Notice of the State Administration for Market Regulation on Soliciting Opinions on the”Rules for the Review of Dairy Products Production Licensing (Draft for Solicitation of Comments)”
By: Date: 2021-08-02 Categories: authoritativerelease Tags: ,
   In order to standardize and guide the production of dairy products and strengthen the quality and safety supervision of dairy products, the State Administration of Market Supervision organized the drafting of the”Detailed Rules for the Review of Dairy Products Production Licensing (Draft for Solicitation of Comments)”, which is now open to the public for comments. All relevant units and individuals are welcome to propose amendments and feedback to the State Administration of Market Supervision before September 1, 2021. The public can provide comments through the following channels and methods:
   1. Log in to the official website of the State Administration for Market Regulation (URL:http://www.samr.gov.cn), and submit opinions in the “Survey Solicitation” section of the “Interaction” section on the homepage.
   2. Send an e-mail to [email protected], with the subject of the e-mail indicating”Public Solicitation of Comments on the Detailed Rules for Examination of Dairy Products Production License”.
  3. Mail to the Food Production Department of the State Administration of Market Supervision, No. 1, Beiluyuan, Zhan Road, Xicheng District, Beijing (Postal Code:100037), and indicate on the envelope”Public Solicitation of Opinions on the Detailed Rules for Examination of Dairy Products Production License” Typeface.
  State Administration of Market Supervision and Administration
   August 2, 2021

   Dairy product production license review rules (draft for comments)

   Chapter 1 General Rules
   Article 1 These rules apply to the review of the production conditions of dairy products applied by enterprises. The term”dairy products” in the detailed rules refers to products made by using milk and its processed products as the main raw material, using the conditions required by laws, regulations and standards, and adding or not adding appropriate amounts of vitamins, minerals and other raw materials.
   Article 2 The categories of dairy products application are:liquid milk (category number 0501), milk powder (category number 0502) and other dairy products (category number 0503). The product name of the production license must indicate the food category, dairy product category and category name, that is, dairy products [liquid milk (pasteurized milk, high-temperature sterilized milk, modified milk, sterilized milk, fermented milk), milk powder (whole milk) Milk powder, skimmed milk powder, part of skimmed milk powder, modified milk powder, whey powder), other dairy products (concentrated milk products, cream, cream, anhydrous cream, cheese, processed cheese, specialty dairy products, etc.)] . The supplementary page of the production license must indicate the details of the dairy products for which the production license has been obtained. See Table 1 for a detailed list of specific food categories and varieties of dairy product production licenses.
Table 1 List of food categories and varieties of dairy products production license
Food category
Category name
Species details
Executive standards and definitionsa
Remarks
Dairy products
Liquid milk
1. Pasteurized milk
“National Food Safety Standard Pasteurized Milk”
(GB 19645)
Including the products made by separating the fat from the raw milk, and after the separated fat is pasteurized, homogenized and mixed with skimmed milk sterilized by microfiltration or centrifugation, and then pasteurized.
2. High temperature sterilized milk
“National Food Safety Standard High Temperature Sterilized Milk” (GB XXXX)
3. Modified milk
“National Food Safety Standard Modified Milk” (GB 25191)
4. Sterilized milk
Ultra high temperature sterilized milk
“National Food Safety Standard Sterilized Milk” (GB 25190)
Includes full-fat, skimmed and partially skimmed sterilized milk.
Keep sterilized milk
5. Fermented milk
Fermented milk
“National Food Safety Standard Fermented Milk” (GB 19302)
Yogurt
Flavor fermented milk
flavored yogurt
Milk powder
1. Milk powder
Whole milk powder
“National Food Safety Standard Milk Powder” (GB 19644)
skimmed milk powder
Part of skimmed milk powder
2. Modified milk powder
3. Demineralized whey powder, non-demineralized whey powder
“National Food Safety Standard Whey Powder and Whey Protein Powder” (GB 11674)
4. Whey protein powder
5. Add oil whey powder
There is no national food safety standard, please refer to the corporate standard.
Add oil whey powder:use whey or whey powder as raw material, add vegetable oil or milk fat (cream, cream or anhydrous cream, etc.) and lactose, whey protein powder or milk protein, add or not Processed by adding food additives and nutritional fortifiers
Other dairy products
1. Concentrated dairy products
evaporated condensed milk
“National Food Safety Standard-Concentrated Dairy Products” (GB 13102)
Modulated condensed milk is divided into modulated evaporated milk and modulated sweetened condensed milk (modulated sweetened condensed milk).
To be implemented by the enterprises after the”National Food Safety Standard for Concentrated Dairy Products” is released.
Sweetened condensed milk
Prepared condensed milk
Concentrated milk for food industry
2. Cream
“National Food Safety Standard Cream, Butter and Anhydrous Butter” (GB 19646)
3. Cream
4. Anhydrous cream
5. Cheese
Mature cheese
“National Food Safety Standard Cheese” (GB 5420)
Immature cheese
6. Processed cheese
“National Food Safety Standard Processed Cheese” (GB 25192)
According to the dry matter content and fat content in the dry matter, the products are divided into 5 grades
7. Special dairy products
Local specialty dairy products
Local specialty dairy products implement local food safety standards or corporate standards
Local specialty dairy products:dairy products with local or ethnic characteristics
Such as:local traditional dairy products:milk skin, milk tofu, Chula, Cheuk, Cege, Bixirag, etc.
Non-fat bovine (sheep) colostrum powder
There is no national food safety standard for skimmed bovine (sheep) colostrum powder, please refer to the corporate standard
Smeared bovine (sheep) colostrum powder:a powdered product made from milk expressed within 72 hours after delivery from healthy cows (sheep) that are normally raised without infectious diseases and mastitis
skimmed bovine (sheep) colostrum
There is no national food safety standard for skimmed bovine (sheep) colostrum, please refer to the corporate standard
Smeared cow (sheep) colostrum:It is made from the milk that is expressed within 72 hours after delivery from a healthy cow (sheep) that is bred normally and is free of infectious diseases and mastitis through degreasing, sterilization and other processes. Liquid products
Casein
“National Food Safety Standard Casein” (GB 31638)
lactose
“National Food Safety Standard:Lactose” (GB 25595)
a:The definition of food refers to the corresponding national food safety standards.

  Article 3 An enterprise only has packaging sites, procedures, equipment, or the enterprise has complete production equipment and production process conditions, but the packaging process is used as the start of production, all of which belong to the act of sub-packaging, and no production license is granted.
   Article 4 The documents and standards quoted in these rules become the content of these rules through reference. For undated reference documents and standards, the latest version (including all amendments) is applicable to these rules.
   Chapter 2 Production Site
  Article 5 The site selection and design of the production enterprise shall comply with the relevant provisions of the”National Food Safety Standard and General Hygiene Code for Food Production” (GB 14881) and the”National Food Safety Standard for Good Manufacturing Practice for Dairy Products” (GB 12693). It should be far away from livestock and poultry farms, and no animals should be kept in the factory area. There should be facilities to prevent rodents and insects from breeding. Each functional area has appropriate separation or separation measures to reduce the potential pollution risk of the environment to food production. The roads in the plant area should be paved with hard materials, the vacant land should be hardened or greened, there should be a drainage system, and there should be no dust or water accumulation under normal climatic conditions.
   Article 6 There should be production workshops and auxiliary production facilities that are compatible with the production capacity of the enterprise, and their design should be arranged in an orderly and reasonable manner according to the technological process and hygiene requirements. The production operation area should be set up according to the process flow and the requirements of preventing cross-contamination, and divided into clean operation area, quasi-clean operation area and general operation area according to the cleanliness level. Each operation area shall be distinguished by a significant mark. Work areas with different cleanliness levels should be effectively separated physically to prevent cross-contamination. See Table 2 for the division of dairy production operations.
Table 2 Division of Dairy Products Production Operation Area
Serial number
Product category
Clean the work area
Quasi-cleaning work area
General work area
Liquid milk
Filling workshop (except maintenance sterilization process)
Raw material pretreatment workshop (standardized room), packaging material temporary storage room (area), sterilization room (area), agitated fermented milk fermentation room, filling workshop (maintenance sterilization process), other processing workshops
Milk collection room, raw material warehouse, coagulated fermented milk fermentation room, packaging material warehouse, outer packaging workshop and finished product warehouse (equipped with cold storage or refrigeration equipment when needed)
Milk powder wet
Law process
Powder outlet area after spray drying or fluidized bed, process product temporary storage room (area), temporary storage room (area) after disinfection of inner packaging materials (except tin packaging), inner packaging workshop
Clean room for inner packaging of raw and auxiliary materials, weighing and batching room (area), canning (listening) room, raw and auxiliary material pretreatment workshop, concentration workshop, spray drying workshop, packaging material dismantling and outsourcing cleaning and disinfection room (area), etc.
