企业生产婴幼儿配方乳粉许可条件审查细则010版__和企业生产乳制品许可条件审查细则2010版_(英文版).doc

rules for the examination of licensing criteria for enterprises producing formula milk powder for infants and young children (2010 version)1scope of applicationthe rules are applicable to the examination of production conditions and inspection of production licenses applied by enterprises which are supposed to process and produce formula milk powder for infants, older infants and young children (less than 3 years old) under production conditions required by laws and standards, with cow milk or goat milk and its processed products (whey powder, whey protein, skimmed milk powder and whole milk powder, etc.) as main raw materials and with addition of appropriate amount of vitamins, minerals and other adjuvants.formula milk powder for infants and young children has one application scope and its category number is 0502. product names on the production license shall be marked with formula milk powder for infants and young children (wet-mix process, dry-mix process). variety details of formula milk powder for infants and young children shall be indicated on the attached sheet of the production license.production license examination shall be not performed for the cases of there being only packaging area, work procedures and equipment, which do not constitute complete production conditions.the rules contain documents and standards which, through reference in this text, constitute provisions of the rules. for dated references and standards, all the subsequent amendments to (excluding corrections), or revisions of, any of these publications are not applicable to the rules. for undated references and standards, the latest edition (including all the amendments) is applicable to the rules.2examination of production licensing 2.1examination of management system.the completeness of food quality and safety management system established by enterprises shall be examined according to relevant laws and regulations such as food safety law of the peoples republic of china and regulation on the implementation of the food safety law of the peoples republic of china and regulation on the supervision and administration of the quality and safety of diary products as well as general principles on examination of food production license. the contents to be examined mainly include:2.1.1examination contents of main raw materials and products management system:(1) system of testing and recording inspection of incoming raw milk and raw milk powder by batches; (2) regulations on handling measures of unqualified raw materials and adjuvants such as rejection, scrapping and return; (3) regulation on judgment of unqualified semi-finished products and finished products as well as relevant treatment measures; (4) disposal measures of products being manufactured when production is interrupted due to such particular reasons as equipment fault, power failure and water failure to ensure that non-conforming products are disposed as unqualified products; and (5) recall system of unqualified outgoing products shall contain relevant contents in the national standard good producing practice for milk products (gb12693) and shall have management regulations for implementing recall electronic information system.2.1.2examination contents of personnel requirements management system:(1) job training and appraisal measures for technical and operating personnel; (2) arrangement of suitable production, quality and inspection technicians for important sections as well as post responsibilities; (3) implementation of training plans for periodical education on quality safety, processing techniques and quality management of milk products; and (4) safety protection measures for production and processing personnel and ensuring that production and processing personnel in direct contact with raw materials and products shall be transferred away from original posts in case of catching diseases affecting food safety regulated by laws and regulations.2.1.3examination contents of technical standards and process documents:(1) related current texts of national standards listed in annex 1; (2) regulations on management of technical standards, process documents, accounts, production process and critical control points, etc., and regulation of keeping records for 2 years; and (3) records of accounts and production process established by enterprises shall include incoming material acceptance records, incoming materials accounts, environment and workplace cleaning records, production equipment cleaning and disinfection records, storehouse safekeeping records, production feeding records, control records of critical control points, factory inspection records, product inspection and sample retention records, unqualified products disposal records, unqualified raw materials treatment records, product sale records, unqualified products recall records, returned goods disposal records, employee health examination records, learning and training records, customer complaint acceptance records, risk collection records, food safety accidents disposal records, equipment inspection records, production suspension and recovery records, etc.2.1.4examination contents of enterprise procurement system:(1) measures for evaluating raw material and adjuvant suppliers; (2) incoming material acceptance system shall include contents such as verification, inspection, recording and reporting of main incoming raw materials as well as disposal suggestions on accepted or rejected materials and approval procedures; (3) procurement system shall ensure that raw materials and adjuvants shall conform to provisions of corresponding national, local and enterprise food safety standards, prevent enterprises from using animal protein (excluding food additives allowed for use) apart from milk or milk products or other products made from non-food raw materials as production raw