Code of Practice for Minimally Processed Ready-to-Eat Fruit and Vegetables
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Table of Contents
- Part I Good Agricultural Practices
- Part II Pre-Requisites
- Part III Processing Controls
The health benefits associated with consumption of fresh produce combined with the on-going consumer trend toward consuming prepared and/or ready-to-eat foods have contributed to an increase in the popularity of minimally processed ready-to-eat fruit and vegetables.
The availability of affordable minimally processed ready-to-eat fruit and vegetables has moved the preparation step of these products from the consumer's home to processing establishments and retail. Although chemical and physical hazards are of concern; such as the presence of agricultural chemicals and food additives above the maximum residue limits or the presence of metals and other injurious particles; the hazards specific to minimally processed ready-to-eat fruit and vegetables reside mainly with microbial contaminants.
Some of the microbial pathogens associated with fresh fruit and vegetables include Listeria monocytogenes, Salmonella spp., Shigella spp., enteropathogenic strains of Escherichia coli, Hepatitis A virus, and the protozoans Cryptosporidium, Cyclospora and Giardia. The possible sources of contamination involve the incoming raw fruit and vegetables from fields and/or greenhouse of conventional or organic productions, workers hygiene and handling practices, and the condition of the processing environment and equipment used to minimally process fruit or vegetables. When fruit or vegetables are minimally processed (for example chopped or shredded), the release of plant cellular fluids provides a nutritive medium in which microorganisms can grow. The high moisture content of fresh fruit and vegetables, neutral pH,, the lack of further "kill step" to eliminate microbial pathogens, and the potential for temperature abuse during preparation, distribution and storage, further intensify the risk of food-borne illness. In addition, the increased time and distance from harvesting, processing to final point of consumption of certain fresh fruit and vegetables may contribute to microbial growth and subsequently contribute to increased risks of food-borne illness.
In response to the increased consumption of minimally processed ready-to-eat fruit and vegetables and the risks of food-borne illness associated with these products, this code of practice has been updated to reflect current industry's best practices and Codex Alimentarius recommendations for the minimally processed ready-to-eat fruit and vegetables. This code does not guarantee the production of safe minimally processed fresh fruit or vegetables; rather, it provides a sound basis for risk mitigation and hygienic production, and is subject to change as additional scientific information becomes available.
This code is intended to provide guidance to the Canadian domestic establishments and importers sourcing fresh-cut products from foreign suppliers. As there are various operations and methods available to minimally process these products, a general approach has been taken in developing this code. It may not cover all possible options of implementing preventative measures to minimize product contamination. Alternative approaches may be used for specific operations to adequately minimize and control food safety hazards. Industry is encouraged to use the general recommendations of this code in order to comply with Canadian regulatory safety requirements.
This code of practice has been developed for raw fruit and vegetables that have been minimally processed (i.e. peeled, sliced, chopped or shredded) prior to being packaged for sale in Canada. Applicable products include but not limited to: shredded lettuce, shredded cabbage, mixed leafy vegetable salads, broccoli florets, peeled baby carrots, veggie kebobs, cut melon, sliced apples, peeled and cored pineapple. Packaging includes single serving containers (e.g., sealed pouches or plastic trays), larger consumer or institutional size packages and bulk containers. With the possible exception of the addition of dressing or croutons by the end-user, these types of products do not require further preparation before consumption.
Part I of this code outlines good agricultural practices (GAP) for the primary production and harvesting of fresh fruit and vegetables. It is important to adhere to GAP and good manufacturing practices (GMP) to minimize and control microbial, chemical and physical hazards through all stages of food chain continuum from primary production to minimal processing in order to ensure the safety of minimally processed ready-to-eat fruit and vegetables.
Part II of this code deals with prerequisite programs, which assist in controlling the likelihood of introducing food safety hazards to the product through the work environment and operational practices. Part III deals with process controls, which are the factors during processing that need to be controlled to ensure the safety and integrity of the product. It is important to assess the recommendations in this code individually and, when necessary, consider alternative approaches that may be more appropriate to particular operations in the achievement of general safety objectives.
Minimally processed ready-to-eat fruit and vegetables must conform with sections 4 and 7 of the Food and Drugs Act. Subsection 4. (1) states that: "No person shall sell an article of food that has in or on it any poisonous or harmful substance; is unfit for human consumption; consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; is adulterated; or was manufactured, prepared, preserved, packaged or stored under unsanitary conditions." Section 7 states that: "No person shall manufacture, prepare, preserve, package or store for sale any food under unsanitary conditions."
Part I Good Agricultural Practices
Microbial, chemical and physical contamination may occur during the primary production and harvesting of fresh produce. The safety of minimally processed ready-to-eat fruit and vegetables is highly dependent upon the degree of preventative measures used by primary producers to prevent contamination. Growers should implement GAP to minimize risks of microbial, chemical and physical contamination during the primary production and harvesting of fresh produce. The general aspects of GAP contributing to the safety of fresh produce include the following:
Previous and current use of land and adjoining sites should be evaluated (e.g., presence of nearby housing, feedlots, toxic waste site, etc.) to identify potential sources of produce contamination such as agricultural chemicals, fecal and/or microbial contamination or other hazards. Appropriate steps should be taken to prevent the access of farm and wild animals to the growing sites of fresh produce to avoid potential fecal contamination of the soil and crop and to reduce the risk of microbial contamination.
