How Disinfectants and Hand Sanitizers are Regulated in the US During COVID-19

The United States became the first nation worldwide since the pandemic began to surpass 10 million covid-19 infections. To help enterprises faster access to the US market, the 12th Chemical Regulatory Annual Conference & Asian Helsinki Chemicals Forum is honored to have the attendance of Ms. Alexandra Dapolito Dunn from the US EPA and Dr. Shannon L. Gainey from REACH24H USA， who shared the latest regulatory updates on disinfectants under US EPA(FIFRA) and FDA. In the United States, hand sanitizers don’t necessarily equivalent to disinfectant, the differences depend on the intended use of the product. Hand sanitizer is for use for human hands and disinfectant is for use for inanimate surfaces. Therefore, the compliance requirements of the two are worlds apart. Surface disinfectants are regulated by the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), while hand Sanitizers are regulated as an Over-the-Counter (OTC) drug by the US…

Dec. 07th, 2020

The EU and US Biocide Regulation Trends in the Times of Covid-19

The covid-19 pandemic has increased the demand for biocidal products across the world. For example, in the UK, disinfectant sales have risen 255% year-to-year in February 2020. However, these products are highly regulated in most parts of the world.  During a special session of the 12th Chemical Regulatory Annual Conference & Asian Helsinki Chemicals Forum on December 4, Mr. Klaus Berend from the European Commission and Dr. Shannon L. Gainey from REACH24H USA offered a comprehensive introduction to the EU and US biocide regulation. EU BPR Framework The EU Biocidal Products Regulation 528/2012 covers a wide range of products intended to destroy, deter, rendering harmless, prevent or otherwise exert a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. Furthermore, articles with deodorizing or antimicrobial claims that have been treated with, or intentionally incorporating, one or more biocidal products need to comply with…

Dec. 04th, 2020

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

China Ends the Emergent Market Entry of Disinfectants

On August 4, 2020, the General Office of the National Health Commission released the final notice regarding the enhanced regulation of disinfection products during the Covid-19 control, which was consulted early on June 19. Apart from the aims of resuming normal record-filing management of non-new disinfectants and intensifying the quality management and ex-post surveillance of disinfection products already been placed on the market mentioned in the consultation draft, the emergently placed disinfectants will have a longer transitional period to complete the normal record-filing procedures until December 31, 2020. In February this year, NHC announced the interim measures for the emergency use of 4 disinfectants: Alcohols, chlorines, chlorine dioxide, and peroxyacetic acid disinfectants that satisfy simple technical requirements can be placed on the market instead of completing the full record-filing formality with the provincial health authorities, the compulsory requirements for the market entry of all non-new disinfectants in China. NHC pointed…

Aug. 17th, 2020

US FDA’s Temporary Policy for Production of Hand Sanitizers to Help Support Shortage in the United States

Given the outbreak of the novel coronavirus (COVID-19) and the World Health Organization’s declaration of it becoming a pandemic, the United States has recently seen a surge in COVID-19 cases and is facing significant shortages in supplies to protect against the virus. Hand hygiene is an important part of the U.S. response to COVID-19. Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol (also referred to as ethanol or ethyl alcohol). In the United States, hand sanitizer is regulated as an OTC drug under the U.S. Food and Drug Administration (FDA). Under this regulation, there are requirements around the…

Mar. 30th, 2020

How Can Disinfectants Contribute to the Ongoing Fight Against COVID-19?

The 2019–2020 coronavirus outbreak is an ongoing public health emergency that has reached international levels, involving the spread of the novel Coronavirus 2019, now referred to COVID-19. As of 5 March 2020, more than 95,000 cases had been confirmed, of which 7,100 were regarded as serious. More than 3,200 people have died. Eighty-five countries and attached territories have been affected, with major outbreaks in Central China, South Korea, Italy, and Iran. [From Wikipedia] What do we know about this COVID-19 so far? COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS coronavirus 2 or SARS-CoV-2). SARS-CoV-2 is an enveloped virus with a positive-sense single-stranded RNA genome and a nucleocapsid of helical symmetry. The infection is spreading from one person to another via respiratory droplets produced when an infected person coughs or sneezes. The time between exposure and symptom onset may be ranging from one to…

