Regulations on Good Hygiene Practice for Food 【Date：2017-03-15】
Source: Taiwan FDA
Regulations on Good Hygiene Practice for Food
MOHW Food No. 1031301901 promulgated, November 7, 2014
Chapter 1 General Provisions
Article 1 This Regulation is prescribed in accordance with Paragraph 4 of Article 8 of the Act Governing Food Safety and Sanitation (hereinafter referred to as “Act”).
Article 2 The scope of this Regulation is applicable to food businesses in paragraph 7 of Article 3 of the Act. In addition to meeting the requirements established herein, the architecture and equipment of a food factory shall meet the Establishment Standards of Construction andEquipment.
Article 3 The following terms as used in this Regulation are defined as follows:
1.Materials Raw and Packaging Material: This refers to include raw materials and packaging material.
2.Raw Materials: This refers to the constituents in the edible part of a finished product, including the main raw material, ingredient, and food additives.
3.Main Raw Material: This refers to the major component of material in the finished product.
4.Ingredient: This refer to the minor component of material in the finished product besides the main raw materials and food additives.
5.Interior packaging material: This refers to food container such as a bottle, can, box, or bag that comes in direct contact with food and packing material such as aluminum foil, film, paper, and waxed paper that wraps or covers food directly.
6.Exterior packaging material: This refers to the packaging material that is not come in direct contact with food, such as a label, carton box, binder, etc.
7.Food operation site: This refers to the place where food is processed at all stages, treatment of materials raw and packaging material, manufacturing, preparation, processing, compounding packaging and storing.
8.Harmful microorganisms: This refers to microorganisms that are capable of causing food quality deterioration or having public health significance.
9.Food Contact Surface: This refers to a surface that comes into contact with food directly or indirectly.
(1)Direct contact surface: This refers to a surface of equipment that comes into contact with food directly.
(2)Indirect contact surface: This refers to a surface of overflowing liquid or steam under normal operations that will come into contact with food or the surface that contacts food directly.
10.Water activity: This refers to an indication of the free moisture in a food, and is the quotient of the water vapor pressure of the food divided by the vapor pressure of pure water at the same temperature.
11.Partition: This refers to the tangible or intangible isolation measure adopted at a food operation site based on criteria such as site, time or air flow.
12.Food plant: This refers to food manufacturer who has factory license.
Article 4 The site and the environment of food businesses shall meet the requirements of the Good Hygiene Management Guidelines for the site and the environment in Table 1.
Article 5 Food practitioners, equipment and utensils, cleaning and disinfection, waste treatment, edible deep-fry oil, and sanitation managers of food businesses shall meet the requirements of the Good Hygiene Management Guidelines in Table 2.
Article 6 Warehouse control of food businesses shall meet the following requirements:
1.Warehouses for materials raw and packaging material, semi-finished products and finished products shall be set up separately or be adequately partition from one another and be given sufficient room to facilitate transport.
2.Items inside the warehouse shall be classified and placed on pallets, shelves or other effective measures shall be adopted. The items may not be placed directly on the floor and shall be kept clean and well ventilated.
3.Warehouse operations shall be based on the principle of first in and first out and be precisely recorded.
4.When it is necessary to control the temperature or humidity during storage, the control method and criteria shall be established and precisely recorded.
5.The warehouse shall be periodically inspected with precise records kept. Any abnormality shall be handled immediately to ensure the quality and sanitation status of materials raw and packaging material, semi-finished products, and finished products.
6.For items or packaging materials likely to contaminate materials raw and packaging material, semi-finished products, or finished products, there should be measures to prevent against cross contamination. When prevention against cross contamination is impossible, they may not be kept together with materials raw and packaging material, semi-finished products, or finished products.
Article 7 Transport control of food businesses shall meet the following requirements:
1.Transport vehicles shall be checked for their equipment and be kept clean and sanitary prior to carrying foods.
2.When products are to stack up, they shall be kept steady with air circulation maintained.
3.Before carrying low-temperature foods, transport vehicles shall be checked to ensure that foods in the trunks are kept at a valid low temperature.