The use of natural fertilizers (e.g., manure, organic materials, slaughter wastes, sewage sludge, etc.) in the production of produce should be appropriately managed (e.g., maximize the time between application and harvest) and treated (e.g. composting, pasteurization, heat drying) to limit the potential for microbial and chemical contamination.
Water used for irrigation and application of pesticides and fertilizers is a potential source of contamination as it may contain microbial pathogens, heavy metals and other chemicals. Growers should evaluate the source (e.g., well, open canal, ponds, reservoir, re-used irrigation water, etc.), quality of water and how and when it is used on farm, as well as monitor its safety to prevent and/or control potential sources of contamination. Growers should keep records of agricultural water monitoring and testing.
Growers should only use agricultural chemicals which are approved for the cultivation of the specific produce and should use them according to manufacturer's instructions for the intended purpose. Growers should keep records on agricultural chemical applications (e.g., agricultural chemical used, rate and date of application, etc.).
Harvester and Handler Health and Hygiene
Hygiene and health requirements should ensure that personnel who come directly or indirectly into contact with produce are not likely to contaminate produce. People known or suspected to be carriers of a disease or illness likely to be transmitted through produce should not be allowed access to areas of the fields or indoor premises where there is a likelihood of contaminating produce. To ensure good personal hygiene, growers should provide toilets and hand washing facilities easily accessible to farm workers. All employees should be trained to follow good hygienic practices and proper hand washing technique. Records should be kept documenting employee training.
Diseased, damaged, bruised or overripe fruit or vegetables could be susceptible to microbial contamination and therefore should not be harvested. At the time of harvesting, produce should be inspected for the presence of physical contaminants such as stones, pieces of wood, metals or glass, spiders and insects. These and any other foreign materials should be removed prior to shipment of produce to processing establishments.
Transportation and Storage
Vehicles for transporting produce and storage facilities should be suitable for produce and adequately cooled. Containers, vehicles, and storage facilities should be cleaned and sanitized regularly and secured from pests (rodents, insects, etc.) to minimize risks of contamination. Transportation of incompatible foods, materials and animals with fresh produce should be avoided to prevent contamination. Records should be kept documenting the cleaning and sanitation of transport conveyances and storage facilities.
Part II Pre-Requisites
1. Processing Establishment
Establishment should not be located in areas where the presence of potentially harmful substances would lead to unsafe finished product.
Potential sources of contamination need to be considered when deciding where to locate processing establishment as well as the effectiveness of any reasonable measures that might be taken to protect food. In particular, establishment should be located away or protected from:
- environmentally polluted areas and industrial activities which could pose a risk of contaminating produce;
- areas subject to flooding unless sufficient safeguards are implemented;
- areas prone to infestation of pests or where wastes cannot be removed effectively.
1.2 Premises and Rooms
1.2.1 Design and Layout
Building interiors and structures should permit good hygienic practices, including protection against cross-contamination between and during operations.
1.2.2 Internal Structures and Fittings
Structures within a processing establishment should be soundly built of durable materials for proper maintenance, cleaning and, where appropriate, sanitation.
In particular the following specific conditions should be adhered to, where necessary, to protect the safety of food:
- The surfaces of walls, doors, partitions and floors should be made of impervious materials with no toxic effect;
- Walls and partitions should have smooth surfaces; Floors should be constructed and finished to allow adequate drainage and cleaning;
- Ceilings and overhead fixtures should be constructed and finished to minimize the build-up of dirt, condensation, and where necessary, be protected to prevent the shedding of particles;
- Windows should be accessible for cleaning, be constructed to minimize the build-up of dirt and where necessary, be fitted with removable and cleanable insect-proof screens. Where necessary, windows should be fixed;
- Doors should be tight fitting, have smooth, non-absorbent surfaces, and be accessible for cleaning and, where necessary, sanitized.
1.2.3 Food Contact Surfaces
Food contact surfaces should be constructed of appropriate materials and be maintained in a manner to prevent contamination of food.
- Equipment and containers coming into contact with food should be made of materials with no toxic effect, and where appropriate, designed and constructed to ensure that they can be adequately cleaned, sanitized and maintained.
- Food contact surfaces should be located so as to prevent contamination (e.g. tables sufficiently above floor, equipment away from drains)
Adequate natural or artificial lighting should be provided to operate in a hygienic manner.
- The intensity of lighting should be adequate to the nature of the operation. Where appropriate, lighting fixtures should be protected to minimize the risk of produce contamination by breakage.
1.2.5 Air Quality and Ventilation
Adequate ventilation should be provided to prevent excessive heat, condensation, and to remove contaminated air and dust.
- Ventilation should provide sufficient air exchange to prevent unacceptable accumulations of heat, condensation or dust. The ventilation system should prevent air flow from the most contaminated to the least contaminated areas.
- Ventilation openings should be equipped with close fitting screens or filters to prevent the intake of contaminated air. Filters should be cleaned or replaced as appropriate.
1.2.6 Drainage and Waste Disposal
Adequate drainage and waste disposal systems and facilities should be provided to operate in a hygienic manner.
Drainage and waste disposal systems should be designed and constructed to prevent the contamination of produce and the potable water supply. Suitable provision should be made for the storage and removal of waste.
