K-BPR: New Requirement for the Packaging and Advertising of Household Chemical Products and Biocidal Products

On February 10, 2022, the South Korean Ministry of Environment (MoE) issued the MoE Ordinance No.972 to announce amendments to the Enforcement Rules of the Act on Safety Management of Household Chemical Products and Biocides (a.k.a. K-BPR Enforcement Rules). A new requirement was added in the revised K-BPR Enforcement Rules, stipulating that the corresponding report/approval number of the household chemical products or the approval number of the biocidal products is also required for the packaging or advertising to verify the compliance with the safety standards. This new requirement will take into effect on August 11, 2022. Consumers can use the report number or approval number to search on the MoE official website to check relevant information, including contact information of the manufacturer/importer, ingredients and contents of the product, hazard information, permitted uses, etc. The MoE expects to increase information transparency and reduce potential risks caused by such products by providing the information mentioned above….

Mar. 22nd, 2022

FDA Withdraws Temporary Guidance for Hand Sanitizers

Companies may no longer manufacture under Temporary Guidance beyond December 31, 2021 The Temporary Emergency Use Authorization (EUA) on hand sanitizers was first authorized by the US FDA in March 2020 given the difficulties consumers and health care professionals experienced accessing alcohol-based hand sanitizers at the start of the COVID-19 pandemic.   Hand sanitizers are regulated as an Over-the-Counter (OTC) drug in the US and must meet all of safety requirements outlined by the FDA.  The temporary EUA relaxed some of the requirements to allow for other companies to support the need/demand for hand sanitizers.  Hand Sanitizers manufactured under the US FDA’s Temporary EUA may no longer be manufactured/imported in the US after December 31, 2021.   Distributors/Resellers may continue to sell/distribute products manufactured under the EUA until March 31, 2022.    Retailers may continue to sell existing inventory until depleted or until the expiry date of the product, whichever occurs first. The…

Dec. 23rd, 2021

South Korea Clarifies Submission Deadlines for 5 Types of Existing Active Biocidal Substance

On September 6, 2021, the South Korean online chemical management system CHEMP disclosed the latest instruction from the Environmental Ministry, clarifying the formality deadline for 5 types of existing biocidal active substances which need to be approved by December 31, 2022, including disinfectants, algaecides, rodenticides, insecticides, and repellents. Relative importers and manufacturers need to submit the notification application and application plan by September 30, 2021, and the whole dossier for substance approval by October 31, 2021. Considering of the process of the whole registration, at least 18 months will be required for the completeness check, technical assessment, and other formalities and implicit description on the final deadline causing a relatively slow response from the industry. The document stressed that the online submission system will be suspended and any papery submission shall not be accepted. For those importers and manufacturers who failed to submit the dossier before the deadline, MoE will…

Sep. 08th, 2021

South Korea NIER Released Data Exemption Criteria for 8 Rodenticides and Preservatives

On June 4, the South Korean National Institute of Environmental Research (NIER) released the required/excepted data items of 8 rodenticides and preservatives to be approved through the simplified process, as well as the exemption details for the 2nd batch of disinfectants and insecticides. Compared to the exemption criteria for the 1st batch of disinfectants and insecticides released on May 24 and May 28, these substances would be complexly required for a 90-day inhalation test and environmental impact data conditionally. No. Active Substance CAS No. Conditionally Required Test Data 1 Colecalciferol 67-97-0 Biological sewage treatment (anaerobic biodegradation) 2 Coumatetralyl 5836-29-3 Acute toxicity to terrestrial plants; Chronic toxicity to terrestrial plants; Chronic toxicity to terrestrial invertebrates; Impacts on soil microbial; Aquatic and sediment adsorption and desorption; Biological sewage treatment (aerobic biodegradation) Biological sewage treatment (anaerobic biodegradation) Soil accumulation 3 Boric acid 10043-35-3 Inhalation toxicity (90 days) Air photodegradation; 4 Bromadiolone 28772-56-7 Biological…

Jun. 17th, 2021

New trends of Hygiene and Safety Evaluation of Disinfection Products in China

By the end of 2019, there had been 6259 Chinese enterprises producing various disinfection products including disinfecting apparatus, disinfectants and sanitary products. By September 2020, over 12000 Category I and Category II disinfection products of 8000 enterprises have filed the hygiene and safety evaluation report with provincial health authorities. Disinfection products have turned from a niche product to daily necessities and China becomes a very attractive market for disinfectant producers，but disinfectants must comply with the local regulatory framework. During a special session of the 12th Chemical Regulatory Annual Conference & Asian Helsinki Chemicals Forum on December 3, Ms. Gu Jian from the Technical Committee on Disinfection Standardization of the National Health Commission offered her insight into China’s disinfectant regulation and implementation, based on her deep understanding of regulation system and rich enforcement experience. Product Scope The hygiene and safety evaluation of disinfection product refers to a comprehensive evaluation on product…

Dec. 03rd, 2020

Supervision of China’s disinfection products is on the way

[Abstract] Officials in China increase supervision efforts on disinfectant products to improve market order and protect peoples’ health.

Mar. 29th, 2018
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