This code is concerned only with those refrigerated packaged foods which are formulated and processed to critically rely upon maintenance of the integrity of the cold chain for their safety, quality and wholesomeness.
The refrigerated packaged foods which the provisions of this code concern are products that:
are heat treated or processed using other technologies to reduce their original microbiological population;
may use hurdles in addition to heat or other technologies and refrigeration, to retard or prevent the proliferation of undesirable microorganisms;
are packaged, not necessarily hermetically, before or after the process (heat or other preservation treatments);
are low acid, that is, with pH > 4.6 and are high water activity aw > 0.92;
are intended to be refrigerated during their shelf life to retard or prevent the proliferation of undesirable microorganisms;
have an extended shelf life of more than 5 days1
may not necessarily require heating prior to consumption.
It includes, but is not limited to :
It excludes:
Fermented vegetables,
Foods that contain one or more ingredients that are excluded and one or more ingredients that are included are covered by this code (see Appendix II - Examples - 3, Assembled salad).
For purposes of this code, the terms and expressions below are defined as follows:
Container (“récipient”): any box, tin, plastic or other receptacle, or wrapper in direct contact with the food product.
Cooling equipment (“appareil de refroidissement”): equipment to reduced a product's temperature to a given refrigeration temperature.
Filling and sealing (“conditionnement”): operation consisting of placing a food product in a container and closing it.
Good manufacturing practices (GMP) (“BPF”): basic requirements as defined in this Code and the Code of Practice - General Principles of Food Hygiene.
Hermetically sealed container (“récipient hermétiquement fermé”): Containers which are designed and intended to protect the contents against the entry of viable microorganisms after closing.
High Risk Area (HR): In addition to the characteristics of GMP, the high-risk area is an isolated area, designed to maintain a high level of hygiene, where the practices concerning personnel, materials, equipment and the environment are managed so as to prevent contamination by pathogenic microorganisms. The HACCP approach will allow the identification of when the use of High Risk area is necessary.
Lot: all units of a product in the same container type and size, produced using the same conditions and during the same processing period, usually not exceeding 24 hours.
Modified atmosphere (“atmosphère modifiée”): atmosphere in a packaged product that differs from the ambient atmosphere (vacuum or gas).
Packaging (“emballage”): any case, carton or container for the food containers. Any operation consisting in placing the containers in cases, cartons, etc.
Packaging material (matériau pour récipient ou emballage”): materials such as cardboard, paper, glass, plastic film, metal, etc., used to manufacture containers or packaging for refrigerated packaged food.
Pasteurization value (“valeur pasteurisatrice”): The pasteurization value is the length of time at a given temperature to obtain a specified level of destruction of a microorganism whose heat resistance characteristics are known.
The heat resistance of a microorganism is characterized by D and z values defined as follows:
D = time (in minutes) to achieve a 90% or one log reduction of a microbiological population
at a given temperature;
z = the number of degrees required for the thermal destruction curve to traverse one log cycle
(expressed in degrees Celsius or Farenheit).
Rapid cooling (“refroidissement rapide”): lowering the temperature of the food in a way such that the critical zone for microbiological proliferation (60°C - 10°C) is passed through as rapidly as possible. The cooling time is established during HACCP application.
Refrigerated food (“aliment réfrigéré”): Food which is kept at cold storage temperatures to maintain its safety, quality and wholesomeness, for the intended shelf life.
Refrigerated storage facility (“enceinte réfrigérée”): facility designed to keep refrigerated foods at the intended temperature.
Shelf life (“durée de vie”): This is the period during which the product maintains its microbiological and sensory qualities. It is based on identified hazards for the product, heat or other preservation treatments, packaging method and other hurdles that may be used and storage temperature.
Use-by-date (“date limite de consommation”): The date after which the product should not be consumed. It is calculated from the date of production, utilizing the product shelf life, building in a margin of safety as determined by the manufacturer.
For sections III, IV, V and VI, specific provisions applicable to General Principles of Food Hygiene will be identified when this draft is circulated for Government comments.
These are not covered by the present code; for recommendations relative to raw materials see Section VII.
This section deals with the areas where foods are prepared, cooked, chilled, and stored. Prevention of contamination calls for every reasonable measure to be taken to avoid direct or indirect contact of food with sources of potential contamination. Starting with the design and setting up of installations, several fundamental principles should be respected to prevent cross contamination:
“one-way-flow”, or rational progression of the product in the course of successive processing operations;
separation of the prepared foods from the raw materials and waste;
strict separation in the plant of the HR area from other production areas;
ease of cleaning, sanitizing and maintenance of installations and equipment
When designing installations, it is also necessary to take into account:
types of products to be processed and technologies to be used;
amounts of product intended to be processed
When installations are registered by the health authorities or some other Agency, the Agency having jurisdiction should be contacted at the design phase for advice and agreement in principle. While the installations are being constructed, it is important to verify on a regular basis that the work is being done properly and the specifications manual is followed.
4.1 Location
The establishment should be located in a suitable area that is in compliance with applicable building codes and requirements, that is free from unpleasant odors, smoke, dust or other contaminants and not subject to floods, unless sufficient safeguards are provided.
4.2 Access roads and areas suitable for motor vehicles
The access roads and areas serving the establishment, situated on its perimeter or immediately adjacent, should be suitable for motor vehicle traffic and have a suitable drainage system.
4.3 Buildings and installations
4.3.1 Buildings and installations should be constructed according to building regulations and maintained in good condition. Construction materials used should not be capable of transmitting undesirable substances to the foodstuffs. It is advisable to avoid use of materials that are difficult to clean and disinfect, unless it is certain that they are not a source of contamination. All dimensions of buildings and installations should be sufficient to maintain good sanitary processing conditions.
4.3.2 Sufficient work spaces should be provided to allow each operation to be properly carried out.
4.3.3 The design should allow for adequate, easy cleaning, sanitation and good control of food hygiene.
4.3.4 Buildings and installations should be designed to prevent pests from entering and becoming established, and to prevent entry of contaminants from outside, such as smoke, dust, etc.
4.3.5 Buildings and installations should be designed in such a way that operations which might give rise to across contamination are separated either by their location, by partition walls or any other effective means. They should also be designed so that the principle of one-way-flow of product can be respected.
Storage facilities should also respect the principle of “one-way-flow” and “first in, first out” and be looked at from the point of view of temperature, humidity and ventilation to keep raw materials, in-process products and final products in optimal conditions.
It would be preferable to have separate storage facilities for raw materials, in process goods and finished product. If it is not possible to use separate facilities, the products should be separated and protected from cross contamination.
