CodeofChina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed by and is under the jurisdiction of the National Health Commission of the People's Republic of China.
Hygienic requirements for antibacterial and bacteriostatic lotion
1 Scope
This standard specified the raw material requirements, technical requirements, inspection methods, packaging, transportation, storage, labeling and instruction requirements for antibacterial and bacteriostatic lotion.
This standard is applicable to antibacterial and bacteriostatic lotion products applied to intact skin, vaginal mucosa and oral mucosa.
2 Normative references
The following referenced documents are indispensable for the application of this document For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging — Pictorial marking for handling of goods
GB 15979 Hygienic standard for disposable sanitary products
GB 38598 General requirement for label and instruction book of disinfection products
Pharmacopoeia of the People's Republic of China
Safety and Technical Standards for Cosmetics
Technical specification for disinfection (2002 Edition)
Hygienic code for disinfectant product manufacturer2 (2009 Edition)
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
antibacterial lotion
liquid preparations that directly contact human skin or mucosa (excluding feet, eyes, nails, axils, scalp, hair, nasal mucosa, anorectum and other specific parts), which are not for the purpose of treatment or relieving the symptoms of skin or mucosa, and have certain bactericidal action with a killing rate higher than or equal to 90%
3.2
bacteriostatic lotion
liquid preparations that directly contact human skin or mucosa (excluding feet, eyes, nails, axils, scalp, hair, nasal mucosa, anorectum and other specific parts), which are not for the purpose of treatment or relieving the symptoms of skin or mucosa, and have certain bacteriostatic action with a inhibition rate higher than or equal to 90%
3.3
killing rate
percentage used for expressing the reduction number on microorganisms in killing test of microorganisms
[WS/T 466-2014, Definition 4.27]
3.4
inhibition rate
percentage used for expressing the bacteriostatic effect on microorganisms in inhibition test of microorganisms
4 Requirements for raw materials
4.1 The raw materials shall meet the quality requirements of food grade, medical grade, cosmetics and other corresponding standard specified in the currently valid Pharmacopoeia of the People’s Republic of China
4.2 Production water shall meet the requirements of Hygienic code for disinfectant product manufacturer (Edition 2009).
4.3 Product formula shall not be included:
a) the drugs and their raw materials of the same name in the currently valid Pharmacopoeia of the People’s Republic of China;
b) pharmaceutical made of raw materials such as microorganisms, cells, animal or human tissues and body fluids, made by biological technology, and used to prevent, treat and diagnose human diseases, such as vaccines, blood products, biotechnology drugs, microecological agents, immunomodulators, diagnostic products, etc. (except deep ricin and lysostaphin);
c) prohibited substances listed in the currently valid Safety and Technical Standards for Cosmetics (except iodine);
d) other prohibited substances stipulated by the national administrative department of health.
5 Technical requirements
5.1 Physical and chemical indexes
5.1.1 pH value
The pH value shall be controlled within the range of ± 1 of the marked average value.
5.1.2 Content of active ingredients
5.1.2.1 The content of active ingredients shall meet the relevant national standards or the implementation standards of enterprise products.
5.1.2.2 The limit of active ingredients in the specific use liquid shall meet the requirements in Table 1.
Table 1 The limit requirement of active ingredients in antibacterial and bacteriostatic lotion g/L
Item Skin Mucosa
Chlorhexidine gluconate and chlorhexidine acetate ≤45.0 ≤5.0
2,4,4’-trichloro-2’-hydroxydiphenyl ether ≤20.0 ≤3.5
Benzalkonium bromide and benzalkonium chloride ≤5.0 ≤2.0
5.1.3 Limit requirement for lead, arsenic and mercury
The limit of lead, arsenic and mercury shall meet the requirements in Table 2.
Table 2 Limit requirement of lead, arsenic and mercury mg/kg
Item Requirement
Lead (in Pb) ≤10
Arsenic (in As) ≤2
Mercury ≤1
5.1.4 Stability
The validity period of the product shall be longer than or equal to 12 months, and the active content within the validity period shall not be lower than the lowest value of the labeling. If it can't be determined by chemical method, the stability shall be determined by biological method, to verify whether the product could still keep its antibacterial or bacteriostatic effect.