4.During transport, foods shall be kept away from direct sun exposure, rain, drastic temperature or humidity changes, collision, and puddles inside the vehicle.
5.For items or packaging materials likely to contaminate materials raw and packaging material, semi-finished products, or finished products, there should be measures to prevent against cross contamination. When prevention against cross contamination is impossible, they may not be transported together with materials raw and packaging material, semi-finished products, or finished products.
Article 8 The product complaint and recall control of food businesses shall meet the following requirements:
1.Management of product complaints shall be recorded.
2.Product recall and subsequent management shall be recorded.
Chapter 2 Food Manufacturers
Article 9 Process management and quality control in the food manufacturers shall meet the requirements in the Process Management and Quality Control Guidelines in Table 3.
Article 10 Inspection and measuring control in the food manufacturers shall meet the following requirements:
1.Food manufacturers with their own inspection sites shall be equipped with sufficient room and inspection equipment to facilitate performance of quality control and sanitation management-related inspection. When it is considered necessary, a publicly credible research or inspection agency institution shall be authorized to perform inspection.
2.Food manufacturers with their own microbiological inspection sites shall adequately separate the sites with other inspection sites in a tangible manner.
3.Precision of measuring devices or recorders used in measurement, control, or recording operations shall be calibrated periodically.
4.There shall be effective control measures against biological, physical, and chemical contaminant sources that might occur during inspection.
5.When simplified inspection methods are adopted, they shall be verified against those required by the competent authority or established in laws and regulations periodically and be recorded.
Article 11 Food manufacturers shall establish recycling management plans with regard to product recall and enforce the plans accordingly.
Article 12 Related records, documents, and electronic files or databases created by food manufacturers in accordance with the requirements herein shall be kept for at least five years.
Chapter 3 Food Plant
Article 13 Food plant shall establish related standard operating procedures and keep records of related treatments in accordance with the requirements in Article 4 to the preceding article.
Article 14 Configuration and space at a food operation site shall meet the following requirements:
1.Sites of different operating natures shall be set up separately or be partition from one another effectively and remain clean.
2.There shall be sufficient room to place operating equipment and food utensils, food containers, and packaging, set up sanitary facilities, and store materials raw and packaging material.
Article 15 Food process management and quality control shall meet the following requirements:
1.Test status of materials raw and packaging material, semi-finished products, and finished products in a process shall be adequately indicated and managed.
2.There should be reasonable criteria for the establishment of an expiry date for a finished product. When it is considered necessary, a durability test shall be performed.
3.There shall be a reserved sample of finished products to be kept until expiry date.
4.There shall be process management and quality control records.
Chapter 4 Food Logistics Industry
Article 16 The food logistics industry shall establish standard operating procedures for logistics control that contain the information in Article 7 and the following requirements:
1.Operation sites for different materials raw and packaging material, semi-finished products and finished products shall be set up separately or be adequate partition and be given sufficient room to facilitate transport.
2.Items shall be classified and placed on pallets and shelves or other effective measures shall be adopted. Items may not be placed directly on the floor and shall be kept clean.
3.Operations shall be based on the principle of First in and First out and be precisely recorded.
4.When it is necessary to control the temperature or humidity during operations, the control method and criteria shall be established and precisely recorded.
5.The storage process shall be periodically inspected and precisely recorded. Any abnormality shall be handled immediately to ensure the quality and sanitation status of materials raw and packaging material, semi-finished products, and finished products.
6.Before loading and unloading low-temperature foods, the temperature of the foods shall be inspected and recorded.
7.The handling, loading, and unloading of low-temperature foods shall take place at a temperature below 15°C and conducted quickly.
8.Logistics operations shall be based on the product storage temperature requirement established by food manufacturers.
Chapter 5 Food Retailers
Article 17 Food dealers shall meet the following requirements:
1.Facilities and sites for selling and storing foods or food additives shall be kept clean and be equipped with measures to effectively guard against invasion by pests.
