South Korea Regulatory News

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.  

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.  

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. 

According to the K-REACH database, there are currently no substances that have been added to the Authorisation List under K-REACH.  However, dibutyl phthalate (DBP; CAS No. 84-74-2), benzyl butyl ...

According to the K-REACH database, there are currently no substances that have been added to the Authorisation List under K-REACH. 

However, dibutyl phthalate (DBP; CAS No. 84-74-2), benzyl butyl phthalate (BBP; CAS No. 85-68-7), and di-(2-ethyl hexyl) phthalate (DEHP; CAS No. 117-81-7) have been proposed as the first three substances subject to authorization under K-REACH. These are phthalates that are classified as toxic to reproduction and are widely used as plasticizers in various products.  

The Ministry of Environment (MoE) invited stakeholders to submit their comments or information on these chemicals from October 6, 2023, to December 4, 2023. If adopted, the authorization requirement will apply to the manufacture, import, or use of these substances in South Korea, even if they have already completed registrations. This means that companies will need to obtain authorization from the MoE before using these substances or switch to safer alternatives. 

On December 28, 2023, the Risk Assessment Research Department of the National Institute of Environmental Research (NIER) announced that it will publish the risk assessments results of 10 chemicals, in...

On December 28, 2023, the Risk Assessment Research Department of the National Institute of Environmental Research (NIER) announced that it will publish the risk assessments results of 10 chemicals, including cyclohexane and 1,4-dichlorobenzene, on the K-REACH portal. 

From 2019 the National Institute of Environmental Research has been conducting risk assessments for chemicals manufactured and imported in quantities of 10 tonnes or more per year for chemical management purposes, and based on the results of the risk assessments, chemicals that are likely to be harmful will be identified as substances subject to control.  

In the future, the NIER will continue to publish the results of risk the assessment for chemicals with high circulation, and so far the risk assessment reports of 29 substances has been published on the K-REACH portal. 

The Korean Ministry of Environment and the Korea Environment Corporation are offering financial support to small and medium-sized enterprises (SMEs) that handle hazardous chemicals to upgrade their ag...

The Korean Ministry of Environment and the Korea Environment Corporation are offering financial support to small and medium-sized enterprises (SMEs) that handle hazardous chemicals to upgrade their ageing facilities and prevent chemical accidents. The support project, called the “Chemical Safety Workplace Creation Support Project”, will cover 70% of the improvement costs, up to 42 million won per company. The total budget for the project is 8 billion won. The application period is from January 22 to February 26, and the selected companies will be able to start improving their facilities in March. The project aims to promote safe chemical management and reduce the cost burden for SMEs.