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Title: The Establishment Standards of Construction and Equipment of a Food Factory CH
Amended Date: 2018-09-27
Category: Ministry of Health and Welfare(衛生福利部)
Chapter I: General Provisions
Article 1
These standards are set forth in accordance with the second paragraph of Article 10 of Act Governing Food Safety and Sanitation.
Article 2
Unless otherwise stipulated by law, the construction of buildings and equipment of the food factories shall be made in accordance with the regulations of these standards.
Article 3
The food factories prescribed by these standards refer to factories that should apply for factory registration.
Article 4
The construction of food factories should conform to the regulations prescribed in Chapter 2; and the following specialized food factories should conform to regulations prescribed in Chapter 3. The relevant regulations for specialized food factories:
(1) Canned food factories
(2) Frozen food factories
(3) Candied fruit factories
(4) Beverage factories
(5) Soy sauce factories
(6) Dairy product factories
(7) Edible oil factories
(8) Dehydrated vegetable and fruit factories
(9) Lunch box food factories
(10) Instant noodle factories
(11) Food additive factories
The classifications of the preceding specialized factories are made in reference with Taiwan’s Standard Occupational Classification and Industrial Category and Classification, Ministry of Economic Affairs.
Chapter II: The Universal Basic Standards for Food Factories
Article 5
The environment of food factories should conform to the following regulations:
1.The factory premises should be constructed with unobstructed gutters, the open space paved with concrete, asphalt or green covering and free from flying dust. The environment should be kept clean always with the ground being swept regularly to maintain cleanliness.
2.The drainage system should be cleaned up regularly to keep it unobstructed and free from foul smell.
3.Livestock, pets, etc., should be kept under control and appropriate measures should be taken to avoid contaminating the food.
4.The staff dormitories should be completely isolated from the operating site and be constructed with separate entrance doors.
5.Vector control measures should be implemented.
Article 6
The food factories should include an office, raw material preparation site, processing or dressing site, inspection room or laboratory, packaging room, warehouse, electrical room, boiler room, maintenance room, changing rooms, hand washing and sterilizing room, restaurant, staff rest rooms, staff dormitories and toilets, etc. For sites with different applications and cleanliness requirements, they should be constructed individually or isolated effectively and managed, and their buildings should conform to the following regulations:
1. Walls and pillars: The walls and pillars of raw material preparation sites, processing, dressing and other buildings should be in white or light-colored, the section at least one meter above the ground should be paved with non-absorbent, water impermeable and easily-washable material, and its surface should be smooth with no cracks and kept clean regularly.
2. Floor: The building’s surface of raw material preparation, processing, dressing and indoor packaging sites should be paved with non-absorbent, water impermeable, acid/alkali resistant and wear resistant material. The floor should feature an appropriate drainage gradient and water discharge system.
3. Floor slab or ceiling: It should be in white or light-colored to ease cleaning, constructed to avoid dust accumulation. Condensation is not allowed on the floor slab or ceiling directly above the exposed food, and it should be kept clean and maintained in good condition.
4. Light: Except for warehouses, all other buildings of food factories should be able to get adequate light; the work table or dressing table should maintain more than 200 lux, and the machinery and equipment table should maintain more than 100 lux. The light source used should not be able to change the color of food.
5.Ventilation: The factory buildings should be well-ventilated, and installed with fans, exhaust fans and other effective ventilation equipment if necessary. The air vents should be equipped with facilities to prevent the intrusion of disease vectors. Any confined processing room or packaging room should be installed with air conditioning facilities.
6. Entrances, doors, windows and other channels: They should be made of durable non-absorbent, easily-washable, water impermeable and durable materials, and equipped with facilities to prevent the intrusion of disease vectors.
7.Water drainage system: There should be a complete unobstructed water drainage system and the gutters equipped with intercepting facilities to intercept solid wastes, and the exit equipped with facilities to prevent the intrusion of disease vectors.
8.Warehouse: The raw material warehouse and finished product warehouse should be constructed separately or independently, the floor at warehouse interior higher than warehouse exterior, and constructed with water impermeable material, and the warehouse interior prepared with sufficient pallets to cope with inventory and production operation needs.
9. Toilet:
(1) The toilet construction site should be prevented from contaminating the water source.
