Management responsibilities for wet wipes, both domestically and internationally

Generally speaking, wet wipes are simply divided into two categories: personal-use wipes and object-use wipes.

 

Human-use wipes are divided into regular wipes and hygiene wipes. Object-use wipes, in turn, are categorized into kitchenware wipes, bathroom wipes, and other-purpose wipes.

 

This article primarily addresses the regulatory classification of wet wipes intended for personal use.

 

 

I. The European Union

 

The European Commission released the latest version (Version 2.2, February 2016) of the Guidance on the Scope of Application for the Cosmetics Regulation [Regulation (EC) No 1223/2009] in May 2017.

 

This manual was prepared by the Edge Products Group and approved by the Cosmetics Working Group led by the European Commission. Although it is not an official document of the European Commission and does not represent its formal stance, nor does it carry legal binding force—since only the European Court of Justice can provide authoritative interpretations of EU law—it nonetheless serves as a crucial guide and practical tool in determining the classification of relevant edge products during the actual implementation of EU regulations.

 

In the answer to the question in Section 1.6—"Are wet wipes that release substances considered cosmetics?"—the manual explains that wet wipes serve as a delivery system for substances or mixtures applied to human skin, and since these substances meet the definition of cosmetics, wet wipes should primarily be classified as leave-on products. Consequently, wet wipe products fall under the regulatory scope of cosmetic legislation.

 

All ingredients used in these products must comply with the relevant requirements of EU Cosmetics Regulation (EC) No 1223/2009.

 

 

II. The United States

 

According to the U.S. Food and Drug Administration (FDA) website, which provides answers to questions about disposable wet wipe products, the entity responsible for regulating wet wipes in the United States—and the specific regulatory approach—depends on the product's intended use.

 

Wipes designed for skin cleansing or moisturizing—such as those intended for babies, hand cleaning, makeup removal, body wiping (when bathing isn’t possible), feminine hygiene, or other personal care uses—are classified as cosmetics.

 

Wet wipes used for tanning or deodorizing purposes also fall under the category of cosmetics. Cosmetics—or their ingredients (excluding colorants)—do not require FDA approval before being marketed, though the cosmetic responsible party bears the legal responsibility to ensure their safety.

 

Wipes intended for therapeutic purposes—such as skin antiseptics or those used to treat acne, diaper rash, or other skin conditions—are classified as pharmaceutical products and must meet the FDA’s stringent approval requirements for safety and efficacy before they can be marketed.

 

Wipes used to control bacteria on surfaces (for sterilization or disinfection), as well as insecticide-containing wipes, are regulated by the U.S. Environmental Protection Agency (EPA).

 

Wet wipes used for cleaning in homes, offices, gyms, and public spaces are regulated by the U.S. Consumer Product Safety Commission (CPSC).

 

 

3. Japan

 

Baby wipes are classified as cosmetics, while regular wet wipes fall under the category of daily-use hygiene products. Cosmetics are regulated by the "Law Concerning Pharmaceuticals, Medical Devices, etc." (formerly known as the "Pharmaceutical Affairs Law").

 

 

4. South Korea

 

According to an announcement released by South Korea's Ministry of Food and Drug Safety on April 2, 2015, wet wipes, previously managed as industrial products, have been reclassified under the cosmetics category starting from July 2015.

 

All raw materials used in wet wipes from the production stage onward must meet safety standards specific to the cosmetics industry. However, catering wipes and funeral wipes are classified as public health products and are therefore exempt from cosmetic standards.

 

 

5. Taiwan, China

 

According to an announcement issued by the relevant regulatory authorities on April 1, 2016, baby-specific wet wipes will be classified as cosmetics starting June 1, 2017, and must comply with the provisions of the Cosmetics Hygiene Management Regulations.

 

General-purpose wet wipes for wiping human skin (excluding those specifically designed for babies, makeup use, or medical purposes) are governed by the standard CNS8157 "Wet Wipes," with its latest revised edition published on September 14, 2016.

