Regulatory Status of Disinfectant Wet Wipes in China

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Regulatory Status of Disinfectant Wet Wipes in ChinaIn China, disinfection products are defined as disinfectant, sterilizing agent, antimicrobial agent, medical/common disinfector/sterilizer, packed-sterilized articles with sterilization marking, biological and chemical indicators of sterilization effect and various hygiene products including wet wipe and hygiene/disinfection wipes. The definition, classification, national registration/ provincial record filling of novel/existing disinfectant and sterilizer are complete while the legal framework of other disinfection products types is comparatively absent. As disinfectant-carrying wipes are rapidly developing in China, the term “vehicle disinfectant” has been proposed by the NHFPC/NHC and would affect regulation of certain consumer products. 

With the rise of emerging infectious diseases such as SARS and human avian Influenza and so on, a sort of wet wipes called "hygiene wet wipe" or "disinfection wet wipe" have appeared on the market and are developing rapidly in China. As wet wipes are traditionally categorized as hygienic products and exempted from premarketing evaluation on its antimicrobial/disinfection claims, safety concerns have long been discussed by regulators. In this article, we will explore the statutory definition, classification, technical criteria, and regulatory forecast of wet wipes.

Evolution of Product Definition

Wet Wipes refer to fabric or paper-based products used for the cleansing/ germicidal/disinfecting of human body, common surface and other surfaces. The hygienic and germicidal criteria for wet wipe were firstly specified under the “GB 15979-2002: Hygienic Standard for Disposable Sanitary Products” together with other disposable products such as gloves, respirators, sanitary napkins and diapers, etc.

In 2011, China issued a national standard exclusively for wet wipes, the “GBT/27728-2011: Wet Wipes”, which classifies wet wipes into human-use wipes and article-use wipes. The former can be further divided into common wipe and hygiene wipe and the latter are divided into kitchen-use wipe, bathroom-use wipe and wipes for other purpose. The standard specifies the physical and chemical properties, hygienic and germicidal criteria for human-use wipes, kitchen use wipes and bathroom use. In 2013, NHFPC/NHC issued a ministerial regulation, “Rules on the Hygienic and Safety Assessment on Disinfection Products”, which specifies the product category and test scope of all disinfection products subject to premarketing hygienic and safety assessment and the term “Vehicle disinfectant” was firstly presented in the annex. To further distinguish disinfection wipes from other wipes, NHFPC/NHC has tried to develop a separate standard for disinfection wipes and 2 drafts were respectively compiled in 2014 and 2016, but neither of them has been officially published yet due to the heavy workload of publishing authority.

As an expedient, NHFPC/NHC implemented a hygienic industrial standard on disinfection practice for medical institutions in 2016, which defines disinfection wipes as disinfectant containing wipes that have cleansing and disinfecting effect on human, common surface and surface of medical device. Furthermore, the “WS 525-2017(hygienic industry standard): Hygienic Requirements for Hygiene Wet Wipes”, was implemented on 1 Mar 2018.  It defines hygiene wipes as disinfectant containing wipes that have cleansing and germicidal effect on treated objects including human skin and membrane and other surfaces and specifies the general requirements on raw materials and active ingredients, product hygienic and germicidal criteria and maximum allowable limit of specific active ingredients such as chlorhexidine acetate/digluconate, triclosan and benzalkonium chloride/bromide. If the hygiene wipes was used on human, toxicity test will be required prior to placement on the market.

Through the technical specifications in the above standard/draft, wet wipes can be classified as wipes (common wipes), hygiene wet wipe and disinfection wet wipes in accordance with composition, treated object, function/claim and applicability of hygienic/germicidal criteria (see table).

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