GB 4789.12-2025 National food safety standard -Food microbiological examination - Examination of botulinum neurotoxin-producing Clostridia and botulinum neurotoxin
1 Scope
This standard specifies the examination methods for botulinum neurotoxin-producing Clostridia and botulinum neurotoxin in food.
This standard is applicable to the examination of botulinum neurotoxin-producing Clostridia and botulinum neurotoxin in food.
2 Terms and definitions
botulinum neurotoxin-producing Clostridia
a general term for Gram-positive anaerobic bacilli that can form oval spores, generally larger than the cell and located subterminally, and are capable of producing botulinum neurotoxin under suitable culture conditions, including Clostridium botulinum, Clostridium butyricum, etc.
3 Equipment and materials
In addition to conventional sterilization and incubation equipment used in microbiological laboratories, other equipment and materials required are as follows.
3.1 Refrigerator: 2°C~8°C, -18°C~-20°C, and -80°C.
3.2 Balance: sensitivity of 0.1g and 0.001g.
3.3 pH meter, pH colorimetric tube, or precision pH test paper.
3.4 Sterile scissors, forceps, and reagent spoon.
3.5 Stomacher blender or sterile mortar.
3.6 Centrifuge: 3 000g and 14 000g.
3.7 Anaerobic culture devices: anaerobic incubator, anaerobic jar, anaerobic bag, or devices providing equivalent anaerobic effect.
3.8 Constant temperature incubator: 36°C±1°C and 28°C±1°C.
3.9 Constant temperature device: 36°C±1°C, 60°C±1°C, 80°C±1°C, and 100°C±1°C.
3.10 Microscope: 100×~1 000×.
3.11 Conventional PCR instrument and real-time fluorescence PCR instrument.
3.12 Conventional electrophoresis apparatus or capillary electrophoresis apparatus.
3.13 Gel imaging system or ultraviolet detector.
3.14 Nucleic acid protein analyzer or ultraviolet spectrophotometer.
3.15 Micropipettes and matching sterile tips: 2 μL, 10 μL, 20 μL, 100 μL, 200 μL, 1 000 μL.
3.16 Sterile pipettes: 1 mL (with 0.01 mL graduations), 10 mL (with 0.1 mL graduations), and 25 mL (with 0.1 mL graduations).
3.17 Sterile conical flasks: 100 mL.
3.18 Petri dishes: diameter of 90 mm.
3.19 Centrifuge tubes: 1.5 mL, 5 mL, and 50 mL.
3.20 Sterile filters: membranes with pore sizes of 0.45 μm and 0.22 μm.
3.21 PCR reaction tubes.
3.22 Sterile syringes: 1 mL.
3.23 Mice: body weight of 15g to 20g. Each batch of tests shall use KM (Kunming) or ICR mice of the same strain and single sex, the weight difference between individuals of the same sex shall not exceed ±20% of the average weight, and if female, they shall be unmated and non-pregnant.
Contents
Foreword i
1 Scope
2 Terms and definitions
3 Equipment and materials
4 Culture media and reagents
5 Examination procedures
6 Operation steps
7 Results and report
Annex A Culture media and reagents
Standard
GB 4789.12-2025 National food safety standard - Food microbiological examination - Examination of Clostridium botulinum toxin and botulinum toxin (English Version)
Standard No.
GB 4789.12-2025
Status
to be valid
Language
English
File Format
PDF
Word Count
8500 words
Price(USD)
255.0
Implemented on
2026-3-2
Delivery
via email in 1 business day
Detail of GB 4789.12-2025
Standard No.
GB 4789.12-2025
English Name
National food safety standard - Food microbiological examination - Examination of Clostridium botulinum toxin and botulinum toxin
Chinese Name
食品安全国家标准 食品微生物学检验 产肉毒毒素梭菌及肉毒毒素检验
Chinese Classification
Professional Classification
GB
ICS Classification
Issued by
National Health Commission and State Administration for Market Regulation
GB 4789.12-2025 National food safety standard -Food microbiological examination - Examination of botulinum neurotoxin-producing Clostridia and botulinum neurotoxin
1 Scope
This standard specifies the examination methods for botulinum neurotoxin-producing Clostridia and botulinum neurotoxin in food.
This standard is applicable to the examination of botulinum neurotoxin-producing Clostridia and botulinum neurotoxin in food.
2 Terms and definitions
botulinum neurotoxin-producing Clostridia
a general term for Gram-positive anaerobic bacilli that can form oval spores, generally larger than the cell and located subterminally, and are capable of producing botulinum neurotoxin under suitable culture conditions, including Clostridium botulinum, Clostridium butyricum, etc.
3 Equipment and materials
In addition to conventional sterilization and incubation equipment used in microbiological laboratories, other equipment and materials required are as follows.
3.1 Refrigerator: 2°C~8°C, -18°C~-20°C, and -80°C.
3.2 Balance: sensitivity of 0.1g and 0.001g.
3.3 pH meter, pH colorimetric tube, or precision pH test paper.
3.4 Sterile scissors, forceps, and reagent spoon.
3.5 Stomacher blender or sterile mortar.
3.6 Centrifuge: 3 000g and 14 000g.
3.7 Anaerobic culture devices: anaerobic incubator, anaerobic jar, anaerobic bag, or devices providing equivalent anaerobic effect.
3.8 Constant temperature incubator: 36°C±1°C and 28°C±1°C.
3.9 Constant temperature device: 36°C±1°C, 60°C±1°C, 80°C±1°C, and 100°C±1°C.
3.10 Microscope: 100×~1 000×.
3.11 Conventional PCR instrument and real-time fluorescence PCR instrument.
3.12 Conventional electrophoresis apparatus or capillary electrophoresis apparatus.
3.13 Gel imaging system or ultraviolet detector.
3.14 Nucleic acid protein analyzer or ultraviolet spectrophotometer.
3.15 Micropipettes and matching sterile tips: 2 μL, 10 μL, 20 μL, 100 μL, 200 μL, 1 000 μL.
3.16 Sterile pipettes: 1 mL (with 0.01 mL graduations), 10 mL (with 0.1 mL graduations), and 25 mL (with 0.1 mL graduations).
3.17 Sterile conical flasks: 100 mL.
3.18 Petri dishes: diameter of 90 mm.
3.19 Centrifuge tubes: 1.5 mL, 5 mL, and 50 mL.
3.20 Sterile filters: membranes with pore sizes of 0.45 μm and 0.22 μm.
3.21 PCR reaction tubes.
3.22 Sterile syringes: 1 mL.
3.23 Mice: body weight of 15g to 20g. Each batch of tests shall use KM (Kunming) or ICR mice of the same strain and single sex, the weight difference between individuals of the same sex shall not exceed ±20% of the average weight, and if female, they shall be unmated and non-pregnant.
Contents of GB 4789.12-2025
Contents
Foreword i
1 Scope
2 Terms and definitions
3 Equipment and materials
4 Culture media and reagents
5 Examination procedures
6 Operation steps
7 Results and report
Annex A Culture media and reagents
