GB 23790-2023National food safety standard - Good manufacturing practice for formula foods for infants and young children (English PDF)

Foreword

This document was issued on 6 September 2023 by the State Administration for Market Regulation; Standardization Administration of the PRC and takes effect on 6 September 2024.

It is a GB standard without the /T suffix: compliance is mandatory in China.

It replaces GB 23790-2010, which is superseded.

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

GB 23790-2023 governs how a plant making formula foods for infants and young children is sited, built, equipped and run, from the choice of ground and the surrounding environment through the layout of buildings and workshops to the facilities and equipment inside them. It carries the process definitions that separate the ways such products are made, and the clause on food safety control during production is the longest in the document, with its own requirements for the powdered infant and young child formula lines. Around that sit health management with its cleaning and disinfection regime, control of raw materials, food additives and food-related products, inspection, storage and transport, product recall, training, the management system and the people who run it, and the records and documents that make a batch traceable. The detail exists because a baby fed on formula has no other diet: a contaminant picked up in a drying tower or a filling room reaches a consumer with no reserve, and a recall that cannot say which batches went where becomes a recall of everything. As a mandatory national standard it is required reading for producers supplying the Chinese market, for their auditors, and for importers qualifying a supplier.

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 degrees C~25 degrees C,

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.

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