Interpretation of Compliance Requirements for Wet Wipes in China

Wet wipes are common in life and have huge market potential. When the companies produce or sell wet wipes in China, they often fail to do compliance sales as they are not familiar with relevant regulations and standards, resulting in a notice of criticism or administrative penalty by relevant quality control department and affecting corporate image and reputation. Chemical Inspection and Regulation Service Limited (CIRS) will interpret relevant regulations and standards for wet wipes in detail, to remind the companies of some precautions.

1.Classification of wet wipes

Wet wipes can be roughly classified into general purpose wet wipes, hygiene wet wipes and disinfecting wet wipes based on intended use. General purpose wet wipes refer to general cleaning wipes without bactericidal effects which can be applied on human body, kitchen utensils and toilet utensils; hygiene wet wipes refer to cleaning and bactericidal wipes applied on hand, skin, mucous membrane or surface of ordinary objects; disinfecting wet wipes refer to disinfectant wipes applied on hand, skin, mucous membrane or surface of ordinary object and medical device. General purpose wet wipes and hygiene wet wipes are disposable sanitary products, and disinfecting wipes may be treated as carrier disinfectants in future according to the newly issued draft standard Hygienic Requirements for Carrier Disinfectant. General purpose wet wipes and hygiene wet wipes do not have to do notifications and only need to be tested before being marketed. However, the disinfecting wet wipes may need to complete the safety evaluation report and to do notifications in local health departments before being put to the market, and can be marketed after approval.

2 Compliance requirements for wet wipes in China

Compliance requirements of wet wipes in China are divided into two parts: first of all, the label or instruction shall be compiled in accordance with related provisions, and not include noncompliance contents; secondly, in aspect of hygienic indicator, the product shall be tested accordingly, and the test result shall meet corresponding standards. Products satisfying the above requirements can be put into market.

2.1 Compliance requirements on labels and instructions

Wet wipes are disinfection products, so the labels and instructions shall be compiled in accordance with the Specification on Management of Label and Instruction for Disinfection Product. The label and instruction shall not have any false or exaggerated contents, nor involve any disease treatment functions and effects, whether expressed or implied. Besides, the label and instruction shall include the following contents:

(1) Product name

(2) General purpose wet wipes shall be marked with name of main raw materials. Hygiene wet wipes and disinfecting wet wipes shall be marked with active germicidal ingredients and their contents

(3) Manufacturer (name, address, Tel. and zip code)

(4) Hygienic license No. of the manufacturer (except the imported wipes)

(5) Country of origin or area of origin (except the domestic wipes)

(6) Date of production and validity period/batch number and expiration time

(7) Disinfection grade sanitary products shall be marked with the word "disinfection grade"

(8) Hygiene wet wipes and disinfecting wet wipes shall also be marked with active germicidal ingredients and their contents, use methods, scope of application and precautions

(9) The disinfecting wet wipes shall also be marked with the formulation type, specification, category of microorganisms killed and executing standard

(10) Disinfecting wet wipes applied on mucous membrane shall also be marked with "only for diagnosis and treatment by medical and health institution"

Among them, the product name shall comply with the Regulations on Naming of Health-related Products issued by the Ministry of Health, and include trade name (or brand name), common name and property name. “##®” shall be marked if the trademark has been registered. "##TM" shall be marked if the trademark is applied for registration. The remaining products shall be marked with "## 牌(brand)". It is not allowed to label antibacterial and bactericidal effects on general purpose wet wipes. It is not allowed to include the words "antibacterial effect" in name of hygiene wipes. Hygiene wet wipes and disinfecting wet wipes shall not be labeled with contents such as medication, quick acting, high efficiency, no toxicity, prevention of sex transmitted disease, disease treatment, alleviation of symptoms, anti-inflammatory effect, scope of application and object not based on tests, dosage and method, antibacterial effect and category of microorganism killed and expiration date not based on test, as well as being applied on feet, eyes, nails, axilla, scalp, hair, nasal mucosa, anorectal part and other specific parts.

Besides, plants or other substances which can't be marked with main active ingredients shall be labeled with name of main raw material (Latin name for plants) and amount of raw materials added in unit volume. It is not allowed to add and label antibiotic, hormone, metronidazole, adrenocortical hormone and other prohibited ingredients in wet wipes.

2.2 Compliance requirements on hygienic indicator

2.2.1 Hygienic indicator for general purpose wet wipes

General purpose wet wipes are disposable sanitary products and should meet the requirements of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products and GB/T 27728-2011 Wet Wipes and relevant standards. It mainly includes the following test items: total number of bacterial colonies, coliform bacteria, pathogenic purulent bacteria (pseudomonas aeruginosa, staphylococcus aureus and hemolytic streptococcus), total number of fungal colonies, liquid content, transverse tensile strength, packing and sealing performance, pH value and migratable fluorescent whitening agent, etc.