(2)The toilet entrance should not face directly towards the food processing site, but such restriction does not apply if it is constructed with a buffer facility to control airflow effectively and to prevent contamination.
(3)It should be equipped with ventilation, day lighting, anti-pest, anti-rodent and other facilities, as well as running tap water, detergent, hand washing and drying facilities with hand dryers or paper towels, and trash bins.
(4)It should be installed with a sign to remind users to wash their hands after visiting the toilet.
10.Changing room: There is a need for food factories, depending on requirements, to construct changing rooms at appropriate locations adjacent to the processing/dressing site but isolated from the food processing site. Changing rooms should be separated by gender, and equipped with mirrors, dust cleaning equipment, and sufficient personal lockers, shoe cabinets, etc.
11.Hand sterilizing room: There is a need for food factories, depending on requirements, to set up a hand sterilizing room. It should be adjacent to the processing/dressing or indoor packaging room, and installed with sufficient hand washing and drying facilities.
12. The safety facilities installations are required for freezing refrigeration equipment.
Article 7
The mechanical design and material of machinery and equipment in food factories shall meetconform to the following requirements:
1.Design of mMachinery and equipment design: The design and structure of the machinery and equipment used for production of food or food additives should prevent hazards from deteriorating the quality and hygiene of food or food additives and should permit easy cleaning, sterilization and inspection. Moreover, the structural design should safeguard products against contamination of lubricants, metal filings, wastewater, or other contaminants.
2.Materials of mMachinery and equipment material: The equipment and utensils used in the food or food additive processing section or likely to have contact with food or food additives should be made of materials incapable of producing or dissolving and generating toxins and bad or unpleasant odors; moreover, materials should be non-absorbent and corrosion-resistant and capable of withstanding repeated washing and sterilization procedures. The use of materials which produce contact corrosion shall also be avoided.
Chapter III. Production and Inspection Equipment Standards and Basic Facility Requirements Standards ofor Food Factories
Article 8
The canned food factories should possess the following production and inspection equipment are required for canned food factories:
1.Production equipment:
(1)Stable heat source: The main steam supply pipe pressure shall be maintained at 6kg/cm2 or above.
(2)Capping equipment: The capping equipment should be able to ensure safety cap sealing and the type used should be able to conform to product needs.
(3)Disinfection equipment
2.Inspection equipment:
(1)Constant temperature incubator
(2)Can vacuum tester and pressure resistance tester (essential for metal canned food factories)
(3)pH meter or litmus paper
(4)Closed volume micrometer (essential for metal canned food factories)
(5)Compressive strength measuring device (essential for retort pouch canned food factories)
The following production and inspection equipment are optional for canned food factories depending on the production and inspection needs:
1.Production equipment:
(1)Raw material washing equipment
(2)Blanching equipment (equipped with cooler)
(3)Dressing table and dressing tools
(4)Degassing equipment
(5)Cleaning and sterilizing equipment
(6) Post-disinfection cooling equipment
(7) Filling solution preparation equipment
(8)Batch number and date labeling equipment
(9) Empty can (bottle) spray washing equipment
(10)Freezer (refrigerator)
(11)In-process vacuum leak detector or vacuum probe.
2.Inspection equipment:
(1)Fixed can opener
(2) Weighing scale
(3) Thermometer
(4) Glucose meter
(5) Residual chlorine analyzer or litmus paper
(6)Water supply device and washing equipment
(7)Measuring device for residual air in bag
(8)Can leak detection device
(9)Point micrometer
Article 9
The following freezing equipment are required for production processes in frozen food factories.
The following production and inspection equipment are optional for a frozen food factoriesy depending on the production and inspection needs:
1.Production equipment:
(1)Raw material washing equipment
(2)Blanching and cooling equipment
(3)Cold storage vehicle: If it is available, Tthe temperature of the food should be maintained at below -18°C.
(4)Cleaning and sterilizing equipment
(5)Metal or and foreign matter detector
2.Inspection equipment:
(1)Residual chlorine analyzer or litmus paper
(2)Microbiological testing equipment
(3)Product temperature testing instrument
(4)Weighing scale (sensitivity below 1mg)
(5)Oxidase detection device, pH meter or litmus paper, glucose meter
(6)Drug residue detection device
(7)Volatile basic nitrogen (VBN) determination device
(8)Crude fat quantitative determination device
(9)Histamine quantitative determination device
Article 10
The following basic facilities and inspection equipment are required for candied fruit factories:
1.Basic facilities:
(1)If the processing and packaging sites are confined spaces, they should be equipped with air conditioning equipment.