- To avoid pest and minimize microbial contamination, waste should not be accumulated in produce handling and storage areas or the adjoining environment.
- Storage areas for waste should be kept clean.
1.3 Sanitation Facilities
1.3.1 Employee Facilities
Employee hygiene facilities and toilets should be made available and be adequately maintained to prevent contamination.
- Adequate and conveniently located changing facilities and toilets should be provided in proximity to the processing operation areas.
- Facilities should provide adequate means to hygienically wash and dry hands, including wash basins, soap, disposable towels and a supply of hot and cold (or suitably temperature controlled) water.
- Toilet facilities should be designed to allow hygienic removal of waste and be located to avoid contamination of produce or premises.
- Toilet facilities should be maintained under sanitary conditions and good repair at all times.
- Hand washing notices should be posted in appropriate areas and in the language of employees
1.3.2 Equipment Cleaning and Sanitizing Facilities
Equipment cleaning and sanitizing facilities should be adequately designed, constructed and maintained to prevent contamination.
- Facilities and equipment should be designed for their intended use and be properly maintained and cleaned. They should be adequately separated from food storage, processing and packaging areas to prevent contamination.
- Facilities and equipment should be constructed of corrosion resistant materials.
- Facilities should be equipped with potable water at temperatures appropriate for the cleaning chemicals used.
1.4 Quality and Supply of Water and Ice
An adequate supply of potable water with appropriate facilities for its storage, distribution and temperature control should be available where appropriate.
- Water should meet the requirements of Health Canada's Guidelines for Canadian Drinking Water Quality. Water from sources other than municipal supplies must be treated as necessary by the processor. Water should be analyzed by the processor or municipality at a frequency adequate to confirm its potability.
- There should be no cross-connections between potable and non-potable water supplies. All hoses, taps, or other similar sources of possible contamination should be designed to prevent back-flow or back siphonage.
- Where it is necessary to store water, storage facilities and water storage tanks should be adequately designed, constructed and maintained to prevent contamination.
- The volume, temperature and pressure of the potable water should be adequate for all operational and cleanup demands.
- Water treatment chemicals, where used, should be accompanied by a "letter of no objection" from Health Canada, where necessary.
- The chemical treatment should be monitored and controlled to deliver the desired concentration and to prevent contamination.
- Recirculated water should be treated, monitored, and maintained as appropriate for the intended purpose. Recirculated water should have a separate distribution system which is clearly identified.
- Ice used in an establishment, should be made from potable water and be protected from contamination.
2. Transportation and Storage
2.1 Temperature Control
The temperature of incoming fruit or vegetables and finished products should be appropriately controlled during transportation and storage to minimize the growth of pathogenic microorganisms.
Subsequent to the control of product temperature during processing, refrigeration of the finished product throughout its expected shelf life is recommended to minimize the growth of pathogenic microorganisms.
- Temperature during transportation and storage should be controlled to maintain optimum storage conditions for incoming fresh fruit or vegetables and finished products.
- All incoming ingredients requiring refrigeration should be transported and stored at 4°C or less.
- Refrigeration facilities (transportation vehicles, storage rooms) should be equipped with temperature measuring devices, preferably recording thermometers. If recording thermometers are not used, maximum/minimum thermometers should be used to control and monitor temperature.
2.2 Conveyances and Containers
Conveyances and containers should not be a source of contamination.
- Transportation and storage of food products should take place in conveyances and containers dedicated to food use only. When used for food and non-food loads, procedures should be in place to restrict the type of loads to those that do not pose a risk of contamination to foods in the same shipment or to subsequent food loads.
- Conveyances and containers should be designed, constructed, maintained, cleaned and utilized in a manner to prevent contamination of food.
- Conveyances and containers should be inspected prior to loading to ensure that they are free from visible debris, dry, clean and suitable for the transportation of food.
- Conveyances and containers should be loaded, arranged and unloaded in a manner that prevents damage and contamination.
2.3 Incoming Ingredients, Packaging Materials and Finished Products
Incoming ingredients, packaging materials and finished products should be stored and handled in a manner to minimize spoilage, prevent damage and contamination.
- Temperature of the storage rooms should be controlled to maintain optimum storage conditions (refer to section 2.1, Part II: Temperature Control).
- "First-in-first-out" stock rotation should be practiced.
- Allergen control plan should be in place to prevent cross contact with ingredients, packaging materials and finished products.
2.4 Non-Food Chemicals
Non-food chemicals should be received and stored in a manner to prevent contamination of food, packaging materials and food contact surfaces.
- Chemicals should be received, stored and handled in dry, well ventilated areas and according to manufacturer's specifications.
- Chemicals should be stored in designated areas such that there is no possibility for contamination of food or food contact surfaces.
- Chemicals should be stored and mixed in clean, correctly labelled containers.
- Chemicals required for use in food handling areas (e.g., conveyor lubricants) should be separated from food and stored appropriately to prevent contamination of food, food contact surfaces or packaging materials.
3.1 Design and Installation
All equipment and utensils should be designed and constructed to permit effective cleaning and sanitation, and to prevent contamination.
- Equipment should be designed, constructed and installed to ensure that it is capable of delivering the requirements of the process (e.g., refrigeration equipment).