2.Foods or food additives shall be kept properly and piled neatly to avoid contamination and spoilage.
3.For hot holding of foods, they should be maintained above 60°C of the core temperature.
4.Items inside warehouses shall be classified and placed on pallets and shelves or other effective measures shall be adopted; they may not be placed directly on the floor and shall be kept well ventilated.
5.There shall be sanitation managers to take charge of food sanitation management on site.
6.Sale and storage operations shall be based on the principle of First in and First out.
7.When control over the temperature and humidity is required for sale and storage operations, related control methods and criteria shall be established and enforced accordingly.
8.Labels or storage status of products shall be periodically inspected during sale and storage operations. Any abnormality shall be handled immediately to ensure quality and sanitation of foods or food additives.
9.For items or packaging materials likely to contaminate materials raw and packaging material, semi-finished products, or finished products, there should be measures to prevent against cross contamination. When prevention against cross contamination is impossible, they may not be kept together with material raw and packaging material, semi-finished products, or finished products.
10.Illumination shall be provided so that sale site shall be no less than 200 lux or above and the light source may not change the natural color of the food.
When food retailers are wholesalers, they shall establish related standard operating procedures and keep records of related treatments in accordance with the requirements in Articles 4 to 8.
Article 18 For food retailers that sell and store frozen or refrigerated foods, besides the requirements in the preceding articles, the following requirements shall also be met:
1.Retailers may not change the food storage temperature originally set by manufacturers.
2.Frozen foods shall be contained in intact sealed basic packaging. Frozen (Refrigerated) foods may not be fixated with metal nails or rubber bands or other similar materials. Foods with broken packaging may not be sold.
3.Frozen foods shall be stored and sold separately from refrigerated ones.
4.When stored or displayed inside a freezer or refrigerator, frozen (refrigerated) foods may not be loaded higher than the maximum line.
Article 19 For food retailers that sell and store bakery product, besides the requirements in the Article 17, the following requirements shall also be met:
1.Bakery product to be sold but without packaging shall be kept in clean containers and displayed in their respective categories. There shall also be measures and equipment available to prevent against contamination and clean tongs and baskets (trays) available for customers to select and carry the products.
2.Cakes or pies with cream, pudding, jelly, fruits or filling that are prone to deteriorate or be spoiled as their ornaments or stuffing shall be kept in refrigerators at a temperature below 7°C.
Article 20 For food retailers that sell poultry, livestock and aquatic products, besides the requirements in the Article 17, the following requirements shall also be met:
1.Tables used to display poultry, livestock, and aquatic products shall be made of water impermeable and corrosion-resistant materials and shall meet requirements of sanitation standards for food utensils, food containers, and packaging.
2.There shall be adequate washing and drainage facilities at the sale site.
3.Work tables, chopping boards, or knives shall be kept tidy and clean. There shall be separate knives or chopping boards for raw edible fish or fish and meat products that can be consumed without being heated.
4.Meat grinders and slicers, among others, shall be kept clean and free of contamination.
5.Fresh aquatic products shall be kept in water tanks and treated with running tap water and prevented from contaminating finished products to be sold.
6.There shall be adequate temperature and time control for the storage, display, and sale of poultry, livestock, and aquatic products.
7.There shall be freezers (refrigerators) or related facilities for frozen (refrigerated) poultry, livestock, and aquatic products.
8.When poultry, livestock, and aquatic products are to be stored, displayed, or sold in ice, the ice shall meet the Drinking Water Quality Standart.
Article 21 For stands or small retailers that also sell foods, competent authority in the municipality, county, or county-level city may apply requirements herein depending on the actual situation.
Chapter 6 Food Service Businesses
Article 22 Operation sites of the food services shall meet the following requirements:
1.There shall be sufficient running tap water and dishware rinsing and sterilizing facilities that are capable of rinsing, flushing, and effective disinfection in one at the rinsing site. The height of the faucet shall be above the maximum water level in the tank to avoid reflux and contamination. When there is no sufficient running tap water, disposable dishware shall be provided.
