, 2023, the Ministry of Environment (MoE) in South Korea issued a pre-announcement regarding the partial amendment of the Enforcement Regulations of the Act on the Promotion of Saving and Recycling of Resources. 

The main motivation for this revision is that paper cups have already been banned in certain establishments, including group catering centres and food service establishments (such as restaurants and coffee shops). To address the practical challenges faced by businesses, such as the need to hire personnel for cleaning multi-use cups and the installation of cleaning facilities, the regulations governing disposable paper cups will be appropriately improved. 

As a result of these revisions, disposable paper cups have been removed from the existing regulations. 

The "Safety Management Guidelines for Biocidal Treated Products (Automobile)" have been distributed for the safety management of automobile-related biocides. It includes the obligations and responsibi...

The "Safety Management Guidelines for Biocidal Treated Products (Automobile)" have been distributed for the safety management of automobile-related biocides. It includes the obligations and responsibilities of stakeholders (automobile, parts manufacturer, supplier, etc.), parts, and the implementation period. 

• Guidelines for Biocidal Treated Products (Automobile): 

1. These guidelines address the safety management of biocides used in automobiles. 
2. They outline the obligations and responsibilities of stakeholders, including automobile manufacturers, parts manufacturers, and suppliers. 
3. The guidelines cover various aspects related to biocides, including implementation periods and specific parts. 
4. Key areas of focus include labelling and advertising practices for biocidal products used in automobiles. 

• Concerns about Labelling and Advertising: 

1. If you label or advertise a biocidal product (such as “antibacterial,” “virus removal,” or “99.9% antibacterial power”) on materials such as preserved leather, textiles, or filters commonly used in cars, there are potential risks. 
2. Once the transitional measures for the authorisation of biocidal products expire, such labelling may be considered as unauthorised disinfectants. 
3. Inadvertent marketing of illegal products can have serious consequences. 

• Recommendations and Efforts: 

1. To prevent such issues, efforts should be made to: 

- Remove inappropriate labelling and advertising in advance. 

- Distribute and guide safety management guidelines to automobile manufacturers, parts manufacturers, and importers. 

      2. Prompt action is crucial, as correcting labelling errors, after market release can be challenging and time-consuming. 

• Collaboration for Industry Compliance: 

In response to these concerns, several entities in Korea have collaborated: 

• Ministry of Environment 

• Korea Consumer Agency 

• Korea Automobile Mobility Industry Association 

• Domestic automakers: Hyundai Motor, Kia Motors, GM Korea, Renault Korea Motors, and KG Mobility 

Together, they have developed the “Safety Management Guidelines for Biological Treatment Products (Automobile Facilities)”—a significant step toward ensuring compliance with biocide regulations in the automobile industry.  

A partial amendment to the Cosmetics Act was promulgated on February 6, 2024, to provide a legal basis for cosmetics manufacturers to apply to the Minister of Food and Drug Safety for approval or modi...

A partial amendment to the Cosmetics Act was promulgated on February 6, 2024, to provide a legal basis for cosmetics manufacturers to apply to the Minister of Food and Drug Safety for approval or modification of raw materials that cannot be used in the manufacture of cosmetics and to clearly reorganize the text so that the contents of cosmetics can be checked from ouside of the bottle. 

1. Purpose of Amendment: 

• The amendment provides a legal basis for cosmetics manufacturers to apply to the Minister of Food and Drug Safety. 

• It allows for the release or modification of raw materials that cannot be used in the production of cosmetics. 

• The aim is to increase transparency and allow external verification of cosmetic contents. 

2. Changes Introduced: 

• The amendment focuses on Cosmetics Safety Standards. 

• It authorises certain entities (such as cosmetics manufacturers, distributors, or research institutes) to apply for specific actions related to raw materials. 

• These actions include: 

        - Cancellation or modification of designated or publicly announced raw materials. 

        - Designation and publication of standards for the use raw materials not previously designated or announced. 

        - Changes to standards for the use of raw materials that have been designated and publicly announced. 

3. Review Process: 

• When an application is submitted, the head of the Ministry of Food and Drug Safety reviews its validity. 

• If the validity is confirmed, the following actions may be taken: 

         - Cancel or modify previously designated raw materials. 

         - Announce new standards for previously unspecified raw materials. 

         - Change standards for previously designated raw materials. 

• The applicant will be notified in writing of the results of the review. 

4. Labelling and Advertising: 

• Article 10 specifies matters that must be included in the labelling of cosmetic products. 

• For example, product labels must include contact information and identify fragrance allergens. 

• Labels for products intended for use by licensed professionals must indicate this restriction. 

This amendment is a significant step towards ensuring safety and transparency in the cosmetics industry.  

On February 7, 2024, the South Korean Ministry of Food and Drug Safety (MFDS) announced a partial revision to the Cosmetics Act, adding 1,2,4-Trihydroxybenzene (CAS 533-73-3) to the list of prohibited...

On February 7, 2024, the South Korean Ministry of Food and Drug Safety (MFDS) announced a partial revision to the Cosmetics Act, adding 1,2,4-Trihydroxybenzene (CAS 533-73-3) to the list of prohibited raw materials for cosmetics. This revision aims to include harmful ingredients in the list of raw materials prohibited for use in cosmetics. The decision, made under Article 8 of the Cosmetics Act, is based on risk assessments, considering factors such as the status of foreign powers. 

The amendment seeks to strengthen safety management in the cosmetics industry and protect public health. Cosmetics manufactured or imported before the enforcement of this notice must be sold, displayed, or stored for sale by October 1, 2024. 

On January 31, 2024, the Korean Ministry of Food and Drug Safety announced new regulations for cosmetics.   The new regulations include:  Strengthening labelling requirements for some sm...

On January 31, 2024, the Korean Ministry of Food and Drug Safety announced new regulations for cosmetics.  

The new regulations include: 

• Strengthening labelling requirements for some small-capacity cosmetics, such as intimate hygiene soap and permanent wave products for eyelashes, to inform consumers about the ingredients and precautions. 

• Allowing the use of various private institution certification results for cosmetic advertising based on demonstration. 

• Preparing a procedure for reporting and improving the non-performance of responsible sales managers or manufacturers of customized cosmetics. 

• Streamlining the administrative work for changing or closing the cosmetics business, such as checking the family relationship certificate and handling the business closure report as submitted. 

The Ministry of Food and Drug Safety expects that the revision will help consumers use cosmetics more safely and revitalize the domestic cosmetics certification industry.