South Korea Regulatory News

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) takes part in the WNT (Working Group of the National Coordinators for the Test Guidelines Programme) meetin...

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (Minister Oh Yu-Kyoung) takes part in the WNT (Working Group of the National Coordinators for the Test Guidelines Programme) meeting that is held at the OECD headquarters in Paris, France from April 24 to 29. It participates in the deliberation and approval of OECD guidelines and presents the current status of the liver organoid-based toxicity assessment (complex collections of cells that are three-dimensional tissue cultures derived from stem cells or cells of organ origin. Organoids replicate the structure and function of real organs. They can be used in various areas such as safety evaluation, efficacy evaluation, and the development of treatment) methods developed in Korea.

On 29 June 2023 the Korean National Institute of Environmental Research (NIER) announced that the evaluation of the registered biocidal product application is scheduled to be conducted.  In relati...

On 29 June 2023 the Korean National Institute of Environmental Research (NIER) announced that the evaluation of the registered biocidal product application is scheduled to be conducted. 

In relation to this, NIER posted guidelines for naming biocidal products for the purpose of registration application. 

Guidelines for naming biocidal products: 

1. The product name should be displayed in Korean on the outer surface of the product, excluding special characters. If Chinese characters or foreign languages are displayed along with Korean, the size of Korean letters should be larger. 

2. The product name should be displayed according to the biocidal product name indicated in the approved notification for biocidal products, following the format specified in Annex No. 24 of the enforcement rules. If there are multiple product names, one representative name should be written on one side of the approval notification, and the remaining names should be listed separately. 

3. To prevent confusion or the use of exaggerated names that may mislead consumers about the actual effects or potential risks associated with product use, product names should not cause confusion with other products or use exaggerated terminology. 

4. The product label should include clear and easily understandable information, including the product name, biocidal product type, biocidal substance (name and composition ratio by weight (%)), expiration date, statements regarding effectiveness, precautions for use, and other relevant information, in order to facilitate product labelling and advertising. 

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." 

In South Korea, the government has decided to break down uniform chemical regulations for small and medium-sized companies by unifying multiple ministries' double approval process to resolve corporat...

In South Korea, the government has decided to break down uniform chemical regulations for small and medium-sized companies by unifying multiple ministries' double approval process to resolve corporate site difficulties significantly. 

On the 7th of June, the government held an "Economic Regulatory Innovation Task Force" meeting presided over by the Deputy Prime Minister and Minister of Strategy and Finance, Choo Kyung-ho, at the Government Complex Seoul and announced the "5th Economic Regulatory Innovation Plan" and the "Small and Medium Business Chemical Regulatory Innovation Plan." 

The burden of customs administration such as certification and reporting of import and export companies is also expected to decrease. Suppose an approved exporter for each item acquires certification rights for several new items. In that case, the validity period of the certification varies depending on the time of acquisition. Still, the validity expiration date of the certified items is integrated into one date. 

Regarding the regulation of chemicals in small and medium-sized enterprises, the enforcement regulations of the Chemical Substance Control Act will be revised to extend the validity period of the technical personnel standard that meets the criteria for completing the curriculum by five years from December this year to December 2028. In addition, when evaluating the qualifications of hazardous chemical managers, it was decided to additionally recognize surface treatment and precision industrial chemical qualifications that deal with the safety management of hazardous chemicals. 

If the Ministry of Employment and Labor approves the import of banned substances by revising the Enforcement Rules of the Ministry of Employment and Labor's Occupational Safety and Health Act, the import licensing system will become one, recognized as a permitted import license by the Ministry of Employment and Labor (MOEL).

The government will also revise the Act on Registration and Evaluation of Chemical Substances in the first half of 2024 and strengthen the protection of trade secrets by allowing "EU-style generic names" for trade secrets when transferring or transferring mixed products. 

To this end, based on the management system reform plan discussed by the public, industry, and government at the Chemical Safety Policy Forum in December 2022, a revision to the Chemical Substance Control Act and the Act on Registration and Evaluation of Chemical Substances will be prepared by August 2023 by related ministries, including the Ministry of Environment,

During the second half of 2023, the government will also push for revisions of the Act on Registration and Evaluation of Chemical Substances and the Chemical Substance Control Act, including the establishment of a management system based on the harmfulness, handling volume, and risk of chemicals. 

On June 12, 2023, the National Institute of Environmental Research (NIER) released an announcement regarding the contents of the amendment of the Regulations on Consumer Chemical Products and Biocide...

On June 12, 2023, the National Institute of Environmental Research (NIER) released an announcement regarding the contents of the amendment of the Regulations on Consumer Chemical Products and Biocides Safety Control Act. 

The amendment focuses on Article 10, Paragraph 6 of the " Consumer Chemical Products and Biocides Safety Control Act," as well as Article 6 of the Enforcement Decree and Article 6 of the Enforcement Rules of the same Act. The following are the key contents of the amendments to the "Regulations on Approval of Consumer Chemical Products Subject to Safety Verification."  

Key Amendment Contents: 

A. Mandatory labelling: The approved disinfectants for surface use now require the inclusion of a label that states the "Prohibition of air disinfection when using air disinfection devices such as aerosol disinfectants and high-pressure spray disinfection." This addition clarifies the usage instructions and dosage, emphasizing that these approved disinfectants do not possess air disinfection properties. 

B. Elaboration on protective clothing: The revised rule specifies the necessary protective clothing for operators working with disinfectants and pesticides. It states that when using the product, the operator must wear appropriate protective clothing, including a suit with upper and lower parts, protective gloves, and work shoes suitable for the situation. In addition, they should utilize designated respiratory protective equipment, such as respirators with face filtration or powered air-purifying respirators, as well as facial protective equipment like safety goggles and face shields. This amendment aims to provide specific details regarding the required protective clothing for operators. 

In April 2023, the National Institute of Environmental Research (NIER) in South Korea was consulted on a draft amendment of the regulation on test methods for chemical substances under the Act on Reg...

In April 2023, the National Institute of Environmental Research (NIER) in South Korea was consulted on a draft amendment of the regulation on test methods for chemical substances under the Act on Registration and Evaluation of Chemicals (K-REACH). This was to update the regulation based on updated international chemical regulations, including OECD’s animal alternative test methods. 

On the 2nd of June 2023, according to Article 14 (1) of the Chemical Substances Registration Evaluation Act and Article 5 (1) 1 of the Enforcement Rules of the same Act, 11 items were revised to reflect the latest chemical test methods (122 items). Test methods for chemical substances were partially revised, 9 test items in the field of health effect test and added 2 new items.  

clause 4 - Eye irritation and serious eye damage test 

clause 5 - Skin Sensitization Test 

clause 14 - Toxicokinetic test 

clause 27 - In vitro skin irritation test (human skin model test) 

clause 33 - Skin hypersensitivity test (regional lymph node test, LLNA) 

clause 34 - Skin sensitization test (regional lymph node test, LLNA: DA) 

clause 36 - Chemical skin sensitization test (peptide binding test, amino acid derivative binding test, dynamic peptide binding test) 

clause 54 - Estrogen receptor transcriptional activity test 

clause 66 - Eye irritation test using Vitrigel. 

clause 71 - Skin sensitivity test (Defined Approached: 2 out of 3 methods) 

clause 72 - In vitro human skin model (RhE) phototoxicity test  

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.