5.2 Requirements for killing (inhibiting) microorganisms by antibacterial and bacteriostatic lotion
5.2.1 Requirements for killing microorganisms with antibacterial lotion
The killing test of microorganisms shall be in accordance with the instruction and the results shall meet the requirements of Table 3.
Table 3 Requirements for killing microorganismsa by antibacterial lotion
Item Action time, min Killing rate, %
Escherichia coli 8099 ≤5 ≥90
Staphylococcus aureus ATCC6538 ≤5 ≥90
Candida albicans ATCC10231b ≤5 ≥90
a This killing test shall be carried out if the label and instruction is indicated that the lotion is having a killing effect on a specific microorganism.
b This killing test shall be carried out if the label and instruction is indicated that the lotion is having a killing effect on fungus or is used on external vulva.
5.2.2 Requirements of antibacterial lotion for inhibition of microorganisms
The inhibition test of microorganisms shall be in accordance with the instruction and the results shall meet the requirements of Table 4.
Table 4 Requirements for inhibiting microorganismsa by bacteriostatic lotion
Item Action time, min Inhibition rate, %
Escherichia coli 8099 ≤5 ≥50
Staphylococcus aureus ATCC6538 ≤5 ≥50
Candida albicans ATCC10231b ≤5 ≥50
a This inhibition test shall be carried out if the label and instruction is indicated that the lotion is having a inhibition effect on a specific microorganism.
b This inhibition test shall be carried out if the label and instruction is indicated that the lotion is having a inhibition effect on fungus or is used on external vulva.
5.2.3 Microbiological indexes
The total number of bacterial colonies shall be less than or equal to 200 CFU/mL; the total number of fungal colonies should be less than or equal to 100 CFU/mL; and pathogenic bacteria (especially staphylococcus aureus, pseudomonas aeruginosa and hemolytic streptococcus) and coliforms shall not be detected.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for raw materials
5 Technical requirements
6 Determination methods
7 Packaging, transportation and storage
8 Labels and instructions
Bibliography
CodeofChina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed by and is under the jurisdiction of the National Health Commission of the People's Republic of China.
Hygienic requirements for antibacterial and bacteriostatic lotion
1 Scope
This standard specified the raw material requirements, technical requirements, inspection methods, packaging, transportation, storage, labeling and instruction requirements for antibacterial and bacteriostatic lotion.
This standard is applicable to antibacterial and bacteriostatic lotion products applied to intact skin, vaginal mucosa and oral mucosa.
2 Normative references
The following referenced documents are indispensable for the application of this document For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging — Pictorial marking for handling of goods
GB 15979 Hygienic standard for disposable sanitary products
GB 38598 General requirement for label and instruction book of disinfection products
Pharmacopoeia of the People's Republic of China
Safety and Technical Standards for Cosmetics
Technical specification for disinfection (2002 Edition)
Hygienic code for disinfectant product manufacturer2 (2009 Edition)
3 Terms and definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
antibacterial lotion
liquid preparations that directly contact human skin or mucosa (excluding feet, eyes, nails, axils, scalp, hair, nasal mucosa, anorectum and other specific parts), which are not for the purpose of treatment or relieving the symptoms of skin or mucosa, and have certain bactericidal action with a killing rate higher than or equal to 90%
3.2
bacteriostatic lotion
liquid preparations that directly contact human skin or mucosa (excluding feet, eyes, nails, axils, scalp, hair, nasal mucosa, anorectum and other specific parts), which are not for the purpose of treatment or relieving the symptoms of skin or mucosa, and have certain bacteriostatic action with a inhibition rate higher than or equal to 90%
3.3
killing rate
percentage used for expressing the reduction number on microorganisms in killing test of microorganisms
[WS/T 466-2014, Definition 4.27]
3.4
inhibition rate
percentage used for expressing the bacteriostatic effect on microorganisms in inhibition test of microorganisms
4 Requirements for raw materials
4.1 The raw materials shall meet the quality requirements of food grade, medical grade, cosmetics and other corresponding standard specified in the currently valid Pharmacopoeia of the People’s Republic of China
