Details of the review of beverage production licenses: Review requirements for bottled (barreled) drinking water production licenses

Beverage products subject to food production license management refer to products that are quantitatively packaged, can be drunk directly or mixed with water, and have an ethanol content not exceeding 0.5% by mass. They include: bottled (barreled) drinking water, carbonated beverages (soda), tea (type) beverages, fruit and vegetable juices and their beverages, protein beverages, solid beverages and other beverages.

Section 1 Scope of License

Article 5 Bottled (barreled) drinking water subject to food production license management refers to water that is directly sourced from the surface, underground or public water supply system, processed and sealed in packaging materials and products for direct drinking. The category number of bottled (barreled) drinking water production license is 0601, including: drinking natural mineral water, packaged drinking water (drinking purified water, drinking natural spring water, drinking natural water, other drinking water).

Article 6 Drinking natural mineral water refers to water that naturally emerges from deep underground or is drilled and collected, contains a certain amount of minerals, trace elements or other components, is uncontaminated in a certain area and takes preventive measures to avoid contamination; under normal circumstances, its dynamic indicators such as chemical composition, flow rate, water temperature, etc. are relatively stable within the range of natural periodic fluctuations.

Article 7 Packaged drinking water refers to water that is sealed in packaging materials and products that meet food safety standards and relevant regulations and can be directly drunk (except drinking natural mineral water).

Section 2 Production Site Verification

Article 8 Production sites should generally have water treatment areas, filling protection areas, packaging areas, warehouses for raw and auxiliary materials and packaging materials, and finished product warehouses. When using turnable containers to produce bottled (barreled) drinking water, a separate inspection and pretreatment area for the turnover containers should be set up. Turnover containers must not be stored in the open air to avoid contamination. If food additives (except gases) are used, a batching area should be set up.

Article 9 Production workshops are generally divided into: non-food production and processing areas (offices, power distribution, power equipment, inspection rooms, etc.), general operation areas (water treatment areas, storage areas, outer packaging areas, inspection areas for turnover containers, etc.), quasi-clean operation areas (batch areas, pre-packaging cleaning and disinfection areas, etc.), and clean operation areas (filling protection areas, etc.).

Article 10 A dressing room, hand washing, hand drying and disinfection facilities, shoe changing (wearing shoe covers) or work shoe disinfection facilities should be set up at the entrance of the production site or production workshop.

Article 11 A secondary dressing area, hand washing, hand drying and (or) disinfection facilities, shoe changing (wearing shoe covers) or work shoe disinfection facilities, and air shower facilities should be set up at the entrance of the clean operation area. The equipment for bottle blowing, filling, and capping (sealing) with its own clean room and clean environment automatic recovery function, and the equipment that forms a clean working environment inside it may not be set up in the clean operation area, and the above facilities may not be set up at the entrance of the filling protection area:

Article 12 The filling protection area filters and purifies the air, and an Air Filter device should be installed and cleaned regularly. The air cleanliness (suspended particles, settling bacteria) of the filling protection area should reach 10,000 mesh when static, and the filling part should reach 100, or the overall cleanliness should reach 1000.

Section 3 Equipment and Facility Verification

Article 13 Production equipment shall be equipped according to actual process needs, generally including: water storage equipment (raw water storage, finished water storage, etc.), water treatment equipment, cleaning and disinfection system, cleaning and disinfection equipment (bottle, barrel and cap cleaning and disinfection), fully automatic filling and capping equipment (manual filling and capping are prohibited), automatic coding equipment, etc. Water storage badgers for food processing should be equipped with air respirators. If a blowing, filling and capping integrated equipment is used, and the equipment has its own empty bottle dust removal and bottle cap disinfection functions, it is not necessary to set up a separate cleaning and disinfection equipment. The addition of food additives must be controlled by automated control equipment, and manual addition is prohibited. Water from non-public water supply systems, such as drinking natural mineral water, drinking natural spring water, and drinking natural water, as source water for production, should be transported in closed pipelines to prevent contamination, and cannot be transported to other places in containers.