Similarly, the design of areas for unwrapp, and unpacking should be based on a detailed study of this kind of work area, including aspects relative to disposal of garbage and non-edible materials. All operations that might present risks of food contamination: preparation, trimming, cutting, washing of material and utensils, etc., should be done in separate rooms or in areas specially designed for the purpose.
4.3.6 Buildings and installations should be designed to facilitate hygenic conditions of operations through their regular progression, from arrival of raw materials to final product, and should ensure appropriate temperature for the processing of the product.
The plant should be designed and equipped in such a way that the interior temperature is compatible with keeping products at a temperature that controls proliferation of microorganisms during the various operations, regardless of the outside temperature. These premises should also allow for work to be organized so that the periods of time products spend in critical areas are limited to the time strictly necessary for operations to be carried out.
Meeting these temperature requirements may call for an air conditioning system to be installed.
4.3.7 In areas for handling foodstuffs:
floors should be made of material that is waterproof, smooth and crack resistant, non-absorbent, washable and should not have cracks. They should be easy to clean and disinfect and be kept in good sanitary condition. They should be sloped enough to allow liquids to flow through drains equipped with traps.
walls should be constructed of materials that are waterproof, non-absorbent and washable, and should be light in color. The surface should be smooth and crack resistant and without cracks up to a suitable height for operations. They should also be easy to clean and disinfect and be kept in good sanitary condition. Angles of walls, walls and floor and walls and ceiling should be joined and rounded to facilitate cleaning so that they cannot conceal insects or microorganisms.
ceilings should be designed, constructed and finished to prevent accumulation of filth and to minimize vapor condensation, development of molds and flaking. They should be constructed of materials that are waterproof, crack resistant, easy to maintain and kept in good sanitary condition.
windows and other openings, in particular ventilation ducts, should be constructed in such a way as to avoid accumulation of dirt, and those opening to the outside should be sealed tight and equipped with insect screens. The screens should be easily removable to facilitate their cleaning and maintenance. The inside of window frames and sills of windows should be slanted to prevent their being used as shelves. Windows should be kept in working order. In the packaging area, windows should remain closed at all times after cleaning and disinfection of the area until such time as the packaging of the product is completed.
doors should be smooth and water-tight and, when necessary, close automatically and be sealed to assure a tight fit within frames.
stairways, elevator shafts, equipment and accessories such as platforms, ladders, chutes, etc., should be located and constructed in such a way as not to cause contamination of foods. Chutes should be equipped with openings for inspection and cleaning.
In HR areas:
entrances should be provided with foot baths or shoe change facilities, and hand washing and sanitizing installations.
windows should be closed and not capable of being opened.
where appropriate the premises should be equipped with temperature monitoring and recording devices and a reliable system, to signal loss of control, for example, an audible alarm or blinking light.
if the temperature in the HR areas has been determined to be critical and is exceeded, the manufacturer should demonstrate the product's safety.
air should be filtered and under positive pressure in locations where foodstuffs are handled in order to limit risks of contamination.
doors, apart from fire doors and emergency exits, should not open directly to the outside of the building or into areas that are potential sources of contamination, such as areas for handling raw materials or unprocessed products, toilets, etc. Doors should be closed when not in use, fit tightly and kept in good sanitary condition and in working order.
fire doors and emergency exits opening directly to the outside should fit tightly and be used only in case of emergency.
4.3.8 In areas where foodstuffs are handled, all equipment and accessories situated in an elevated position should be installed so as to avoid direct or indirect contamination of foods and raw materials by formation of condensation that could drop onto products. Their design should not hinder cleaning operations. Equipment should be insulated when necessary. The construction should be such that dirt accumulation, development of mold and chipping is prevented. They should be easy to clean and sanitize.
4.3.9 Living areas, toilets and outside areas where animals are kept should be kept entirely separate from areas where food is handled and should not open directly into them.
4.3.10 Establishments should be designed so that access can be controlled.
4.3.11 Water supply
A plentiful supply of water, conforming to the WHO's “Guidelines for Drinking Water Quality”, maintained at an appropriate pressure and temperature, should be supplied, as well as suitable installations for its storage and distribution, with sufficient protection from contamination.
Samples for analysis should be taken regularly to monitor the continued potability of the water. The sampling frequency depends on the source and use of water, for example, sampling usually being more frequent when there is a private water supply versus a municipal water supply. According to the analytical results of these checks, if disinfection is necessary, chlorine or other disinfectants must be used. In the case of chlorination, it is best to determine the amount of free chlorine daily, using chemical tests. Water should be sampled at point of use. When a problem exists at the point of use, samples must be taken at the establishment's water intake or source as a check on the integrity of the water system.
Ice should be made from potable water; it should be made, handled and stored in conditions protecting it from any contamination.
Steam which comes in direct contact with foods, or surfaces in contact with food, should be free from any substance presenting a health risk or apt to contaminate the product.
Non-potable water (for use in, for example, fire control, steam production, refrigeration and other similar purposes where it would not contaminate food), should have a separate system. Non-potable water systems should be easily identified. They should not connect with, nor should there be a risk of back flow into potable water systems.
Recycled water within the establishment should be treated so that its use does not contribute to health risk. Treatment should be monitored. Recycled water should circulate in separate, easily identifiable pipes. Approval for use of recycled water for any food processing procedure should be requested from the agency having jurisdiction.
4.3.12 Removal of effluent and waste
Establishments should have and keep in good working order an effective system for removing effluent and waste.
All pipes for evacuation of effluent, including sewer lines, should be sufficiently large to ensure they can handle drainage during peak periods and should be constructed in such a way so as to avoid any contamination of potable water supplies. All drainage pipes should be connected to a sewerage system or appropriate septic system.
Drainpipes should be designed and maintained to prevent back flow (equipped with traps, for example), to be regularly cleaned and to prevent accumulation of water during periods of normal usage and when the plant is not in operation.
For HR areas:
Drains from the HR areas should be planned so that there is no contamination from other drains, that is to say no waste water from contaminated areas of the plant should flow into drainpipes from the areas where products are handled.
Waste water from refrigeration equipment, installations for hand washing and machinery should be piped to the sewerage system so as to minimize any risk of contamination of products. Particular attention should be paid to the risk of back flow of condensed water from the drain systems for refrigeration equipment.
4.3.13 Cooling and Refrigeration Equipment
4.3.13.1 Refrigeration
Establishments should have refrigerated rooms and/or freezers that are sufficient to hold raw materials at an adequate temperature, in conformity with sections 7.1.4 and 7.1.5.
