On December 1, 2021, China began to enact the national standard, “GB 38456-2020 Hygienic Requirements for Antibacterial and Bacteriostatic Lotion”. The standard clarifies the definition, requirements on raw materials, technical criteria, testing methods, labeling and instruction of these body-use disinfecting products, which would provide scientific foundations for the quality evaluation, correct product claim and consumer choice and promote the standardization process of China’s antimicrobial industry.
Product Scope
Antibacterial and bacteriostatic lotions are used for antibacterial/ bacteriostatic treatment on intact skin, vagina mucosa and oral mucosa, but excluding those applied on specific body parts such as feet, eyes, nails, axilla, scalp, hair, nasal mucosa, and anorectal area, etc. The most typical antibacterial and bacteriostatic lotions used in our daily life are mouthwash, hand sanitizer and feminine wash with an anti-microbial claim.
Raw Materials and Banned Substances
All raw materials used shall conform to the quality criteria specified in the Chinese Pharmacopoeia in force, as well as other quality specifications for food grade, medicine grade and cosmetic-grade, etc. The productive water shall satisfy the requirements in the “Hygienic Practice for Producers of Disinfection Products (2009)”.
Pharmaceutical active ingredients listed in the Chinese Pharmacopoeia，animal/human-derived and biologically obtained materials that used for disease prevention, treatment and diagnosis, and banned ingredients listed in the “Safety and Technical Standards for Cosmetics”(excluding iodine), as well as other ingredients banned by the health department are prohibited from the formula of antibacterial/ bacteriostatic lotion.
Technical Requirements
Antibacterial/bacteriostatic lotion shall comply with a series of technical indicators through physicochemical property, efficacy and toxicological aspects.
Its PH value shall be within the range of the value labeled and active ingredients used and harmful substances shall comply with the following limits:
Active Ingredient(g/L) | Skin-use | mucosa |
Chlorhexidine digluconate/ acetate | ≤45.0 | ≤5.0 |
Triclosan | ≤20.0 | ≤3.5 |
Benzalkonium Bromide/ Chloride | ≤5.0 | ≤2.0 |
Lead, arsenic and mercury content
Substance(mg/kg) | Skin-use |
Lead | ≤10 |
Arsenic | ≤2 |
Mercury | ≤1 |
For stability, the shelf life shall not be less than 12 months. The content of the active ingredient shall be greater than the lower limit labeled within the validity. If the stability can not be tested through chemical methods, biological methods can be used.
Antibacterial and bacteriostatic lotion shall keep a bactericidal rate of 90% with a disinfecting time of fewer than 5 minutes 50% respectively and 3 bacterial species would be tested depending on the target bacterium claimed. The total bacterial count shall not be greater than 200 CFU/mL and the total fungal count shall not be great than 100. pathogenic bacterium shall not be detected (including Staphylococcus aureus, Pseudomonas aeruginosa and haemolytic streptococcus)
Toxicologically, antibacterial and bacteriostatic lotion shall be tested non-irritant or slightly irritant through acute or multiple skin tests, mucosa, or eye irritation tests depending on the target body part claimed.
Label Claim | Irritation Test |
Skin | Multiple skin irritation |
Rinse-off | 2-hour acute skin irritation only |
Vagina mucosa | Vagina mucosa irritation |
mucosa | Eye irritation |
Referenced Testing Methods
The above indicators shall be tested by the method specified in the following technical regulations or standards:
Test | Referenced regulation and standard |
PH value | Technical specification for disinfection (2002 version) |
Content of active substance | Technical specification for disinfection (2002 version) or relevant national standard |
Lead, arsenic and mercury content | Safety and Technical Standards for Cosmetics |
Stability | Technical specification for disinfection (2002 version) |
Antibacterial efficacy | Technical specification for disinfection (2002 version) and GB 15979 |
Bacteriostatic efficacy | Technical specification for disinfection (2002 version) and GB 15979 |
Microbial contaminant | GB 15979 |
Toxicological test | Technical specification for disinfection (2002 version) |
Furthermore, in the effort to stop the use of banned substances, China has enacted 3 hygienic standards to detect pharmaceutical substances in disinfectants and antibacterial/bacteriostatic lotion:
- WS/T 684-2020 Analytical method and evaluation requirements for antibacterial drugs in disinfectant and antibacterial and bacteriostatic agents
- WS/T 685-2020 Analytical method and evaluation requirements for antifungal drugs in disinfectant and antibacterial and bacteriostatic agents
- WS/T 686-2020 Analytical method and evaluation requirements for antiviral drugs in disinfectant and antibacterial and bacteriostatic agents.
Labels and Instruction
These body-use antimicrobial products shall follow the basic requirements in the national standard, “GB 38598 2020-General Requirements for Label and Instruction Book of Disinfection Products”, which was also enacted on December 1, 2021.
Items of information to be compulsorily displayed on minimum sales packaging, transport packaging and instruction, as well as prohibited function claims and phrases are summarized as follows:
| Minimum sales packaging | Transport packaging | Use instruction |
Product name | √ | √ | √ |
Net content | √ | | |
Name, address and contact information of the manufacturer | √ | √ | √ |
Hygienic license number of the manufacturer (homemade product) or country/region of origin (imported products) | √ | √ | √ |
Batch number and expiration date (or production data and validity period) | √ | √ | |
Storage conditions | √ | | |
Packing condition | | √ | |
Precaution for storage and transport | | √ | |
Name and content of active ingredient used and use scope (For products used on vaginal mucosa, the phase” shall not be used for STD prevention” shall be included) | √ | | √ |
Application method Use precaution Number of product executive standard product specification for tablet formulation target microbial organism | | | √ |
Function claims and phrases prohibited from being displayed on product instruction |
- Anti-inflammatory, diminishing inflammation, treat or relieve diseases or symptoms, description or explanation of symptoms, STD prevention;
- Apply to damaged skin, damaged mucosa and wound, etc.;
- High-efficacy, disinfecting, sterilizing, degerming, spermicidal, contraceptive;
- Used on feet, eyes, nails, axilla, scalp, hair, nasal mucosa and anorectal area, etc.
- One treatment period lasts X day, or as directed by qualified health care consultant; prevent recurrence; beneficial for healing wounds, auxiliary of pharmacotherapy
|
GB 38456-2020 further put forward some precautions to be compulsorily displayed:
- Antibacterial/bacteriostatic lotion shall not be used for disease treatment or symptom improvement;
- This lotion shall not be swallowed. Keep out of children's reach
- Avoid using together with antagonists;
- Do not use if allergy;
- Keep Away from light and moisture. Sealed in a cool and dry place.
Pre-marketing Process
Antibacterial/bacteriostatic lotion falls into the Class II disinfection product subject to hygienic and safety evaluation and filing at the provincial health department. Producers need to complete a series of tests at CMA/CNAS labs or centers for disease control at the provincial level and summarize the test report, product information and other supporting documents into a unified format called the report of hygienic and safety evaluation of disinfection product, which should be submitted either online or in a papery manner. China launched an informational website in 2019, enabling visitors to access the evaluation results nationwide filed through over 30 provinces.
