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GB 38456-2020: Hygienic requirements for antibacterial and bacteriostatic lotion
GB 38456-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080
C 50
Hygienic requirements for antibacterial and bacteriostatic
lotion
ISSUED ON: NOVEMBER 17, 2020
IMPLEMENTED ON: DECEMBER 01, 2021
Issued by: State Administration for Market Regulation;
Standardization Administration of the People's Republic of China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 4
4 Requirements for raw materials ... 5
5 Technical requirements ... 6
6 Testing methods ... 8
7 Packaging, transportation and storage ... 9
8 Labels and Instructions ... 10
Bibliography ... 11
Hygienic requirements for antibacterial and bacteriostatic
lotion
1 Scope
This Standard specifies the raw materials, technical requirements, testing methods,
packaging, transportation, storage, label and instructions requirements for antibacterial
and bacteriostatic lotion.
The Standard applies to antibacterial and bacteriostatic lotion products for use on intact
skin, vaginal 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 and storage marks
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
Technical specification for cosmetics safety 1
Technical specification for disinfection 2 (Edition 2002)
Hygienic standard for manufacturers of disinfection products 2 (Edition 2009)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 antibacterial lotion
A liquid preparation that is directly contact with human skin or mucous membranes
(excluding human feet, eyes, nails, armpits, scalp, hair, nasal mucous membranes,
1 The document was issued by the former State Food and Drug Administration.
2 The document was issued by the former Ministry of Health of the People's Republic of China.
anorectal and other specific parts), not for the purpose of treating diseases or improving
symptoms of skin and mucous membranes, with certain sterilization effect, and the
killing rate is greater than or equal to 90%.
3.2 bacteriostatic lotion
A liquid preparation (except suppository and soap) that is directly contact with human
skin or mucous membranes (excluding human feet, eyes, nails, armpits, scalp, hair,
nasal mucous membranes, anorectal and other specific parts), not for the purpose of
treating diseases or improving symptoms of skin and mucous membranes, with certain
sterilization effect, and the inhibition rate is greater than or equal to 50%.
3.3 killing rate
In the microbial killing test, the value of the reduction of microorganisms expressed as
a percentage.
[WS/T 466-2014, definition 4.27]
3.4 inhibition rate
In the microbial inhibition test, the value of the microbial antibacterial effect expressed
as a percentage.
4 Requirements for raw materials
4.1 Raw materials shall meet the quality requirements of the currently valid
Pharmacopoeia of the People's Republic of China for food level, medical level,
cosmetics and other corresponding standards.
4.2 Production water shall meet the requirements of Hygienic standard for
manufacturers of disinfection products (Edition 2009).
4.3 Product formulations must not contain:
a) Drugs and raw materials with the same names listed in the currently effective
Pharmacopoeia of the People's Republic of China;
b) Preparations made from microorganisms, cells, animal or human-derived tissues
and body fluids and biological techniques for the prevention, treatment and
diagnosis of human diseases, such as vaccines, blood products, biotechnological
drugs, probiotics, immune Regulators, diagnostic products, etc. (except deep
castor enzyme and lysostaphin);
c) Prohibited substances listed in the currently valid Technical specification for
cosmetics safety (except iodine);
6.4.1 Testing of total number of bacterial colonies
Test according to the method in GB 15979.
6.4.2 Testing of coliform bacteria
Test according to the method in GB 15979.
6.4.3 Testing of staphylococcus aureus
Test according to the method in GB 15979.
6.4.4 Testing of hemolytic streptococcus
Test according to the method in GB 15979.
6.4.5 Testing of pseudomonas aeruginosa
Test according to the method in GB 15979.
6.4.6 Testing of total fungal colonies
Test according to the method in GB 15979.
6.5 Test methods for toxicological safety
Test according to the method in Technical specification for disinfection (Edition 2002).
7 Packaging, transportation and storage
7.1 Packaging
The packaging shall be tight to prevent moisture. Packaging marks shall meet the
requirements of GB/T 191.
7.2 Transportation
It shall be airtight during transportation. Shipping containers shall be anti-corrosive.
Loading and unloading shall be handled with care. Throwing is strictly prohibited. It
shall be protected from sun, rain and moisture during transportation.
7.3 Storage
7.3.1 Store in a cool, dry and dark place.
7.3.2 Stacking shall be more than 10 cm above the ground. Stack height shall not exceed
12 boxes. The distance from the wall shall be more than 20 cm.