Milk receiving room, raw and auxiliary material outer packaging cleaning and unpacking room (area), outer packaging workshop, packaging material warehouse, raw material and finished product warehouse
Dry milk powder
Law process
Raw and auxiliary material weighing and batching room, pre-mixing room (area), feeding and mixing area, temporary storage room (area) after packaging material disinfection (except canned packaging), process product temporary storage room (area), filling and Inner packaging workshop
Cleaning area for inner packaging of raw and auxiliary materials, tunnel sterilization area, unpacking and outsourcing cleaning and disinfection room (area), canning (listening) room, etc.
Raw material warehouse, outer packaging cleaning workshop, outer packaging workshop, packaging material warehouse and finished product warehouse, raw and auxiliary material outer packaging cleaning and unpacking room (area)
Other milk
Products
Temporary storage room for packaging materials (except for maintaining sterilization process), storage of semi-finished products to be packaged, filling and inner packaging workshops, and concentrated milk filling areas for the food industry, etc. Skimmed bovine (sheep) colostrum powder freeze-drying area, low-temperature drying process produces skimmed bovine (sheep) colostrum powder with the wet process of milk powder, and skimmed bovine (sheep) colostrum is the same as liquid milk.
Raw material pretreatment, batching and mixing workshop, raw and auxiliary material inner packaging clean area, packaging material temporary storage room (maintenance sterilization process), etc.
Milk collection room, outer packaging clean workshop, raw material warehouse, packaging material warehouse, unpacking workshop, outer packaging workshop and finished product warehouse, etc.

   Article 7 The entry and exit of the cleaning work area should be reasonably restricted and controlled. The entrances and exits of the cleaning work area and the quasi-clean work area should be installed with doors that can automatically close (such as automatic sensors or door closers) and ( Or) Air curtain, and ensure that the doors on both sides are not opened at the same time. Personnel, raw materials, packaging materials, wastes, tools, etc. entering and leaving the clean operation area shall have measures to prevent cross-contamination. The packaging and cleaning facilities for raw and auxiliary materials and the cleaning and disinfection facilities for packaging materials should be set up, and the doors on both sides of the raw and auxiliary material channels entering and exiting the cleaning operation area should be prevented from being opened at the same time.
   Article 8 The cleaning operation area should be kept dry, and water supply facilities and systems should be minimized. If it is unavoidable, corresponding protective measures should be taken.
   Article 9 The inspection room set up in the factory building shall be separated from the production area. The process inspection room set up in the workshop shall meet the relevant regional sanitation requirements and have measures to prevent pollution. If necessary, the setting area of ​​online monitoring equipment (such as net content monitoring equipment, tightness testing equipment, hydrometer, etc.) in the production area should be reasonable.
   Article 10 The building structure of the factory building and workshop shall comply with the relevant standards, and the building shall be kept in good condition, the environment shall be clean, and measures shall be taken to prevent the intrusion and breeding of insect pests. The walls, ceilings, doors and windows in the production workshop should be flat without cracks and easy to clean. The ground should be constructed with non-toxic, odorless, impermeable and corrosion-resistant materials, and its structure should be flat, easy to clean, disinfect and prevent water accumulation.
   Article 11 An enterprise shall have storage facilities suitable for the quantity and storage requirements of the products produced, as well as ventilation and lighting facilities, as well as temperature and humidity control facilities when necessary, to meet the storage conditions of materials or products and products Security requirements. All material storage places should be marked, and personnel access to the place should be controlled.
   Article 12 The raw materials, process products, finished products, packaging materials, etc. shall be stored in separate storage locations or areas according to their nature. Unqualified, returned or recalled materials or products shall be stored separately or in areas, and shall be clearly marked. When necessary, temperature and humidity control measures should be provided. If an automated warehouse management system is used to control materials, the equivalent controllability should be ensured.
   Chemicals such as toxic and hazardous substances, detergents and disinfectants should be stored separately with raw and auxiliary materials, process products, and finished products to prevent cross-contamination, and should be clearly marked.
  The receiving, issuing and shipping areas should be able to protect materials and products from outside weather (such as rain and snow), and the layout and facilities of the receiving area should be able to ensure that the materials can be packaged and cleaned as necessary before entering the storage area .
   Chapter 3 Equipment and Facilities
  Article 13 Production equipment should be equipped with production scale, process flow and process parameters. Production processes and equipment that are prohibited or explicitly eliminated by the state and local governments should not be used. The basic production equipment and facilities for dairy products are shown in Table 3. If the company uses production equipment other than those listed in Table 3, it should have a necessity and safety evaluation report and be compatible with the production process requirements.
Table 3 Basic dairy production equipment and facilities
Variety name
Basic production equipment and facilities
Pasteurized milk, high-temperature sterilized milk
Pretreatment equipment:raw milk transportation equipment, filtration equipment, cooling equipment, milk storage tanks, milk purification equipment (total processing capacity should not be less than 5t/h), homogenization equipment (total processing capacity should not be less than 5t/h ), pasteurization or high-temperature sterilization equipment, filling equipment, refrigeration equipment, automatic CIP cleaning equipment (automatic cleaning process control), insulated transport vehicles
Mixed milk
Pretreatment equipment (except products with milk powder as raw material):raw milk transportation equipment, filtration equipment, cooling equipment, milk storage tanks, milk purification equipment (total processing capacity should not be less than 5t/h), batching equipment, Homogenizing equipment (total processing capacity should not be less than 5t/h), sterilization or sterilization equipment, filling equipment or aseptic filling equipment, refrigeration equipment, automatic CIP cleaning equipment (automatic cleaning process control), heat preservation transportation vehicle (When needed)
Sterilized milk
Pretreatment equipment (except products with milk powder as raw material):raw milk transportation equipment, filtration equipment, cooling equipment, milk storage tanks, milk purification equipment (total processing capacity should not be less than 5t/h), homogenization equipment (Total processing capacity should not be less than 5t/h), sterilization equipment, filling equipment or aseptic filling equipment, refrigeration equipment, automatic CIP cleaning equipment (automatic cleaning process control)
Fermented milk
Pretreatment equipment (except products with milk powder as raw material):raw milk transportation equipment, filtration equipment, cooling equipment, milk storage tanks, milk purification equipment (total processing capacity should not be less than 5t/h), sterilization equipment, Batching equipment, homogenizing equipment (total processing capacity should not be less than 5t/h), fermentation tank (fermentation chamber), filling equipment, refrigeration equipment, automatic CIP cleaning equipment (automatic cleaning process control), heat preservation transportation tool (required Time)
Milk powder
1. Wet process:pretreatment equipment (except products with milk powder as raw material):raw milk transportation equipment, filtration equipment, cooling equipment, milk storage equipment, milk purification equipment (total processing capacity should not be less than 5t/h), batching equipment (excluding whole milk powder), homogenizing equipment (total processing capacity should not be less than 5t/h), refrigeration equipment (when needed), sterilization equipment, concentration equipment (double-effect or multi-effect vacuum concentration evaporation Equipment, single-machine evaporation capacity above 2.4t/h), vertical spray drying equipment (single-tower moisture evaporation capacity above 0.5t/h), sterilization equipment or facilities for inner packaging, foreign body detection equipment, automatic small packaging equipment Or semi-automatic large packaging equipment, automatic CIP cleaning equipment (requires automatic control of the cleaning process, should cover the production line before concentration, no dead ends. The CIP cleaning system of the concentration equipment can be set independently), etc.
2. Dry process:raw material metering equipment, tunnel sterilization equipment (continuous, closed), pre-mixing equipment, mixing equipment (automated, closed equipment, at least 1:1000 of the two materials are evenly mixed and processed (Capacity 2t/h or above), sterilization equipment or facilities for inner packaging, foreign body detection equipment, automatic small packaging equipment
3. Modulated milk powder dry-wet compounding process:all production equipment except for the finished product packaging and the production equipment necessary for the dry process should be provided for the wet process.
