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GB 23790-2023: National food safety standard - Good manufacturing practice for formula foods for infants and young children
GB 23790-2023
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
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.
2.3 Dry-wet combined (production) process
A complete production process in which part of the ingredients of powdered infant and
young child formula foods are processed in a liquid state, dried, and then another part
of the solid ingredients is added by using a dry process, and then packaged (filled) to
make the final product.
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.
3.2 It shall be kept away from livestock and poultry farms, and animals shall not be
raised in the factory area.
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:
a) Wet areas and dry areas shall be effectively separated; contamination caused
by personnel, equipment, facilities, and material flow shall be effectively
controlled to prevent microorganisms that are easily harmful to infants and
young children from entering the cleaning work area, such as Salmonella,
Cronobacter spp. (Enterobacter sakazakii).
b) The cleaning work area shall prevent the generation of condensation water.
c) The wet cleaning process shall be reasonably designed, and improper wet
cleaning shall be prevented in dry areas.
d) All kinds of pipes, cables, and penetration gaps that pass through the floor,
ceiling, and wall of the building shall be enclosed or sealed.
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.
a) The common work areas include the milk collection room, raw material
warehouse, packaging material warehouse, outer packaging workshop and
finished product warehouse, sterilization area for the sterilizing-after-filling
liquid products after filling and sealing, etc.
b) The quasi-cleaning work areas include raw material pretreatment workshops,
raw material inner packaging cleaning or packaging material disinfection or
tunnel sterilization areas, wet processing areas for powdered products (such as
weighing, batching, and concentration), areas for weighing, batching, heat
treatment, disinfection or sterilization of liquid products, filling area for the
sterilizing-after-filling liquid products, etc.
c) The cleaning work areas include workshops where food is in contact with the
air environment and there are no subsequent disinfection or sterilization
operations (such as weighing, batching, and mixing), filling areas for liquid
aseptic filling products, and auxiliary areas with special cleaning requirements
(such as temporary storage rooms for temporarily storing cleaned and
disinfected inner packaging), storage areas for exposed semi-finished products
to be packaged, filling and inner packaging workshops, etc.
4.2.3 Effective separation shall be set up between working areas with different
cleanliness levels. 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
unpurified air from entering the cleaning work area and causing cross-contamination.
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. that enter and
exit the cleaning work area, measures shall be taken to prevent cross-contamination,
such as setting up changing rooms for personnel to change work clothes, work shoes or
shoe covers, dedicated logistics channels, and waste sealing protection. For materials
transported through pipelines by using airflow as a carrier to enter the cleaning work
area, an appropriate air filtration system shall be designed and installed for the carrier
airflow.
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. The dynamic control requirements for the cleaning work area in the production
of liquid infant and young child formula foods shall comply with ...