All refrigerated rooms should have devices to monitor and record the temperature and a reliable system, such as an alarm, to signal loss of control. These devices should be clearly visible and placed so that the maximum temperature in the refrigerated area is recorded as accurately as possible. Devices should be checked at regular intervals, against a known accurate standard, and adjusted, repaired or replaced.
4.3.13.2 Cooling
Establishments should also have rooms or equipment which permit quick-chilling methods to be used, as well as refrigerated storage for a quantity of prepared food equal at least to the maximum daily production of the establishment.
Rapid cooling of large quantities of food requires equipment capable of rapidly extracting heat from the maximum quantity of food likely to be produced. Ideally, the method used should ensure that the foodstuffs are not kept for more than two hours at temperatures between 600C and 100C where feasible. Other cooling regimens can be used provided there is evidence to assure the safety of the product.
The equipment's operation should be checked periodically to make sure that it remains within the specified margins to ensure that the appropriate product temperature is maintained.
4.3.14 Cloakrooms and toilets
All establishments should have suitable, well-located cloakrooms and toilets. Toilets should be designed to ensure sanitary operation. These areas should be well lit, ventilated and, when necessary, heated: they should not open directly into food handling areas. Washbasins with warm or hot water and cold water, suitable products for washing and disinfecting hands and a hygienic single-use drying device should be located immediately adjacent to the toilets and placed so that employees should pass in front of them when returning to the work area. Installations dispensing hot and cold water should be equipped with mixers. When paper towels are used, a sufficient number of distributors and receptacles should be located next to each washbasin. It is preferable to have taps that cannot be operated by hand. Signs should be posted instructing personnel to wash their hands every time after using toilets.
4.3.15 Washbasins in processing areas
In all cases where the nature of the operation requires it, there should be adequate, convenient installations for staff to wash and dry their hands and, when necessary, disinfect them. These installations should be equipped with warm or hot water and cold water, as well as suitable products for washing and disinfecting hands. Installations dispensing hot and cold water should be equipped with mixers. When paper towels are used, there should be a sufficient number of distributors and receptacles next to each washbasin. It is preferable to have taps that cannot be operated by hand. Installations should be equipped with traps and waste pipes connected to sewers.
4.3.16 Disinfecting installations
When necessary, adequate installations should be provided for cleaning and disinfection of utensils and work equipment. These installations should be constructed of corrosion-resistant material that is easy to clean and supplied with a sufficient supply of hot and cold water.
4.3.17 Lighting
Sufficient natural or artificial light should be provided throughout the establishment. When needed, lighting should not alter colors and light intensity should not be less than:
540 lux at all inspection points
220 lux in workrooms
110 lux elsewhere.
Bulbs and fixtures installed over foodstuffs, at whatever stage of preparation, should be of the type known as safety lights and protected so as to prevent contamination of foods in case of breakage. Light fixtures should be designed and installed to minimize accumulation of dust and debris and should be kept clean and dust-free.
4.3.18 Ventilation
The ventilation system should be designed to be hygienic. Attention should be paid to the location of the establishment as well as to other environmental conditions which may lead to the contamination of the products.
Adequate ventilation should be provided to prevent dust, excessive heat, condensation on walls and ceilings, as well as to adequately circulate air. Air should never flow from a contaminated area to a clean area. Ventilation outlets should be equipped with grilles or any other protective apparatus constructed of a corrosion-resistant material. Grilles should be easily removable for cleaning. Air should be filtered and a positive pressure maintained in food handling areas.
Precautions should be taken to ensure that the roofs and ledges beside which the intake pipes for the ventilation system are located are not a source of contamination for ventilated air.
In HR areas:
The ventilation system should be capable of maintaining a sufficiently low temperature, where appropriate, to assure that the temperature of the product is not adversely affected. It should be designed and used so as to prevent condensation and circulation of dust.
The air supplying the premises should be treated to remove particles.
Ventilation systems, including filters, should be inspected with sufficient frequency to ensure they are functioning properly. The program shall also describe corrective actions required in cases of deficiencies revealed on inspection. Air in HR areas should be kept under positive pressure around surfaces and areas where final products are assembled.
4.3.19 Installations for storage of waste and non-edible material
Installations should be provided for short term storage of waste and non-edible material before they are removed from the establishment. These installations should be designed to prevent pests from having access and to avoid contamination of foods, potable water, equipment, premises or access roads on the plant site.
4.4 Equipment and materials
4.4.1 Materials
All equipment and utensils used in food-handling areas that might come in contact with food should be made of materials that cannot transfer toxic substances or undesirable odors or flavors. They should be non-absorbent, corrosion-resistant and strong enough to withstand repeated cleaning and disinfection operations. Surfaces should be smooth and free of cavities and cracks. Some suitable materials are stainless steel and synthetic rubber. It is best to avoid use of wood and other materials that are difficult to clean and disinfect, unless it can be determined that they will not be a source of contamination. Utilize corrosion resistant metals for food contact surfaces.
Equipment and utensils are a potential source of contamination transfer and should not be used indiscriminately for raw and cooked foods. All equipment and utensils used for raw foods should be thoroughly cleaned and disinfected before being used for cooked and precooked foods. Entry into the product-assembly or preparation area of equipment used for processing, handling or transport outside of the area should not be authorized. Equipment leaving the product assembly area should be cleaned and disinfected before being readmitted.
In HR areas:
Equipment designed for handling heat-treated products should be used solely for this purpose and should be kept separate from equipment used to handle material before heat or other preservation treatments. If reusable trays are used, once they are cleaned and sanitized they should not pass through a area where they may be contaminated unless they are appropriately covered.
4.4.2 Hygienic design of equipment
All equipment and utensils, including filling machines, transport equipment, conveyor belts and packaging equipment, should be designed and constructed to minimize any contamination risk and to allow for easy, complete cleaning and disinfecting. Equipment and utensils should be accessible for inspection. Fixed equipment should be installed in such a way that it is easily accessible and can be thoroughly cleaned and disinfected in place.
All apparatus used in the establishment should be regularly checked and calibrated according to a written procedure.
Containers intended for non-edible matter and waste should have tight fitting covers and be watertight, made of metal or any other impermeable material, and be easy to clean or disposable after use.
4.4.3 Identification of equipment
Equipment and utensils used for non-edible matter or waste should be identified and not used for edible products.
4.4.4 Particular recommendations for certain equipment
4.4.4.1 Compressed air
Compressed air coming in direct contact with food or with food contact surfaces (including filters) should be filtered or treated in such a manner to remove contaminants.
4.4.4.2 Thermal Processing Equipment
Thermal processing equipment should be properly maintained and be cleaned and disinfected as required.
