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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 the provisions in Table
2, and the inspection shall be carried out regularly. The number of settling microbes in
the air in the quasi-cleaning work area shall be ???50 CFU/dish (measured according to
GB/T 16294 for 5 minutes) and shall be monitored and recorded.
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
5.2.1 In the cleaning work area where powdered infant and young child formula foods
are produced, drainage facilities shall be avoided. If necessary, appropriate measures
shall be taken to keep the drainage facilities in a dry state during production.
5.2.2 Drainage facilities shall have a slope, be kept smooth, and be easy to clean. There
shall be no dead corners for cleaning at the joints between the sides and bottom of the
drainage ditch, or corresponding measures shall be taken to prevent the generation of
water accumulation. Drainage facilities in the work area shall avoid sewage backflow
and turbid gas escape, and hygienic clean floor drains shall be used when necessary.
5.2.3 There shall be no water supply pipelines for production water in and below the
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.
5.3.2 Necessary cleaning measures shall be taken before personnel enter the cleaning
work area, and a dedicated changing room shall be set up at the entrance of the
personnel. Hand disinfection facilities shall be set up at the entrance of the cleaning
work area, but hand washing facilities do not need to be set up.
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. They shall be far away from pollution sources and exhaust
outlets, and shall be equipped with air filtering equipment. The exhaust outlet shall be
equipped with an easy-to-clean, corrosion-resistant mesh cover to prevent animal
intrusion.
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. When air conditioning, air intake and exhaust, or fans are
used in the factory building, the air shall flow from areas with high cleanliness
requirements to areas with low cleanliness requirements to prevent food, production
equipment, and inner packaging materials from being contaminated.
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. Equipment installation, repair, and maintenance operations shall not affect
the quality of the product. It shall be ensured that the performance of the repaired
equipment meets the process requirements and it shall be verified if necessary.
Equipment that is out of service for any reason shall be cleaned and protected, and
clearly marked. Equipment operating status identification should be displayed by an
automated control system or manually identified.
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. before use
(outsourced qualified products that meet production requirements can be used directly).
5.5.3 The inner walls and welds of equipment in contact with materials shall be smooth,
flat, without dead corners, easy to clean, and corrosion-resistant. The inner surface shall
be made of materials that do not react with materials, release particles, or absorb
materials. They shall not cause stagnation or accumulation of materials.
5.5.4 For the production of powdered and liquid infant and young child formula foods,
after the sterilization equipment is installed, the sterilization effect of the materials shall
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.
6.2.2 The following measures shall be taken for cleaning work areas that need to be
kept dry:
a) Adopt a dry-cleaning process suitable for the place and equipment. When
using a disinfectant containing necessary moisture, it shall be able to ensure
that the cleaning work surface is dry, or dry cleaning shall be carried out in a
dry state without using disinfectants;
b) When using wet cleaning measures under controlled conditions, it shall be
ensured that the equipment and environment can be restored to dryness in a
timely and thorough manner so that the area is not contaminated;
c) Mixing cleaning tools in different work areas shall be avoided.
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, the type and concentration
of cleaning agents and disinfectants are appropriate, and the CIP system meets the
relevant temperature and time require...