South Korea Regulatory News

On August 1st, 2023, the National Institute of Environmental Research (NIER) in South Korea partially revised and notified the Notice of Designation of Toxic Substances, in accordance with Article 2(6...

On August 1st, 2023, the National Institute of Environmental Research (NIER) in South Korea partially revised and notified the Notice of Designation of Toxic Substances, in accordance with Article 2(6) and Article 20 of the 「Act on the Registration and Evaluation of Chemicals」 and Article 2(2) of the 「Chemical Substances Control Act」 and Article 2 of the Enforcement Decree of the same Act. 

Three highly hazardous chemicals (CAS 37348-84-8, CAS 932384-12-8, CAS 95-46-5) were added as toxic substances under K-REACH. 

The details of the substances are as follows: 

1. Cobalt manganese nickel oxide (CAS 37348-84-8) and mixtures containing 0.1% or more. 

2. Silica gel reaction products with chromium oxide (CrO3) and ethoxydiethylalumium (CAS 932384-12-8) and mixtures containing 10% or more of the same. 

3. 1-Bromo-2-methylbenzene (CAS 95-46-5) and mixtures containing at least 25% thereof. 

Starting this August, the Ministry of Environment in South Korea is introducing a preliminary review system to expedite the completeness review period conducted by the National Institute of Environmen...

Starting this August, the Ministry of Environment in South Korea is introducing a preliminary review system to expedite the completeness review period conducted by the National Institute of Environmental Research. 

1. This system is voluntary and not governed by the Chemical Product Safety Act. It is not included in the statutory review period and can be applied for voluntarily. 

2. The preliminary review period lasts a maximum of 5 days from the day after the request, with only one preliminary review allowed per application. 

3. After the preliminary review, the reviewed items must be confirmed, supplemented, and submitted to the Chemp system before the formal approval process can begin. 

4. The content of the preliminary review is limited to the completeness of the application and some of the required submissions. 

5. The preliminary review period is planned to remain in operation until further notice. However, it may be temporarily suspended in the event of a substantial influx of applications. 

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.