How to Prepare a Compliant Label for Antibacterial and Bacteriostatic Agents

Antibacterial and bacteriostatic agents refer to the products that can kill or inhibits the growth, reproduction and activity of pathogenic microorganisms, which can be only used for hands, skins as well as mucous membrane. Some common antibacterial and bacteriostatic agents include anti-bacterial hand wash, women personal care liquid wash etc. In accordance with the requirements of ‘Provisions for the Hygiene and Safety Evaluation of Disinfection Products’ (2014), antibacterial and bacteriostatic agents are Class II disinfection products. Products responsible entities must submit qualified labels when they apply to local health commission for notifications of this kind of products, besides, the label is also a mandatory requirement for selling the antibacterial and bacteriostatic agents in China market legally. Here to better make applicants understand the requirements of a compliant label, CIRS will give an interpretation of the label requirements listed in the ‘Management Measures of Labels and Instructions of Disinfection Products’, and remind some matters needing attention.

The label of a minimum sales package for antibacterial and bacteriostatic agents must contain the following information:

(1) Product name

The product name shall contain trade name (brand name), general name and attribute name; if the trademark of the products have been registered, then the name of the products shall be ##®; if the trademark of the products are pending, then name of the products shall be ##TM; in other cases, name of the products shall be ##. Besides, products name shall not express or imply the therapeutic effect on diseases. The following products names are all non-compliant: XX multi-functional agent, XX full-functional agent, etc.

(2) Raw material

The raw materials must be labeled in their chemical name; if the antibacterial and bacteriostatic agents contain plant compounds, then the Latin name of the main plants shall also be labeled.

(3)  Active ingredient(s) and concentration

The active ingredient(s) shall be labeled in their chemical name, and the concentration of the active ingredients should be in accordance with the concentration range specified in the product’s quality/company standard. Besides, if the products contain plants or other items that cannot label the active ingredient’s chemical name, the latin name of the raw material as well as the amount of the raw material added per unit volume should be labeled.

(4)  Manufacturer (name, address, tel. and postcode)

The manufacturer name and address must be consistent with that recorded in the hygienic license.

If the products are entrusted for processing, then the name of responsible entities (the entrusting party), its address, the name of actual manufacturer (the entrusted party) as well as hygienic license number must be labeled as well.

When the information of the responsible entities is inconsistent with that of the actual manufacturer, then the information of the responsible entities as well as the manufacturer shall both be labeled. For example, if the responsible entity is the head office while the actual manufacturer is an affiliated company, then the information of both the head office and the affiliated company must be labeled.

For imported products, information of the responsible entities in China shall also be labeled besides the manufacturer information.

(5) Hygienic license number for domestic products

(6) Country or region of origin for imported products

(7) Manufacturing date and period of validity (guarantee period)/ batch number and expiry date

In attention to the above, the following aspects shall also be paid attention to:

  • (a) If the killing rate of the indicator microorganisms equals to or is higher than 90%, then the products can label “bactericidal efficacy”; if the bacteriostatic rate of the indicator microorganisms reaches 50% or the diameter of the bacteriostatic ring is larger than 7mm, label “possess bacteriostatic effect”; if the bacteriostatic rate equals to or is higher than 90%, label “possess strong bacteriostatic effect”; if the antibacterial and bacteriostatic agents can be used for vaginal mucosa, should label “cannot be used to prevent sexually transmitted diseases during sexual life”.
  • (b) Formulation of the antibacterial and bacteriostatic agents can be liquid, tablet, powder, etc. Suppository and soaping agents are not allowed.
  • (c) Antibacterial and bacteriostatic agents shall not label the following words and expressions: high efficient, non-toxic, disinfection, sterilization, anti-inflammation, treatment of illness, alleviate symptom, prevention of sexually transmitted diseases, sperm killing and some disable components including antibiotic, hormone, etc.; the products can be used for foot, eyes, nails, axilla, scalp, hairs, nasal mucosa, anorectum and other specific parts of the body; the products can be used for damaged skins, mucous membrane, wounds, etc.; use dosage, and objects, the species of inhibited/killed microorganisms, validity period and antibacterial and bacteriostatic effects info without testing basis.
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