2.2.2 Hygienic indicator for hygiene wet wipes

Hygienic wet wipes refer to wipes using non-woven fabrics, textile, wood pulp composite fabrics and wood pulp papers as carriers, added with appropriate amount of production water, disinfectant solution and other raw materials, and cleaning and sterilizing the objects (such as the hand, skin, mucous membrane and surface of ordinary objects). The hygienic wet wipes shall comply with not only the requirements of GB 15979-2002 Hygienic Standard for Disposable Sanitary Products, but also relevant requirements of WS 575-2017 Hygienic Wipes. Specific requirements are as follows:

Table 1 Requirements on the Active Ingredient Limit of Hygiene Wipes Applied on Hand, Skin and Mucous Membrane

Use Object	Chlorhexidine Gluconate, Chlorhexidine Acetate (g/L)	2,4,4'-trichloro-2'-hydroxydiphenylether(triclosan) (g/L)	Benzalkonium Bromide, Benzalkonium Chloride (g/L)	Other restricted substances required by the state
Hand, skin	≤45.0	≤20.0	≤5.0	Compliant
Mucous membrane	≤5.0	≤3.5	≤2.0	Compliant

Table 2 Requirements for Microbiological Index

Product type	Total number of bacterial c olonies (CFU/g)	Coliform bacteria	Pathogenic purulent bacteria	Total number of fungal colonies (CFU/g)
Hygienic wet wipes	≤20.0	Non-detectable	Non-detectable	Non-detectable

Table 3 Requirement for Microorganism Killing Index

Product type	Escherichia coli	Staphylococcus aureus	Monilia albican a	Other microorganisms b
Hygienic wet wipes	≥90	≥90	≥90	≥90
a: This test shall be conducted if it is labeled as killing fungi b: The corresponding microorganism killing test shall be conducted if it is labeled as killing other microorganisms

Table 4 Requirement of Toxicological Safety Indexes

Object	Multiple intact skin irritation test	Vaginal mucosa irritation test a	Acute eye irritation test b	Skin sensitization test c
Hand, skin	Non-irritation or slight irritation	-	-	Non or extremely slight irritation
Mucous membrane	Non-irritation or slight irritation	Non-irritation or extremely slight irritation	Non-irritation or slight irritation	Non or extremely slight irritation
Note: "-" represents that the test is not needed.
a. For hygiene wet wipes for the vaginal mucosa, a vaginal mucosal irritation test shall be conducted when occasionally or in intervals of several days of use; multiple vaginal mucosal irritation tests shall be conducted in case of continuous use. b Hygienic wipes for use on mucous membranes other than the vaginal mucosa. c Hygienic wipes for babies.

Besides, the WS 575-2017 has specific requirements on pH value, stability, metal corrosion and other indexes of the hygiene wet wipes. It is suggested that the companies involving hygiene wet wipes shall learn more about this standard.

2.2.3 Compliance requirements for disinfecting wet wipes

Previously, as the disinfecting wet wipes were not included in the catalogue of disinfection products, there were no regulations and standards for disinfecting wipes, and the regulatory authorities were uncertain, the domestic supervision on disinfecting wipes has been in a mess. However, the draft for comments of Hygienic Requirements for Carrier Disinfectant issued by China Health Inspection Association Group Standards Committee recently may change this situation. The draft for comments clearly states that the disinfecting wipes are carrier disinfectants and can be applied on hand, skin, mucous membrane, surface of ordinary object, medical devices and medical supplies and environmental surface. Based on the use object and Technical Requirements for the Hygiene and Safety Evaluation of Disinfectant Products, the disinfecting wipes belong to Class I and Class II disinfectant product. Before putting to the market for the first time, the responsible entity shall complete the safety evaluation report and notification in the provincial health department. Then It can be marketed after approval. The above-mentioned group standard provides a basis for market regulation and compliance requirements of disinfecting wet wipes.

The draft for comments of Hygienic Requirements for Carrier Disinfectant has the same requirements on active ingredient content and toxicology as hygiene wet wipes, but has higher requirements on microbiological and microorganism killing indexes, as follows:

Table 1 Requirements for Microbiological Index

Product type	Total number of bacterial colonies (CFU/g)	Coliform bacteria	Pathogenic purulent bacteria	Total number of fungal colonies (CFU/g)
Disinfecting wet wipe	≤10.0	Non-detectable	Non-detectable	Non-detectable

Table 2 Requirement for Microorganism Killing Index

Test strain	Disinfection object							Killing logarithm value
	Hand	Skin	Mucous membrane	Surface of object	Surface of medical device
					High level disinfection	Intermediate level disinfection	Low level disinfection
Escherichia coli 8099	+	-	-	+	-	-	-	≥5.00
Staphylococcus aureus ATCC6538	+	+	+	+	-	+	+	≥5.00
Pseudomonas aeruginosa ATCC15442	-	+	+	+a	-	+	+	≥5.00
Monilia albican ATCC10231	+	+	+	-	-	-	+	≥4.00
Mycobacterium chelonei ATCC93326	-	-	-	-	-	+	-	≥4.00
Bacillus subtilis var.niger ATCC9372	-	-	-	-	+	-	-	≥5.00
Vaccine strain of Virus. Polio types Ⅰ	-	-	-	-	-	+	-	≥4.00
Simulated field disinfection test	-	-	-	-	+	+	+	≥3.00
Field disinfection test	+	+	+	+	-	-	-	≥1.00
Note: "+" represents that the tests shall be done，and "-" represents that the test is not needed.

In addition to the above-mentioned three types of wet wipes, there is also makeup remover wipes, which belong to the category of cosmetics and must pass the notification in accordance with relevant regulations and standards of cosmetics before putting to the market.

After the wet wipes are sold in China, the quality and technical supervision department or the hygiene supervision department where the wet wipes are sold will conduct regular or irregular snap check on the wet wipes in its jurisdiction. There will be corresponding notice of criticism and punishment for nonconforming product, so relevant companies should fully understand relevant laws and regulations to ensure compliance of products.

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