Whey powder and whey protein powder
Whey storage tank, heat exchange equipment (when required), centrifuge or rotary filter (when required), particle collection tank (when required), cream separation equipment (when required), sterilization equipment, desalination Equipment (according to process requirements), concentration equipment, spray drying equipment, packaging equipment, automatic CIP cleaning equipment (automatic cleaning process control), etc.
Add oil whey powder
Dosing equipment, homogenization equipment, sterilization equipment, evaporation equipment (when needed), spray drying equipment, packaging equipment, automatic CIP cleaning equipment (automatic cleaning process control), etc.
Condensed milk
Pretreatment equipment (except products with milk powder as raw material):raw milk transportation equipment, filtration equipment, milk storage tanks, milk purification equipment (total processing capacity should not be less than 5t/h), homogenization equipment (total processing The capacity should not be less than 5t/h, except for condensed milk), sterilization equipment, concentration or flash evaporation equipment, crystallizer and refrigeration equipment (applicable for sweetened condensed milk), filling equipment, sterilization equipment (when needed), automatic CIP cleaning equipment (Fully automatic control of cleaning process) etc.
Concentrated milk for food industry
Raw milk transportation equipment, filtration equipment, cooling equipment (when required), milk storage tanks, milk purification equipment, homogenization equipment (when required), concentration equipment, refrigeration equipment, filling equipment, automatic CIP cleaning equipment ( Fully automatic control of the cleaning process) etc.
Cream, cream and anhydrous cream
Pretreatment equipment (except for the production of anhydrous butter with cream):raw milk transportation equipment, filtration equipment, milk storage tanks, milk purification equipment, cooling equipment, fat separation equipment, sterilization or sterilization equipment, fermentation equipment (according to Process requirements), filling equipment (for cream), compression equipment, packaging equipment, vacuum drying equipment (for anhydrous butter), automatic CIP cleaning equipment (automatic cleaning process control), etc.
Cheese
Pretreatment equipment:raw milk transportation equipment, filtration equipment, cooling equipment, milk storage tanks, milk purification equipment, sterilization equipment, mixing equipment, curd equipment, squeezing equipment, refrigeration equipment, automatic CIP cleaning equipment (cleaning process Fully automatic control) etc.
Processed cheese
Measuring equipment, mixing tank, heat melting equipment, sterilization equipment, packaging (filling) equipment, automatic CIP cleaning equipment (automatic cleaning process control), etc.
Non-fat bovine (sheep) colostrum powder
Refrigeration equipment, milk purification equipment, centrifugal degreasing equipment (when needed), concentration equipment, sterilization or sterilization equipment, low-temperature drying equipment, packaging equipment, automatic CIP cleaning equipment (automatic cleaning process control), etc.
Smeared bovine (sheep) colostrum
Refrigeration equipment, milk purification equipment, centrifugal degreasing equipment, membrane concentration equipment, membrane sterilization equipment, aseptic filling equipment, automatic CIP cleaning equipment (automatic cleaning process control), etc.
Casein
Centrifugal degreasing equipment, sterilization equipment, curdling equipment, membrane equipment (for membrane separation), washing equipment, solid-liquid separation equipment, drying equipment, powder processing equipment, etc.
lactose
Three-phase centrifuge, pasteurization, evaporator, crystallizer, decanter, drying equipment
Local specialty dairy products
Pretreatment equipment (except products with milk powder as raw material):raw milk transportation equipment, filtration equipment, freezing equipment, cooling equipment, milk storage tanks, milk purification equipment, sterilization equipment, filling or packaging equipment, etc.
Note:The equipment and facilities listed in this table are the basic equipment and facilities of the enterprise, which can be reasonably increased or decreased according to the actual production situation.

  Article 14 The equipment is well maintained, and its performance and accuracy meet the requirements of the production process. Vulnerable equipment directly in contact with raw and auxiliary materials for production shall be inspected and recorded regularly.
  Article 15 Production equipment, facilities, etc. shall have operation status identification, and production equipment, monitoring equipment and inspection equipment that need to be verified or calibrated shall have verification or calibration status identification. Fixed pipeline facilities should have the name and flow direction identification of the materials in the pipeline.
  Article 16 The materials of all equipment and utensils in direct or indirect contact with raw materials, process products, and finished products shall meet the requirements of food-related product standards, and bamboo and wooden tools shall not be used.
  Article 17 The water supply facilities should be able to ensure that the quality of food processing water meets the”Sanitary Standards for Drinking Water” (GB 5749) and relevant national regulations. Products involving drinking water sanitation and safety used in self-provided water supply facilities shall also comply with relevant national regulations. Food processing water and other water not in contact with food (such as indirect cooling water, sewage or wastewater, etc.) transportation pipelines should be completely separated, and each pipeline system should be clearly marked for distinction.
   Article 18 There are reasonable drainage facilities and wastewater treatment facilities, and the drainage flow should be from areas with high cleanliness requirements to areas with low cleanliness requirements, and there is a design to prevent wastewater from backflow. The entrance of the drainage system should be installed with water The floor drain is sealed to prevent solid waste from entering and foul gas from escaping. Sewage should be purified before being discharged.
   Article 19 Equipment, facilities, and utensils for cleaning and disinfection of production equipment and tools shall be equipped and placed in a special place or area for safekeeping.
   Article 20 Wastes generated during production and processing should be stored in special facilities, and containers for wastes should not be mixed with containers for products and raw materials, and should be clearly marked. There shall be dedicated waste transportation channels in the cleaning operation area. The waste storage place should not have bad smell or toxic or harmful gas escape. The waste should be removed regularly, and the perishable and deteriorating waste should be removed in time.
   Article 21 The changing room of the quasi-clean work area should be located at the entrance of the production work area, and sufficient non-manual hand washing, hand drying, and disinfection facilities should be provided inside, and hand washing should be marked in a prominent position adjacent to the hand washing facility Disinfection procedure. The order of changing clothes, washing hands, and disinfection when entering the quasi-clean work area should comply with the work instructions. The general process is changing shoes, changing clothes, washing hands, cleaner overalls, and hand disinfection.
   Article 22 The entrance of the cleaning operation area should be equipped with a secondary dressing room, and a blocking shoe cabinet, separate storage and disinfection facilities for clean clothes, etc. should be installed.
  The order of changing clothes when entering the cleaning work area is changing shoes, changing work clothes (or no change), hand disinfection (or washing and hand disinfection), cleaner work clothes, and hand disinfection. The air cleanliness of the room with cleaner overalls should meet the requirements of the clean work area. After the second dressing, you need to enter the cleaning work area through the interlocking airlock room or air shower room.
   Article 23 The overalls of the employees in the cleaning work area shall be one-piece or disposable overalls, and be equipped with hats, masks and working shoes. The work clothes of the employees in the quasi-clean work area and the general work area should meet the sanitation requirements of the corresponding area, and be equipped with hats and work shoes.
   Article 24 Toilets set up as needed should be kept clean, have hand-washing facilities, and must not be directly connected to production, packaging or storage areas, and the doors and windows of the toilet must not be opposite to the entrance of the production operation area. The toilets in the factory buildings should be equipped with hand washing and disinfection facilities.
  Article 25 The air blown into the drying tower and the clean low-temperature air in the fluidized bed should be filtered by filtration facilities, and dehumidification devices or facilities should be equipped if necessary. Filtering facilities should be checked and replaced regularly to meet production control requirements. The gas discharged from the drying tower should be treated with dust.
  Article 26 The production enterprise shall equip the production and auxiliary workshops with air conditioning and purification systems as required to adapt the temperature and relative humidity to the production process to ensure that the air flows from areas with high cleanliness requirements to low cleanliness requirements And form a certain pressure gradient. The operation of the air purification system shall be inspected and maintained in accordance with regulations, and there shall be operating records.
   The air supply system of the clean work area should be set independently, using three-stage filtration of primary, medium, and high-efficiency (sub-high-efficiency) filters to maintain positive pressure in the clean work area.
  Article 27 For the air that enters the clean operation area with raw materials or products transported through air-driven pipelines, it is necessary to design and install an appropriate air filtration system.
   Article 28 In the production workshop where there is odor and gas (steam or harmful gas) or where a large amount of humid or hot air is produced, one-way exhaust equipment with sufficient capacity shall be adopted, and the vent must be equipped with Easy to clean and corrosion-resistant mesh cover. In dust-contaminated areas, there should be appropriate collection or control devices.