(2) The pickled pool should be a covered facility, and the pickled tank or barrels should be set up indoors and equipped with covers.
The pickled pool should be a covered facility, and the pickled tank or barrels should be set up indoors and equipped with covers
(3)If a drying field is needed in drying, it should be constructed of water-impermeable material.
(4)Steam-jacketed kettle, soup cooking barrels, candied tanks or barrels, paddles, plates, knives, forks and other utensils may should be made of stainless steel to the extent possible. These can be exempted for factories not manufacturing candied fruits.
2.Inspection equipment:
(1)Glucose meter or glucose refractometer (can be exempted for factories not manufacturing candied fruits)
(2)Salinity meter
The following inspection equipment are optional for candied fruit factories depending on the production and inspection needs:
1.Residual chlorine analyzer or litmus paper
2.Sulfur dioxide quantitative determination device
3.Thermometer
4.pH meter or litmus paper
5.Weighing scale
Article 11
The following production equipment are required for beverage factories:
1.General beverage factoriesmanufacturing plants:
(1) Filling machine
(2) Filter
(3) Disinfect equipment
2.Fruit and vegetable juice factoriesmanufacturing plants:
(1)Filling machine
(2)Fine filter, centrifuge or homogenizer
(3)Disinfection equipment
The following production and inspection equipment are optional for beverage factories depending on the production and inspection needs:
1.Production eEquipment :
(1)General beverage factoryies:
A.Container washing and sterilizing equipment
B.Water reservoir: Its capacity should be sufficient to meet daily processing needs.
C.Stainless steel blender and stainless steel tank
D.Bottled water inspection equipment, dip tank and lighting fluoroscopy unit, etc.
E.Bottled drink automatic filling and capping machines
F.Canned drink power cap sealing machine
G.Carbonated mixer
H.Freezer (essential for carbonated drink factories)
(2)Fruit and vegetable juice factories:
A.Container washing and sterilizing equipment
B.Washing tank or rotary washing machine
C.Crusher
D.Juicer
E.Cooling equipment
2.Inspection equipment:
(1)Microscope
(2)Microbiological testing equipment
(3)Constant temperature incubator
(4)pH meter or litmus paper
(5)Glucose meter or glucose refract meter (excluding packaged drink and mineral water factories)
(6)Weighing scale
(7)Residual chlorine analyzer or litmus paper
(8)Centrifugal separator and vacuum tester
(9)Pressure detector
(10) Turbidity and color determination equipment
Article 12
The following inspection equipment are required for soy sauce factories:
1.pH meter or litmus paper
2.Weighing scale
3. Salt detector, analyzer, orand salinity meter
4. pH testing equipment
5. Residual chlorine analyzer or litmus paper
The following production and inspection equipment are optional for soy sauce factories depending on the production and inspection needs:
1.Production equipment:
(1)Raw material sorting equipment (can be exempted for factories using pre-screened raw materials)
(2)Steam cooker
(3)Wheat frying equipment (can be exempted for factories not using wheat additive)
(4)Blender
(5)Koji making equipment
(6)Salt dissolving equipment
(7)Fermentation equipment
(8)Compressing equipment
(9)Filtering equipment
(10)Settling tank
(11)Disinfection or heating/cooking equipment
(12)Spray washer (essential required for soy sauce factories that package product in reusable glass bottles)
(13)Filling equipment (including capping machine)
2.Inspection equipment
(1)Sterile room, sterile container or microbial incubator
(2) Total nitrogen measuring device
(3)Amino nitrogen determination equipment
(4)Moisture detector
(5)Color analyzer or color disc
Article 13
The following basic facilities, production and inspection equipment are required for dairy product factories:
1.Basic facilities
(1)Milk storage, processing, repacking, dressing and other treatments of dairy product factories should be done within the factories. All processing equipment must meet excellent sanitation conditions; the flowing channels of milk emulsion and powered milk, and the equipment that the milk emulsion or powered milk gets in touch with, should be made of stainless steel with smooth interior walls that are free from pinholes, right angles and slits.