- Equipment should be accessible so that it permits adequate maintenance, cleaning, sanitizing, and inspection to prevent contamination of the product.
- Equipment should be designed, constructed and installed to permit proper drainage and, where appropriate, should be connected directly to drains.
- Equipment used to cool product should be designed to achieve and maintain the required temperatures as rapidly as necessary. Such equipment should be designed to control and monitor temperatures.
Temperature Measuring Devices
- Temperature measuring/recording devices should be installed, calibrated and maintained as necessary to ensure accuracy.
- Magnets should be installed in manner to effectively remove metal before or after certain operations (e.g., dicing, slicing or filling).
- The strength of magnets should be appropriate to the need and should be tested as necessary.
- Metal detection equipment should be installed, calibrated, maintained and operated in accordance with the manufacturer's manual to ensure effective removal of metals. This may include adjustment for the nature of the product, selection of target metal and size and timing of the reject mechanism.
- Flow meters (e.g., chlorine feed rate meters, gas pressure meters, etc.) should be verified to ensure accuracy at the time of installation and thereafter.
- Other specialized instrumentation necessary for the control of critical factors should be in place and calibrated as necessary (e.g., chlorine injectors, chlorine concentration test equipment, pH meters).
3.2 Equipment Maintenance and Calibration
Maintenance and calibration programs should be in place to ensure that equipment performs consistently as intended and prevents contamination of product.
- An effective written preventative maintenance program should be in place to ensure that equipment, which may impact food safety, functions as intended. This should include: records of equipment requiring regular maintenance; maintenance procedures and frequencies.
- An effective written calibration program should be in place to ensure that equipment, which may impact food safety, functions as intended. This should include records of equipment requiring regular calibration, calibration methods, procedures and frequencies.
- The maintenance procedures and frequencies should be based on the equipment manufacturer's manuals or on operating conditions that could affect the performance of the equipment.
- Maintenance and calibration of equipment should be performed by appropriately trained personnel.
Personnel should be trained in personal hygiene and hygienic handling of food such that they understand the precautions necessary to prevent the contamination of food.
- An effective written training program should be in place, including the appropriate records.
- Appropriate training in personal hygiene and hygienic handling of food should be provided to all food handlers at the beginning of their employment.
- The food hygiene training should be reinforced and updated at an appropriate frequency.
4.1.1 Technical Training
Personnel should be trained to have the adequate technical knowledge and understanding of the operations or processes for which they are responsible.
Training should be appropriate to the complexity of the process and the tasks assigned.
- Personnel should be trained to understand the importance of the critical control points for which they are responsible, the critical limits, the procedures for monitoring, the actions to be taken if the limits are not met, and the records to be kept.
- Personnel responsible for the maintenance of equipment impacting food safety should be appropriately trained to identify deficiencies and take the appropriate corrective action (i.e., in house repairs, contract repairs).
- Personnel responsible for the sanitation program should be appropriately trained to understand the principles and methods required for effective cleaning and sanitation.
4.2 Hygiene and Health
Hygiene and health requirements should be followed to ensure that personnel who come directly or indirectly into contact with food are not likely to contaminate produce. Visitors should, where appropriate, wear protective clothing and adhere to the personal hygiene provisions of this section.
4.2.1 Cleanliness and Conduct
All persons entering food handling areas should take the appropriate precautions to prevent the contamination of food.
- All persons should wash and sanitize their hands upon entering food handling areas, before starting work, after handling contaminated materials, after breaks, and after using toilet facilities.
- Protective clothing, hair covering, footwear and/or gloves, should be worn and maintained in a sanitary manner.
- Persons entering food handling areas should avoid behaviours which could result in the contamination of food, such as eating, using tobacco, chewing gum, or unhygienic practices such as spitting.
- Persons entering food handling areas should not wear jewelry or other objects which could fall into or otherwise contaminate food. Jewelry which cannot be removed, including wedding bands or medical alerts, should be covered.
- Personal effects and street clothing should not be kept in food handling areas.
- The traffic pattern of employees should prevent cross-contamination of the product. Access of personnel and visitors should be controlled to prevent contamination.
4.2.2 Communicable Diseases and Injuries
Preventative measures should be in place to minimize the risks of directly or indirectly contaminating water, ice and food by persons with communicable diseases or injuries.
Persons known to be infected with diseases likely to be transmitted through food, or with open cuts or wounds, should not work in food handling areas where there is a likelihood of directly or indirectly contaminating food.
- Supervisors should be trained to know typical symptoms and signs of infectious disease (e.g. vomiting, diarrhea).
- Employees should inform management when they are suffering from symptoms of infectious disease likely to be transmitted through food.
- Employees having open or infected cuts or wounds should not handle food or touch food contact surfaces unless the injury is completely protected by a secure waterproof covering (e.g., rubber gloves).
5. Sanitation and Pest Control
5.1 Cleaning and Sanitation Program
An effective sanitation program for equipment and premises should be in place to prevent contamination of food.
Cleaning and sanitation programs should ensure that equipment and all areas of an establishment are cleaned appropriately. Cleaning and sanitation programs should be reviewed regularly and modified as needed.
- Written cleaning and sanitation programs should be followed for all equipment and premises (production and storage areas), including all work surfaces, walls and floors. The program should include but is not limited to: the name of the responsible person; the frequency of the activity; the procedures for cleaning and sanitizing; the chemicals and concentrations used; the temperature requirements; and the type and frequency of inspection to verify the effectiveness of the program.