For HR areas:
Thermal processing equipment should be designed and located so as to create a barrier between the area for preparation of raw materials and the HR areas for product processing. It should be possible to easily load such equipment with raw materials from the GMP areas and unload hygienically in the HR areas preventing any risk of cross-contamination by utensils, products, equipment or personnel.
All thermal processing apparatus should be designed to be hygienic and should be provided with suitable instrumentation. Systems for steam removal and humidity should be effective, hygienically designed and well maintained to minimize risk of condensate or other cross contamination of heat-treated product.
4.4.4.3 Cooling equipment
Equipment should be designed to allow for ease of cleaning and to minimize accumulation of condensation. It should be cleaned and sanitized as required.
4.4.4.4 Transport vehicles
Vehicles should be constructed, insulated, and have adequate refrigeration equipment to maintain the product at the prescribed temperature or less throughout loading and transit. The vehicle should be equipped with a temperature-monitoring and recording system that is easy to read and should be checked regularly against a known accurate standard and adjusted, repaired or replaced. The temperature sensor should be so located to measure the temperature of the refrigerated compartment. This system should be suitably positioned with sensors located beside the air return system and the outflow from the evaporators. Vehicles should be suitably equipped to prevent water entry and allow drainage of condensate.
5.1 Maintenance
Buildings, material, utensils and all equipment in the establishment - including manholes for the waste-water drainage system - should be maintained in good order. As far as possible, the premises should remain free of steam, condensation and waste water.
5.2 Cleaning and disinfecting
5.2.1 Cleaning and disinfection should meet the requirements Appendix I of General Principles of Food Hygiene (CAC/RCP 1 - 1969, Rev. 2 (1985)) and to those of this code.
Cleaning standards, including those for cleaning protective clothing, should be compatible with the hygiene standards required for the area concerned.
5.2.2 Equipment, materials, utensils etc. which come in contact with foods, especially raw materials (fish, meat, vegetables) are contaminated by microorganisms. These could contaminate other products which could be subjected to further processing. This is why it is necessary to clean them and if necessary to take them apart at frequent intervals during the day, at least after each break and when there is a change from one food to another. The dismantling, cleaning and disinfecting at the end of the work day is necessary to prevent microbiological proliferation. Implementing sanitary controls is recommended.
Drainpipes should be regularly cleaned and disinfected; tools used to clean these pipes should not be used for other purposes.
For HR areas:
Equipment and utensils for handling products after heat or other preservation treatments should be cleaned and sanitized at regular intervals.
5.2.3 Necessary precautions should be taken to prevent contamination of foods from splashing of water, detergents or diluted or undiluted disinfectants during cleaning or disinfection of premises. equipment or utensils.
Detergents, disinfectants or sanitizers should be suitable for the job for which they are being used and there should be documentation and approval for the use described.
Any residue from these substances left on surfaces that may come in contact with food should be removed where permitted using an adequate method, for example, rinsing with potable water, before the premises or equipment are used again for food handling. Regular monitoring of the cleanliness of the surfaces that come in contact with foods should be done before production begins. This monitoring should be verified by regular microbiological validations.
For HR areas:
Environmental sampling for microorganisms is recommended.
5.2.4 Immediately after work ends for the day, or at any other time circumstances require it, floors, including drainage channels and manholes for waste-water drains, auxiliary structures and walls of food-handling areas should be thoroughly cleaned and disinfected, where appropriate.
5.2.5 Sponge mops, scrapers, cloths, equipment for condensation removal and spray hoses are particular sources of contamination. They should not be used, or if such use is necessary, they should be frequently cleaned and sanitized.
High-pressure spray cleaning equipment should not be used. If such use is necessary, they should be used only between production periods in the absence of product and by designated and trained staff. They should not be used to clean drains unless the entire area is subsequently cleaned and sanitized.
5.2.6 Cloakrooms and toilets should be kept clean at all times.
5.2.7 Access roads and the yards immediately adjacent to and serving the buildings should be kept clean.
5.3 Hygiene control program
Each establishment should be provided with a continuing program for cleaning and disinfection to ensure that all areas are suitably cleaned and that particular attention is paid to critical equipment and areas. This program should be regularly reviewed and regular examination of cleaning methods should be done to verify the program's effectiveness. This review should include evaluation of detergents and disinfectants, as well as the temperatures, pressures and concentrations at which they are used.
This program should state precisely the methods for cleaning and sanitizing to be used as well as methods for checking the cleaning schedule, the kind of detergents and disinfectants used and instructions for cleaning and the results of cleaning.
One person should have overall responsibility for cleanliness of the establishment. This person should be completely familiar with the inherent dangers of contamination. All staff assigned to cleaning the establishment should be experienced in sanitation maintenance methods and should verify that proper methods have been used and recorded.
5.4 By-products of raw materials
By-products such as trimmings, peelings, scraps and so on, that are not classed as waste and that can be put to later use, should be stored in such as way as to avoid contamination of foods and so that they do not spoil. They should be removed from work areas as often as necessary.
5.5 Storage and removal of waste
In rooms used for processing of prepared refrigerated foods, waste matter should be placed in receptacles specially designed and marked for this use. Receptacles should be kept in good condition and be easy to clean and sanitize. They should be sealed or provided with covers and removed from the work area when they are full, or after each work shift, and emptied into covered garbage bins, which should never be brought into preparation areas. Reusable receptacles should be cleaned and disinfected every time they are brought back into the processing areas.
Garbage bins should be kept in a closed area reserved for this purpose, away from food storage rooms. This location should be kept at as low a temperature as possible and be well-ventilated and protected from insects and rodents; it should be easy to clean, wash and disinfect. It should be designed so as to avoid contamination of foods, potable water, equipment or premises. Garbage bins should be regularly emptied, cleaned and disinfected.
Cartons and packaging, when they have been emptied, should be treated in the same way as waste. Waste-compressing equipment should be placed away from food-handling areas.
If a system for waste disposal through chutes is installed, it is essential that debris and waste are placed in single-use closed bags. The chute openings should be cleaned and disinfected every day.
5.6 Excluding domestic animals
The presence of animals at large or which could possibly be a health hazard should be prohibited in the establishment.
5.7 Pest control
5.7.1 An ongoing effective pest-control program should be implemented. Establishments and surrounding areas should be checked regularly to detect any sign of infestation.
5.7.2 If pests do get into the establishment, necessary measures should be taken to eliminate them. These measures, including treatment with chemical, physical or biological agents, should not be applied without direct supervision of a staff member who is completely aware of the dangers inherent in such treatment, including possible risks from product residue. These measures should be carried out only on the recommendation of the authority concerned.