materials; (4) procurement system shall ensure that each batch of incoming raw milk and raw milk powder is inspected for such items as melamine according to relevant provisions; (5) enterprise regulations on raw milk purchase and inspection which shall ensure that purchased raw milk is from fresh milk purchasing stations with fresh milk purchasing license, each batch has inspection reports to indicate conformity of raw milk to quality and safety requirements in gb19301 raw milk, certificate & voucher claiming system is executed strictly, records are made well; indexes of such toxic and hazardous substances as veterinary drugs and heavy metals or pathogenic parasites, microbes and biotoxin shall conform to relevant national food safety standards; and (6) the procurement system shall ensure that purchased vitamins and microelements are subject to conformity verification to guarantee product quality.2.1.5examination contents of process management system:the process management system shall specify that (1) personnel entering the cleaning work area shall be subject to periodic or aperiodic test for microbes on body surface; (2) work clothes of employees at the cleaning work area are one-piece or disposable work clothes with hats, masks and work shoes, work clothes of employees at the quasi-cleaning work area and commonly work area shall conform to requirements and be provided with hats and work shoes, work clothes and work shoes used at the specified areas can not be worn outside the specified areas, production personnel shall not process and produce formula milk powder for infants and young children before disinfection and wearing work clothes; (3) all equipment and instruments must be washed or disinfected periodically, and those in contact with wet materials shall be washed before and after use, and those in contact with dry materials shall be cleaned by dry cleaning (wet cleaning is applied when necessary) before and after use; and (4) the quality inspection departments of enterprises shall monitor air quality of cleaning areas weekly and shall take annex a monitoring and evaluation measures in gb23790 to ensure effective control of salmonella, enterobacter sakazakii and other enterobacteriaece at the cleaning areas for producing formula milk powder for infants and young children.2.1.6examination contents of product protection management system:the product protection system shall specify (1) a system for effectively preventing formula milk powder for infants and young children from contamination, damage or deterioration during processing and production; (2) the effective control of purchased unqualified raw materials and adjuvants, risk factors found in processing, unsafe food found in factory inspection, etc. and necessary tests on adding and using false substances in all raw materials and adjuvants used according to actual conditions of the purchased raw materials and adjuvants; and that (3) enterprises shall actively collect relevant information about monitoring and evaluating food safety risks found in the enterprise and issued by the state.2.1.7examination contents of inspection management:the inspection system shall specify that (1) voluntary factory inspection of formula milk powder for infants and young children, and products proved qualified by factory inspection shall conform to the national food safety standards and products failing to pass the inspection shall not be delivered; (2) the formula milk powder for infants and young children to be delivered shall be inspected batch by batch, the inspection report shall be kept for 2 years, and samples shall be retained until the shelf life; and (3) qualified milk products shall be marked with the number of certificate of inspection that can be traced to the relevant factory inspection report.2.1.8examination contents of hazard analysis and critical control point system:enterprises shall establish and execute a hazard analysis and critical control point system.2.2workplace inspectionas required by general principles on examination of food production license, the following workplace requirements shall be subject to field examination with reference to application materials submitted by enterprises.2.2.1the plant location and design, interior architectural structure and auxiliary production facilities of enterprises shall conform to related provisions of national standard gb 23790 good producing practice for powdered formulae for infant and young children.2.2.2the production workshop and auxiliary facilities compatible with production capacity of enterprises shall be available.production workshops applying wet-mix process generally include milk collecting workshop, raw material pretreatment workshop, processing workshop, semi-finished product storage and finished product packaging workshop, etc. production workshops applying dry-mix process generally include pretreatment workshop, mixing workshop, filling workshop, etc. auxiliary facilities include inspection room, raw materials and adjuvants warehouse, material warehouse, finished product warehouse, etc.2.2.3production workshops and auxiliary facilities shall be arranged orderly and properly according to production process and sanitary requirements. meanwhile, they shall be separated from each other according to production process, production operation needs and requirement for cleanliness of production operation areas to prevent cross contamination.2.2.4workshops shall be divided into the cleaning work area, quasi-cleaning work area and common work area. the cleaning work area includes power outlet of spray drying tower as required by wet-mix process, ingredients batching and mixing area as required by dry-mix process, temporary packaging material storehouse, storage, filling and inner packing workshop of bare semi-finished products to be packed.the quasi-cleaning work area includes raw material pretreatment workshop, other