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GB 31612-2023: National food safety standard - Hygienic practice for bacterial preparations for food processing
GB 31612-2023
GB
NATIONAL STANDARD OF THE
PEOPLE'S REPUBLIC OF CHINA
National food safety standard - Hygienic specifications for
the production of strain preparations for food processing
ISSUED ON. SEPTEMBER 6, 2023
IMPLEMENTED ON. SEPTEMBER 6, 2024
Issued by. National Health Commission of the People's Republic of China;
State Administration for Market Regulation.
Table of Contents
1 Scope... 3
2 Terms and definitions... 3
3 Site selection and factory environment... 3
4 Factory buildings and workshops... 4
5 Facilities and equipment... 5
6 Health management... 8
7 Raw materials, food additives, and food-related products... 10
8 Food safety control during production... 11
9 Inspection... 13
10 Storage and transportation of products... 13
11 Product recall management... 14
12 Training... 14
13 Management system and personnel... 14
14 Records and document management... 14
Appendix A Microbiological control of processing... 15
National food safety standard - Hygienic specifications for
the production of strain preparations for food processing
1 Scope
This standard specifies the basic requirements and management guidelines for sites,
facilities, and personnel in the production process of strain preparations for food
processing, such as raw material procurement, strain use and management, processing,
packaging, storage, and transportation.
This standard is applicable to the production of strain preparations for food processing,
and is not applicable to products for direct consumption and distiller's yeast, red yeast
rice, etc. produced by solid-state fermentation technology.
2 Terms and definitions
The terms and definitions defined in GB 14881 and GB 31639 and the following apply
to this standard.
2.1 Original seed lot
Viable bacteria for preparing the main seed lot.
2.2 Main seed lot
A sufficient number of uniform composed viable bacteria formed after passage and
propagation of the original seed lot, which are used for preparing the working seed lot.
2.3 Working seed lot
Viable bacteria obtained from the activation and passage of the main seed lot on a
suitable culture medium, which are used for production.
3 Site selection and factory environment
3.1 Site selection
3.1.1 It shall comply with the relevant provisions of GB 14881.
3.1.2 No factory shall be built near the production sites of biological products,
chemicals, and other products that are produced by using microorganisms.
3.2 Factory environment
It shall comply with the relevant provisions of GB 14881.
4 Factory buildings and workshops
4.1 Design and layout
4.1.1 It shall comply with the relevant provisions of GB 14881.
4.1.2 The factory buildings, equipment layout, and process flow shall be reasonably
connected, the building structure shall be complete, and it shall be able to meet the
requirements of production process and hygiene. The following shall be considered in
the design.
a) Avoid cross-contamination between raw materials, semi-finished products and
finished products;
b) Requirements for temperature, humidity, and other process parameters of the
production process to prevent interference in adjacent workshops;
c) Facilitate the cleaning of the inside and outside of raw material storage tanks,
fermentation tanks, semi-finished product storage tanks, etc.;
d) The air inlet for fermentation, drying, and other processes shall be set in a dry
and clean location, and it shall be easy to clean and replace filter facilities;
e) Prevent strains, contact surfaces, or packaging materials from being
contaminated by microorganisms, chemicals, etc. through reasonable layout,
separation, and other measures.
4.1.3 The production area for bacterial strain preparations shall meet the following
requirements.
4.1.3.1 The operation area shall be divided into general work area, quasi-cleaning work
area, and cleaning work area according to the production process and hygiene
requirements.
4.1.3.2 Effective separation shall be set up between work areas with different
cleanliness classes. An independent air purification system with a filter device shall be
installed in the cleaning work area and positive pressure shall be maintained to prevent
air from non-cleaning work areas from entering the cleaning work area and causing
cross-contamination.
4.1.3.3 The enrichment, emulsification, drying, mixing, and inner packaging of
bacterial cells shall be a cleaning work area (except when the enrichment and
They shall comply with the relevant provisions of GB 14881.
5.1.3 Cleaning and disinfection facilities
They shall comply with the relevant provisions of GB 14881.
5.1.4 Waste storage facilities
They shall comply with the relevant provisions of GB 14881.
5.1.5 Personal hygiene facilities
5.1.5.1 They shall comply with the relevant provisions of GB 14881.
5.1.5.2 Disinfection facilities shall be set up at the entrance to the cleaning work area,
and secondary changing rooms and special work clothes, gloves, etc. for the cleaning
work area shall be equipped as needed.
5.1.6 Ventilation facilities
5.1.6.1 They shall comply with the relevant provisions of GB 14881.
5.1.6.2 Air filtering and regulating facilities shall be installed in the cleaning work area,
and the air filtering device shall be cleaned and replaced regularly. The air in the factory
building shall flow from the cleaning work area with high cleanliness requirements to
the quasi-cleaning work area and general work area with low cleanliness requirements.
Ventilation facilities shall be installed in general work areas to remove moist and dirty
air in a timely manner.
5.1.6.3 The air inlet shall be more than 2 m away from the ground or roof, away from
pollution sources and exhaust outlets, and air filtering equipment shall be installed
according to the requirements of the cleanliness class. The exhaust outlet shall be
equipped with an easy-to-clean, corrosion-resistant mesh cover to prevent animal
intrusion; the ventilation device shall be easy to disassemble, clean, repair, or replace.
5.1.6.4 In areas where odors, toxic and harmful gases, or dust is generated, there shall
be elimination, collection, or control devices.
5.1.7 Lighting facilities
They shall comply with the relevant provisions of GB 14881.
5.1.8 Warehousing facilities
They shall comply with the relevant provisions of GB 14881.
5.1.9 Temperature control facilities
They shall comply with the relevant provisions of GB 14881.
5.2 Equipment
5.2.1 Production equipment
5.2.1.1 General requirements
They shall comply with the relevant provisions of GB 14881.Inoculation equipment,
fermentation equipment, and enrichment equipment shall be equipped, and according
to the characteristics of the product production process, drying equipment shall be
equipped when necessary.
5.2.1.2 Materials
5.2.1.2.1 They shall comply with the relevant provisions of GB 14881.
5.2.1.2.2 Equipment and utensils in contact with semi-finished products and finished
products shall be made of materials with smooth and clean surfaces that comply with
national regulations.
5.2.1.3 Design
It shall comply with the relevant provisions of GB 14881.
5.2.1.4 Inoculation equipment
Equipment related to strain inoculation such as ultra-clean workbench shall be equipped.
5.2.1.5 Fermentation equipment
5.2.1.5.1 Fermentation tanks, etc. that are suitable for the production scale shall be
equippe...