(2)The dairy product factories should possess cooling water supply (or other cooling fluid) equipment and should be isolated from the processing/dressing site (excluding powered milk blending).
(3)Milk collection and milk storage equipment (excluding dairy products made from raw milk as the raw material): Weighing equipment, milk storage tank, milk barrel washing and disinfection equipment, milk pump, filter or impurity centrifugal machine, milk cooling equipment, milk storage tank with cooling effect, a set of raw milk inspection equipment (including alcohol testing, precipitate tester, sampling equipment, etc.), cold storage vehicles.
2.Inspection equipment:
(1)Raw milk sampler (excluding powdered milk blending)
(2)Acidic titration device and burette
(3)Raw milk densometer (excluding powered milk blending)
(4) Thermometer
(5)Dryer for detecting moisture (essentialrequired for production factoriesyplants)
(6)Weighing scale
(7)Residual oxygen analyzer (essential for powdered milk blending or manufacturing)
(8)Drug residue testing instruments
The following production and inspection equipment are optional for dairy product factories depending on the production and inspection needs:
1.Production equipment
(1)Fresh milk and flavored milk processing factories:
A.Milk pump
B.Homogenizer
C.Milk fat separator
D.Bottle washing machine (including disinfection equipment), bottle filling machine or automatic paper packing machine
E.Low-temperature (below 7°C and above freezing point) storage room for finished products (excluding enduring milk)
(2)Concentrated milk (milk and condensed milk) production plants:
A.Homogenizer
B.Pre-heat equipment
C.Enrichment equipment
D.Cooling equipment
E.Blending and processing equipment
F.Milk pump
G.Empty can washing and disinfection equipment.
H.Milk and condensed milk automatic filling and sealing machines
(3)Powdered milk manufacturing plants:
A.Milk pump
B.Milk fat separator
C.Homogenizer
D.Milk storage tank
E.Milk emulsion pre-heat equipment
F.Enrichment equipment
G.Milk powder making machine
H.Powder collection and processing equipment
I.Powdered milk storage tank
J.Additive mixer
K.Empty can disinfection and cleaning equipment
L.Automatic powered milk filling and sealing equipment
M.Machinery relating to Iinstant milk powder related equipmentproduction
(4)Fermentation milk production plants:
A.Milk pump
B.Milk fat separator
C.Broth blending tank
D.Fermenter
E.Homogenizer
F.Dilution blending equipment
G.Bottle washing and filling machines, paper packing machine or other container packing machine
H.Bacteria culture control equipment
I.Low-temperature storage room for finished products (below 7°C and above freezing point)
(5)Powdered milk blending plants:
A.Air-conditioning equipment (essential for blending and packaging sites)
B.Vacuum cleaner
C.Nitrogen filling equipment, deoxidant or equipment with equivalent effect
D.Weight inspection machine
E.Metal or foreign matter detector
F.Empty can disinfection and cleaning equipment
G.Powdered milk automatic filling and sealing equipment
H.Weighing equipment
I.Mixing equipment
J.Screening machine
K.Powder storage equipment or container
2.Inspection equipment
(1)Microbiological analysis equipment
(2)Residual chlorine analyzer or litmus paper
(3)Somatic cell count equipment
Article 14
The following basic facilities are required for edible oil factories:
1.Oil solvent extraction factories should construct solvent storage tanks and their storage site, and be equipped with anti-explosion devices and fire equipment such as fire extinguishers and fire sand, etc.
2.Indoor packaging room: Factories producing small packages (less than 3 kg packs) of products should construct independent indoor packaging room equipped with screen windows, screen doors or air curtains, air purifying equipment and disinfection devices installations where necessary (The requirement does not apply to plants that do not manufacture products in small packages.).
3.Animal fat factories should construct cold storage warehouse of temperature below the zero point.
4.All edible oil storage tanks should be made of stainless steel whenever possible. Raw Designated material storage tanks or material storage areasshelves and finished-product storage tanks shall be made available.