   Article 29 There should be sufficient natural lighting or artificial lighting facilities in the factory building, the luster should make the food appear the true color, and the brightness should meet the needs of production and operation. If you need to install lighting facilities directly above the exposed food and raw materials, you should use safe lighting facilities or take protective measures.
  Article 30 If the enterprise declares that the factory inspection self-inspection or part of the self-inspection, it shall have the inspection equipment and facilities required to meet the self-inspection inspection items. The number of inspection equipment should be compatible with the self-inspection capability. Enterprises can use validated non-national standard methods to test equipment and should ensure that the test results are accurate. For inspection items, please refer to Appendix 2″Dairy Product Manufacturer Inspection Item List”.
   Chapter 4 Equipment Layout and Process Flow
   Article 31 The layout, installation and maintenance of production equipment must meet the requirements of the process and be convenient for operation, cleaning, maintenance and disinfection or sterilization. Disused equipment should have obvious signs, and its cleaning and disinfection should meet the requirements of the cleanliness of the corresponding production area to prevent it from polluting the environment.
  Article 32 The production equipment should be in accordance with the product processing technology. The basic process flow and key control links of dairy products are shown in Table 4. If the enterprise uses a production process different from that listed in Table 4, the production equipment should be compatible with the production process.
  全脂奶粉、脱脂奶粉、部分脱脂奶粉不得采用干法工艺生产。调制乳粉干湿法复合工艺是指湿法工艺流程(除包装外)与相应的干法工艺流程相衔接,是一个完整的生产过程,其湿法工艺部分和干法工艺部分应在同一个厂区完成,湿法工艺部分生产的过程产品的暂存应在清洁作业区,如确有需要在一定周期内储存湿法工艺部分生产的过程产品的,可存放在库房专区。
表4 乳制品基本工艺流程及关键控制环节
品种名称
基本工艺流程
生产过程关键控制环节
巴氏杀菌乳、高温杀菌乳
1.巴氏杀菌乳、高温杀菌乳:原料乳→过滤→冷却(需要时)→储存→净乳→标准化(或采用脂肪分离工艺)→均质→巴氏杀菌/高温杀菌→冷却→灌装→冷藏
2.分离脂肪的巴氏杀菌乳:原料乳→过滤→冷却(需要时)→储存→净乳→分离脂肪→巴氏杀菌及除菌(脂肪部分采用巴氏杀菌;脱脂滤液采用过滤或离心除菌)→混合及标准化→均质→冷却→灌装→冷藏
原料验收、标准化、杀菌或灭菌方式、灌装或无菌灌装
调制乳
原料乳→净乳→冷藏→标准化→预热→配料→均质→高温杀菌或其他杀菌、灭菌方式→冷却→灌装→冷藏(需冷藏的产品)
灭菌乳
1.超高温灭菌乳:原料乳→净乳→冷藏→标准化→预热→均质→超高温瞬时灭菌→冷却→无菌灌装→成品储存
2.保持灭菌乳:原料乳→净乳→冷藏→标准化→预热→均质→灌装→保持灭菌→成品储存
发酵乳
1.凝固型:原料乳→净乳→冷藏→标准化→均质→杀菌→冷却→接入发酵菌种→灌装→发酵→冷藏
2.搅拌型:原料乳→净乳→冷藏→标准化→均质→杀菌→冷却→接入发酵菌种→发酵→搅拌→杀菌(需热处理的产品)→冷却→灌装→冷藏
原料验收、标准化、杀菌方式、发酵剂的制备、发酵、灌装
乳粉
1.湿法工艺:原料乳→净乳→冷藏→标准化→均质→杀菌→浓缩→喷雾干燥→附聚、造粒或喷涂磷脂、冷却或筛粉、晾粉→包装
2.干法工艺:拆包(脱外包)→内包装袋的清洁→隧道杀菌→原料粉称量→预混→混料→包装。
3.调制乳粉干湿法复合工艺是指湿法工艺流程(除包装外)与相应的干法工艺流程相衔接,是一个完整的生产过程
1.湿法工艺:原料验收、标准化、杀菌、浓缩、喷雾干燥、包装
2.干法工艺:原料验收、配料的称量、隧道杀菌、预混、混合、包装
乳清粉、乳清蛋白粉、加油乳清粉
1.乳清粉:乳清收集及储存→分离脂肪(需要时)→乳蛋白颗粒收集(需要时)→稀奶油回收(需要时)→电渗析乳清回收→冷却或巴氏杀菌→脱盐(脱盐乳清粉)→浓缩→喷雾干燥→包装
2.乳清蛋白粉:乳清收集及储存→分离脂肪(需要时)→乳蛋白颗粒收集(需要时)→稀奶油回收(需要时)→蛋白质回收→冷却或巴氏杀菌→浓缩→喷雾干燥→包装
3.加油乳清粉:配料→均质→冷却→杀菌→浓缩→喷雾干燥→包装
1.乳清粉:乳清预处理、杀菌、浓缩、喷雾干燥、包装
2.乳清蛋白粉:乳清预处理、杀菌、浓缩、喷雾干燥、包装
3.加油乳清粉:配料、均质、杀菌、浓缩、喷雾干燥、包装
炼乳
原料乳→净乳→冷藏→标准化→预热杀菌→真空浓缩→冷却结晶(加糖炼乳)→装罐→灭菌(淡炼乳)→成品储存
原料乳验收、杀菌及灭菌、冷却结晶、灌装
食品工业用浓缩乳
1.热浓缩法:原料乳验收→净乳→冷藏→均质→巴氏杀菌→热浓缩(≥65℃)→冷却→灌装→成品储存(常温,冷藏或冷冻)
2.非热浓缩法:原料乳验收→净乳和(或)除菌分离→冷藏→均质→非热浓缩(超滤或反渗透)→冷却→灌装→冷藏(或冷冻)
原料乳验收、浓缩、灌装
奶油、稀奶油、无水奶油
1.奶油:原料乳→净乳→脂肪分离→稀奶油→杀菌→发酵(适用于发酵型产品)→成熟→搅拌→排除酪乳→奶油粒→洗涤(需要时)→压炼(需要时)→包装
2.稀奶油:原料乳→净乳→脂肪分离→稀奶油→杀菌或灭菌→发酵或酸化(适用于发酵稀奶油和酸化稀奶油)→灌装或无菌灌装
3.无水奶油:原料乳→净乳→脂肪分离→稀奶油→杀菌→二次分离→闪蒸(真空干燥)→包装
