GB 23790-2023 PDF English
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB 23790-2023 | English | 230 |
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National food safety standard - Good manufacturing practice for formula foods for infants and young children
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| GB 23790-2010 | English | 85 |
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National food safety standard -- Good manufacturing practice for powdered formulae for infants and young children
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| GB/T 23790-2009 | English | 799 |
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Good manufacturing practice for infant formula factory
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GB 23790-2023: National food safety standard - Good manufacturing practice for formula foods for infants and young children
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB23790-2023
GB
NATIONAL STANDARD OF THE
PEOPLE'S REPUBLIC OF CHINA
National food safety standard - Good manufacturing
practice for formulae for infants and young children
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
Foreword... 3
1 Scope... 4
2 Terms and definitions... 4
3 Site selection and factory environment... 5
4 Factory buildings and workshops... 5
5 Facilities and equipment... 9
6 Health management... 11
7 Food raw materials, food additives, and food-related products... 13
8 Food safety control during production... 13
9 Inspection... 18
10 Storage and transportation of food... 18
11 Product recall management... 18
12 Training... 18
13 Management system and personnel... 19
14 Record and document management... 19
Appendix A Guidelines for environmental monitoring of Salmonella, Cronobacter spp.
(Enterobacter sakazakii) and other Enterobacteriaceae in cleaning work areas of
powdered infant and young child formula foods... 20
Foreword
This standard replaces GB 23790-2010 National food safety standard - Good
manufacturing practice for powdered formulae for infants and young children.
Compared with GB 23790-2010, the main changes in this standard are as follows.
-- The terms and definitions of "cleaning work area", "quasi-cleaning work area"
and "commonly work area" are deleted;
-- The dynamic standard control requirements for the cleaning work area of
production of powdered formula foods for infants and young children are
changed, and the dynamic standard control requirements for the cleaning work
area of production of liquid formula foods for infants and young children are
added;
-- "Enterobacter sakazakii" is changed to "Cronobacter spp. (enterobacter
sakazakii)";
-- The technical requirements for sterilization equipment are added;
-- The technical requirements for production specifications of liquid formula foods
for infants and young children are added;
-- The content that liquid formula foods for infants and young children shall be
tested for commercial sterility in accordance with GB 4789.26 is added;
-- The training requirements for sterilization operators, liquid product filling and
sealing operators, and cleaning and disinfection personnel are added.
National food safety standard - Good manufacturing
practice for formulae for infants and young children
1 Scope
This standard specifies the basic requirements and management guidelines for sites,
facilities, and personnel in the production process of formula foods for infants and
young children such as raw material procurement, processing, packaging, storage, and
transportation.
This standard applies to the production of formula foods for infants and young children
with milk and/or soybeans and their processed products as the main protein source.
2 Terms and definitions
The terms and definitions defined in GB 14881, GB 10765, GB 10766, and GB 10767
apply to this standard.
2.1 Wet (production) process
The production process of processing the ingredients of powdered infant and young
child formula foods in a liquid state into the final product. This process usually includes
batching, heat treatment, concentration, drying, packaging (filling), and other processes.
2.2 Dry (production) process
The production process of physically mixing the ingredients of powdered infant and
young child formula foods in a solid state to produce the final product. This process
usually includes batching, mixing (including premixing), packaging (filling), and other
processes.
2.4 Liquid (production) process
The production process of processing the ingredients of infant and young child formula
food in a liquid state into the final liquid product. This process usually includes batching,
homogenization, sterilization, filling, sealing, and other processes (also includes
sterilization process after filling and sealing).
3 Site selection and factory environment
3.1 It shall comply with the relevant provisions of GB 14881.
4 Factory buildings and workshops
4.1 Basic requirements
They shall comply with the relevant provisions of GB 14881.
4.2 Design and layout
4.2.1 Factory buildings and workshops shall be reasonably designed, planned, and
constructed to be compatible with facilities and equipment to prevent microbial
contamination and growth, especially contamination by Salmonella and Cronobacter
spp. (Enterobacter sakazakii). The following shall be considered in the design.
4.2.2 Reasonable zoning shall be carried out according to the product characteristics,
production technology, and the requirements for cleanliness of the production process,
combined with the actual conditions of the factory building and workshop. Generally,
the factory building and workshop are divided into common work areas, quasi-cleaning
work areas, and cleaning work areas.
4.2.3 Effective separation shall be set up between working areas with different
cleanliness levels
4.2.4 Reasonable and effective control measures shall be taken when entering and
exiting the cleaning work area to avoid or reduce microbial and other contamination.