- Procedures for cleaning and sanitizing should identify areas, lines, equipment and utensils to be cleaned and inspected; disassembly/reassembly instructions required for cleaning and inspection; and appropriate methods of cleaning, sanitizing and rinsing.
- All cleaning and sanitation chemicals should be used in accordance with the manufacturer's instructions and if necessary should be accompanied by a "letter of no objection" from Health Canada.
- Cleaning and sanitation programs should be carried out in a manner that does not contaminate food, incoming ingredients and packaging materials during or following cleaning and sanitizing (e.g., aerosols, chemical residues).
- The effectiveness of the sanitation program should be monitored and verified by pre-operational inspection of premises and equipment or, where appropriate, by microbiological sampling and testing. Operations should begin only after sanitation requirements are met. If required, cleaning and/or sanitation program(s) should be reviewed and adjusted accordingly.
5.2 Pest Control Program
An effective pest control program should be in place to prevent entry, eliminate pests, and to prevent the contamination of food.
- A written pest control program for the premises and equipment should be followed. The program should include but not be limited to: the name of the responsible person; where applicable, the name of the pest control company contracted to administer the pest control program; the list of chemicals used and the concentrations; the location, the method and frequency of application; a map of trap locations; and the type and frequency of inspection to verify the effectiveness of the program.
- Pesticides acceptable for use in a food facility should be used in accordance with the manufacturer's instructions and be registered under the Pest Management Regulatory Agency, Pest Control Products Act and Regulations.
- Treatment of equipment, premises or raw incoming fresh fruit and vegetables to control pests should be conducted in a manner to ensure that the maximum residue limit as listed in the Food and Drugs Act and Regulations is not exceeded.
- Birds and animals should be excluded from establishments.
6.1 Recall Program
An effective recall program should be in place to respond to food safety hazards.
A written procedure should be followed to enable traceback, traceforward and recall of any lot of product. Records should be available to provide necessary information to assist in the investigation and identification of any sources of contamination.
- The written procedure should include but not be limited to: the persons responsible (e.g., recall coordinators); the roles and responsibilities for the coordination of a recall; the methods to identify, locate and control recalled products; the requirements to investigate other possibly affected products which could consequently be included in the recall; the methods used to identify the source of contamination; any corrective measures taken and procedure for monitoring the effectiveness of the recall (section 6.2, Part II).
- The appropriate regulatory agency should be immediately notified (e.g., nearest CFIA inspection office). This notification should include, but not be limited to: the reason for the recall; the amount of implicated products produced, in inventory, and distributed; the name, size, code and/or lot numbers of implicated products; the area of distribution (e.g., local, national, or international).
6.2 Recall Capability
Recall procedures should be tested periodically to verify that accurate information is available on a timely basis for rapid identification and removal of all affected products from the market.
- Periodic mock recalls should be conducted.
- Records should be kept to determine the effectiveness of the mock recalls. Any deficiencies in the recall procedure should be identified and corrected.
7. Documentation and Records
Records that adequately reflect product information, programs and operational controls should be available to demonstrate the processing activities.
Water Quality and Supply Records
- Records should be available to demonstrate the adequacy of the microbial and chemical safety of the water including: the source of water, its potability, method of water treatment, sample sites, analytical results, and date of analysis.
Temperature Control Records
- Records of temperatures in all refrigeration facilities should be available. These should include: recorder charts or a daily log of maximum/minimum temperatures, the date and location where the temperature was recorded and the person responsible.
Equipment Maintenance Records
- Records should include: identification of equipment; maintenance activity; the date of maintenance; person responsible.
- Records should include: identification of equipment; the date of calibration, person responsible; calibration results; and corrective action taken.
Cleaning and Sanitation Records
- Cleaning and Sanitation records should include the date, person responsible, the post-inspection findings, corrective action taken, and microbiological test results, where appropriate.
Pest Control Records
- Pest control records should include: results of the inspection programs and any corrective action taken; pest control activities (e.g., pesticide used, method and location of application, dates of treatments); date and person responsible.
- Distribution records should contain sufficient information to permit traceability of the product. Records should include: product identification and size; shipping dates; lot number or code; quantity; customers' names, addresses, and phone numbers to the initial level of product distribution.
Part III Processing Controls
1. Product Formulation
Written specifications for all components, including raw fruits and vegetables, any added ingredients, packaging materials and gases that are necessary for the process and packaging of the finished product should be in place.
Raw fresh fruit and vegetables should be sourced from suppliers that have adopted good agricultural practices and provide evidence that the product was grown, stored and transported to the facility according to written specifications. Refer to Part I Good Agricultural Practices.
Written specifications should be in place for ingredients and components that identify criteria essential for the process and product safety (e.g., allergens, permeability of packaging materials, and grade of gases appropriate with food contact use).
Specifications should include a provision for compliance with the Food and Drugs Act and Regulations, specifically: food additives, if present, must meet the requirements; and packaging materials must be intended for direct food contact.
1.2 Product Formula
Current written formulae should be available for each multi-component product processed into fresh-cut.
Formulae should be followed to produce a consistent and safe final product and to avoid introduction of potential hazards (e.g., adding unlisted ingredients which could cause allergic reactions).