原料乳的验收、杀菌及灭菌、发酵(适用于发酵型产品)、酸化(适用于酸化稀奶油)、包装。
干酪
1.原料乳→净乳→冷藏→标准化→杀菌→冷却→凝乳→凝块切割→搅拌→排出乳清→成型压榨→成熟→包装
2.乳的预处理→混料→均质→杀菌→冷却→凝乳恒温培养(加入凝乳酶)→排乳清或不排乳清→冷却→灌装、封口→冷却贮存
原料乳的验收、杀菌、凝乳、包装
再制干酪
原辅料→前处理→加热融化→杀菌→灌装→冷却→储藏→成品
加热融化、杀菌、灌装
脱脂牛(羊)初乳粉
脱脂牛(羊)初乳的预处理→离心脱脂→杀菌或除菌→低温干燥→包装
原料的验收、杀菌或除菌、低温干燥、包装
脱脂牛(羊)初乳
脱脂牛(羊)初乳→净乳→离心脱脂→凝乳(需要时)→离心分离(需要时)→预过滤→超滤浓缩→无菌过滤(膜除菌)→无菌灌装
原料的验收、超滤浓缩、无菌过滤(膜除菌)、无菌灌装
酪蛋白
1.酸法、酶法:原料乳→脱脂→酪蛋白沉淀(酸凝、酶凝) →过滤→沉淀→干燥
2.膜分离:原料乳→脱脂→酪蛋白(膜过滤) →浓缩→干燥
原料乳验收、沉淀(酸法、酶法)、膜过滤(适用于膜分离法)、洗涤、干燥
乳糖
乳清→离心→巴氏杀菌→浓缩→结晶→倾析→干燥
巴氏杀菌、浓缩、结晶、干燥
注:本表所列生产工艺为企业基本生产工艺,可根据实际生产情况合理增加或减少,并提交合理性说明。

  第三十三条 生产企业应建立工艺文件、操作规程等生产技术文件,技术文件与实际操作应保持一致性。
  第三十四条 新增或调整产品工艺流程及关键设备时,应进行必要性论证和安全性确认,保证产品质量符合要求。
  第三十五条 通过危害分析方法明确影响产品质量的关键工序或关键控制点,并制定操作规程或作业指导书,应至少对乳制品生产关键工序或关键控制点形成电子信息记录。
  第三十六条 生产企业应有控制措施对配料过程的物料称量进行管理及复核。配料过程应根据生产指令单所要求的物料种类、用量,进行物料称量,保存配料记录,配料记录包括物料名称、生产者名称、规格、物料批号、使用数量、配料人、复核人等 ,保证记录可溯源性。投料前需根据投料单对物料标识、品种、数量等进行核对。
  第五章  人员管理
  第三十七条 生产企业应配备与生产能力和生产规模相适应的食品安全管理负责人、食品安全管理人员、技术人员(包括生产及检验人员等)、生产操作人员和其他人员,并符合下列要求:
  (一)应设置独立的食品质量安全管理部门,配备专职或兼职的食品安全管理人员,负责按照国家有关食品安全法律法规和《食品安全国家标准 乳制品良好生产规范》(GB 12693)建立、实施和持续改进食品安全管理制度及生产质量管理体系。
  (二)应明确企业负责人、食品安全负责人和食品安全管理人员的岗位的职责,并应能履行其相应的责任和义务。
  (三)企业负责人是食品安全第一责任人,应熟悉食品安全有关法律法规和乳制品质量安全知识,对本企业的食品安全承担法律责任和义务。
  (四)食品安全负责人应具有食品及相关专业本科以上学历且3年以上相关工作经历,经专业理论和食品安全知识培训合格,掌握食品安全有关的法律法规和乳制品的质量安全知识。食品安全负责人应当是生产企业法定代表人(负责人)或经授权的负责人,应独立行使职权,承担乳制品安全管理和出厂放行责任,其职责不得委托他人,特殊情况需进行授权。
  (五)食品安全管理人员应有相关专业专科以上学历且具有3年以上的乳制品生产工作经历或食品安全管理经验,应掌握乳制品产品涉及的法律法规及标准规定,履行食品安全控制和食品安全保证相应的职责。
  (六)生产技术人员应具有相关专业专科以上学历或3年以上相关工作经验,掌握乳制品生产专业知识。
  (七)从事检验人员应具有食品、化学或相关专业专科以上的学历或者具有1年以上食品检测工作经历。实验室负责人应具有食品、化学或相关专业本科以上学历且有3年以上相关工作经历。企业自行检验的,要求每个检验项目至少2人以上具有独立检验的能力。
  (八)生产操作人员的数量应适应企业规模、工艺、设备要求。关键控制环节操作人员应具有一定的技术经验,掌握生产工艺操作规程,能熟练操作生产设备。特殊岗位的生产操作人员资格应符合有关规定。
  第三十八条 培训管理工作由指定部门或专人负责,负责建立培训管理制度并组织实施。
  企业应当制定新员工上岗培训计划、员工定期培训计划、培训方案及考核方法。培训内容应与岗位要求相适应,至少应包括工艺规程、食品安全知识等。检验人员培训计划应包括专业知识、专业技能以及有关生物、化学安全和防护、救护知识等的培训。
  食品安全管理人员、食品生产技术人员、生产操作人员和检验人员等应经培训考核合格后上岗,检验人员还应进行授权。培训计划和方案应经企业负责人或食品安全负责人审核批准,培训记录应当予以保存,培训效果应当定期考核评估。
  第三十九条 企业应建立从业人员健康管理制度,从事接触直接入口食品工作的食品生产经营人员应当每年进行健康检查,取得健康证明后方可上岗工作。建立人员健康检查记录,保证食品加工人员患有法律法规规定的有碍食品安全的疾病时,应调整到其他不影响食品安全的工作岗位。
  第六章  管理制度
  第四十条 企业应当按照《食品安全法》等有关法律法规和食品安全国家标准的规定建立并实施食品安全管理制度,包括乳制品原料、食品添加剂和包装材料的采购、使用及产品生产、包装、检验、放行和销售等所有环节,并确保管理职责明确,生产管理和食品安全控制活动符合《食品安全国家标准 乳制品良好生产规范》(GB12693)要求。
  第四十一条 制定原辅料供应商审核制度,定期对供应商进行审核。原辅料供应商的确定及变更应进行食品安全评估,并经企业食品安全管理部门批准后方可采购。应与主要原辅料供应商签订食品安全协议,明确双方所承担的责任。
  对国内原辅料供应商的审核至少应包括:供应商的资质证明文件、质量标准、检验报告等。采用进口原辅料的,应审核境外出口商或者代理商包括进口商的备案资质文件、境外生产企业注册文件、原料质量标准、产品出厂的检验报告、海关出具的相关证明等。
  第四十二条 制定进货查验制度,包括原辅料验收标准和进厂的原辅料进行验证、检验、记录、报告以及接收或拒收的处理意见和审批手续等内容。
  企业应建立生乳进货查验制度,生乳的进货查验应有索证索票和逐批检测并记录的规定,保证收购的生乳来自取得生鲜乳收购许可证的生鲜乳收购站,并有检验报告表明每批生乳符合《食品安全国家标准 生乳》(GB 19301)的规定。生乳中农药、兽药残留、重金属等有毒有害物质或者致病性的寄生虫和微生物、生物毒素等指标须符合相关食品安全国家标准规定,应进行定期或不定期监测和安全性评估。
  对含乳原料中可能出现的影响产品质量、危害人体健康的物质进行必要的检验或查验合格报告;
  企业采购的维生素、微量元素等营养强化剂及其他食品添加剂应进行进货验证,确保产品质量安全。对贮存期间质量容易发生变化的维生素和微量元素等营养强化剂及其他食品添加剂进行原料合格的确认,以确保其符合原料规定的要求。
  第四十三条 建立原辅料管理制度。保证采购、使用的原辅料符合相应的食品安全国家标准、地方标准或企业标准的规定。
  不得使用危害人体营养及健康的违禁添加物或其他非食用原料制成的产品作为生产原料;不得使用乳或乳制品以外的动物性蛋白质(允许使用的食品添加剂及有关部门批准的新资源食品原料除外);不得使用经辐照处理过的原辅料。
  包装材料应清洁、无毒且符合国家相关标准及规定。包装材料在特定储存和使用条件下不应影响乳制品的安全和产品特性。除可回收利用的包装材料外不应重复使用包装材料。有对回收再利用的包装材料的管理规定,包括回收及检验标准,安全性检查措施,清洁、消毒的方法,有经检验合格后方可投入使用的规定等。
  第四十四条 企业应制定物料储存和分发制度。建立物料动态信息标示卡和出入库台账,确保物料做到账物相符。物料的使用应遵循“先进先出”和“近效期先出”原则制定物料的使用计划,处于合格状态的物料方可分发。
  物料的接收、发放和使用应有可追溯的清晰发放记录,经收发双方核实并在相应记录上签字确认。