2.Oil interceptor in the kitchen shall be cleaned and kept clean frequently.
3.There shall be adequate treatment measures available for oil fume to prevent its contamination.
4.There shall be measures in the kitchen to keep air pressure and room temperature at an adequate level.
5.When no seats are set, the food service shall have effective partition between their sale counter and preparing, processing, and operating sites.
Article 23 The food service shall adopt one of the following sterilization methods:
1.Boiling sterilization: Towels and cloths shall be boiled for more than five minutes and dishware for more than one minute at 100°C.
2.Steam sterilization: Towels and cloths shall be heated for more than ten minutes and dishware for more than two minutes with steam at 100°C.
3.Hot water sterilization: Dishware shall be heated for more than two minutes in hot water at a temperature above 80°C.
4.Chlorine sterilization: Dishware et al. shall be soaked in the solution containing less than two hundred-millionth of chlorine in total for more than two minutes.
5.Dry heat sterilization: Dishware et al. shall be heated for more than 30 minutes with dry heat at a temperature above 110°C.
6.Other effective sterilization methods approved by the central health competent authority.
Article 24 The ratio of cooking practitioners holding a culinary technician certificate and bakery technician certificate in a food service business shall meet the requirements of the Regulations on Placement and Management of Food Businesses Employment of Professionals with Vocational or Technical Certification in Food Businesses.
The culinary technician certificate holders indicated in the preceding paragraph shall be enrolled in a food service -related association or union in the municipality, county, or county-level city where they work and local competent authority shall authorize an approved association or union to present them with a chef certificate.
The association or union issuing the certificate of cook in the preceding paragraph shall receive guidance from the competent authority in the municipality, county, or county-level city. Failure to abide by guidance or violation against any agreement on the authorization, the competent authority in the municipality, county, or county-level city may terminate the authorization.
The certificate of cook is effective for four years and may be extended upon expiration. Each extension shall involve four years. Extension applicants shall attend sanitation workshops organized by competent authorities at all levels or associations or unions, senior high schools and higher level schools, or other food service-related institutions that are approved at least eight hours a year while the certificate is effective.
The requirement in Paragraph 1 shall be enforced at one year after this Regulation is promulgated.
Article 25 Ratios of cooking practitioners holding a Chinese culinary technician certificate for the food service dealing with Chinese food service within one year after this Regulation is promulgated are as follows:
1.Restaurants in tourism hotels: 80%.
2.Food service that contract with schools: 70%.
3.Box meal businesses supplying schools: 70%.
4.Restaurants organizing banquets: 70%.
5.Catering businesses: 70%.
6.Central kitchen-based food service: 60%.
7.Food service contractors: 60%.
8.Self service cafeterias: 50%.
Article 26 Sanitation management of food service shall meet the following requirements:
1.Equipment and utensils used during preparation shall be operated and maintained to prevent against contaminating foods. When it is considered necessary, different colors shall be used to indicate equipment and utensils for different purposes.
2.Bamboo or wooden chopsticks or other disposable dining ware shall be discarded right after use. For sites where people share a table of food, spoons, chopsticks, forks, and knives, among other dishware for dividing the food shall be provided.
3.The provided dishware shall be kept clean, without residual fat, starch, protein, or detergent. When it is considered necessary, pathogenic microorganism test shall be performed.
4.Cross contamination shall be avoided during preparation.
5.An adequate temperature shall be maintained for the storage and supply of prepared meals. When storing foods and dishware, there shall be sanitary facilities available to prevent against dust and pests.
6.Sanitation and safety of to-go ready-to-serve meals shall be ensured.
7.Machines and utensils used in the preparation of foods shall be kept clean.
8.When raw foods are supplied, preparation, processing, and operation shall be done in an exclusive operating zone.
9.Culture sites of fresh aquatic products shall be effectively partition from the preparation site.
10.Inbound supplies and personnel access to the kitchen shall be adequately controlled during the preparation period.