4.2 Production water shall meet the requirements of Hygienic code for disinfectant product manufacturer (Edition 2009).
4.3 Product formula shall not be included:
a) the drugs and their raw materials of the same name in the currently valid Pharmacopoeia of the People’s Republic of China;
b) pharmaceutical made of raw materials such as microorganisms, cells, animal or human tissues and body fluids, made by biological technology, and used to prevent, treat and diagnose human diseases, such as vaccines, blood products, biotechnology drugs, microecological agents, immunomodulators, diagnostic products, etc. (except deep ricin and lysostaphin);
c) prohibited substances listed in the currently valid Safety and Technical Standards for Cosmetics (except iodine);
d) other prohibited substances stipulated by the national administrative department of health.
5 Technical requirements
5.1 Physical and chemical indexes
5.1.1 pH value
The pH value shall be controlled within the range of ± 1 of the marked average value.
5.1.2 Content of active ingredients
5.1.2.1 The content of active ingredients shall meet the relevant national standards or the implementation standards of enterprise products.
5.1.2.2 The limit of active ingredients in the specific use liquid shall meet the requirements in Table 1.
Table 1 The limit requirement of active ingredients in antibacterial and bacteriostatic lotion g/L
Item Skin Mucosa
Chlorhexidine gluconate and chlorhexidine acetate ≤45.0 ≤5.0
2,4,4’-trichloro-2’-hydroxydiphenyl ether ≤20.0 ≤3.5
Benzalkonium bromide and benzalkonium chloride ≤5.0 ≤2.0
5.1.3 Limit requirement for lead, arsenic and mercury
The limit of lead, arsenic and mercury shall meet the requirements in Table 2.
Table 2 Limit requirement of lead, arsenic and mercury mg/kg
Item Requirement
Lead (in Pb) ≤10
Arsenic (in As) ≤2
Mercury ≤1
5.1.4 Stability
The validity period of the product shall be longer than or equal to 12 months, and the active content within the validity period shall not be lower than the lowest value of the labeling. If it can't be determined by chemical method, the stability shall be determined by biological method, to verify whether the product could still keep its antibacterial or bacteriostatic effect.
5.2 Requirements for killing (inhibiting) microorganisms by antibacterial and bacteriostatic lotion
5.2.1 Requirements for killing microorganisms with antibacterial lotion
The killing test of microorganisms shall be in accordance with the instruction and the results shall meet the requirements of Table 3.
Table 3 Requirements for killing microorganismsa by antibacterial lotion
Item Action time, min Killing rate, %
Escherichia coli 8099 ≤5 ≥90
Staphylococcus aureus ATCC6538 ≤5 ≥90
Candida albicans ATCC10231b ≤5 ≥90
a This killing test shall be carried out if the label and instruction is indicated that the lotion is having a killing effect on a specific microorganism.
b This killing test shall be carried out if the label and instruction is indicated that the lotion is having a killing effect on fungus or is used on external vulva.
5.2.2 Requirements of antibacterial lotion for inhibition of microorganisms
The inhibition test of microorganisms shall be in accordance with the instruction and the results shall meet the requirements of Table 4.
Table 4 Requirements for inhibiting microorganismsa by bacteriostatic lotion
Item Action time, min Inhibition rate, %
Escherichia coli 8099 ≤5 ≥50
Staphylococcus aureus ATCC6538 ≤5 ≥50
Candida albicans ATCC10231b ≤5 ≥50
a This inhibition test shall be carried out if the label and instruction is indicated that the lotion is having a inhibition effect on a specific microorganism.
b This inhibition test shall be carried out if the label and instruction is indicated that the lotion is having a inhibition effect on fungus or is used on external vulva.
5.2.3 Microbiological indexes
The total number of bacterial colonies shall be less than or equal to 200 CFU/mL; the total number of fungal colonies should be less than or equal to 100 CFU/mL; and pathogenic bacteria (especially staphylococcus aureus, pseudomonas aeruginosa and hemolytic streptococcus) and coliforms shall not be detected.
Contents of GB 38456-2020
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for raw materials
5 Technical requirements
6 Determination methods
7 Packaging, transportation and storage
8 Labels and instructions
Bibliography