Article 14 Water treatment equipment should include: coarse water treatment equipment, fine water treatment equipment, sterilization/sterilization equipment (such as ozone generator and mixing equipment, ultraviolet sterilization equipment, filtration and sterilization equipment), etc. Drinking pure water should also have anti-sea permeation equipment or distillation equipment or other deionization equipment. If filtration and sterilization equipment is used, the membrane pore size should be at least 0.45um.

Article 15 If the turnover container is used to produce bottled (barreled) drinking water, it should also be equipped with an empty barrel external washing machine, an empty barrel capping machine, an empty barrel automatic internal washing and disinfection equipment, a light inspection equipment, and a barrel mouth thermoplastic film surface sealing equipment.

The internal cleaning and disinfection equipment of the empty barrels used in turnover should be continuous automated equipment, including at least: pre-cleaning, detergent cleaning, disinfectant cleaning, water rinsing, finished product water rinsing, etc., and no less than 10 cleaning and disinfection stations (including draining process).

If plastic and other soft packaging materials are used to produce bottled (barreled) drinking water, the filling equipment should have sterilization devices such as film washing sterilization or ultraviolet rays. If self-supporting bags are used for filling, the capping and screwing should be fully automated.

Article 16 The inspection equipment that bottled (barreled) drinking water production enterprises should have at least includes: sterile room (or ultra-clean workbench), sterilizing pot, microbial incubator, biological microscope (or colony counter), turbidity meter, acidity meter and conductivity meter (applicable to pure water), analytical balance (0.1mg) (not required when the standard reagent uses platinum cobalt colorimetry to measure color) and related measuring instruments.

Section 4 Equipment Layout and Process Flow

Article 17 The equipment layout should be designed according to the process flow, generally including: coarse filtration, fine filtration, sterilization, filling and capping and light inspection (or automatic monitoring) of water source water. Drinking pure water and other drinking water also include deionization purification (ion exchange, reverse osmosis, distillation, etc.), and other drinking water also includes ingredients and other processes. Specific products are produced according to the actual process flow of the enterprise, but its process flow must be scientific and reasonable and comply with relevant regulations.

Article 18 Water source control. If water from a public water supply system is used as the source water for production, the water quality of the source water, such as pH value, conductivity, and residual gas, should be monitored regularly; if surface water or groundwater from a non-public water supply system is used as the source water for production, the water quality fluctuation (such as water temperature, etc.) should be monitored to determine whether the water source is abnormal due to external influences. The monitoring frequency is at least once each year during the flood season and the dry season. In special circumstances such as earthquakes and floods, the number of monitoring times should be increased.

Article 19 Filtration (coarse filtration, fine filtration) control. When using sand filters, carbon filters, security filters, precision filters, membrane filters, etc., enterprises should regularly monitor and record their filtration effects. For example, membrane filtration equipment should have a membrane integrity monitoring instrument (such as a pressure gauge), and should also regularly replace the filter membrane or filter material according to the filtration effect, and regularly backwash and clean it.

Article 20 Deionization purification control. If pure water and other drinking water have this process, the degree of purification should be regularly monitored and recorded; if ion exchange resins are used for purification, the ion exchange resins and regeneration salts must meet the relevant requirements.

Article 21 Ingredient control. If there is such a process, the ingredient name, purchase time, batch number, etc. should be strictly checked and recorded, and the ingredient device should be calibrated regularly; the ingredients should be reviewed and confirmed.

Article 22 Sterilization control. If the ozone disinfection process is adopted, the ozone concentration should be strictly controlled under the premise of ensuring the sterilization effect to avoid or reduce the production of bromate. If the ultraviolet disinfection process is adopted, the ultraviolet intensity should be monitored regularly; when the ultraviolet intensity drops below the specified requirements, it should be replaced in time to keep the surface of the ultraviolet lamp clean. If the filtration sterilization process is adopted, the filter membrane or filter material should be replaced regularly, backwashed and cleaned regularly, and the membrane performance should be checked.

Article 23 Filling and capping control. Before filling the product, the corresponding foreign matter control device should be set, and the filling temperature, filling volume, etc. should be controlled according to the production process requirements. The capping (mouth) should control the capping torque, capping pressure and other capping sealing parameters. After filling and capping, the product appearance, filling volume and container condition should be checked.