- Current, written formulae for multi-component products should be available to production employees.
- The formulae should contain all details of the formulation such as the identification and amount of ingredients, including food additives.
- If food additives are used their levels must conform to the provisions of the Food and Drugs Act and Regulations.
2. Incoming Material Control
2.1 Incoming Materials
Incoming produce, ingredients, packaging materials and gases should be controlled to minimize microbial, chemical and physical hazards and to prevent mislabelling or misrepresenting of final product. For incoming ingredients that are likely to impact on the safety of finished products, one of the following programs should be in place:
Periodic Evaluation of Incoming Materials:
- A certificate of analysis should accompany each incoming lot.
- At a scheduled frequency appropriate to the risk, representative samples should be taken to verify the accuracy of the certificate of analysis.
- Records of supplier adherence to specifications for each ingredient should be maintained (e.g., analytical results).
- Incoming lots should be inspected and sampled according to a pre-determined sampling plan and evaluated for adherence to specifications.
Records should be maintained to demonstrate adequate knowledge of the supplier's practices and process (e.g., agricultural practices on farm, process flow, etc.)
- Periodic monitoring and auditing of suppliers should be conducted to verify adherence to specifications e.g. validate the status of the supplier adherence to on-farm food safety program.
2.2 Incoming Material Control Records
Records should be maintained to demonstrate the adequacy of incoming material controls.
These records will allow verification of the processor's control over microbial, physical and chemical hazards associated with incoming materials.
- Appropriate records should reflect the established incoming ingredient control program (e.g., analytical results, history of adherence to specification, audit reports etc.).
3. Preprocessing and Processing
All critical processing factors should be controlled to minimize risks associated with the product. Raw fruit and vegetables should be inspected, sorted, trimmed, washed and disinfected, as appropriate, to prevent contamination of the finished product.
3.1 Inspection, Sorting, Trimming and First Wash
During preparation of fruits or vegetables for processing, microbial, chemical and physical hazards should be minimised by conducting the following:
- Visual inspection and removal of decomposed product, extraneous matter, produce contaminated by fuels, (e.g., diesel, gasoline), machine grease or oil.
- Removal of dirt and washing product.
- Metal detection using magnets or metal detectors.
- Sorting /cleaning by gravity, air or water.
3.2 Peeling, Slicing, Chopping, Cutting, and Shredding
Procedures should be in place to minimize contamination with physical (metal) and microbial contaminants during peeling, slicing, chopping, cutting or shredding processes.
Washing cut produce with potable water reduces microbial contamination. In addition, it removes some of the cellular fluids released during the cutting process thereby reducing the level of available nutrients for microbial growth.
- Cut fruit or vegetables should be washed in potable water that meets or exceeds the Guidelines for Canadian Drinking Water Quality.
- Water should be replaced at a sufficient frequency to prevent the build-up of organic material and prevent spreading microbial contaminants over produce.
3.4 Antimicrobial Treatment
Antimicrobial treatments should be used to minimize or reduce contamination of finished products.
3.4.1 Chlorinated Wash Water
Chlorine may be added to wash water to reduce microbial contamination on produce. After the chlorination treatment, excess chlorine should be removed from the produce.
- The chlorine concentration, pH, temperature of the wash water and contact time on the fruit or vegetables should be monitored and controlled.
- The manufacturer's recommended methods for mixing and levels of chlorine in wash water should be used. Otherwise, the recommended concentrations for chlorinated wash water are between 100 and 150 ppm of total chlorine or between 2 to 7 ppm of free residual chlorine after contact. The pH of the water should be between 6.0 and 7.0. The contact time is dependent upon the product and the chlorine concentration but ideally should not exceed 5 minutes.
- Excess chlorinated wash water should be removed from the produce (e.g., by rinsing with potable water, and if appropriate with centrifugal drier, etc.)
3.4.2 Other Antimicrobial Treatments
Antimicrobial treatments other than chlorination should be evaluated for their safety and efficacy by the Food Directorate of the Health Products and Food Branch, Health Canada.
- The antimicrobial treatments must comply with the Food and Drugs Act and Regulations.
- The use of antimicrobial treatments should be monitored and controlled.
3.5 Adherence to Product Formulation
Processing should be controlled to ensure that each multi-component product is produced in accordance with its formula.
Adherences to product formulae ensure that products are consistent and prevent the addition of ingredients not listed on the label that may elicit an adverse reaction in sensitive individuals and ensures that ingredients essential to product safety are added.
- Controls should be in place to ensure that each product contains only the ingredients listed in the formula and on the product label.
- Controls should be in place to ensure that food additives, if present, are used within allowable levels, accurately measured and adequately blended for homogeneity.
- Controls should be in place to prevent the presence of undeclared ingredients that may elicit an adverse reaction in sensitive individuals. Potential areas that may require stricter controls include:
- misdirected ingredients;
- use of reworked product;
- carryover from equipment after product changeovers;
- substitution of ingredients.
3.6 Product Temperature During Processing
Product temperature should be controlled during processing to minimize the growth of pathogenic microorganisms.