The following production and inspection equipment are optional for edible oil factories depending on the production and inspection need:
1.Production equipment:
(1)Soybean oil factories:
A.Crude soybean oil refineries:
a.Screening machine
b.Dryer
c.Crusher
d.Flattening machine
e.Baking machine
f.Oil extraction machine (built-in with Miscella distiller, desolventizer for defatted meal, solvent vapor collector)
B.Refined oil manufacturing plants:
a.Refined soybean oil factories:
Centrifuge
Bleaching equipment
Pressure filter
Vacuum pump
Pre-heat equipment
Deodorizing equipment
Cooling equipment
b.Soybean oil factories: Soybean oil factory equipment requirements include those identical to refined soybean oil factories. Additional installation of requirements are freezer, dewaxing equipment and nitrogen filling equipment is recommended.
(2)Animal fat factories:
A.Hot fried soybean refineries:
a.Slicing (shredding) machine.
b.Frying pan.
c.Hydraulic machine.
d.Cooling tank.
B.Refined animal fat factories: Same as the various equipment required for refined soybean factories.
(3) Margarine, fat spread and shortening oil factories:
A.Margarine, fat spread and shortening oil integrated production plants:
a.The equipment requirements include those identical refined soybean oil factories.
b.Emulsifying tank (indirect heating manner)
c.Disinfection equipment
d.Rapid cold quenching machine (built-in with freezer)
e.Quantifier
B.Processing factories using refined oil as the raw material: The equipment requirements are identical to those of margarine, fat spread and shortening oil integrated production plants.
2.Inspection equipment:
(1)Crude soybean oil refineries: The refineries are required to have instruments, equipment and chemicals needed to perform acidity test and other analyses. Additional equipment requirements include weighing scale, oven and dryer.
(2)Refined oil refineries: In addition to inspection equipment for crude oil refineries, equipment needed to perform iodine value, peroxide value, and color tests are required. A main equipment list is provided below:
A.Color measuring device
B.Weighing scale
C.Incubator
D.Oven
(3)The solvent oil extraction plants should possess solvent residue detection device.
(4)Margarine, fat spread and shortening oil factories:
A.Margarine, fat spread and shortening oil integrated production factories: The inspection equipment requirements for these factories include those identical to refined oil refineries. Additional equipment requirements are instruments needed to perform melting point, freezing point, E. coli, bacteria, saponification value tests. The A main equipment are listed ais followsprovided below:
a.Bacterial culture, testing equipment or rapid bioassay devices (apparatus, instrument and equipment)
b.Sterile room, sterile container or microbial incubator (not required for shortening oil factories)
c.Melting point, freezing point detection device
B.Processing factories using refined oil as the raw material: The inspection equipment requirements include those of crude soybean oil refineries as provided in Subparagraph (1) of this Paragraph, the inspection equipment requirements for margarine, fat spread and shortening oil factories as provided in Items (a) to (c) of Subparagraph (4)A.
Article 15
The following inspection equipment are required for dehydrated vegetable and fruit factories:
1.Moisture or water activity measuring equipmentmeter
2.Weighing scale
The following production and inspection requirements are optional for dehydrated vegetable and fruit factories depending on the production and inspection needs:
1.Production equipment
(1)Dehydrated vegetable factories:
A.Washing machine
B.Blanching machine
C.Head and tail cutting machine
D.Slitting or slicing machine
E.Hot-air drying, freeze-drying or other drying equipment
F.Powder grinding machine (essential for powder making factories)
G.Packaging equipment
(2)Dehydrated fruit factories:
A.Peeling equipment
B.Decoring equipment
C.Batch candied equipment or continuous candied equipment
D.Washing machine or container
E.Corning cutting machine
F.Powder grinding machine (essential for powder making factories)
G.Slicer
H.Blanching machine
I.Hot-air drying, freeze-drying or other drying equipment
J.Packaging equipment
2.Inspection equipment:
(1)Residual chlorine analyzer or litmus paper
(2)Glucose meter and glucose refract meter
(3)pH meter or litmus paper
(4)Ash measuring device
(5)Oven
Article 16
The following basic facilities and inspection equipment are required for lunch box food factories:
1.Basic facilities:
(1)Raw material preparation site
(2)Processing/dressing site
(3)Freezer/ and refrigerator
(4)Packaging site: The meal distribution and packaging of the products should be done using an independent or specialized site and equipment.