  第四十五条 企业应按照《食品安全国家标准 乳制品良好生产规范》(GB 12693)的要求,制定防止微生物污染、化学污染、物理污染的生产过程控制措施外,还应满足以下要求:
  (一)企业应制定清洁作业区空气质量监控计划,每年应由有资质的第三方检测机构检测并出具空气洁净度的检测报告。在设备安装或工艺重大改造后应对清洁作业区的空气洁净度进行检测,符合要求后方可投入生产。日常运行中,清洁作业区的空气洁净度检测和监测按照下表进行。企业应制定准清洁作业区的空气洁净度控制要求,并定期进行监控。
表5 乳制品生产清洁作业区动态标准控制表
项目
内容
控制要求
检测方法
监控频次
微生物
空气浮游菌(动态)
≤300cfu/m3
GB/T 16293
1次/周
空气沉降菌(动态)
(cfu/Φ90mm)
≤64cfu/4h
GB/T 16294
1次/周
静态监测
监测频率按照企业生产实际需要进行
压差
清洁作业区与一般作业区之间
通过压差计测量
≥10Pa
2次/班
换气次数
通过测定风速验证换气次数
通过风速仪测定
≥12次/h
更换高效过滤器时或1次/月
温度
通过温度表测定
18-26℃a
2次/班
相对湿度
通过湿度表测定
≤70%
2次/班
说明:换气次数通过风速进行转换后测定。计算公式为:N=3600SV/A,监测时通过风速计算,其中,N:换气次数(次/h)、S:风口通风面积(m2)、A:车间容积(m3)、V:测得风口平均风速(m/s)。换气次数适用于层高小于4.0m的清洁作业区。层高4.0m以上的清洁作业区可适当调整换气次数,但应确保清洁作业区的洁净度。
a有特殊要求时,按规定。
1.表中各数值均为平均值,单点最大值不宜超过平均值的两倍。
2.动态监测时可使用多个沉降皿连续进行监控,但单个沉降皿的暴露时间需要大于30min,小于4h,按实际时间计算沉降菌。
3.静态监测控制要求:空气浮游菌≤150 cfu/m3,空气沉降菌≤4cfu/30min/φ90mm。

  (二)用于直接接触食品或用于直接接触食品的容器和设备清洁的压缩空气或其它惰性气体应进行过滤净化处理,以防止造成间接污染。
  (三)用于生产设备的可能直接或间接接触食品的部件润滑油应当是食用油脂或能保证食品安全要求的其他油脂。
  (四)当进行现场维修、维护及施工等工作时,应采取适当措施避免异物、异味、碎屑等污染产品。
  第四十六条 应制定生产人员工作服和工作鞋清洁消毒程序,生产中应注意保持工作服和工作鞋干净完好,必要时及时更换。指定区域使用的工作服和工作鞋不能在指定区域以外的地方穿着。清洁作业区工作服和工作鞋应单独清洗、消毒、存放,定期检查,确保符合清洁作业区使用要求。
  第四十七条 建立清洁和消毒制度,制定适宜的计划和程序。确保对所有区域进行清洁,重要区域、设备和器具应进行特殊清洁。严格执行监督程序,以确保人工清洁、就地清洗操作(CIP)以及设备维护等操作流程符合相关规定和标准要求。对清洁和消毒程序进行记录,如洗涤剂和消毒剂的品种、作用时间、浓度、对象、温度等。
  清洁、消毒时应做好产品防护,采用与原料、产品和生产工艺相适应的清洗剂、消毒剂和清洗消毒方式,避免对产品造成污染。
  第四十八条 建立设备设施管理制度,确保设备设施正常运行。设备设施应指定专人进行管理,设备设施的标识、台账、说明书、档案、维护和维修记录应准确、齐全。
  应对生产设备、检验设备、设施的运行状态进行标识管理,明确各种状态及标识的定义,并定期对标识进行检查和维护。
  应制定设备设施维修维护计划,并定期有效实施,确保设备设施正常运行。需检定或校准的设备设施应定期检定或校准。检验设备设施应定期进行维护和期间核查,保证检验设备的性能满足要求。检验设备应有使用记录。
  第四十九条 应建立物料运输管理制度,不得将原辅料、产品与有毒有害物品一同运输。运输工具、车辆应定期检查卫生清洁情况,运输条件应符合物料的储存要求(温度、湿度等)。
  第五十条 企业应建立产品追溯制度,应理清乳制品原辅材料来源、生产环节及衔接、物料流向、信息采集及记录规则等,建立顺向可追踪、逆向可溯源的乳制品质量安全追溯制度,明确追溯目标、措施和责任人员,并定期实施内部审核,以评价追溯体系的有效性。企业可根据实际情况选择采用电子或纸质形式记录,鼓励采用二维码、条码、射频识别(RFID)等追溯形式,采用信息化手段采集、留存信息。
  (一)企业应将包括原辅材料管理记录[包括:生乳验收记录、原辅材料(包括:食品添加剂、包装材料、其他材料)验收记录、库房保管及物料领取记录、进货台账、不合格原料处理记录等]、生产过程管理记录(包括生产计划记录、领料记录、投料记录、返库记录、关键控制点控制记录等)、产品管理记录(包括:成品包装记录、成品检验记录、产品留样记录、产品放行记录、产品贮存记录、产品销售记录、产品退货处置记录、不合格产品召回记录、产品销毁记录、停产复产记录等)、人员记录(包括从业人员健康检查记录/员工管理记录、人员培训记录等)、环境场所清洁记录、设备记录(包括设备台账、设备清洗消毒记录、设备维护保养、使用及检修记录等)、风险防控记录(包括:风险收集记录、食品安全事故处置记录、消费者投诉受理记录)等方面纳入追溯体系,具体乳制品生产企业追溯记录清单见附件1。
  (二)企业应当按照追溯制度对不符合相关法律法规等规定或生产过程中发生食品质量安全问题的,查清流向,召回产品,排查原因,迅速整改。企业可依法采取补救措施、继续销售的,应当记录采取补救措施的时间、地点、人员、处理方式等。
  原辅材料出现问题的,应当立即通报供应商,并对该供应商提供其他原辅材料进行排查,同时重新审核供应商资格。
  (三)企业应严格按照追溯制度开展信息采集、记录、整理、分析等工作,确保各项记录真实、可靠,实现所有环节信息有效衔接。企业可结合实际生产情况和保障乳制品质量安全需要,适当调整或增加记录内容。
  第五十一条 应以实际生产周期为基础进行批号管理或可追溯性编码。批是指按照同一产品配方,一个生产周期内,在同一条生产线上、一次投料、一次连续包装,以相同工艺、稳定条件下持续生产出具有预期质量均一、稳定的一批相同包装规格的成品。
  第五十二条 应建立出厂检验管理制度,检验记录应真实、准确。出厂检验应依据产品执行标准规定的所有检验项目进行每批次检验。针对短保质期乳制品(如巴氏杀菌乳、低温发酵乳等),企业应根据产品特性建立微生物出厂检验制度,明确主体责任,可采用有效的快速检测方法开展检验,或通过有效过程控制措施,保障产品符合食品安全标准。检验结果符合相应食品安全国家标准的合格产品应标注可追溯编码,并可追溯到相应的出厂检验报告。
  第五十三条 企业可以使用非国家标准检验方法进行检验,但应对非标方法进行有效的确认,确保检验数据准确。当检验结果出现不符合食品安全国家标准或企业标准规定的限量时,应采用食品安全国家标准规定的检验方法进行验证;无食品安全国家标准检验方法的应采用必要的质量控制措施进行监控。
  第五十四条 应建立产品留样制度,及时保留样品。产品留样间应满足产品储存条件要求,留样数量应满足检验要求,产品留样应保存至保质期满,并有相应记录。
  第五十五条 建立产品出厂放行制度。明确批准出厂的标准、职责。产品出厂检验合格后方可批准放行。
  第五十六条 应按照《食品安全国家标准 乳制品良好生产规范》(GB 12693)、《食品召回管理办法》等有关规定,建立不安全产品的召回制度和实施产品召回的电子信息管理规定。应对召回的产品采取补救、无害化处理等措施,记录召回和处理情况,并向所在地县级人民政府市场监管部门报告。
  第五十七条 应制定原辅料、过程产品和成品的不合格管理制度及相关处理办法,建立和保存不合格品处理过程记录。
  第五十八条 应定期对已建立的生产质量管理体系的运行情况进行自查,保证其有效运行,并形成自查报告。
  第五十九条 应主动收集国家发布的乳制品安全风险监测、行业和媒体发布的有关乳制品质量安全风险信息,建立风险收集记录,针对相关信息开展自查和评价,并采取有效措施防范食品安全风险。
