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GB 38598-2020 General Requirement for Label and Instructions Book of Disinfection Products Came Effective on December 1, 2021

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The industry currently supervises and manages the labeling instructions of disinfection products mainly based on the Standard for the Management of Labeling Instructions for Disinfection Products (2005 version), which is a regulatory document implemented as a supportive standard to Disinfection Management Measures issued by the Ministry of Health and is not a national mandatory standard to meet the current regulatory needs. Therefore, the National Health Commission and other relevant departments drew up a mandatory health standard - GB 38598-2020 General Requirement for Label and Instructions Book of Disinfection Products. The standard was released on November 17, 2020 and came effective on December 1, 2021.

Requirements,China,Label,Instruction,Disinfectants

General Requirement for Label and Instructions Book of Disinfection Products specifies the general requirements of labels and instructions for disinfectants, disinfection devices, indicators, and hygiene products and the labelling requirements of each index, which applies to disinfection products produced, sold, and used in the People's Republic of China. The standard differs from the 2005 version of the specification in a number of ways.

  • The standard proposes definitions of new disinfection products, biological indicators, and chemical indicators, e.g., new disinfection products are disinfectants and disinfection devices produced using new materials, new process technologies, and new sterilization principles.
  • Added the requirement to label the new disinfection products with the "New Disinfection Product Health License Number" to further strengthen the regulation of disinfection products.
  • Refined the labelling requirements of each indicator, such as the height of text and letters should be greater than 1.8 mm, different expression requirements for active ingredients according to liquid disinfectants and solid disinfectants, and specified that the range of stable active ingredient content should be ±10% of the central value and ±15% of the central value for unstable ones.
  • In the section of precautions, it is proposed that disinfection products included in the Hazardous Chemicals Catalogue should be transported and packaged in accordance with both the GB/T 191 and GB 190, and that products with foreseeable adverse effects or a danger as result of using incorrectly or storing incorrectly should have protective or warning content.
  • The standard lists examples of various types of disinfection products in Appendix A such as product name, sizes, net content, active ingredient content, intensity of germicidal factor, product health licensing information, category of microbial killing or inhibition, application scope, use method, production date and expiration date. etc.
  • The disinfection product execution standard should be the national standard of the relevant product or the enterprise standard that is self-declared public in the national enterprise standard information public service platform. The standard number may not be marked with a chronological number, and the enterprise standard should meet the requirements of relevant national regulations, standards and specifications.

Below, we take disinfectants, antibacterial agents, sanitary wipes as examples for a reference.

Disinfectants

Definition

Preparations used to kill microorganisms on the media to achieve disinfection or sterilization requirements

Special precautions for the smallest sales package

Scope of use (disinfectants for mucous membranes should be marked as “medical and health institutions use only")

Banned contents on the labels and instructions

a) anti-inflammatory, disease treatment, alleviation or mitigation of clinical symptoms of disease, description or interpretation of disease symptoms, prevention of venereal diseases, spermicide, contraception.

b) application on the human feet, eyes, nails, armpits, scalp, hair, nasal mucosa, anal area.

c) X days as a course of treatment, or as prescribed by the doctor, prevent recurrence, facilitate wound healing, assist with drug treatment.

Product name examples

XX® skin and mucous membrane disinfectant; XXTM glutaraldehyde disinfectant; XX brand trichloroisocyanuric acid disinfectant tablets; XX® iodophor disinfectant; XX brand disinfectant (multi-purpose or multiple active bactericidal ingredients)

Anti-bacterial agents

Definition

Antibacterial agents: a preparation with a certain bactericidal effect that directly contacts the intact skin or mucous membrane of the human body.

Bacteriostat: a preparation with a certain bacterial inhibiting effect that directly contacts the intact skin or mucous membrane of the human body.

Special precautions for the smallest sales package

Antibacterial agents or bacteriostat should also be marked with the active ingredient and its content, application scope (for the use of vaginal mucous, it should be marked as "no prevention of disease in sexual life”)

Banned contents on the labels and instructions

d) anti-inflammatory, diseases treatment, alleviation or relief of disease symptoms, prevention of venereal diseases.

e) applicable for the broken skin, broken mucous membranes, wounds, etc.

f) high efficiency, disinfection, sterilization, de-bacterization, spermicide, contraception.

g) application on the human feet, eyes, nails, armpits, hair, scalp, nasal mucosa, anorectal areas.

h) X days as a course of treatment, as prescribed by the doctor; prevent recurrence; facilitate wound healing; assist with drug treatment.

Product name examples

XX brand antibacterial hand soap; XX® oral antibacterial spray

Sanitary wipes

Definition

The wet wipes, using non-woven fabric, fabric, wood pulp compound, wood pulp paper, etc. as the carrier, adding appropriate amount of production water and disinfectant solution and other raw materials, apply to the processing objects (such as hands, skin, mucous membranes and ordinary object surface) with a function of cleaning and sterilization.

Special precautions for the smallest sales package

Sanitary wipes should also be marked with product size, the name of the main raw materials, the implementation standard number, main active ingredients and their contents of extruded liquid of sanitary wipes (production fluid required if bactericidal factors have the function of adsorption), category of killing microorganisms, and application scope.

Banned contents on the labels and instructions

The label of sanitary wipes should not be marked as sterilization, disinfection, antibacterial, sterilization, drugs, efficient, prevention of epidemics, treatment of disease, alleviate or relieve the symptoms of disease, anti-inflammatory. Product name should not contain the word of "antibacterial".

Product name examples

XX® sanitary wipes

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