2.Inspection equipment:
(1)Microbiological inspection equipment
(2)General quality inspection equipment (stainless steel probe thermometer for detecting internal temperature, residual chlorine analyzer or litmus paper, etc.)
The following production equipment are optional for lunch box food factories industries depending on the production needs:
1.Rice washing, cooking and other staple food processing equipment
2.Specialized vegetable and meat cutting tools
3.Frying, cooking, stir frying, deep frying and other food processing equipment
4.Conveyor belt or stainless-steel dressing table
5.Food container washing and sterilizing equipment
6. Knife and cutting board storage cabinet
7.Washingers (hot-water or steam) equipment
8. The machines or equipment that would generate steam, hot air, fumes or frying oil while treating with the heating oil in the processing/dressing site should be installed with exhaust hood devices (including smoke exhaust equipment).
9. The packaging site should be installed with filter or ventilation facilities.
10.The finished products should be delivered by appropriate transportation equipment or specialized vehicles.
Article 17
The following production equipment are required for instant noodle factories:
1.Noodle manufacturing making equipment
2.Continuous deep frying equipment or noodle steaming and drying machines
The following production and inspection equipment are optional for instant noodle factories depending on the production and inspection needs:
1.Production equipment:
(1)Boiler
(2)Cooker
(3)Cooling equipment
(4) Packaging equipment
(5)Metal or foreign matter detector
2.Inspection equipment:
(1)Moisture detector
(2)Weighing scale
(3)Crude fat determination equipment
(4)Oil nature inspection equipment (moisture content, acid value, peroxide value, iodine value and total polar compounds, etc.)
Article 18
The following basic facilities and inspection equipment are required for food additive factories:
1.Monosodium glutamate (MSG) factories:
(1)Basic facilities:
A.These factories should possess a full set of integrated operation from basic raw materials until crystallization of MSG (including raw material preparation site, fermentation plant, glutamine acid plant, refining plant, packaging room, etc.).
B.The intermediate product discharged from crystallization cans should be processed completely using confined coherent equipment including dewatering machine, conveyor, dryer, screening machine, etc.
C.Microbial culture room and equipment.
D.The packaging room should conform to relevant regulations prescribed in Article 6 of these standards, and come with hand washing equipment.
(2)Inspection equipment:
A.Glutamic acid analyzer or automatic chemical analyzer
B.Weighing scale
C.pH meter or litmus paper
D.Total nitrogen detection equipment
E.Amino nitrogen measuring device
F.Microbiological testing equipment
2.The following inspection equipment are requiredments for apply to all food additive factories with the exception of monosodium glutamate (MSG) factories:
(1)Weighing scale (sensitivity below 1mg)
(2)pH meter or litmus paper
(3)Moisture detector
The following production and inspection equipment are optional for food additive factories depending on the production and inspection needs:
1.Inspection equipment for MSG factories:
(1)Residual chlorine analyzer or litmus paper
(2)Microscope
(3)Moisture or water activity measuring equipmentmeter
(4) Incubator
(5)Oven
(6)Photoelectric colorimeter
(7)Granularity screening machine
(8)Biomass measuring device
2.Food additive factories other than MSG factories:
(1)Production equipment:
A.Crusher
B.Screening machine
C.Mixer
D.Dryer or oven
E.Mist sprayer, air blower, and drying equipment
F.Powder collection and processing equipment
G.Stirring and blending equipment
H.Filtering equipment
I.Heating reactors
J.Concentration equipment
K.Electrolysis device
L.Dissolving equipment
M.Storage device
N.Filling equipment
O.Metal or foreign matter detector
(2)Inspection equipment
A.Photoelectric colorimeter
B.Gas chromatography
C.Liquid chromatography
D.Spectrophotometer
E.Microbiological testing equipment
F.Hydrometer
G.Atomic absorption spectrophotometer
H.Turbidimeter
I.Electrical conductivity meter
J.Polarimeter
K.Refractometer
Article 19
Food factories that fail to meet the basic facility, production equipment or inspection equipment requirements provided in Article 8 to Article 18 in the Standards are required to submit a statement explaining the reason(s) and provide supporting documents.
Chapter IV. Supplementary Provisions
Article 20
These standards shall be implemented from the date of promulgation.
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