  建立消费者投诉处理制度,对消费者提出的意见、投诉等,企业相关部门应作记录并查找原因,妥善处理。
  第六十条 应制定食品安全事故处理制度,对可能发生的食品安全事故或与食品安全有关的特殊事件,预先制定应对的方案和措施,必要时做出响应,以减少食品可能发生安全危害的影响。
  当生产条件发生变化,不再符合食品安全要求的,应当立即采取整改措施;有发生食品安全事故潜在风险的,应当立即停止生产,并向所在地县级人民政府市场监督管理部门报告。特殊事件包括使产品受到不可抗力因素影响的情况,如突然停电、停水、机械故障、自然灾害、突发疫情、恐怖袭击等。保存应急预案实施记录,定期演练并验证其有效性。
  第六十一条 建立文件管理制度,并建立完整的食品质量安全管理档案。文件应分类归档、保存,分发和使用应为批准的现行有效文本。已废除或失效的文件除留档备查外,不应在工作现场出现。
  第六十二条 建立记录管理制度,确保记录内容应完整、真实、准确。所有与产品保质期相关的记录(包括电子记录)保存时间不得少于产品保质期满后6个月,其他记录根据其内容及性质另行规定。记录的任何更改都应当标注姓名和日期,并使原有信息仍清晰可查。
  企业建立的台账和生产过程的记录包括但不限于:生鲜乳查验记录、进货查验记录、设备台账、进货台账、环境场所清洁记录、生产设备清洗消毒记录、设备维修记录、库房保管及物料领取记录、生产投料记录、关键控制点控制记录、出厂检验记录、产品检验留样记录、不合格产品处置记录、不合格原料处理记录、产品销售记录、不合格产品召回记录、退货处置记录、从业人员健康检查记录、培训记录、消费者投诉受理记录、风险收集记录、食品安全事故处置记录、检验设备的使用记录、停产复产记录及《食品追溯 信息记录要求》(GB/T 37029—2018)中要求的其他记录等。
  第七章  试制产品检验合格报告
  第六十三条 企业应根据所申报乳制品生产许可的产品种类,按照表6《试制产品检验及要求》中的“品种明细”及要求进行试制产品检验。检验项目按产品适用的食品安全国家标准及相关管理公告的内容进行检验。脱脂牛(羊)初乳粉、地方特色乳制品等没有食品安全国家标准、食品安全地方标准的,可按照行业标准或者企业标准执行。
表6 试制产品检验及要求
类别编号
类别
名称
序号
品种明细
执行标准
试制产品检验要求
0501
液体乳
1
巴氏杀菌乳
《食品安全国家标准 巴氏杀菌乳》(GB 19645)
涵盖标准中所有检验项目。
2
高温杀菌乳
《食品安全国家标准 高温杀菌乳》(GB XXXXX)
涵盖标准中所有检验项目。
3
调制乳
《食品安全国家标准 调制乳》(GB 25191)
检验项目最多的产品进行试制产品检验,涵盖标准中所有检验项目。
4
超高温灭菌乳
《食品安全国家标准 灭菌乳》(GB 25190)
涵盖标准中所有检验项目
5
保持灭菌乳
涵盖标准中所有检验项目
6
酸乳
《食品安全国家标准 发酵乳》(GB 19302)
涵盖标准中所有检验项目
7
风味酸乳
检验项目最多的产品进行试制产品检验,并涵盖标准中所有检验项目。
8
发酵乳
涵盖标准中所有检验项目
9
风味发酵乳
检验项目最多的产品进行试制产品检验,并涵盖标准中所有检验项目。
0502
乳粉
1
全脂乳粉
《食品安全国家标准 乳粉》(GB 19644)
涵盖标准中所有检验项目。
2
脱脂乳粉
涵盖标准中所有检验项目。
3
部分脱脂乳粉
涵盖标准中所有检验项目。
4
调制乳粉
检验项目最多的产品进行试制产品检验,并涵盖标准中所有检验项目。
5
脱盐乳清粉
《食品安全国家标准 乳清粉和乳清蛋白粉》(GB 11674)
涵盖标准中所有检验项目。
6
非脱盐乳清粉
7
乳清蛋白粉
8
加油乳清粉
企业标准
涵盖企业标准中所有检验项目
0503
其他乳制品
1
淡炼乳
《食品安全国家标准 浓缩乳制品》
(GB 13102)
涵盖标准中所有检验项目。
2
加糖炼乳
涵盖标准中所有检验项目。
3
调制炼乳
检验项目最多的产品进行试制产品检验,并涵盖标准中所有检验项目。
4
食品工业用浓缩乳
涵盖标准中所有检验项目。
5
稀奶油
《食品安全国家标准 稀奶油、奶油和无水奶油》
(GB 19646)
涵盖标准中所有检验项目。
6
奶油
7
无水奶油
8
成熟干酪
《食品安全国家标准 干酪》(GB 5420)
涵盖标准中所有检验项目。
9
未成熟干酪
10
再制干酪
《食品安全国家标准 再制干酪》(GB 25192)
涵盖标准中所有检验项目。
11
地方特色乳制品
食品安全地方标准或企业标准
涵盖所有产品及其标准中的所有检验项目。
12
脱脂牛(羊)初乳粉
企业标准
涵盖企业标准中所有检验项目。
13
脱脂牛(羊)初乳
企业标准
涵盖标准中所有检验项目。
14
乳糖
《食品安全国家标准 乳糖》(GB 25595)
涵盖标准中所有检验项目。
15
酪蛋白
《食品安全国家标准 酪蛋白》(GB 31638)
涵盖标准中所有检验项目。
  
  第八章  附  则
  第六十四条 本细则由国家市场监督管理总局负责解释。
  第六十五条 本细则自发布之日起施行,原企业生产乳制品许可条件审查细则(2010版)同时废止。
  附件:1.乳制品生产企业追溯信息记录清单
  2.乳制品生产检验项目表
  附件1
乳制品生产企业追溯信息记录清单
序号
 
记录名称
记录应包括但不限于以下内容
 
原辅料信息记录
生乳验收信息记录
来源牧场或奶站名称、规模、质量协议、牧场或奶站资质审核记录、质检批次、数量、铅封信息、运输车辆信息、温度监控结果、接收时间、企业检验报告、检验人、留样记录等。
原辅材料(包括添加剂、包装材料)验收信息记录
原辅材料名称、规格、数量、生产日期(生产批号)、保质期、供货者信息(包括名称、地址、负责人姓名、联系方式)、产地、合同号(订单号)、采购负责人、供货者资质审核记录、索证索票、进货日期、验收记录、验收要求、检验结果(报告)、检验时间、检验人、复核人、入库时间、入库人员、仓库信息等。
原辅料贮存信息记录
原辅料贮存信息记录:包括原辅材料台帐、仓库温湿度记录、需冷藏冷冻或其他特殊条件贮存的原辅材料贮存设备温湿度记录、留样记录、出库时间、发放人、数量等
2
生产管理信息记录
生产计划信息记录
包括产品名称、生产日期(生产批号)、生产数量、依据的标准、生产开始时间、生产结束时间、生产工序操作人、复核人、使用原辅材料的名称、规格、数量、生产日期(生产批号)、生产厂家等。
领料信息记录
包括原辅材料名称、规格、数量、生产日期(生产批号)、生产厂家、储奶罐号、领取时间、领取人等。
投料信息记录
包括原辅材料名称、规格、数量、生产日期(生产批号)、生产厂家、储奶罐号、投料时间、投料人员、进暂存罐号、内部批号等
返库信息记录
包括退回的原辅材料名称、规格、数量、生产日期(生产批号)、生产厂家、退回库(罐)号、退回时间、退回人员、接收人员等。
生产过程信息记录
包括设备清洗消毒和工艺参数记录、杀菌温度和时间记录、制冷设备温度和时间记录、CIP 清洗记录、发酵温度等。
产品包装信息记录
包括产品名称、规格、数量、包装日期(生产批号)、内部批号、包装设备、操作人、复核人、金属异物检测记录、密封性测试记录、外观检查记录、标签标识等
生产条件信息记录
包括环境场所清洁(消毒)记录、生产和包装车间环境监测记录(包括温度、湿度、压差及微生物检测)、清场记录等。
生产过程检验信息记录
包括半成品的检验批号、检验时间、检验方法、检验结果、检验人、生产过程检测记录等
生产验证信息记录
包括物料平衡记录、特殊问题或异常事件记录等
 
停产复产记录
停工时间、停工范围、停工原因、生产前采取的措施、复产时间、复产产品
3
产品管理信息
产品生产信息
包括产品名称、生产日期(生产批号)、保质期、生产班次、生产数量(包括取样、留样、入库、不合格品数量)、分装机编号、操作人、审核人等
成品检验信息
