K-BPR: South Korea Urges Approval of Existing Active Substances

Enterprises handling Group B existing biocidal active substances are advised to submit dossiers in a timely manner since the corresponding deadline is approaching. On March 10, 2023, South Korea’s Ministry of Environment (MoE) issued a notice to urge enterprises handling \’Group B existing biocidal active substances\’ to speed up dossier preparation and submission for approval under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR). Under K-BPR, existing biocidal active substances are classified into four groups with the corresponding grace periods for approval depending on the product type. For Group B, the grace period for approval will expire on December 31, 2024. Considering the fact that about 18 months will be taken for the administrative procedures of approval (including official review and technical evaluation after the dossier submission), by the notice, the MoE stipulates the corresponding deadlines for Group B active substances as below. Pre-registration application submission deadline 2023.3.31 Plan report submission deadline 2023.6.30…

Mar. 31st, 2023

Complying with Disinfectant Regulations in China: Key Considerations

In 2022, Chinese officials fined a company for violating multiple regulations related to disinfectant products. This incident serves as a reminder that the Chinese government has strict regulations that must be followed by companies operating in China. To avoid penalties and fines, enterprises targeting China should take into account key considerations. In June 2022, the Hangzhou Health Commission imposed a fine of nearly 3.5 million CNY on a company for several violations, including adding lidocaine illegally to disinfectants, failing to conduct proper hygiene and safety evaluations before marketing, and providing false information on product packaging labels. The company produced and sold several batches of disinfectant products containing lidocaine, which were detected in the bacteriostatic liquid products with batch numbers 2021120903, 2022011001, and 2022011702. The total value of the illegal products was 457,730.2 CNY, with an illegal income of 140,126.2 CNY. Additionally, the company sold 369 boxes of bacteriostatic liquid products…

Mar. 15th, 2023

K-BPR: South Korea Bans 623 Household Products from Market, Including Fragrance, Pesticides, and Fungicide

On August 11, 2022, South Korea’s Ministry of Environment (MoE) and the Korea Environmental Industry& Technology Institute (KEITI) issued a prohibition on the manufacture, importation and distribution of 623 household products, due to violations of the Act on the Safety Management for Household products and Biocides (hereinafter as K-BPR regulations). These products have been listed on the Hazardous Product Sales Prevention System (http://upss.gs1kr.org) operated by the Korea Chamber of Commerce and are subject to an immediate prohibition in stores and supermarkets. At the same time, the Korea Online Shopping Association prohibits the sale and distribution of these household products. The MoE stated that the future recirculation of these products will also be monitored continuously. Why are the 623 Household Products Prohibited Under K-BPR? Non-Compliance with Safety Standards and Notification Requirements 543 products are not qualified for the incompliance with the safety standards and notification requirements, including 232 fragrances, 133 candles,…

Sep. 19th, 2022

What to Do After EPA Disinfectant Registration: State, Supplemental, and Amendment Registration

Since the outbreak of COVID-19, the US EPA has issued a series of friendly policies to encourage companies to register disinfectants to meet the demands for disinfectants by US citizens. Driven by both market demands and government policies, many Chinese companies seize this opportunity and access the disinfectant market in America. To date, REACH24H has assisted dozens of companies in disinfectant registration. We have sorted out the following issues of concern for companies to better comply with disinfectant regulations in the US. State Registration & Supplemental Registration Finishing EPA federal registration and obtaining an EPA product registration certificate are only the beginning steps to entering the US market, while state registration is a critical one for the future sale and distribution of disinfectants in various states. Registration requirements (review fees and review time) vary from state to state. The total amount of review fee in 51 states is about $12,500,…

Aug. 26th, 2022

K-BPR: South Korea Expands QR Codes Pilot to 39 Household Chemical Products Subject to Safety Confirmation

South Korea piloted QR codes for disinfectants from Sep 2021 and expanded it to include all listed household products (39 sub-categories) from June 2022. South Korea’s Ministry of Environment (MoE) invited the industry to pilot QR codes for disinfectants last year (South Korea to Use QR Code on Household Chemical Products Subject to Safety Confirmation). According to the newly disclosed data, in total 143 enterprises involving 227 disinfectant products participated the pilot scheme from October 2021 to June 2022. Building on its success, MoE from June 2022 expanded the use of QR codes to all household chemical products (39 sub-categories) that are subject to safety confirmation under K-BPR. Below is the implementation timeline for your reference. [Read More on ChemLinked] Reference Links QR Code Implementation Guide South Korea to Conduct 2022 Safety Investigation under K-BPR K-BPR: New Requirement for the Packaging and Advertising of Household Chemical Products and Biocidal Products…

Aug. 22nd, 2022

K-BPR: South Korea Expands QR Codes Pilot to 39 Household Chemical Products Subject to Safety Confirmation