For personnel, raw materials, packaging materials, waste, equipment, etc.
4.2.5 The dynamic control requirements for the cleaning work area in the production of
powdered infant and young child formula foods shall comply with the provisions in
Table 1.
4.2.6 The cleaning work area for powdered infant and young child formula foods shall
be kept dry. Water supply facilities and systems shall avoid passing through the upper
space of the main production work area. If this cannot be avoided, protective measures
shall be taken to prevent pollution.
4.2.7 Factory buildings, workshops, and warehouses shall have facilities to prevent pest
intrusion.
5 Facilities and equipment
5.1 Basic requirements
They shall comply with the relevant provisions of GB 14881.
5.2 Drainage facilities
5.3 Personal hygiene facilities
5.3.1 The changing rooms (including for changing shoes or wearing shoe covers), hand
washing and hand drying facilities, and disinfection facilities shall be set up near the
entrance of the production site or production workshop.
5.4 Ventilation facilities
5.4.1 The temperature and humidity of the clean working area where powdered infant
and young child formula foods are produced shall be adjustable, and a monitoring
device shall be installed.
5.4.2 Effective measures shall be taken for outdoor air inlets to prevent animals or other
foreign objects from entering, such as being more than 2 m away from the ground or
roof, and setting up fences.
5.4.3 Compressed air or other gases used for food production and cleaning food contact
surfaces and equipment shall be filtered and purified to prevent indirect pollution.
5.4.4 In areas where odors, gases (steam and harmful gases), or dust are generated that
may contaminate food, there shall be appropriate elimination, collection, or control
devices.
5.4.5 A purification air-conditioning system shall be installed in the cleaning work area
to prevent steam condensation and keep the indoor air fresh; ventilation facilities shall
be installed in the common work area or ensure good ventilation to remove moist and
dirty air in a timely manner.
5.4.6 The ventilation facilities of the production area and the inspection room shall be
kept independent of each other. The exhaust outlet of the ventilation facilities in the
inspection room shall not pollute the fresh air supplementary inlet in the production
area.
5.5 Equipment
5.5.1 Production equipment shall have obvious operating status signs to indicate its
status of normal, repair, out-of-use, limited, etc., and shall be repaired and maintained
regularly.
5.5.2 Compressed air or other inert gases used for food and food contact surfaces shall
be filtered and purified at least to remove oil, water, bacteria, dust, etc.
5.5.5 The production equipment of liquid infant and young child formula foods shall
also meet the following requirements.
5.5.6 When a computer system and its network technology are used for critical control
point monitoring data collection and record management, the relevant functions of the
computer system and its network technology may refer to the provisions of Appendix
A in GB 12693.
6 Health management
6.1 Basic requirements
They shall comply with the relevant provisions of GB 14881.
6.2 Cleaning and disinfection
6.2.1 In cleaning work areas that require dry operations (such as dry mixing, filling, and
packaging), an effective dry-cleaning process shall be implemented for the production
equipment and processing environment, and wet cleaning shall be avoided as much as
possible. Wet cleaning shall be limited to equipment parts that can be moved to a
dedicated room or the situation that drying measures can be taken immediately after
wet cleaning.
6.2.3 Effective supervision measures shall be developed to ensure that key processes
such as manual cleaning, cleaning in place operations (CIP), and equipment
maintenance comply with relevant regulations and standard requirements, especially to
ensure the applicability of cleaning and disinfection plans,
6.2.4 A cleaning and disinfection plan shall be formulated for the cleaning work area to
ensure that all zones of the cleaning work area are cleaned. A cleaning or disinfection
plan shall be developed for quasi-cleaning work areas and common work areas based
on needs to prevent cross-contamination.
6.3 Work clothes management
Employees in the cleaning work area shall wear work clothes (or disposable work
clothes) that meet the hygiene requirements of the area, and be equipped with hats,
masks, and work shoes.
7 Food raw materials, food additives, and food-related products
7.1 They shall comply with the relevant provisions of GB 14881.
7.2 The food raw materials and food additives used shall comply with the requirements
of corresponding national standards and/or relevant regulations, and shall ensure the
safety of infants and young children and meet their nutritional needs. The supplier
management, transportation, storage, procurement, and acceptance of raw milk shall
7.3 For raw materials and food additives that directly enter the dry mixing process,
measures shall be taken to ensure that the microbial indicators meet the requirements
of product standards. For raw materials containing soybeans or soy protein components,
the urease activity shall be ensured to be negative.