Section 5 Personnel Verification

Article 24 Food safety management personnel, food safety professional and technical personnel, inspection personnel, and production personnel (including personnel directly engaged in water supply and management) must obtain a health certificate before they can take up their posts, and undergo a health check at least once a year.

Section 6 Management System Review

Article 25 A review system for suppliers of raw materials, auxiliary materials, and packaging materials should be established, and regular review and evaluation should be conducted; the food safety responsibilities of both parties should be clearly stated in the contract signed with the supplier.

Article 26 A purchase inspection record system should be established. If the production source water comes from a public water supply system, the water quality should meet the requirements of the "Sanitary Standard for Drinking Water" (GB 5749); if the production source water comes from a non-public water system (surface water, groundwater), the water quality should meet the sanitary requirements of the "Sanitary Standard for Drinking Water" (GB 5749) for drinking water sources (except pH value). After the source water is treated, the water quality of food processing water should meet the requirements of GB5749, and the source water of drinking natural mineral water should meet the provisions of "Drinking Natural Mineral Water" (GB 8537).

The exploitation of drinking natural mineral water, drinking natural spring water, and drinking natural water sources must be approved by the relevant management departments and have a "Water Extraction Permit" (implemented according to local specific policies); the water source of drinking natural mineral water should also have a water source evaluation report, a "Mining Permit" (implemented according to local policies), and a water source water quality tracking and monitoring report; other substances added to drinking water should comply with the "National Food Safety Standard Food Additives Use Standard" (GB 2760) and the relevant announcements of the State Council's health administrative department. The barrels for recycling should comply with relevant regulations and be made of food-grade polycarbonate (PC) and other materials. After recycling, they must be checked for damage and contamination.

Article 27 A production process management system should be established to control the quality and safety of water treatment, ingredients (if there is such a process), sterilization, filling and capping, cleaning and disinfection, storage and transportation, and delivery in the production process.

Water treatment should specify the cleaning and replacement requirements of the filter device, formulate the control indicators of the treated water and monitor and record them. If there is an ingredient process, it needs to be reviewed and confirmed. Sterilization should specify the sterilization method, sterilization conditions and evaluation method of the sterilization effect. The filling and capping should specify the capping method, equipment and materials to ensure that the seal is tight, the container is not damaged, and the water quality is not polluted. During the production process, the concentration (or parameters) of the cleaning agent and disinfectant should be checked regularly to verify the cleaning and disinfection effect of the bottle (barrel) and the cap, the residual disinfectant, and record it. The cleaning of the turnover barrel should set a reasonable flushing time, pressure, concentration of detergent and disinfectant, etc. to ensure the cleaning and disinfection effect of the empty barrel. Compressed air that directly contacts the product or packaging should be degreased, dehydrated and filtered.

Article 28 The hygiene monitoring requirements should be reasonably set in accordance with the "National Food Safety Standard Packaged Drinking Water Production Hygiene Specification" (GB 19304) and refer to the "National Food Safety Standard General Hygiene Specification for Food Production" (GB 14881) Appendix "Guidelines for Microbiological Monitoring Procedures in Food Processing".

Article 29 Enterprises should formulate inspection management systems, including management regulations for raw materials, processes, factory and type inspections. The inspection capacity shall at least meet the determination of total colony count, coliform group, turbidity (if necessary), ozone concentration (if such process is available), conductivity (pure water), pH value (pure water requires), chromaticity and other items.

Enterprises may use rapid detection methods and equipment, but the test results shall be accurate. When the rapid detection methods and equipment used are used for factory inspection, they shall be regularly compared or verified with the Inspection methods specified in national standards. When the rapid test results are unqualified, the inspection methods specified in the standards shall be used for confirmation.

Article 30 The inspection management system shall stipulate the requirements for type inspection, which shall be carried out at least once every six months (once a year for seasonal products). Type inspection shall be carried out in a timely manner when the main raw and auxiliary materials and key production processes are changed, before resuming production after suspension for more than three months, and when the factory inspection results are significantly different from normal production.

Section 7 Inspection of Trial Products

Article 31 Enterprises shall take representative samples from the same specifications and batches of trial products for inspection according to the types of bottled (barreled) drinking water (drinking natural mineral water, packaged drinking water) and implementation standards declared. For those who produce both bottled water and barreled water, priority should be given to inspecting barreled water products.