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GB 23790-2023: National food safety standard - Good manufacturing practice for formula foods for infants and young children Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB 23790: Historical versions
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 ContentsForeword... 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... 20ForewordThis 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 children1 ScopeThis 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 definitionsThe 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 environment3.1 It shall comply with the relevant provisions of GB 14881.4 Factory buildings and workshops4.1 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 equipment5.1 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 management6.1 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 products7.1 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 production8.1 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 Inspection9.1 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. |