 

Although the wet wipes standardized in this guideline are not classified as cosmetics, they clearly stipulate that the preservatives used must comply with the "Reference Table of Preservative Ingredients and Their Maximum Permissible Limits in Cosmetics."

 

 

6. Mainland China

 

According to the relevant provisions outlined in the "Hygiene Standards for Disinfectant Product Manufacturing Enterprises (2009 Edition)," the "Regulations on Hygiene Licensing for Disinfectant Product Manufacturing Enterprises," the "Catalogue of Disinfectant Product Classification," and the "Regulations on Hygiene and Safety Evaluation of Disinfectant Products" issued by the National Health and Family Planning Commission, Wet wipes, like sanitary wipes, both fall under Category 3 of disinfection products—specifically, the category of hygiene products.

 

According to the requirements of the Hygiene and Safety Evaluation Regulations for Disinfectant Products, hygiene products such as wet wipes and sanitary wipes do not require safety evaluation reports and can instead be implemented in accordance with their respective regulatory standards.

 

Disinfecting wipes are simply a new type of carrier-based disinfectant, and currently there are no clear regulations or classification systems in place.

 

Currently, there are two national standards in China that regulate the quality of wet wipes: GB 15979-2002, "Hygiene Standard for Disposable Hygienic Products," and GB/T 27728-2011, "Wet Wipes." Additionally, the new industry standard, "Hygiene Requirements for Hygienic Wet Wipes" (WS575-2017), was released on September 10, 2017, and came into effect on March 1, 2018. As you can see, The country has adopted a more systematic approach to classifying and managing hygiene wipes.

 

Wet wipes It uses nonwoven fabrics, textiles, wood-pulp composite fabrics, carpenter's paper, and more as carriers, Add production water and non-sterilized ingredients in appropriate amounts. , on the object being processed Has a cleaning effect The wet wipes. Currently, the wet wipes still comply with GB15979-1995, the "Hygiene Standard for Disposable Hygiene Products."

 

Wet wipe products must meet the required microbiological standards outlined in the relevant specifications. Additionally, depending on the intended user group, appropriate toxicology tests should be conducted—such as skin irritation tests, vaginal mucosa irritation tests, and skin sensitization tests (selected based on the material used). Wet wipes are primarily designed for cleansing purposes and do not offer antibacterial or disinfecting effects. They can be safely used to clean hands, mouth areas, skin, and surfaces.

 

Hygiene Wipes It refers to using nonwoven fabrics, textiles, wood-pulp composite fabrics, carpenter's paper, and similar materials as carriers, Suitable Carefully add raw materials such as production water and disinfectants. , for treating objects such as hands, skin, mucous membranes, and common object surfaces Possessing cleaning and antibacterial properties The wet wipes.

 

In addition to complying with GB15979-1995, the "Hygiene Standard for Disposable Hygiene Products," sanitary wipes also follow the newly revised "Hygiene Requirements for Sanitary Wipes."

 

Disinfecting wipes , using nonwoven fabric, textiles, dust-free paper, or other raw materials as carriers, with purified water as the production water, A product formulated by appropriately adding raw materials such as disinfectants, designed to deliver both cleaning and disinfecting effects, Suitable for human bodies, surfaces of common objects, surfaces of medical devices, and other object surfaces.

 

Disinfectant wipes are not yet listed in the catalog of disinfection products and therefore cannot be managed as such. They do not carry a "disinfection product" registration number, nor are they subject to hygiene and safety evaluation requirements. Hospitals using these wipes should verify their safety and efficacy by reviewing relevant test reports. According to Section 5.5 of the "Management Specification for Cleaning and Disinfection of Environmental Surfaces in Medical Institutions," disinfectant wipes can be used for cleaning and disinfection when surfaces show no visible contamination. Overall, disinfectant wipes appear to be a growing trend in this field.

 

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