Aug. 12th, 2018

Disinfectant & Biocide

How are Antibacterial (Bacteriostatic) Products regulated in China?

According to the Chinese Catalogue of Disinfectant Products, disinfection products include disinfectants, disinfection equipment and sanitary products. Sanitary products are one of the most commonly used disinfectants in our daily life, such as tissues, wet wipes, feminine wipes, diapers, antibacterial (bacteriostatic) products, contact lens solutions and so on.

Antibacterial (Bacteriostatic) products are a type of disinfectant which are in direct contact with human skin and the mucous membrane, and consequently cause a specific bactericidal effect. Products of this sort may reduce bacterial infections on the human body and keep the body germ clean and hygienic. Common antibacterial (bacteriostatic) products include skin antiseptic ointments, women's anti-bacterial lotions, anti-bacterial hand sanitizers, and anti-bacterial mouthwashes, among others.

Key characteristics of Antibacterial (Bacteriostatic) products which differ from regulated drugs:

✔ Domestic products are marked with "消证字号": (For example: 浙卫消证字（2018）第1234号); ✔ Range of use is limited to human skin or the mucous membrane; ✔ Products have antibacterial or bacteriostatic effect. Misconceptions regarding Antibacterial (Bacteriostatic) products Antibacterial (Bacteriostatic) products are in their essence different from drugs and they have no effect on the treatment of diseases. It is not advised that they be used as a replacement for medical drugs, since their use may even delay recovery from an illness. This applies even to antibacterial products purchased from drug stores. Wording on Antibacterial (Bacteriostatic) products cannot be confused with drugs ✔ Labels and instructions of antibacterial (bacteriostatic) products are prohibited from stating various disease names and disease symptoms, such as "psoriasis"," neurodermatitis ", among others; ✔ In the scope of use and methods of use, antibacterial (bacteriostatic) products are not allowed to claim similar effects, use doses and objects as drugs without a test basis, such as "X times per day", "XX days as a course of treatment, or following doctor's advice", etc. Therefore, it should be clear that antibacterial (bacteriostatic) products are regulated as disinfection products and not as drugs, as they are regarded as having only an antibacterial or bacteriostatic effect. Labels and advertisements can be misleading, promising to cure illnesses, so consumers should stay vigilant and aware of this relevant distinction to avoid compromising their health.

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