processing workshops, unpacking and tunnel sterilization area as required by dry-mix process, etc. the commonly work area includes milk collecting workshop, raw material warehouse, packing material warehouse, outer packing workshop, finished product warehouse, etc.2.2.5aerobic bacterial count in the air of the cleaning work area and quasi-cleaning work area shall be controlled below 30 cfu/dish and 50 cfu/dish respectively (determined as per natural precipitation method in gb/t 18204.1) and annual air cleanliness detection report issued by qualified inspection agency shall be submitted.the cleaning work area shall be internally separated and the ground shall be made of materials conforming to production hygiene requirements; temperature and relative humidity shall be compatible with the production process; the temperature shall be not higher than 25 and relative humidity shall be lower than 65% when there is no special requirement; and air shall be subject to sterilization, disinfection or purification treatment and shall be maintained at positive pressure.2.2.6ground of the production workshop shall be flat and easy for cleaning and disinfection.2.2.7the changing room shall be arranged at the entrance of workshop and adjacent to hand-washing and disinfection room. the hand-washing and disinfection room shall be equipped with sufficient non-manual hand-washing facilities, disinfection facilities and inductive hand drying facilities. the secondary changing room shall be arranged at the entrance of the cleaning work area, and the disinfection facilities shall be provided before the cleaning work area.2.2.8rest rooms in the production area shall be provided with hand-washing and disinfection facilities and their outer doors shall not be opposite to doors and windows of the cleaning work area and the quasi-cleaning work area.2.3equipment examinationexamination shall be performed on the adaptation level of production capacity declared by the applicants in article 11 of application for food production license to quantity and parameters of enterprise production equipment.2.3.1production equipment(1) enterprises producing formula milk powder for infants and young children shall have the production equipment compatible with design capability in application for food production license; (2) all containers, tools and instruments for raw materials, process products and semi-finished products in contact with formula milk powder for infants and young children shall be made of stainless steel or other non-toxic inert materials, and bamboo and wooden tools shall not be used in the cleaning work area; (3) the containers holding waste shall not be mixed with those holding products and raw materials and shall be clearly marked; (4) vulnerable equipment in direct contact with raw materials (e.g. glass thermometer) must have safety sheath; (5) air supply facilities blowing air into the drying tower must meet requirements and exhaust gas shall be subject to dedusting treatment; (6) equipment account, specification, curriculum vitae and files shall be kept completely; and (7) equipment shall be maintained in good condition, its performance and accuracy shall conform to requirements of production regulations, and equipment maintenance schedules and records shall be complete.the following table gives production equipment and requirements essential for producing formula milk powder for infants and young children.production equipment essential for producing formula milk powder for infants and young childrenequipment basic conditionsminimum parameters or special requirementsproduction equipment for wet-mix process1. milk storage equipmentmilk storage tanks ensuring that raw milk required by factories are 0 4 having automatic constant temperature system or thermal insulation system; and milk storage capacity of the plant is required to be over 30 tons.2. milk clarifiercentrifugal milk clarifierthroughput 5000 kg/h, over 2 sets.3. homogenizertwo-stage high pressure homogenizerthroughput 5000 kg/h, over 2 sets.4. refrigerating equipmentammonia or fluorine refrigerating unit or other equivalent equipmentequipment with over 54 kw refrigerating capacity under standard work conditions.5. dispensing equipmentelectronic balance or associated equipment such as flowmeter and high speed shearing machine for ingredient measuringingredients are measured by mass, and high speed shear is on-line shear or shear in cylinder or tank.6. concentratordouble-effect or multi-effect vacuum concentration evaporatorevaporating capacity of single machine is over 2400kg/h.7. sterilizing equipmenttube (plate) or other equivalent sterilizerheat recovery rate of sterilizers is over 90 %.8. high pressure pump1000 kg/h or above processing capacity, over 2 sets.9. spray drying equipmentvertical spray drying equipmentsingle-tower water evaporation capacity is over 500 kg/h.10. air purification systemconforming to requirements of 5.1.8 in gb23790.11. packaging equipmentfull-automatic small packaging machine or semi-automatic large packaging equipmentclosed or semi-closed full-automatic packaging machine with automatic mass measurement and automatic calibration system. semi-automatic large packaging equipment is subject to manual bagging, automatic measurement filling and sealing.12. cleaning equipmentfull-automatic cip equipmentcovering all production lines without any dead corner.production equipment for dry-mix process1. measuring equipment of raw materials, semi-finished products and finished productsqualified measurement verificationmeasuring by mass.2. pre-mixing equipmentqualified measurement verificationpre-mixing equipment is semi-closed.3. mixing equipmentautomatic measurement or non-automatic measurement mixermixing equipment is of closed and continuous type, with throughput of 500 kg/h or above 4. tunnel sterilizing equipmentultraviolet or other sterilization facilitiest