Mar. 09th, 2020

2019 Compliance Review: Disinfectants Regulatory Updates in China, EU and US

[China] Requirements for the Health and Safety Evaluation of Disinfection Products is Officially Implemented On March 1, 2019, a set of requirements for the health and safety evaluation of disinfection products was officially implemented by the National Health Commission of the PRC as mandatory technical standards, stipulating the basic requirements and content of sanitary safety evaluation of disinfection products. Health and safety assessments of disinfection products have proven strong practicality and operability. [China] National Health Commission Has Twice Sought the List of Active Ingredient of Antibacterial/ Bacteriostatic Lotion (Draft for Comments) The National Health Commission of the PRC entrusted the Disinfection Professional Standards Committee to analyze the effective ingredients of non-plant antibacterial agents, study the prohibited substances, summarize and refer to the regulatory models of antibacterial agents in the United States, Japan and the European Union, and formulate the list of active ingredients and inclusion principles in line with the…

Feb. 29th, 2020

National Health Commission of China (NHCC) Issued a List of Active Ingredients for Anti-Bacterial Agents (draft for comments)

Abstract: On April 23, the National Health Commission of China (NHCC) issued a list of active ingredients for anti-bacterial agents (draft for comments), solicit opinions from enterprises, institutions and individuals, and publish it at an option after revision. Background and process In order to thoroughly implement the China State Council policies about “Delegate power and optimize service”, optimize the supervision mode, improve the efficiency of law enforcement, guide enterprises to standardize production, strengthen the implementation of corporate responsibility, effectively promote the healthy and orderly development of the anti-bacterial market, and effectively protect the health rights and interests of the people. The NHCC organized and analyzed anti-bacterial agent active ingredients of non-plants, studied the substances that are prohibited from adding, and combed the regulatory models of anti-bacterial agents in main countries, such as the United States, Japan, and the European Union, and formulated a list of effective ingredients and inclusion principles in line…

Jun. 04th, 2019

The Managements of Drinking Water Disinfection and Disinfection By-Products (DBPs) in China

Early this year, MUJI announced a worldwide recall of its bottled water products after detecting excessive bromate contaminant, a disinfection by-product (DBP) generated during ozone disinfection. Although the products mentioned in the recall notice have never entered Chinese mainland, the news was quickly spread on social media Weibo and aroused much widespread concern over drinking water safety, whose market penetration of water purifier/disinfector is only about 20% and household water purifier market will keep a growth of over 10% until 2022. This article explains how the drinking water disinfectants and DBPs are regulated in China and the latest regulatory developments in drinking water quality standard, the GB 5749, which is closely related to the premarket approval of drinking water-related products. Health Supervision of Drinking Water Related Products The drinking water regulatory system stems from the “Law on the Prevention and Treatment of Infectious Disease” and the “Administrative Measures for the…

Apr. 19th, 2019

How to enjoy a buffer period for placing biocidal products in Korea for more for 10 years? –Get your K-BPR Notification before June 30th!

Korea household chemicals and Biocides Safety Management Act (K-BPR) already took into force since 1 January 2019. There are four groups (disinfectant, pest control, preservative and others) and 15 categories for biocidal products under K-BPR. Please refer to figure 1. Group Category Biocidal Product Types Disinfectant (1) Disinfectant (2) Algicide Pest Control (3) Rodenticide (4) Control of other Vertebrate (5) Insecticides (6) Control of other Non-Vertebrate (7) Repellents Preservative (8) Product Preservative (9) Product Surface Preservative (10) Fabric/Leather Preservative (11) Wood Preservatives (12) Construction Material Preservatives (13) Material/Equipment Preservatives (14) Embalming or Taxidermist Fluids Others (15) Contamination Inhibitor for Ship/Underwater Facilities Table 1 Biocide Product Types under K-BPR The deadline for notification of existing biocidal substances of K-BPR is 30 June of 2019, which overlaps with the notification time of chemical substances K-REACH. Active substance with relevant product types which is notified and approved before the deadline will be included…

Mar. 28th, 2019
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