Certification and Registration
WS 575 Hygienic Requirements for Wet Wipes
Category:
Hygiene Products
WS 575 Standard Description
WS 575 Hygiene requirements for sanitary wipes
WS 575 Standard Introduction
WS 575-2017 Hygienic Requirements for Sanitary Wipes is an important hygiene industry standard in China formulated for sanitary wipes with cleaning and antimicrobial functions. It applies to wipes using nonwoven fabrics or other materials as carriers and containing antimicrobial liquids for use on hands, skin, mucous membranes or object surfaces. The standard specifies systematic requirements for raw materials, active ingredients, microbial control, toxicological safety, usage instructions, packaging labels and other aspects. It helps regulate industry production, improve product quality and ensure consumer safety.
WS 575 Scope of Application
WS 575 defines sanitary wipes as wipes made from carriers such as nonwoven fabrics, textiles, wood pulp composite fabrics and wood pulp paper, with appropriate amounts of production water and disinfectant solutions added, which provide cleaning and antimicrobial effects for intended surfaces such as hands, skin, mucous membranes and common object surfaces. Examples include hand cleaning and disinfecting wipes, skin care wipes and baby skin cleaning wipes.
WS 575 Raw Material Requirements
Carrier Material Requirements
◎ Nonwoven fabrics, textiles or other raw materials shall be clean, non-toxic and comply with relevant national requirements.
◎ Recycled materials or waste materials shall not be used, and prohibited substances such as extractable fluorescent whitening agents shall not be present.
Antimicrobial Ingredient Requirements
◎ The antimicrobial active ingredients contained in sanitary wipes for hands, skin and mucous membranes (including ingredients with cleaning functions):
◎ Shall use non-industrial grade raw materials.
◎ Acute oral toxicity shall be classified as non-toxic or low-toxic, and the ingredients shall not have mutagenic effects.
◎ Heavy metal limits: Lead (Pb) <40 mg/L; Mercury (Hg) <1 mg/L; Arsenic (As) <10 mg/L.
◎ Preservatives shall comply with the Pharmacopoeia of the People’s Republic of China or food/cosmetic raw material standards.
◎ Fragrances, skin-conditioning agents and other auxiliary ingredients shall also comply with food or cosmetic raw material requirements.
Restrictions on Prohibited Substances
◎ Substances listed in the "Disinfectant and Antiseptic Ingredient List" in Part II of the Pharmacopoeia of the People’s Republic of China (except purified water), or raw materials with the same names, shall not be added.
◎ Other prohibited substances specified by national health administrative authorities shall not be added.
Production Water Requirements
◎ The conductivity of water used in sanitary wipe production shall not exceed 5.1 μS/cm (25°C).
Packaging Material Requirements
◎ Packaging materials directly contacting the product shall be non-toxic, harmless and clean, and shall have sufficient strength to ensure that products are not contaminated or damaged during circulation.
WS 575 Technical Requirements
Sensory Properties (Visual and Odor Inspection): The product appearance shall be clean; no lint shedding or fiber shedding shall occur; no abnormal odor or foreign matter shall be present.
Liquid Content (GB/T 27728):
The weight ratio of liquid to carrier material in sanitary wipes shall be ≥1.7.
Active Ingredient Content:
◎ Shall comply with the value indicated on the product label.
◎ The limits for wipes used on hands, skin and mucous membranes are as follows:
|
Restricted Substance |
Reference Standard |
Hands/Skin (g/L or g/kg) |
Mucous Membrane (g/L or g/kg) |
|
Chlorhexidine gluconate or chlorhexidine acetate |
GB/T 26367 |
≤45.0 |
≤5.0 |
|
2,4,4'-Trichloro-2'-hydroxydiphenyl ether |
GB/T 27947 |
≤20.0 |
≤3.5 |
|
Benzalkonium bromide or benzalkonium chloride |
GB/T 26369 |
≤5.0 |
≤2.0 |
|
Other restricted substances specified by national regulations |
WS/T 10009 |
Comply |
Comply |
pH Range: For sanitary wipes intended for hands, skin and mucous membranes, the pH value of the squeezed liquid shall be between 3.5 and 8.5.
Product Stability (Technical Standard for Disinfection or relevant product standards):
The product shelf life shall not be less than 1 year.
Packaging Sealing Performance: Packaging shall be intact without liquid leakage, air leakage or damage.
Metal Corrosion: For sanitary wipes used on metal surfaces, the production liquid shall be essentially non-corrosive.
Microbiological Indicators (GB 15979 Appendix B):
◎ Total bacterial count ≤20 CFU/g.
◎ Coliforms, Pseudomonas aeruginosa, Staphylococcus aureus, hemolytic Streptococcus and fungi shall not be detected.
Microbial Killing Performance (GB 15979 Appendix C):
◎ The killing rate against Escherichia coli and Staphylococcus aureus shall be ≥90%.
◎ If antifungal efficacy is claimed on the label, the killing rate against Candida albicans shall also be ≥90%.
◎ Other microorganisms shall also achieve a killing rate of ≥90% if such efficacy is claimed.
Toxicological Safety Indicators (Required before initial market launch, tested according to applicable methods in the Technical Standard for Disinfection):
|
Intended use |
Repeated Complete Skin Irritation Test |
Vaginal mucosal irritation test ᵃ |
Acute Eye Irritation Test ᵇ |
Skin hypersensitivity test ᶜ |
|
Hands, skin |
Non-irritating or mildly irritating |
- |
- |
Not observed or very mild |
|
Mucosa |
Non-irritating or mildly irritating |
Non-irritating or extremely mild irritation |
Non-irritating or mildly irritating |
Not observed or very mild |
|
Note: “-” indicates that the test is not required. |
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|
a For sanitary wipes intended for vaginal mucosa use, occasional use or use at intervals of several days requires a single vaginal mucosal irritation test; continuous-use products require a repeated vaginal mucosal irritation test. b Applicable to sanitary wipes intended for mucous membranes other than vaginal mucosa. c Applicable to sanitary wipes intended for infants. |
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