South Korea Regulatory News

On December 7, 2023, the Ministry of Food and Drug Safety (MFDS, Director Oh Yoo-kyung) announced that 1,2,4-trihydroxybenzenes (THB) will be designated as a prohibited raw material for use in cosmeti...

On December 7, 2023, the Ministry of Food and Drug Safety (MFDS, Director Oh Yoo-kyung) announced that 1,2,4-trihydroxybenzenes (THB) will be designated as a prohibited raw material for use in cosmetics and that the regulation on cosmetic safety standards will be revised to include it in the prohibited list. 

The measure is based on the results of the safety verification conducted by the Cosmetic Raw Materials Safety Verification Committee in accordance with the recommendation for improvement made by the previous Regulatory Reform Committee. 

As a result of a comprehensive review of domestic and foreign toxicity data on THB, data submitted by the Ministry of Food and Drug Safety, and data submitted by the company, the verification committee concluded that the possibility of genetic toxicity of THB could not be excluded and submitted a stability verification report to the Ministry of Food and Drug Safety.

Accordingly, the MFDS plans to announce an administrative notice on the revision of regulations on cosmetic safety standards, etc., and revise the notice after a regulatory review by the Regulatory Reform Committee, to add THB to the list of banned ingredients as a precautionary measure according to the potential genetic toxicity of THB. 

After the revision of the notice, THB cannot be used in the manufacture of cosmetics, but products already manufactured before the revision can be sold until October 1, 2024. 

The prohibition on the production and import of cosmetic items containing 1,2,4-THB will go into force on April 9, 2024.

On 7th November 2023, the South Korean Ministry of Food and Drug Safety (MFDS) released a notification regarding the partial revision of the Regulations on Safety Standards for Cosmetics, etc. In acco...

On 7th November 2023, the South Korean Ministry of Food and Drug Safety (MFDS) released a notification regarding the partial revision of the Regulations on Safety Standards for Cosmetics, etc. In accordance with Article 46 of the Administrative Procedure Act, the MFDS issued a notice entitled "Regulations on Cosmetic Safety Standards" in advance to inform the public about the revision's grounds and key contents. 

Objective of revision 

The chemical identification number (Cas No.) and chemical name of raw materials that cannot be used in cosmetics and raw materials that require restrictions on use have been added to improve the convenience of raw material identification. and one sunscreen ingredient has been added in accordance with "Regulations on Designation and Change of Standards for Use of Cosmetic Ingredients (Ministry of Food and Drug Safety Notice) 

New points added to the standard 

• The addition of chemical names and chemical identification numbers (CAS No.) for raw materials whose use is restricted or cannot be used in cosmetics (Appendix 1, Appendix 2) 

• In accordance with the Regulations on Designation and Change of Standards for Use of Cosmetic Ingredients (Ministry of Food and Drug Safety Notice) one type of UV ray-blocking component has been added to the list of raw materials with limits on use (Appendix 2). As a result, the UV protection component 'Methoxypropylaminocyclohexynylideneethoxyethylcyanoacetate' was introduced. 

Opinion submission 

Organizations, institutions, or individuals that have comments on this Partial Revision Notice (draft) are asked to submit a written comment to the Director General of the Ministry of Food and Drug Safety (Reference: Cosmetics Policy Division) by 27th November 2023. 

The written comments must contain: 

1. Opinion in favor or against the notice 

2. The name, address, and contact details of the institutions, organizations, or individuals. 

3. Other notes 

Comments can be submitted to mfdscos@korea.kr. 

The South Korean Ministry of Food and Drug Safety (MFDS) announced a new guideline for animal testing on October 18, 2023, entitled Guideline of Alternative Animal Testing Methods for Cosmetics: Eye I...

The South Korean Ministry of Food and Drug Safety (MFDS) announced a new guideline for animal testing on October 18, 2023, entitled Guideline of Alternative Animal Testing Methods for Cosmetics: Eye Irritation (Acute Eye Damage or Irritation) Test using Reconstructed Human Cornea-like Epithelium (RhCE).

Animal testing

Many countries prohibit animal testing. Since 2013, South Korea has also been a pioneer in the protection of animal rights. According to the South Korean Cosmetics Act, no cosmetics or cosmetic materials that have been tested on animals may be supplied in the country. The ban on animal testing also applies to imported cosmetics.

The MFDS has previously issued twenty-nine recommendations previously on alternative animal testing methods to help cosmetic companies conduct safety tests efficiently.

RhCE model

The reconstructed human corneal-like epithelial model (RhCE) is a model created by culturing immortalized human-derived corneal epithelial cells that have a lamellar structure and a highly differentiated squamous epithelium. It consists of at least four living cell layers and measures survival after topical exposure to a test substance. RhCE tissue viability measures the extent to which the bioluminescent dye MTT is converted to formazan dye by living cells and predicts the overall ocular damage/irritation response to chemicals.

Guidelines

The recently published guidelines explain alternative testing methods for eye irritation in cosmetics using the RhCE model. It describes the position of the Food and Drug Administration (FDA) and is based on scientific evidence and laws in effect as of October 18, 2023. It may be applied differently depending on recent amendments.

"Eye damage or irritation" refers to adverse effects such as damage or irritation caused by the test chemical coming into contact with the eyes. The RhCE eye irritation test technique is anticipated to assist companies in developing safer cosmetic products without the use of animal testing.