Numerous factors may affect product temperature during processing including: variations in the temperature of incoming produce; fluctuations in ambient temperature; and changes in wash water temperature. If the product is packaged at elevated temperature, there may be an unacceptable time lag before the product reaches refrigeration temperature. This could result in growth of microbial pathogens to unacceptable levels. The processing should be controlled to ensure that product temperature is reduced to refrigeration temperature (4°C or less) within an acceptable time frame.
The processor should demonstrate the control of product temperature through one of the following programs or equivalent:
Cold Chain Concept
- Produce temperature should be maintained at, or reduced to, 4°C or less prior to the start of processing.
- The air temperature in the rooms where fresh produce is processed should not exceed 4°C. Wash solutions should be maintained at 4°C or less. Any other treatments that are part of the process should not cause the temperature of the produce to increase above 4°C.
- At all times, finished product temperature should be at 4°C or less.
3.7 Product Processing Records
Records that reflect the control of critical processing factors should be available upon request.
Records will allow verification of the process and product composition and should be available to demonstrate the following:
- Adequate control of critical process and composition such as: chlorine concentration, pH, contact time, use of other antimicrobial treatments.
- Control of product temperature during processing.
- Noted deviations during the process and corrective actions.
4.1 Packaging and Containers
Packaging and product handling should be controlled to prevent product contamination.
An effective system should be in place to prevent the use of contaminated, damaged or defective containers that come in contact with produce. The controls that are in place should be verified through periodic checks.
- Containers should be used only for their intended purpose.
- Packaging should be handled and transferred in a manner to minimize damage and contamination. There should be controls in place for receiving, storage and conveying.
- Packaging should be examined for damage and contamination before use.
- Where containers are re-used, the processor should have in place an effective cleaning and sanitizing system, before use.
4.2 Critical Packaging Factors
Container filling and sealing should be controlled to meet the criteria outlined in the establishment's process design.
Deviation from the packaging criteria could result in contamination or growth of microbial pathogens.
- All critical packaging factors should be identified and controlled, such as: bag or container composition; gas mixture; flushing time; and sealing of container.
- Controls should be in place to identify and correct situations where container damage could occur.
- Packaging records should be available to demonstrate adequate control of critical packaging factors.
5. Container Coding and Labelling
5.1 Product Identification
Each packaged food product should be marked to allow the identification of product in the event of a recall.
- Each prepackaged food product should be permanently and legibly marked on the label, the package or container with the following product information: the brand, type of product, the responsible party for the production or marketing of the product; ingredient list, if applicable.
- A code, from which the production date can be determined, should be permanently and legibly marked on the label, the package or container. The "best before" date may form part of this code.
- Code marks and their meaning should be available. Where used, case codes (master containers) should be legible and should correspond to the identifying marks on the product within.
5.2 Label Accuracy
Label information should be complete and accurately represents the product. The label must meet the requirements of the Food and Drugs Act and Regulations and the Consumer and Packaging and Labelling Act and Regulations.
Controls should be in place to prevent mislabelling. Accurate labels inform and protect individuals allergic or sensitive to certain foods or with specific dietary needs.
- Procedures should be in place to ensure that labels accurately reflect product formulation and composition. These controls should include:
- Effective separation of product types during changeovers.
- Separation of product labels or pre-labelled packaging during processing activities and storage.
- On-line checks to ensure that products are correctly labelled.
5.3 Labelling – Storage Temperature
All finished products should be labelled with the statement: "Keep Refrigerated".
Products should be kept at refrigeration temperature during storage, transportation and display for sale to minimize the potential for growth of microbial pathogens. Proper labelling is required to ensure that all persons handling the product are aware of the storage temperature requirement. "Keep Refrigerated" as defined by the Food and Drug Regulations means kept at 4°C.
6. Deviations and Corrective Action
6.1 Deviation Procedures
Procedures should be in place to identify, isolate and evaluate products when critical limits are exceeded or when other defects occur which could affect product safety.
Identification of Deviation
- System should be in place to identify deviations when they occur.
Isolation of Affected Product
- Effective procedures should be in place to isolate, clearly mark and control all products produced during the deviation period.
- All affected product should be isolated from the point where the process was last in control and be clearly marked (e.g., tags firmly attached with information such as: reason for hold; amount of product; person in charge; date; etc.).
- Affected product should be controlled until its final disposition or until other actions are required following evaluation and assessment.
Evaluation of Affected Product:
- Product evaluation should be conducted by a qualified person and should adequately assess potential health hazards. The evaluation should include adequate sampling to identify the extent of the problem; appropriate tests; etc.
- The product should not be released unless the evaluation determines that no health hazard exists.
- Actions on affected product (e.g., sorting, re-processing, and disposal) should be conducted in an appropriate manner by adequately trained personnel.
6.2 Corrective Action
Effective corrective actions should be implemented to prevent the recurrence of deviations.
Corrective action procedures should be in place in order to determine the cause of the problem, take action to prevent a recurrence and verify with monitoring and reassessment to ensure the efficiency of the actions. The corrective action procedures should include:
- An investigation to determine the cause of the deviation.
- Effective measures to prevent recurrence of the deviation.
- Verification of the effectiveness of the corrective actions taken.
6.3 Deviation and Corrective Action Records
Records should be available to demonstrate controls of deviations and the effectiveness of corrective actions.
Maintaining complete and accurate records will allow verification of the adequacy of the processor's control of deviations and the implementation of effective corrective action procedures.