5.7.3 Pesticides should not be used unless other precautionary measures cannot be used effectively. Before using pesticides, it is advisable to protect all food, equipment and utensils from possible contamination. After their use, contaminated equipment and utensils should be thoroughly cleaned and disinfected before they are used again.
5.8 Storage of hazardous substances
Pesticides or other susbtances should carry appropriate labeling including how they are to be used. They should be stored in locked rooms or cupboards that are kept exclusively for this purpose. They should be distributed and handled only by authorized and duly-trained personnel. Every precaution should be taken to avoid contamination of foods.
5.9 Personal effects and clothing
Personal effects and clothing should not be left in food-handling areas. They should be placed in the cloakrooms provided for in paragraph 4.3.14.
6.1 Hygiene training
Because the health status, clothing and behaviour of personnel is of utmost importance in hygiene, everything should be done to motivate food handlers to adopt practices and attitudes consistent with food hygiene.
The establishment's management should organize continuing training and information in methods of food handling and personal hygiene for all persons responsible for handling food, so that they understand precautions and responsibilities for the safety and quality of the food product.
This training, bearing in particular on the sections of the present code which deal with these matters, should be done at the time persons are hired and regular refresher sessions should take place. Content should be in a printed, possibly illustrated, text so that it can be easily consulted by staff. Permanent posting of hygiene rules is advised.
All employees should be given a printed copy of the establishment's rules on hygiene policy.
Personnel that specialize in certain tasks should receive detailed descriptions of the work they are to do.
For HR areas:
Personnel, including cleaning and service staff, working in these areas should be specially trained and instructed about the need for a high level of personal hygiene at all times.
6.2 Medical examination
Persons who come in contact with food in the course of their work should have had a medical examination before being employed. A medical examination should also be given every time it is necessary for clinical or epidemiological reasons, in particular, after interruption of work caused by an infection that can have after-effects that could cause contamination of handled food. A regular medical examination -- at least once a year -- is strongly advised.
6.3 Transmittable diseases
Management should take necessary measures to see that any person who is known to have or is suspected of having a disease that can be transmitted by food, or is a carrier of such a disease, or has infected wounds, infected skin irritations or diarrhea, cannot contaminate food directly or indirectly. These measures include:
looking out for persons who are sick or have an infection.
prohibiting affected persons from handling foodstuffs or packaging material during the period of time when they present a potential hazard.
in exceptional cases and with medical advice, keeping healthy, asymptomatic carries on the job, when stronger precautions can be taken.
Any person who presents a risk of this kind should immediately inform management.
6.4 Wounds
Any person with an open cut or wound should not touch foods or surfaces that come in contact with food unless the wound is entirely covered with a waterproof dressing which is firmly affixed, clearly visible and can be worn along with appropriate gloves for effective protection. A first-aid service should be provided for this purpose.
6.5 Hand washing
During work, any person working in the food-handling area should wash his or her hands as well as arms and fingernails often and thoroughly, using a product suitable for cleaning and disinfection of hands, in hot, running, potable water. A one time use means of drying hands should be provided. Personnel should always wash hands before starting work, immediately after using toilets, after touching soiled objects, after each break, when staff moves between different production areas, and whenever necessary.
After handling materials that are apt to transmit disease, such as uncooked raw materials (meat, fish, poultry, vegetables), staff members should immediately wash and disinfect hands. Signs should be posted encouraging staff to wash their hands and checks should be made to see that this instruction is complied with.
6.6 Personal cleanliness
Persons assigned to food handling should maintain a high level of personal cleanliness during working hours. This includes wearing hair nets and beard covers, and footwear should be of construction to not contribute to poor hygiene, washable or disposable after use and should be kept as clean as is required by the nature of the employee's job.
Protective clothing should be changed at least daily, more often if necessary and not reused until it has been cleaned. These clothes should not be worn outside the establishment; they should be put on and removed on the premises.
Aprons and other accessories should be washed in a suitable place. When food is handled, staff working in food handling should not have on their person jewelery or any object that could fall into the food.
For HR areas:
Personnel (including sanitation and service staff) working in HR areas should change into work uniforms in a specific room. They should wear protective clothing and footwear specific to the area. These clothes should not be removed from this area and should be taken off in the cloakroom before personnel leave the production line for any reason. Clean clothing should be worn at the beginning of the work day and should be changed at the end of the work day, shift or more frequently if needed. Footwear should be suitably cleaned and sanitized.
6.7 Behaviour of personnel
Anything that might cause contamination of food, for example, eating, smoking, or any other unhygienic practice, chewing (gum, candies, betel nuts, etc.), spitting, should be prohibited in food-handling areas. Personnel that sneeze or cough should be kept out of food handling areas.
Management should put in place a plan for movements of personnel, and also for visitors, to reduce cross-contamination. A system of color coding may be used to identify personnel assigned to different areas of the plant. Visitors should move from the cleanest areas towards the most contaminated.
6.8 Gloves
When gloves are used for handling foodstuffs, they should be sturdy, clean and hygienic. Gloves should be manufactured from non porous non absorbent material. Wearing gloves does not eliminate the need to carefully wash hands. Gloves should be disposable and changed as often as necessary or should be reusable and disinfected as often as necessary. Metal-mesh gloves are particularly difficult to clean and disinfect because of their texture. Careful cleaning is necessary and should be followed by heating or long immersion in disinfectant.
In HR areas:
Personnel should wear gloves to handle products. When disposable sterile gloves are used, they should be changed at least every two hours or when they are damaged or when the employee leaves the production line. For some tasks, heavier-duty sterilizable gloves may be used and should be kept satisfactorily sanitized.
6.9 Visitors
Precautions should be taken to prevent persons who visit or are involved in the food-handling areas from contaminating them. These precautions include wearing protective clothing or garments.
Visitors should respect the provisions of sections 5.9, 6.3, 6.4 and 6.7 of this code and should be warned in advance of the rules they will have to comply with.
6.10 Supervision
Responsibility for ensuring observation by all personnel of the requirements of sections 6.1 to 6.9 should be given specifically to a competent staff member.
Management should understand the requirements with regard to microbiological safety of products for the establishment under their responsibility and should set a good example.
7.1 Recommendations for raw materials and packaging materials
7.1.1 Any raw material or ingredient known to contain parasites, microorganisms, toxic or decomposed substances or foreign matter which cannot be brought to acceptable levels by visual sorting procedures, preparation; or processing should not be accepted by the establishment. HACCP principles should be used to determine which hazards may be associated with raw materials/ingredients to be used in the product.
