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Regulatory Updates

The Marvelous Hygiene Products! Bacteriostatic Agent/Antibacterial Agent
Publication date:2022-08-25
What is bacteriostatic agent/antibacterial agent?

Bacteriostatic agent/antibacterial agent, being the major category of hygiene products in disinfection products, is the agent with the effect of killing bacteria and inhibiting bacteria, which is directly in contact with human intact skin or mucous membrane, playing the role of keeping human body clean and hygienic, reducing the external pathogenic microorganisms on the human body. Hygiene products are classified as Class Ⅲ products of disinfection products and have a low risk. It’s okay to implement regular administration to ensure the product is safe and effective. Though bacteriostatic agent/antibacterial agent is categorized as hygiene products, its required that it shall be notified with provincial health department as Class Ⅱ disinfection products prior to be placed on the market.  

 

Classification

Bacteriostatic agent/antibacterial agent includes two types of products:

  1. Bacteriostatic agent: a preparation capable of killing microorganisms and inhibit their growth and reproduction. These products have a certain bactericidal effect on microorganisms, and the killing rate of them with the used dose for testing bacteria specified in the test items is ≥90%.
  2. Antibacterial agent: compared with bacteriostatic agent, it’s only capable of inhibiting the growth of microorganisms but not killing them. The killing rate of these products with the used dose for testing bacteria specified in the test items is ≥50%.
 
Scope

The common bacteriostatic agent/antibacterial agent on the market are: Antibacterial lotion for women, antibacterial mouthwash, antibacterial handwash. However if you believe a product is a bacteriostatic agent/antibacterial agent when you see the words “antibacterial or bacteriostatic”, you are wrong!

According to state regulations, products specially applied to specific parts like human body feet, eyes, nails, armpits, scalp, hair, nasal mucosa, anorectum, namely claiming medical effects for rhinitis, armpit odor, tinea pedis, gray nails and hemorrhoids, etc., even if they have antibacterial or bacteriostatic function, they are not bacteriostatic agents/antibacterial agents.

Additionally, products not applied to human skin mucous membranes are not bacteriostatic agent/antibacterial agent, such as antibacterial laundry detergent, antibacterial wipes, antibacterial socks, etc.

Therefore, when buying bacteriostatic agents/antibacterial agents, please check three parts of the label instructions:

1.Scope of use, applied to human skin or mucous membrane but not to the 8 specific parts.

2. Use, promote antibacterial or bacteriostatic effects.

3. Hygiene license No., Chinese domestic products shall be labeled with “Disinfection Product Number”, for example if the product is produced in Guangdong, the hygiene license No. is YUEWEIXIAOZHENGZI(year) NO.******. (YUE represents the acronym of Guangdong province. WEI represents hygiene. XIAO represents disinfection. ZHENG represents license. ZI represents a typical Chinese character used in the license number.)

 
Whats the difference between bacteriostatic agent/antibacterial agent and drugs?

The approval number of bacteriostatic agent/antibacterial agent: “WEIXIAOZHENGZI” is categorized as the hygiene product of disinfection products, having antibacterial or bacteriostatic function, and is mainly applicable to "prevention-oriented" sub-healthy people.

The approval number of drugs: “GUOYAOZHUNZI” is categorized as drug, having antibacterial, sterilization, anti-inflammatory and other effects, and is mainly applicable to non-healthy people.

 

*Bacteriostatic agents/antibacterial agents are not drugs and cannot cure diseases, please do not use them as drugs, delaying treatment and causing deterioration!