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How to Comply with the Chinese Regulations after the Wet Wipes and Hygiene Wet Wipes are Imported into China

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How to Comply with the Chinese Regulations after the Wet Wipes and Hygiene Wet Wipes are Imported into China


1  Major inspection items for wet wipes

After the wet wipes pass the customs clearance and are put into the Chinese market, the local quality and technology supervision departments or the health supervision bureaus will carry out regular or irregular inspections for the wet wipes within their administrative regions. Substandard products will be notified to the public online. The major inspection items are as follows: total number of bacteria 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 portable fluorescent whitening agent (11 test items in total) (in accordance with the requirements of GB 15979-2002 Hygienic Standards for Disposable Sanitary Products ,GB/T 27728-2011 Wet Wipes and other standards.)

2  Regulatory compliance requirements for hygiene wet wipes

In September 2017, National Health and Family Planning Commission of the P.R.C (now for the National Health Commission of the P.R.C) issued a mandatory hygiene standard – WS 575-2017 Hygiene Requirements for Wet Wipes. It is the first time China has released a hygiene standard concerning hygiene wet wipes. This standard has been implemented from 1 Mar. 2018. That is to say, after exporting hygiene wet wipes to China, overseas enterprises shall not only fulfill the toxicological requirements listed in the GB 15979-2002 Hygienic Standards for Disposable Sanitary Products concerning the import declaration, but also shall fulfill the toxicological safety requirements listed in the WS 575-2017 Hygiene Requirements for Wet Wipes after entering China market. CIRS warmly suggests that enterprises should better comply with both of the two requirements when they conduct the toxicological tests, and do the compliance sale. Please see the specific toxicological safety indexes listed in the WS 575-2017 in table 2

Table 2 The requirement of toxicological safety indexes

Objects

Multiple skin irritation test

Vaginal mucosal 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. Hygiene wet wipes for the vaginal mucosa: One vaginal mucosal irritation test shall be conducted when occasionally or in intervals of several days of use, Multiple vaginal mucosal irritation test shall be conducted when continuously use.

b. Hygiene wet wipes for mucous membrane other than vaginal mucosa.

c. Hygiene wet wipes for babies.

Besides, the WS 575-2017 has specific requirements on the contents of the active ingredients, pH value, stability, metal corrosion and other indexes of the hygiene wet wipes. It is suggested that enterprises involved hygiene wet wipes shall learn more about this standard. Take the requirements on the active ingredient limit as an example. See the requirements on hand, skin and mucous membrane in the following Table 3.

Table 3 Requirements on the Active Ingredient Limit of Hygiene Wet Wipes applied on Hand, Skin and Mucous Membrane

Object

Chlorhexidine Gluconate, Chlorhexidine Acetate (g/L)

5-Chloro-2-(2,4-dichlorophenoxy)phenol (g/L)

Benzalkonium Bromide, Benzalkonium Chloride (g/L)

Other restricted substances required by the state

Hand, skin

≤45.0

≤20.0

≤5.0

Compliance

Mucous membrane

≤5.0

≤3.5

≤2.0

Compliance

After the hygiene wet wipes pass the customs clearance and are put into the Chinese market, the quality and technology supervision departments or the health supervision bureaus will carry out regular or irregular inspection, for the hygiene wet wipes within their administrative regions. Substandard products will be notified to the public online. The major inspection items are as follows: total number of bacteria colonies, coliform bacteria, pathogenic purulent bacteria (pseudomonas aeruginosa, staphylococcus aureus and hemolytic streptococcus), total number of fungal colonies, liquid content, contents of active ingredient, pH value, packing and sealing performance, ,microbes killing index  and etc. (in accordance with the requirements of GB 15979-2002 Hygienic Standards for Disposable Sanitary ProductsGB 575-2017 Hygiene Requirements for Wet Wipes and other standards).



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