7.1.2 Specifications for raw materials and packaging materials
Based on the hazard analysis, appropriate specifications for raw materials and packaging materials should be established with suppliers. These specifications should cover labeling, packaging, conditions for transport and storage, as well as the sensory, physical, chemical, parasitological and microbiological characteristics of delivered goods. Control measures should be listed in detail in the specifications manual. Suppliers should be encouraged to operate under a HACCP plan. Manufactures should ensure, by means of audits, for example, that suppliers have put in place a program to ensure the safety of their products.
Raw material specifications, including those for the hurdles (e.g. pH, water activity, salt - see Annex I), should be determined with the HACCP application and validated during the product design phase (Section VIII).
Packaging materials should be suitable for the type of product, the conditions provided for storage and the equipment for filling, sealing and packaging, and the transportation conditions.
7.1.3 Controls on receipt
Raw material and ingredients should be inspected, sorted and if needed subjected to laboratory examination before being introduced on the processing line. Type and frequency of examinations depend upon the hazard identified and on the ability of suppliers to meet specifications. They may be received refrigerated, frozen or at ambient temperature. They may have suitable hurdles to prevent microbiological growth, such as being dehydrated, acidified, fermented, salted, cured or processed such as shelf stable canned foods.
Raw materials and ingredients should be examined and analyzed when necessary, for the following:
temperature measurement;
visual examinations, in particular for foreign materials;
sensory observations (e.g. odor, visual appearance);
hurdles used (e.g. pH. % salt, water activity, etc.);
microbiological analysis.
When such analyses are conducted, raw material and ingredients should meet specifications established in agreement with the supplier.
When refrigerated or frozen raw materials and ingredients are received, their temperatures as well as the temperature inside the delivery vehicle, should be measured and recorded to ensure that they are within the limits specified in the specifications manual. Cleanliness of the vehicle should also be checked.
If the required temperature limits have been exceeded when goods are delivered, trained personel should decide whether the raw materials should be immediately used for manufacture, stored for a limited period, returned to supplier, used in another way or discarded. Unacceptable raw materials and ingredients should be stored separately from raw materials and ingredients used for manufacture of refrigerated foods. Discarded raw materials should be clearly marked so as to identify them as unusable for manufacture of products.
When necessary, some characteristic of packaging materials and of materials from which containers are made should be checked. It may be necessary to carry out visual examination and physical testing in order to measure their properties (maintaining a vacuum or the modified atmosphere in the Package), and their resistance to mechanical, chemical and thermal stress encountered in the course of the product's shelf life. All results of these tests should be recorded and filed.
7.1.4 Storage of raw materials and packaging materials
7.1.4.1 Raw materials should be stored in a suitable area as quickly as possible after delivery. Raw materials should be stored so that contamination of in-process or final products or packaging materials is prevented. Raw materials and ingredients stored within the establishment should be kept in conditions designed to prevent their spoilage, protect them from contamination by microorganisms, insects, rodents, foreign bodies and chemical products and minimize possible damage. They should be used in manufacture as soon as possible after delivery.
Raw materials that are subject to spoilage should be placed without delay in cold storage at the required temperature. There should be documented procedures specifying necessary action to be taken in case of deviation.
7.1.4.2 All packaging materials should be stored in satisfactorily clean and hygienic conditions.
7.1.4.3 Non-edible materials, such as cleaning compounds, should be received and stored in separate locations, away from packaging materials and ingredients. Non-edible materials should not pass through or remain in processing areas during processing.
7.1.5 Storage temperatures
Raw materials should be stored at temperatures appropriate for the product. Temperatures should be checked and recorded at least once a day.
There should be suitable rotation of stock of raw materials -- “first in, first out”. So that this can be achieved, all lots of raw materials should be coded and an appropriate procedure for stock management should be used. Documentation of stock rotation should be kept.
7.2 Preventing cross contamination
7.2.1 Effective measures should be established and taken to avoid contamination by direct or indirect contact with sources or vectors of potential contamination. Proper procedures should be defined. In particular, raw foods should be sufficiently separated from in process foods.
7.2.2 Persons who handle raw materials or in-process products that are apt to contaminate final products should not touch the latter. If they must, they should first sanitize or change their footwear, wash their hands, change into clean protective clothing and change gloves.
7.2.3 Unpacking of raw materials should be done with a maximum of precautions to limit risk of contamination by soil, filth, etc., on the outside of the packaging.
7.2.4 If there is a possibility of contamination, personnel should wash and disinfect hands between handling operations at different stages of processing.
7.2.5 All equipment that has been in contact with raw materials or contaminated material should be cleaned and disinfected before coming in contact with cooked and pre-cooked foods. It is preferable to provide separate utensils for raw materials and in-process or final products, especially for cutting, slicing and chopping.
7.3 Use of water in food processing (See 4.3.11)
7.4 Procesing
7.4.1 Production of refrigerated foods involves a sequence of several separate operations for the processing and assembling of raw materials into a final product. It requires supervision by technically competent personnel. All processing operations should be performed in accordance with a HACCP plan.
7.4.2 All steps in production, including packaging, should be accomplished without delays and in conditions such that contamination, deterioration or growth of microorganisms is prevented. In all steps of processing, critical temperatures for multiplication of microorganisms (10°C to 60°C) should be avoided or in any case passed through rapidly.
If there are delays in manufacture, raw materials and in-process products should quickly be placed in refrigerated storage areas and kept at ≤4°C or else kept at ≥60°C until normal production is resumed.
7.4.3 Raw materials of differing origin (meats, vegetables, fish, etc.) should be prepared in different places. If this is not possible, these operations should be carried out at different times, with cleaning and disinfection being done between operations.
In order to prevent microbiological recontamination and growth, special care should be maintained during the debrining, rehydration, neutralization of raw materials or ingredients used for further processing.
7.4.4 Thawing (total or partial)
When total or partial thawing is necessary, the thawing procedures should be defined in terms of time and temperature and strictly controlled by the manufacturer. The time and temperature parameters should be selected so as to avoid conditions favorable for development of microorganisms.
Particular attention should be paid to controlling condensation and drip from the product during thawing.
After thawing, raw materials should immediately be processed or refrigerated until they are used, usually a temperature of 4°C or less. When a microwave oven is used, manufacturer's instructions should be scrupulously followed to prevent over heated areas and uneven thawing. Thawing equipment should be kept clean.
7.4.5 Heat or other preservation treatments
Heat or other preservation treatments result in the reduction of microbiological population. Pasteurizing values can be used to quantify the lethality of a heat treatment on a reference microorganism.