South Korea piloted QR codes for disinfectants from Sep 2021 and expanded it to include all listed household products (39 sub-categories) from June 2022. South Korea’s Ministry of Environment (MoE) invited the industry to pilot QR codes for disinfectants last year (South Korea to Use QR Code on Household Chemical Products Subject to Safety Confirmation). According to the newly disclosed data, in total 143 enterprises involving 227 disinfectant products participated the pilot scheme from October 2021 to June 2022. Building on its success, MoE from June 2022 expanded the use of QR codes to all household chemical products (39 sub-categories) that are subject to safety confirmation under K-BPR. Below is the implementation timeline for your reference. At present, it is not obliged to attach QR codes to household products. However, as planned MoE will amend K-BPR enforcement rules (Article 7 Paragraph 2) on labelling standards this year to mandate QR…

Aug. 22nd, 2022

South Korea to Conduct 2022 Safety Investigation under K-BPR

On June 13, 2022, South Korea’s Ministry of Environment (MOE) issued a notice (hereinafter referred to as the Notice) on conducting a safety investigation of approved consumer chemical products in 2022. According to Article 7 of the Consumer Chemical Products and Biocides Safety Act (K-BPR) and Article 9 of the Framework Act on Product Safety, MOE shall conduct safety investigations on the consumer chemical products under K-BPR every year. Categories of Consumer Chemical Products Subject Stipulated to Random Safety Investigation in 2022 Health pesticides Pesticides for preventing infectious diseases Disinfectants for preventing infectious diseases Rodenticides for preventing infectious diseases The products will be tested with regard to their main chemical content and checked if they conform to the corresponding safety standards. Testing and Analysis Institutions Responsible for Safety Investigation Korea Environmental Industry and Technology Institute, Seokyung University, and Other 6 testing and analysis institutions designated by MOE. If the authority requires…

Jun. 27th, 2022

Analysis of disinfection products classification in China

With the continuous improvement of the economic and living standards, China pays more attention to medical and health care. At the same time, the investment in health care continues to increase. The number of medical institutions has increased significantly, and residents’ health awareness has also continued to improve.   All of these drive the development of the disinfection product industry from the demand side. Especially under the influence of the COVID-19 epidemic, Chinese medical institutions and other public places require large-scale, long-term, and high-frequency disinfection, and the demand for disinfection and anti-virus products has risen sharply.   What’s the difference between China’s disinfection products, EU biocides, and antimicrobial pesticides in the U.S.? To help enterprises better understand China’s disinfection products classification system, today we will introduce the detailed definitions and types of disinfection products in China.      Disinfection Products in China In China, disinfection products refer to the health-related…

May. 10th, 2022

China Enacts Mandatory Standard for Body-use Antimicrobial Lotions(GB 384056-2020)

On December 1, 2021, China began to enact the national standard, “GB 38456-2020 Hygienic Requirements for Antibacterial and Bacteriostatic Lotion”. The standard clarifies the definition, requirements on raw materials, technical criteria, testing methods, labeling and instruction of these body-use disinfecting products, which would provide scientific foundations for the quality evaluation, correct product claim and consumer choice and promote the standardization process of China’s antimicrobial industry. Product Scope Antibacterial and bacteriostatic lotions are used for antibacterial/ bacteriostatic treatment on intact skin, vagina mucosa and oral mucosa, but excluding those applied on specific body parts such as feet, eyes, nails, axilla, scalp, hair, nasal mucosa, and anorectal area, etc. The most typical antibacterial and bacteriostatic lotions used in our daily life are mouthwash, hand sanitizer and feminine wash with an anti-microbial claim. Raw Materials and Banned Substances All raw materials used shall conform to the quality criteria specified in the Chinese Pharmacopoeia in force, as well as…

Dec. 17th, 2021

China Enacts Mandatory Standard for Body-use Antimicrobial Lotions(GB 384056-2020)

On December 1, 2021, China began to enact the national standard, “GB 38456-2020 Hygienic Requirements for Antibacterial and Bacteriostatic Lotion”. The standard clarifies the definition, requirements on raw materials, technical criteria, testing methods, labeling and instruction of these body-use disinfecting products, which would provide scientific foundations for the quality evaluation, correct product claim and consumer choice and promote the standardization process of China’s antimicrobial industry. Product Scope Antibacterial and bacteriostatic lotions are used for antibacterial/ bacteriostatic treatment on intact skin, vagina mucosa and oral mucosa, but excluding those applied on specific body parts such as feet, eyes, nails, axilla, scalp, hair, nasal mucosa, and anorectal area, etc. The most typical antibacterial and bacteriostatic lotions used in our daily life are mouthwash, hand sanitizer and feminine wash with an anti-microbial claim. Raw Materials and Banned Substances All raw materials used shall conform to the quality criteria specified in the Chinese Pharmacopoeia in force, as well as…

Dec. 17th, 2021
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