- Deviation records should include information such as: product and code; date when the product was manufactured, held, released or destroyed; description of deviation and reasons for the hold; amount of product held; results of evaluation (e.g., amount analyzed, number and nature of defects); disposition of product (e.g., amount sorted, destroyed); name of person responsible for hold and evaluation; and if required, signed authorization for disposition.
- Corrective action records should include information such as: cause of deviation identified; corrective action taken to correct the deviation; follow-up/assessment of effectiveness of corrective action; date corrective action was taken and verified; and name of person responsible.
7. Verification of Product Safety
7.1 Verification Procedures
Supplementary methods should be used to evaluate and verify the effectiveness of controls affecting food safety.
The purpose of verification is to determine the effectiveness of processing controls in preventing health hazards and to indicate areas where improvements are required.
- Qualified individuals responsible for verification should be identified.
- The verification frequency and methods should be appropriate to the hazards associated with the product and process.
- Methods of verification should include: sampling and analyses of in-process and finished product for the appropriate chemical or microbial hazard (e.g., Listeria monocytogenes, Salmonella spp., etc.); verification of the concentration of antimicrobial treatment, pH and/or temperature of wash water; independent external or internal audits; analyses of consumer complaints; trends; and audits of suppliers or customers (e.g., verification if transportation and storage temperatures are being followed as per specifications).
7.2 Verification Records
Records should be available to demonstrate the effectiveness of verification procedures.
- Verification records should include methods of verification, date, individuals responsible, results, findings, conclusions, and corrective actions taken.
8. Complaint Handling
8.1 Product Complaints
An effective system for handling and investigating complaints should be in place.
Customer and/or consumer complaints are an important indicator of possible deficiencies of processing controls and/or the distribution handling procedures.
- Qualified individual responsible for receiving, recording, evaluating, categorizing and/or investigating complaints should be identified.
- Complaints should be accurately categorized according to the risks.
- Safety-related complaints should be forwarded immediately to the appropriate personnel for action.
- Safety-related complaints should be investigated by appropriately trained technical personnel.
- Examination of the complainant's specimen, retail product or other product of the same code should be part of the investigation into food safety related complaints.
- The depth of the investigation should be appropriate to the risk and similar complaint trends.
- Appropriate corrective actions should be taken for deviations identified during the investigation.
8.2 Complaint Records
Records of product complaints, investigation findings and actions taken should be available upon request.
- Consumer information records should include information such as: the name, address, telephone number, and date received; the details of complaint and/or illness; the product name, code and size; and the retail outlet where the product was purchased.
- Investigation records should include information such as: the name of the person responsible for the investigation; the action taken on products as a result of the investigation; and the corrective action taken.
- Adverse food reaction
- a general term that can be applied to a clinically abnormal response to an exposure to a food or food component.
- in this document, process to ensure and verify the reliability and the capability of a supplier to consistently manufacture within the processor's specifications. This may include periodic monitoring to verify adherence to specifications and audits to validate the status of the supplier certification program.
- Challenge test
- scientific study by which specific microorganisms of concern are added to a product to confirm the adequacy of a theoretical process.
- the removal of soil, dirt, grease or other objectionable matter.
- measure to ensure that an operation: performs consistently within predetermined limits based on process capability; meets process requirements; and consistently results in a safe product.
- Corrective action
- any action to bring the process into control and manage any affected product when critical limits or other criteria are not met. The action is to be prompt and appropriate to the seriousness of the deficiency.
- Critical control point
- a point, step or procedure at which control can be applied and food safety hazard can be prevented, eliminated, or reduced to acceptable levels.
- Critical factor
- any property, characteristic, condition, or other variable parameters which may affect the validated process and compromise the safety of the product.
- Critical limit
- a value which delimits acceptability from non-acceptability for which the safety of the product may be compromised. Critical limits are different from control limits or specification limits. Control limits indicate what the process is capable of delivering and are tighter than specification limits which are in turn tighter than critical limits.
- for produce, deterioration can be used interchangeably with spoilage, When applicable to non-food products such as packaging materials, deterioration is a physical or chemical change in the material that may adversely affect the safety of the food.
- failure to meet the critical limits or other specified requirements for a critical factor.
- A biological, chemical or physical agent or condition of food having the potential to cause an adverse health effect.
- he amount of product of a specific container size, product style and code produced by a food establishment during a specified period of time.
- Minimally processed ready-to-eat fruit or vegetables
- raw fruit or vegetables that have been peeled, sliced, chopped or shredded prior to being packaged for sale. With the possible exception of the addition of dressing or croutons by the end-user, the product does not require further preparation before consumption.
- a planned sequence of observations or measurements of control parameters to assess whether a critical control point [or other activity] is under control.
- Periodic mock recall
- internal activities conducted on a periodic basis to verify the capability of the processor to rapidly identify and control a given lot of product. These activities do not necessarily require the processor to contact customers.
- documented observations and measurements to determine adherence to critical limits or other specified requirements for critical factors.
- an estimate of the likelihood of occurrence of a hazard.
- is a process that removes or reduces the number of microorganisms, including pathogens.
- a process whereby food quality and/or food safety is rendered unacceptable through microbiological or chemical reaction.
- confirmation of the accuracy, correctness or effectiveness of process controls through testing, investigation or comparison with a standard.
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