Article 27 Catering businesses shall meet the following requirements:
1.The cooking site and the supplied foods shall be kept away from direct sun exposure, rain, or contact with pollutants and there shall be shelters, freezing (refrigerating) equipment or facilities.
2.Cooking utensils and dishware shall be kept clean.
3.Preparation of foods shall meet the principles of being fresh, clean, quick, heated, and refrigerated and cross contamination shall be avoided.
4.To organize a catering event serving more than 200 people, filing with the local health authorities in the municipality, county, or county-level city directly or through the direct association or union for reference should be done at three days in advance. Contents filed for reference shall include the sponsor, the undertaker, the location, the number of participants, and the menu.
Article 28 Food service contractors shall meet the requirements of Articles 24 and 26. Before accepting a contract, they shall file with the local health authorities directly or through their direct association or union for reference; contents filed for reference shall include the sponsor, the undertaker, the location, and the number of people to be served.
Chapter 7 Food Additive Businesses
Article 29 The acceptance, storage, and management of food additives shall meet the following requirements:
1.The acceptance procedure and tracing and tracking system shall be established for the acceptance of food additives or raw materials and information such as the source, content, and quantity shall be recorded.
2.Materials raw and packaging material, semi-finished products or finished products shall be kept in different places. When it is considered necessary, they may be kept in the freezer (refrigerator) and separated from other materials or items not to be used in foods in a tangible way.
3.Warehouse management shall follow the principle of First in and First out.
Article 30 The operation sites for food additives shall meet the following requirements:
1.Manufacturing areas or process steps for food additives and chemical raw materials or chemical products shall be separated.
2.When there is concern of hazardous substance leaks as a result of the use of solvents or powder or dust explosions during the manufacturing process, preventive facilities or equipment shall be in place.
Article 31 Equipment, utensils, containers, and packaging used while food additives are being manufactured shall meet the following requirements:
1.They shall be easy to clean, disinfect, and inspect.
2.They shall meet the requirements of the sanitation standards for food utensils, food containers and packaging.
3.Mixture with lubricant, metal chips, sewage, or other possible polluting substances in the food additives shall be prevented.
Article 32 The process and quality management of food additives shall meet the following requirements:
1.Process and quality control procedures shall be established and completely recorded.
2.The finished products shall meet the Standards for Specification, Scope, Application and Limitation of Food Additives and be completely packaged and labeled. Where each batch of finished products is sold to shall be recorded.
Chapter 8 Low-Acid and Acidified Canned Food Manufacturers
Article 33 The production and processing management of low-acid and acidified canned foods manufactures shall comply with the stipulation of production and processing guidelines in Table 4.
Article 34 The sterilization equipment and method adopted by low-acid and acidified canned foods manufactures shall comply with the stipulation of sterilization equipment and method guidelines in Table 5.
Article 35 Staff of low-acid and acidified canned foods manufactures shall comply with the following stipulation:
1.Canned foods manufacturing plants shall have supervisors of thermal process, as well as sterilizer operators, container closure inspectors, and closing machine operators.
2.The supervisors of thermal process, inspectors and operators for the low-acid metal cans shall be qualified in the training program held by the institutions approved by the central competent authority, and they shall be certified. Other personnel in the forgoing clause shall be trained.
Article 36 Sealing control over containers used in the low-acid and acidified canned foods manufactures shall comply with the stipulation of container sealing control guidelines in Table 6.
Chapter 9 Vacuum Packaged Ready-to-eat Food Manufacturers
Article 37 A vacuum packaged ready-to-eat food is a product that is degassed and sealed within a hermetically sealed container and can be instantly edible after being unsealed, with no need to be processed by any cooking step. The manufacturing of vacuum packaged ready-to-eat foods that can be kept and sold at an ambient temperature shall conform the following stipulations:
1.Vacuum packaged ready-to-eat foods that conform the following stipulations may be kept and sold at room temperature:
(1)water activity ≦ 0.85.
(2)pH value≧ 9.0.
(3)Commercially sterilized products.
(4)Acid foods (natural or normal pH value equal to 4.6 or below).