This test guideline applies to single substances, mixtures, solids, liquids, semi-solids, and waxes. It is applicable to water-soluble or water-insoluble liquids and highly soluble or insoluble solids. It is not appropriate to apply this guideline to gases and aerosols, and scientifically meaningful results should be considered when testing difficult-to-test substances or mixtures not covered by this guideline.

On the 16th of October 2023, the Cosmetics Policy Division of the Ministry of Food and Drug Safety announced that it is considering a pilot project to provide electronic information subject to labelin...

On the 16th of October 2023, the Cosmetics Policy Division of the Ministry of Food and Drug Safety announced that it is considering a pilot project to provide electronic information subject to labeling under the Cosmetics Act. This initiative aims to make it easier for consumers to check information on products, reduce social costs such as the generation of packaging waste, and make it easier for companies to introduce different types of packaging containers.

The information about the pilot project is listed below.

• (Business Purpose) To review the feasibility of introducing an electronic information provision method (e-label) in the cosmetics sector.

* Verification by evaluation index, such as enhancing consumer information readability, reducing costs associated with packaging material disposal, and lowering carbon emissions during the project period, will be conducted.

• (Contents) All information under Article 10 of the Cosmetics Act and sub-regulations should be displayed.

• (Project period) January 2024 – December 2025 (it can be extended)

• (Method of provision) Display some information on the containers and packaging of cosmetics and display all information on the e-label to be provided electronically.

* In the case of QR codes, etc., the display medium and the method of operation (link to the homepage, etc.) will be chosen autonomously by the company

On September 22, 2023, the cosmetic evaluation division of the National Institute of Food and Drug Safety Evaluation(NIFDS) established the guidelines for pigment testing methods in cosmetics. It w...

On September 22, 2023, the cosmetic evaluation division of the National Institute of Food and Drug Safety Evaluation(NIFDS) established the guidelines for pigment testing methods in cosmetics.

It was established in order to allow the cosmetics industry to manage pigment testing methods autonomously.

This guide provides an easy explanation of the pigment testing method for cosmetics or describes the position of the Ministry of Food and Drug Safety.

Since the guide has no external legal effect, it is recommended to use it only for reference despite the description method of the text ('~should be, etc.).

This guide is also based on the current scientific and technical facts and effective regulations as of September 13, 2023, so it can be applied differently depending on the latest revised laws and specific facts.

On September 12, 2023, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a notification to classify 'permanent wave products for eyelashes' as cosmetics in order to handle them securel...

On September 12, 2023, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a notification to classify 'permanent wave products for eyelashes' as cosmetics in order to handle them securely and methodically. In the second half of this year, the Ministry will begin work on revising related regulations.

Cosmetic products for the eyes are popular because they improve the overall appearance of the eyes, but it is important to consider their adverse effects on the human body before using them. There have been reports of eye and cornea damage as a result of customers using 'permanent wave treatments for eyelashes' incorrectly, highlighting the need for improved safety management.

The MFDS expects users to have a proper understanding of how to use 'Permanent Wave Product for Eyelashes' in order to use it safely and avoid any negative effects caused by improper usage. Since June 2023, the Ministry of Food and Drug Safety has been discussing with experts about 'permanent wave products for eyelashes' as cosmetics. The government has also discussed required labelling, monitoring of side effects, and the necessity to ensure the safety of raw materials.

To regulate 'permanent wave products for eyelashes' as cosmetics, the Ministry of Food and Drug Safety will promote the revision of related laws such as the "Enforcement Rules of the Cosmetics Act" and the "Regulations on Precautions for Using Cosmetics and Labelling of Allergenic Ingredients" beginning in the second quarter of 2023.

According to the news published on https://www.meconomynews.com/ in February 2023, the deletion of regulations related to natural and organic cosmetics, which the Ministry of Food and Drug Safety incl...

According to the news published on https://www.meconomynews.com/ in February 2023, the deletion of regulations related to natural and organic cosmetics, which the Ministry of Food and Drug Safety included in the top 100 regulatory innovation tasks in August 2022, is on its way to becoming a reality. 

Korea Cosmetics Association (KCA), which announced a regulatory innovation plan for the growth of cosmetics in Korea, announced on the 17th of February a proposal to delete the Natural and Organic Cosmetics Act and abolish the government-led certification system. The related content has already been discussed with the Ministry of Food and Drug Safety since 2022, and it is expected that the law will be revised this year. 

According to the KCA, Korea is the only country in the world that regulates natural or organic cosmetics and operates a certification system at the government level. World-renowned ECOCERT in France, BDIH in Germany, and Soil Association in the UK are all private certifications. 

Another problem is that products that do not meet the standards of the Ministry of Food and Drug Safety cannot use the same marketing words and phrases in Korea even if they are certified by overseas certification agencies that are highly recognized in the world. 

Even if a company marks, advertises, and sells natural or organic cosmetics with global certification in overseas markets, it must mark, advertise, and sell them as general cosmetics in Korea without informing consumers of the differentiated characteristics of natural or organic cosmetics. 

Accordingly, the KCA association proposed to the Ministry of Food and Drug Safety to abolish the certification system recognized by the Ministry of Food and Drug Safety and revise the law that meets the market's autonomy, along with some revisions to the Cosmetics Act, which acts as natural or organic regulations. 

A KCA official told Meconomynews that "The government doesn’t have to regulate these certifications. We need to convert government-led certification of natural or organic cosmetics to private-led to facilitate market changes, reduce industry burdens such as duplicate certification, and secure market autonomy so that K-beauty can respond quickly to global trends and consumer needs."