7.4.5.1. Scheduled Heat Treatment
The selection of an appropriate heat treatment(s) depends upon the pasteurization values needed for product safety up to the end of its shelf life. These values should take into consideration all factors used. For example, the heat treatment used may be less severe if it is combined with one or more hurdles such as pH reduction, use of preservatives, reduced water activity, etc.
The selection of the reference microorganism, the determination of the desired pasteurization value and the establishment of the scheduled heat treatment should be made by personnel specially trained in this area.
For more information on the development of product and process refer to Section 8.3.
7.4.5.2 Application and Monitoring of Scheduled Heat Treatment
The application of the scheduled heat treatment should be carried out by competent, specially trained personnel. Heat treatment equipment should have devices for monitoring and recording temperature and time. The temperature monitoring and recording equipment should be checked at regular intervals against a known accurate standard and adjusted, repaired or replaced. For example, by measuring the time-temperature relationship of:
the product itself during treatment;
or the heating medium in which the food is placed (hot water, sauce, air in oven, etc.) so as to reach the prescribed time-temperature relationship at the product's coldest point.
Heat-sensitive indicators, or other effective means, to indicate whether the products have been heat-treated should be used, [where warranted]. It is important to ensure that the heat treatment applied conforms to the scheduled process and that the desired pasteurization value has been reached.
The critical factors which were taken into consideration during the development of the process (cf. 8.3) should also be measured, checked and recorded at regular intervals. Records should be kept for at least six months past the shelf life of the product.
7.4.5.3 - Other Preservation Treatments {To be drafted.}
7.4.6 Cooling
The cooling should be carried out so that the centre of the product reaches 4°C in less than 6 hours. Products should be cooled quickly so that their temperature remains for a minimum of time between 60°C and 10°C, the temperature range most favorable for microbiological proliferation. This means bringing the temperature at the centre of the product to under 10°C in less than two hours when feasible.
Other safe alternative cooling methods may be used provided that these are based on scientific evidence.
Choice of cooling equipment depends on the products being processed. Their characteristics, (cooling capacity, etc.) should be adapted to the quantities of products produced in order to allow for:
refrigeration without delay after the heat treatment, as soon as the internal temperature reaches 60°C and
an even temperature distribution in the batch when it is cooled.
The same equipment should be provided with a system for checking and recording the temperature in the cooling environment or at the centre of the product as well as a reliable system, for example an alarm, to signal any loss of control. There should be specified procedures for action to be taken in case of loss of control. Records should be kept for at least six months longer than the shelf life of the product.
Use of equipment for both heat treatment and cooling reduces the time between these two operations, permits continuous recording of temperature and thus results in better control of the microbiological quality of the food and the smooth running of the process. The factors which were taken into consideration during the development of the cooling procedure (c.f. 8.3.3) should be measured, checked and recorded at regular intervals.
7.4.7 Hurdles
When one or more hurdles (see Appendix I) are used in combination with the heat or other preservation treatments, their critical limits need to be specified and met. Critical limits should be measured, checked and recorded at regular intervals.
7.4.8 Non-compliance and corrective actions
When deviations have been noted as a result of monitoring critical control points, corrective actions need to be initiated. Corrective actions may include the following:
proper disposition of the affected product
identification of the source of the problem and corrections to prevent reoccurrence. This may result in modification of working procedures.
Non-compliance and corrective actions need to be recorded.
7.5 Packaging
7.5.1 There may be a need to provide a method for cleaning and disinfecting containers before use, especially if there is no heat or other preservation treatments done after filling and sealing.
Reusable containers should not have been used for other purposes. They should be inspected immediately after use to ensure that they are in satisfactory condition and, if necessary, they should be cleaned and/or disinfected. If they are washed, they should be dry before being refilled.
7.5.2 If filling and sealing is done after heat or other preservation treatments and before cooling, it should be done +- (expect for technical constraints (slicing, assembly, etc.) in manner that limits contamination and growth of microorganisms.
If filling and sealing is done after cooling, it should be done so as to limit risks of contamination. The ambient temperature should be such so as to maintain the product at the required temperature. Any increase in temperature of the product during this operation should be avoided.
7.5.3 It may be necessary to check the seal of the packaging.
7.5.4 Each container, at time of filling and sealing, should be marked indelibly on one side to identify the production plant and the production batch or unit.
7.6 Labelling
Labels should conform to the requirements of local authorities. They should provide the following information:
use-by-date
type of food
identification of the processing establishment
the statement “keep refrigerated at required temperature or less”
preparation method (microwave, oven, water or other), time and temperature required for cooking, other important information for preparation of the product
other information required by regulations, for example, the list of ingredients.
7.7 Storage, transport, distribution and use of final product
7.7.1 General
In order to ensure that safety and quality of the product are maintained during its stated shelf life, it is essential that it be kept continuously cold from the time it is packaged until it is consumed or prepared for consumption. Storage temperatures required, indicated on the product's label, should be maintained, measured and recorded during successive stages of transport, storage, distribution and retail. Refrigerated foods are best kept at 4°C or less if refrigeration is the principal means of preservation and the product has not been processed to destroy relevant pathogens.
Storage temperatures higher than 4°C may be suitable provided that shelf life is appropriate or hurdles (for example product formulation, pH, water activity, B) are incorporated into the product and sufficient scientific evidence can be presented with respect to the safety of such products. In addition storage temperatures may be required to meet criteria established or recognized by the agency having jurisdiction where the food is destined for consumption.
In the course of these successive stages, there should be adequate stock rotation, based on the principle of “first in, first out”.
Regular and effective monitoring of temperatures of storage areas, transport vehicles and store display cases should be carried out:
where the product is stored, and
within the product load, which could be done by using temperature indicating and recording systems.
This monitoring should take place, in particular, when the transport vehicle is loaded or unloaded.
Particular attention should be paid throughout storage and distribution:
to periods of defrosting
to temperatures
to the risk of overloading the cold storage and
to anything that could damage the containers and/or packaging.
Personnel (distribution, transport, sales) should be trained in the basic principles of hygiene, in particular, personal hygiene, the requirements for cleaning and disinfection, cross-contamination and the importance of appropriate storage of foods.
Storage areas should conform to applicable requirements in paragraphs 4.3.13.1 and 7.1.4.1
7.7.2 Loading - Unloading
Loading and unloading should be carried out under conditions of good hygiene and as quickly as possible. Product temperature should be measured and recorded prior to loading. The loading and unloading areas for transport vehicles should be designed so as to protect the products and should be refrigerated.
The vehicle should be cooled prior to loading. Doors should be kept open for as short a time as possible. If there is an extended delay in the loading of the vehicle, the vehicle doors should be shut to maintain the cool temperature.
Transfer to cold storage or store display cases should be made as quickly as possible after unloading.