7.4 Suppliers shall be evaluated, and if necessary, on-site reviews shall be conducted or
the production process shall be monitored.
7.5 Food additives shall be strictly managed, special warehouses or storage areas shall
be set up, clearly marked to avoid cross-contamination and misuse, and a special
register (or warehouse management software) shall be used to record the food additive’s
name, manufacturer or supplier, production date or production batch number, purchase
date, purchase quantity, and usage, etc.
7.6 The food raw materials, food additives, and packaging materials in stock shall be
inspected regularly.
7.7 When automated warehouses are used to store food raw materials and food additives,
effective control measures shall be established for the reliability of the automation
system.
8 Food safety control during production
8.1 Basic requirements
8.1.1 They shall comply with the relevant provisions of GB 14881.
8.2 Special requirements for the production process of powdered infant and young
child formula foods
8.2.1 Heat treatment (wet and dry-wet combined production processes)
8.2.1.1 The heat treatment process shall be regarded as a key control point to ensure the
safety of powdered infant and young child formula foods.
8.2.1.3 Key process parameters such as time, temperature, and enzyme inactivation time
during heat treatment shall be recorded.
8.2.2 Intermediate storage
8.2.2.1 In wet and dry-wet combined processes, corresponding measures shall be taken
for the intermediate storage of liquid semi-finished products to prevent the growth of
microorganisms.
8.2.3 Drying
All conveying pipes and equipment from heat treatment to drying shall be kept airtight
and cleaned and disinfected regularly.
8.2.4 Cooling
In the production of wet and dry-wet combined processes, monitoring measures shall
be established for the air inlet temperature of the fluidized bed and the temperature of
the semi-finished product at the outlet of the fluidized bed. If the dried bare semi-
finished powder needs to be cooled, it shall be cooled and sealed storage in a clean
working area.
8.2.5 Dry mixing
8.2.5.1 Bare powder processes that are in contact with ambient air (such as feeding,
batching, mixing, and filling in dry mixing) shall be carried out in a cleaning work area.
The temperature and relative humidity of the cleaning work area shall be compatible
with the production process of powdered infant and young child formula foods. When
there are no special requirements, the temperature shall be controlled at 16 ℃~25 ℃,
and the relative humidity shall be below 65%.
8.2.5.5 Strict hygiene control requirements shall be established for raw materials,
packaging materials, and personnel. Raw materials shall enter the work area through
necessary cleaning procedures and material channels, and shall follow the procedures
for removing the outer packaging or cleaning and disinfecting the outer packaging.
8.2.6 Inner packaging
8.2.7 Environmental monitoring requirements
Environmental monitoring measures shall be established for Salmonella, Cronobacter
spp. (Enterobacter sakazakii) and other Enterobacteriaceae in the cleaning work area of
powdered infant and young child formula foods, and the monitoring requirements shall
comply with the requirements of Appendix A.
8.3 Special requirements for the production process of liquid infant and young
child formula foods
8.3.1 Product technology
8.3.2 Washing, sterilization, and clean-keeping of packaging containers
8.3.2.1 Food containers, packaging materials, detergents, and disinfectants that comply
with national food safety standards and are approved by the health administrative
department shall be used.
8.3.2.2 Packaging materials, containers, and equipment after final cleaning shall be
handled to avoid recontamination.
8.3.4 Filling of products
8.3.4.1 Automatic mechanical devices shall be used for product filling, and manual
operation is not allowed.
8.3.5 Sterilization of products
8.3.5.1 A suitable sterilization process needs to be established based on the heating
characteristics of the product and the death kinetics of specific target microorganisms.
The product is heated to sterilization temperature and shall be maintained at that
temperature for a certain period of time to ensure commercial sterility. All sterilization
processes shall be verified to ensure process reproducibility and reliability.
The determination process, results, and processing methods shall be recorded in detail.
8.3.6 Verification of sterilization effect
8.3.6.1 The sterilization process parameters (such as sterilization temperature,
sterilization time, and sterilization pressure) of the product shall be comprehensively
determined based on the product characteristics of the liquid infant and young child
formula foods, and the sterilization process effect shall be verified.
8.3.6.2 Methods such as measuring (or calculating) the F0 value of the sterilization
intensity shall be adopted to ensure that the sterilization parameters and sterilization
intensity meet the necessary sterilization requirements.
9 Inspection
9.1 General requirements
All item inspections shall be carried out in accordance with relevant regulations.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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