包括产品名称、规格、生产日期(生产批号)、检验时间、执行标准、检验方法、检验原始记录、检验报告、检验报告编号、检验人、检验报告批准人、检验设备、检测机构、采样地点、样品处置情况等
产品留样信息
包括产品名称、规格、生产日期(生产批号)、留样数量、留样样品完整情况检查记录、留样贮存条件检查记录等
产品放行信息
包括产品名称、规格、生产日期(生产批号)、生产数量、检验情况、放行人等。
产品贮存信息
包括产品名称、规格、生产日期(生产批号)、保质期、入库时间、入库数量、交接记录、出库时间、出库数量、仓库管理人员、发往单位、接收人、仓库温湿度记录、贮存巴氏杀菌乳、需要冷藏的调制乳、发酵乳等产品的设备温湿度记录等
产品销售信息
包括产品名称、规格、数量、生产日期(生产批号)、保质期、检验合格证号、出厂检验报告编号、销售日期(发货日期)、发货地点、购货者信息(包括名称、地址、负责人姓名、联系方式)、销售合同号(订单号)、发货人、销售区域、一级经销商或者销售门店、网络销售记录等
产品退货处置信息
包括产品名称、规格、数量、生产日期(生产批号)、保质期、来源、处置情况等。 ⑧不合格产品召回信息:包括发生召回的产品名称、规格、数量、生产日期(生产批号)、商标、召回区域和地点、发生召回原因、召回等级、召回实施情况、召回公布情况、处置情况、召回效果、召回工作责任人、后续整改方案、控制风险和危害等。
不合格产品召回信息
包括发生召回的产品名称、规格、数量、生产日期(生产批号)、商标、召回区域和地点、发生召回原因、召回等级、召回实施情况、召回公布情况、处置情况、召回效果、召回工作责任人、后续整改方案、控制风险和危害等
产品销毁信息
包括召回产品进行无害化处理、销毁的时间、地点、人员、处理方式等,食品安全监督管理部门实施现场监督的,应记录相关监管人员基本信息;生产企业可依法采取补救措施、继续销售的,应当记录采取补救措施的时间、地点、人员、处理方式等
4
人员设备设施、库房管理信息记录
设备台账
设备编号、规格型号、生产厂家、购买日期、放置地点、使用年限、设备状态记录、设备清洗消毒记录、关键设备维护保养及检修记录等
环境场所清洁记录
清洁开始时间、结束时间、责任人员、清洁剂名称等。
库房保管及物料领取记录
a:应记录仓储单据编号、食品、食品原料、食品添加剂、食品相关产品等的名称、规格、生产日期或生产批号、保质期、入库时间、出库时间、数量、计量单位、责任人员等;
b:应记录食品原料、食品添加剂、食品相关产品名称、规格、生产日期或生产批号、领用或使用日期、保质期、生产地点、数量、计量单位、责任人员等
从业人员健康检查记录/员工管理记录
应记录各阶段责任员工姓名、联系方式、住址、员工岗位信息、健康信息、健康证编号、班次信息、变更信息等。
人员培训记录
培训人、培训对象、培训内容、时间、地点、考核。
5
风险防控记录
风险收集记录
风险原因、处置措施。
食品安全事故处置记录
风险原因、处置措施。
消费者投诉受理记录
应记录投诉购货者姓名和联系方式、购买产品名称、生产日期或生产批号、投诉原因和处理结果等
  附件2
  乳制品生产检验项目表
检验项目
依据标准
对应产品
感官
按照对应标准
全部乳制品
净含量
按照对应标准
全部乳制品
脂肪
GB 5009.6
巴氏杀菌乳、高温杀菌乳、调制乳、灭菌乳、发酵乳、全脂乳粉、脱脂乳粉、部分脱脂乳粉、调制乳粉、浓缩乳制品、稀奶油、奶油、无水奶油、干酪、再制干酪、脱脂牛(羊)初乳粉、
蛋白质
GB 5009.5
巴氏杀菌乳、高温杀菌乳、调制乳、灭菌乳、发酵乳、全脂乳粉、脱脂乳粉、部分脱脂乳粉、调制乳粉、脱脂牛(羊)初乳粉、乳清粉和乳清蛋白粉、浓缩乳制品、特色乳制品
水分
GB 5009.3
全脂乳粉、脱脂乳粉、部分脱脂乳粉、调制乳粉、乳清粉、炼乳(只适用加糖炼乳)、奶油、无水奶油
干物质含量
GB 5009.3
再制干酪
干物质脂肪
GB 5009.6
GB 5009.3
再制干酪
蔗糖
GB 5413.5
调制乳粉(添加蔗糖的产品)、炼乳(只适用加糖炼乳)
乳糖
GB 5413.5
乳清粉
灰分
GB 5009.4
乳清粉、乳清蛋白粉
非脂乳固体
GB 5413.39
巴氏杀菌乳、高温杀菌乳、灭菌乳、发酵乳、奶油
乳固体
GB 5413.5
GB 5009.3
淡炼乳、加糖炼乳
酸度
GB 5009.239
巴氏杀菌乳、高温杀菌乳、灭菌乳、发酵乳、浓缩乳制品、稀奶油、奶油(不适用以发酵稀奶油为原料的产品)
复原乳酸度
GB 5009.239
全脂乳粉、脱脂乳粉、部分脱脂乳粉、脱脂牛(羊)初乳粉
杂质度
GB 5413.30
全脂乳粉、脱脂乳粉、部分脱脂乳粉
免疫球蛋白(IgG)
RHB 602 附录A
脱脂牛(羊)初乳粉
GB 5009.17
巴氏杀菌乳、高温杀菌乳、调制乳、灭菌乳、发酵乳
GB 5009.123
巴氏杀菌乳、高温杀菌乳、调制乳、灭菌乳、发酵乳、全脂乳粉、脱脂乳粉、调制乳粉、脱脂牛(羊)初乳粉
GB 5009.12
巴氏杀菌乳、高温杀菌乳、调制乳、灭菌乳、发酵乳
总砷
GB 5009.11
巴氏杀菌乳、高温杀菌乳、调制乳、灭菌乳、发酵乳、全脂乳粉、脱脂乳粉、调制乳粉、脱脂牛(羊)初乳粉
苯并[a]芘
GB 5009.27
奶油、稀奶油、无水奶油
硝酸盐
GB 5009.33
GB 2762规定的产品
亚硝酸盐
GB 5009.33
GB 2762规定的产品
黄曲霉毒素M1
GB 5009.24
巴氏杀菌乳、高温杀菌乳、灭菌乳、调制乳、发酵乳、全脂乳粉、脱脂乳粉、调制乳粉、脱脂牛(羊)初乳粉、浓缩乳制品、奶油、干酪
菌落总数
GB 4789.2
巴氏杀菌乳、调制乳(采用灭菌工艺生产的除外)、全脂乳粉、脱脂乳粉、调制乳粉、脱脂牛(羊)初乳粉、浓缩乳制品、稀奶油、奶油(不适用发酵稀奶油为原料的产品)、无水奶油(不适用发酵稀奶油为原料的产品)、再制干酪。添加益生菌的产品不适用
微生物(商业无菌)
GB 4789.26
灭菌乳、灭菌工艺的调制乳、炼乳(仅适用于罐头工艺生产的产品)、稀奶油(适用于罐头工艺的稀奶油和超高温灭菌的稀奶油)
大肠菌群
GB 4789.3平板计数法
巴氏杀菌乳、高温杀菌乳、调制乳(采用灭菌工艺生产的除外)、发酵乳、全脂乳粉、脱脂乳粉、调制乳粉、脱脂牛(羊)初乳粉、炼乳、稀奶油、奶油、无水奶油、干酪
霉菌
GB 4789.15
发酵乳、脱脂牛(羊)初乳粉、稀奶油、奶油、无水奶油、干酪(但不适用霉菌发酵产品)
酵母
GB 4789.15
发酵乳、脱脂牛(羊)初乳粉、干酪(但不适用霉菌发酵产品)
金黄色葡萄球菌
GB 4789.10
巴氏杀菌乳、调制乳(采用灭菌工艺生产的除外)、干酪、再制干酪
沙门氏菌
GB 4789.4
巴氏杀菌乳、调制乳(采用灭菌工艺生产的除外)、发酵乳、全脂乳粉、脱脂乳粉、调制乳粉、脱脂牛(羊)初乳粉、乳清粉、浓缩乳制品、奶油、干酪、再制干酪
单核细胞增生李斯特氏菌
GB 25192./GB
4789.30
干酪、再制干酪
乳酸菌数
GB 4789.35
发酵乳(不适用经热处理的产品)
三聚氰胺
《卫生部等5部门关于三聚氰胺在食品中的限量值的公告(2011年 第10号)》
全部乳制品
 
GB 22388
 
食品添加剂
对应的检验方法标准
添加了GB2760允许添加的添加剂的全部乳制品,无检验方法的除外
营养强化剂
对应的检验方法标准
添加了GB14880允许强化的营养强化剂的全部乳制品,无检验方法的除外
标签
GB 7718、GB 28050、GB 13432
全部乳制品

        Notice of the State Administration for Market Regulation on Soliciting Opinions on the”Rules for the Review of Dairy Products Production Licensing (Draft for Solicitation of Comments)”image 乳制品生产许可审查细则(征求意见稿).docx