7.7.3 Sale
Products should not be stacked higher than the maximum level indicated in display cases or in front of air ducts or to close to heat generating lamps; there should be good circulation of cold air. Products that have reached the prescribed use-by-date, are spoiled or have damaged packaging should be removed from the display case, and not be offered for sale.
In case of breakdown of display case, the products should be moved to another case or to a cold room. If the breakdown takes place when the estblishment is closed, temperature of the products should be checked. If it is acceptable, the products should be moved to a suitable area; if not, they should be removed from the case and destroyed if necessary.
7.7.4 Use of product
Refrigerated packaged foods should remain in their containers, at the recommended temperatures, until the final stage of reheating or use.
When reheating is necessary, it should be done so that the product is brought to and held at the desired temperature until the time it is served.
When products are used in a restaurant or institutional setting, refer to the mass catering code (refer to Codex alimentarius ALINORM 91/13).
8.1 General
Refrigerated packaged foods are manufactured using a wide variety of raw materials, process technologies and types of packaging. Biological, chemical and physical risks may vary significantly from one product to another. Each product type has its specific shelf life that the manufacturer determines based on scientific data.
In each production establishment, it is necessary to define the particular procedures that allow product safety to be ensured, with consideration given to conditions specific to the plant (raw materials, environment, processing techniques, organization of labour, etc.) and product characteristics. The process recommended for developing these procedures is the application of the HACCP principles.
Specific hazards -- that is, any biological, chemical or physical property that has an unfavorable effect on the safety of the food -- that are associated with food production, and the preventive measures for their control should be identified. Further, it is necessary to determine the operational steps that can be controlled to eliminate hazards or to minimize the probability that they will arise, to establish critical limits to be respected and a monitoring system to ensure their control, and to establish corrective action to be taken and procedures for verification to demonstrate that the control method is appropriate. Effective record keeping procedures need to be maintained.
The overall responsibility for all measures planned to ensure the safety of the product should be designated to qualified personnel.
8.2 Application of the HACCP Principles
The processor should apply HACCP principles as described in Codex document “HACCP system and guidelines for its application” for all existing product types, and for new product design and development.
It is not possible in this general document to precisely define:
hazards specific to a food plant, a process or a product
critical control points (CCPs)
critical limits associated to CCPs
monitoring procedures
corrective actions
verification procedures
record keeping.
The manufacturer will find in previous sections information that would be useful to facilitate HACCP program development. Moreover, it is very important to establish the shelf life of the product, using scientific data, taking into account the scheduled heat or other preservation treatments, the use of hurdles and anticipated distribution and storage temperatures.
In Appendix 2, three examples are provided which illustrate the application of HACCP principles to different product types.
8.3 Important elements
Establishment of product shelf life, scheduled heat or other preservation treatments and cooling methods require sufficient knowledge, facilities and experience. This code does not provide a comprehensive sequence to follow to produce refrigerated foods. Such recommendations may be unduly restrictive and inadequate as new information and preservation technologies become available. It is recommended that the users of this code consult experts to establish procedures which will ensure that their products are safe for consumption. A number of useful references have been supplied in the appendices.
8.3.1 Determination of product shelf life
Product shelf life depends particularly on the following:
product formulation;
scheduled heat or other preservation treatments and cooling methods applied to product;
type of packaging (hermetically sealed or not, MAP);
storage temperature;
hurdles used, if applicable.
Product shelf life should be determined using scientific studies (challenge studies2 or other scientific data can be used) and should incorporate a margin of safety as determined by the manufacturer.
8.3.2 Development of scheduled heat or other preservation treatments
8.3.2.1 - Development of scheduled heat treatment
During the establishment of the scheduled heat treatment, the following factors should be taken into account, if necessary:
microbial flora and maximum number of microorganisms expected in raw materials;
any potential for growth before heat treatment;
desired number of log reduction of target organism(s);
amount of heat required to bring the product to the desired level of safety;
temperature of product before heat treatment begins;
temperature distribution in heat treatment vessel;
composition (solid to liquid ratio) and consistency (viscosity) affecting rate of heat penetration;
type of product or container that can lead to stratification of product during heating or to a change in dimensions of packaging during heating;
size of packaging, type of material, weight of individual portion and maximum weight for filling;
recommended cooking by end-user before consumption (as long as the cooking temperature results in a reduction of microorganisms of public health significance).
2 Technical Manual No. 20 - Guidelines for Microbiological Challenge Testing - CFDRA -1987
The scheduled heat treatment should at least destroy vegetative forms of pathogenic bacteria. It is calculated for the coldest point of the product during treatment. It should take into account the worst-case scenario with regard to transfer of heat to the product, for example, use of frozen raw materials or large pieces of meat and with regard to the microbiological contamination. When changes in the composition, processing and use of the product are carried out, the necessary changes should be established and validated by a qualified person.
8.3.2.2 - Development of other preservation treatments {To be drafted}
8.3.3. Development of Cooling Method
During the establishment of the cooling method, the following factors should be taken into account, if necessary:
temperature of product before cooling begins;
temperature of cooling medium, circulation and temperature distribution in cooling system;
time of cooling especially for products/packaged product conveyed through cooling equipment;
composition (solid to liquid ratio) and consistency (viscosity) affecting rate of cooling;
size of packaging, type of material, weight of individual portion and maximum weight for filling.
capacity/effectiveness of cooling equipment.
8.3.4 Hurdles
Studies validating use of hurdles in product formulation that inhabit or minimize multiplication of pathogens, and the synergy of these factors, should be conducted. See Appendix I for more information. Use of predictive modelling may assist in the conduct of such studies.
8.3.5 Filling
The following information should be filed:
Procedures, data and calculations leading to the establishment of the scheduled heat or other preservation treatments and cooling methods;
If applicable, procedures, data and records establishing the efficacy of hurdles to maintain the microbiological safety of the product for the intended shelf life;
Procedures, data and records relevant to the establishment of the shelf life of the product;
Any modifications of the product formulation and their validation.
For each production lot, permanent, legible, dated records with information on processing should be kept. These documents should be readily available. These records should be kept for a period of six months beyond the shelf life.
Documents that should be kept are, for example:
for the incoming materials: records of processor's audits on suppliers' premises, suppliers' certificates of conformity of ingredients with the processor's specifications, records of temperature at delivery and during storage of ingredients with a limited shelf life.
for processing steps including storage: records for critical control points monitored, records for non-conformity and corrective action taken
for transportation and distribution: records indicating storage temperatures.
for the equipment used to control critical control points: reports on maintenance.
for deliveries: initial delivery records for each lot.
