Interpreting the Mandatory Requirements for Hygienic Wet Wipes: WS 575-2017

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Interpreting the Mandatory Requirements for Hygienic Wet Wipes: WS 575-2017In 2017 China NHFPC (now knowns as NHC) promulgated the “WS 575-2017 Hygiene Requirements for Hygienic Wet Wipes”. Since its implementation in March 2018, the mandatory standard has played an active role in market regulation, but some of its contents were also misinterpreted/wrongly enforced by manufacturers, law enforcers and users. In a recent scholarly journal, NHC officials reiterated the background and significance and outlined the key technical requirements, as well as clarified the scope, legal positioning and intersection with other disinfection products, in the hope of safety and effective use of health-related products, particularly under the circumstance of Covid-19 pandemic.

Background

Hygienic Wet Wipes are a category of disposable sanitary products widely used in households, schools, catering and tourism service and medical institutions, etc., for the cleaning and bactericidal treatment of hand, skin and mucosa, as well as ordinary object surface. Hygienic wet wipes have been piecemeal mentioned in several regulation and standards:

  • Catalog of Disinfectant Products
  • GB/T 27728-2011 Wet Wipes
  • GB 15979-2002 Hygienic Standard for Disposable Sanitary Products

None of them had offered specific technical requirements targeting hygienic wet wipes. Compared GB/T 27728-2011 and GB 15979-2002 that respectively apply to general wet wipes (with no biocidal effect) and all sanitary products, WS 575-2017 put forward comprehensive requirements on raw materials, germicidal performance, product safety, labeling and manual specific to hygienic wet wipes. offering greater operability in postmortem surveillance.

Hygienic wipes are Class III disinfection products which can be directly placed on the market without completing any evaluation and record-filing formality with the health authorities whenever the following conditions are met:

  • The manufacturer has obtained the hygienic license of disinfection products (only homemade products);
  • The hygienic wet wipe conforms to GB 15979-2002, WS 575-2017 and enterprise standard;
  • The label and manual shall comply with the labeling requirements of disinfection products.

The health authorities at the county level are responsible for the concrete oversight on the production and operation activities of indigenous manufacturers and legal representatives (of imported products), product quality as we as necessary check and acceptance system of downstream retailers and users. The county authorities take random inspection at least once a year and WS 575-2017 serves as an important benchmark for hygienic wet wipes.

Main Requirements

Hygienic wet wipes shall meet a series of requirements including raw materials, quality indicators, toxicological safety, microbial contaminants and bactericidal efficacy., etc., some of which are cross-referred with cosmetic or pharmaceutical regulations and other standards and some of which are closely correlated with label claims affecting potential clients.

1.Raw Materials

The use of migrating fluorescent brighteners in hygienic wet wipes is strictly forbidden. The raw materials used in body-use wipes shall be superior to industrial grade and proved to be non-toxic or low toxic through the acute oral test, and non- mutagenic. The Plumbum, Mercury and Arsenic contents in the raw material shall be less than 40mg/L, 1mg/L and 10 mg/L. The use of preservatives shall comply with the requirements indicated in Chinese Pharmacopoeia or those of food/cosmetic raw materials. It is also forbidden to add the ingredients listed in Section II of Chinese Pharmacopoeia (excluding preservatives and purified water) and other substances banned by the health department.

2.Quality indicators

WS 575-2017 established the maximum limits of specific active ingredients targeting different body part. The extracts of hygienic wet wipes for hand, skin and mucous membrane should satisfy the following limits:

 

Hand and Skin

mucous membrane

Chlorhexidine digluconate/ Chlorhexidine acetate

≤45.0 g/L

≤5.0 g/L

Triclosan

≤20.0 g/L

≤3.5 g/L

Benzalkonium bromide/ Benzalkonium chloride

≤5.0 g/L

≤2.0 g/L

The pH range of the extract of body-use wipes should be kept between 3.5 to 8.5 and the extract of metal surface wipe shall pose no corrosion to metal.

3.Toxicological Safety

Before the placing of hygienic wet wipes on the market, a series of irritation tests need to be completed, depending on the body parts claimed:

Taget body part

Test

Irritation rating

Hand, skin and mucous membrane

Repeated intact skin irritation

Non-irritant or slightly irritant

Vagina mucosa

Single or repeated vagina mucosa irritation, depending on the frequency of use

Non-irritant or slightly irritant

mucous membrane excepting vagina mucosa

Eye irritation

Non-irritant or slightly irritant

Infant use

skin sensitization

Non-sensitizing or slightly sensitizing

4.Microbial contaminants and efficacy

Both GB 15979-2022 and WS 575-2017 have the same requirements on microbial contaminants and biocidal performances:

microbial contaminant

Limit(cfu/g)

Target Microbial Organism

efficacy

Total Bacterial Colonies,

≤20

Coliform

≥90%

Coliform

must not be found

Staphylococcus aureus

≥90%

Pyogenic Pathogen (Pseudomonas aeruginosa, staphylococcus aureus and hemolytic streptococcus)

must not be found

Candida albicans

≥90%(conditionally required if the organism was claimed)

Total fungal colonies

must not be found

Other microbial organisms

Wet Wipes and Disinfection Products

China NHC carries out categorized management on disinfection products and wet wipes are classified as the Class III disinfection products can be placed on the market without any administrative formality (indigenous manufacturers need to obtain a company hygienic license from health authorities)

Class

III

II

I

Scope and typical products

Sanitary products (wipes, diapers, sanitary towel, makeup cotton, paper tableware, facial mask and contact lens solution, etc.) that do not fall into antimicrobial agents;

Other disinfectants, disinfecting apparatuses and chemical   indicators that do not fall into Class I;

Packed-sterilized articles with sterilization marking;

Antimicrobial (bacteriostatic) agents;

high-level disinfectants, disinfecting apparatuses, sterilizing agents and sterilizing apparatuses for medical device treatment;

Disinfectants for skin and mucous membranes treatment;

Biological indicators, and chemical indicators for sterilization effect.

Risk

Relatively Low

Medium

Relatively High

Obligation

Satisfying labeling requirements

Pre-marketing hygienic and safety assessment and record-filing formality at the provincial level

Satisfying labeling requirements

Validity of the assessment

/

Permanent

Retest after every 4 years

During postmortem surveillance, wet wipes would be sampled and tested following different standards. Wet wipes without disinfecting claim are regarded as general wet wipe and inspected as per GB 15979-2022, as long as the microbial contaminant requirements are met, but hygienic wet wipes need to satisfy sufficient disinfection efficacy. In addition to the 2 wet wipes mentioned above, there is also another type of high-level disinfecting product called disinfecting wet wipes, which have removed the scope of medical apparatus and instruments since 2012, but NHC has not yet included them into disinfection products. NHC has tried to put forward a new term “carrier disinfectants”, covering more disinfectant-carrying/releasing products such as alcohol/ iodophor cotton swabs, pad and ball, etc, and a specific standard was drafted in 2016. Nonetheless, the legislation process didn’t go as well as that of the hygienic wet wipes: the standard for carrier disinfectant was enacted in October 2019 in the form of group standard with lower legal force and voluntarily enforced by limited numbers of enterprises and organizations. Disinfecting wipes are still in the gray area of regulation.

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