(5)Fermented foods (when the pH of the food is reduced to 4.6 or less by the growth of acid producing microorganisms; or salt concentration ≧ 10%).
(6)Carbonated beverages.
(7)Any other condition that can inhibit Clostridium botulinum at room temperature.
2.Products with the first, second, fourth, fifth conditions of above mentioned shall be stored and sold in accordance with their labeling. The proprietors shall reserve related test reports or certification documents proved by the laboratories accredited by the central competent authority for reference. The third conditions of above mentioned shall conform the stipulations in Chapter 8.
Article 38 The manufacturing of vacuum packaged ready-to-eat foods sold and stored in cold storage shall conform the following stipulations:
1.As for Vacuum-Packed ready-to-eat foods with water activity above 0.85 that require cold storage, all the processes for storing, transporting and selling them shall be undertaken in the status of cold storage at 7oC.
2.Shelf life of Vacuum-Packed ready-to-eat foods in cold Storage:
If such a product does not meet any of the following conditions, its shelf life shall be within ten days. The proprietors shall reserve related test reports or certification documents proved by the laboratories accredited by the central competent authority, for reference.
(1)Added with Nitrite or Nitrate
(2)Water Activity ≦ 0.94
(3)pH value ≦ 4.6
(4)Salt Concentration ＞ 3.5% (only applicable to smoked and fermented products)
(5)Any other condition that can inhibit Clostridium botulinum.
Article 39 The manufacturing of Vacuum-Packed ready-to-eat foods require frozen storage, all the processes for storing, transporting and selling them shall be undertaken in the status of cold storage at -18oC.
Chapter 10 Plastic Food Utensils, Food Containers or Packaging Manufacturers
Article 40 The development and design of products shall meet the following requirements:
1.The end use environment and conditions for the products shall be established.
2.Appropriate raw materials shall be selected in accordance with the settings in the preceding subparagraph.
3.There shall be records for reference with regard to the development and design data.
Article 41 The storage of raw materials and products shall meet the following requirements:
1.There shall be storage space exclusively for or with the possibility of being partition from other areas for plastic raw materials.
2.Cross contamination shall be avoided in the storage space.
3.There shall be complete records of inbound and outbound plastic raw materials; contents of the records shall include the date and the quantity.
4.Businesses shall keep sanitation and safety data provided by the plastic raw materials suppliers.
Article 42 The manufacturing site shall meet the following requirements:
1.Cross contamination shall be avoided while the flow is being planned.
2.The mixing area, processing area, and packaging area shall be separated from one another in a tangible way and contamination by powder, dust and oil fume shall be prevented.
3.Equipment used in and the process involved in processing, packaging, and transport shall be kept clean.
Article 43 Production and manufacturing shall meet the following requirements:
1.Manufacturing shall take place following the recommended processing conditions provided by plastic raw materials suppliers and be recorded on a daily basis. The same shall apply when there are changes to the recommended conditions.
2.Contact with the floor shall be avoided from manufacturing to packaging. When it is considered necessary, appropriate devices shall be used as containers or carriers during the process.
3.In printing operations, transfer or attachment of ink to the surface that comes in contact with food shall be avoided. When there is concern of ink invading or being extruded to get in contact with foods, colorants allowed in accordance with the Standards for Specification, Scope, Application and Limitation of Food Additives shall be used.
Article 44 Sanitation management of plastic food utensils, food containers or packaging shall meet the following requirements:
1.Transmission, packaging, or transport sites shall be separated in a tangible way and contamination by other substances or microorganisms shall be avoided.
2.Quality control shall be exercised during packaging of finished products.
3.Labeling, testing, removal off shelves, recall, and post-recall disposition and documentation of finished products shall meet the requirements of the Act and applicable laws and regulations.
Article 45 Records of plastic food utensils, food containers or packaging created in accordance with these Regulations shall be kept at least for more than three years after the batch of finished products expires.
Chapter 11 Supplementary Provisions
Article 46 Unless the enforcement date is specified otherwise, these Regulations shall be enforced on the date of promulgation.
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