The types of activities involved in primary production may make eliminating or reducing some hazards difficult. However, by applying prerequisite programmes such as good agricultural practices (GAPs) and/or GHPs, steps can be taken to minimize the occurrence and levels of hazards in the food chain, e.g. at milking for dairy production, steps taken in the hygienic production of eggs, or the controls on irrigation water used for growing salad crops. Not all provisions apply for all primary production situations and consideration will need to be given by the FBO on the appropriateness of the measures to be taken.

6.2.1 Environmental control

Potential sources of contamination from the environment should be identified. In particular, primary production should not be carried out in areas where the presence of contaminants would lead to an unacceptable level of such contaminants in food, e.g. using polluted areas6.2.2 Hygienic production

The potential effects of primary production activities on the safety and suitability of food should be considered at all times. In particular, this includes identifying any specific points in such activities where a high probability of contamination may exist and taking specific measures to minimize and, if possible, eliminate that probability.

Producers should as far as practicable, implement measures to:

- control contamination from soil, water, feedstuffs, fertilizers (including natural fertilizers), pesticides, veterinary drugs or any other agent used in primary production;

- protect food sources from faecal and other contamination (e.g. zoonotic foodborne agents);

- control plant and animal health so that it does not pose a threat to human health through food consumption, or adversely affect the suitability of the product (e.g. observe the withdrawal period of veterinary drugs and pesticides, keeping records where applicable); and

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6.2.3 Handling, storage and transport

Procedures should be in place to:

- sort food to remove material which should not be used for human consumption;

- dispose of any rejected material in a hygienic manner; and

- protect food from contamination by pests, or by chemical, physical or microbiological contaminants or other objectionable substances during handling (e.g. sorting, grading, washing), storage and transport. Care should be taken to prevent deterioration and spoilage through appropriate measures which may include controlling temperature, humidity, and/or other controls.

6.2.4 Cleaning, maintenance and personal hygiene

Appropriate facilities and procedures should be in place to ensure that:

- Cleaning and maintenance are carried out effectively and do not compromise food safety (e.g. ensuring equipment used in harvest is not a source of contamination); and

- an appropriate degree of personal hygiene is maintained to ensure personnel are not a source of contamination (e.g. by human faeces).

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Objectives

Depending on the nature of the operations and the associated risks, premises, equipment, and facilities should be located, designed and constructed to ensure that:

- contamination is minimized;

- design and layout permit appropriate maintenance, cleaning and disinfection and minimize airborne contamination;

- surfaces and materials, in particular those in contact with food, are non-toxic for their intended use;

- where appropriate, suitable facilities are available for temperature, humidity, and other controls;

- there is effective protection against pest access and harbourage; and

- there are sufficient and appropriate washroom facilities for personnel.

Rationale

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6.3.1 Location and structure

6.3.1.1 Location of establishment

Food establishments should not be located where there is a threat to food safety or suitability and hazards cannot be controlled by reasonable measures. The location of an establishment, including temporary/mobile establishments, should not introduce any hazards from the environment that cannot be controlled. In particular, unless sufficient safeguards are provided, establishments should normally be located away from:

- environmentally polluted areas and industrial activities which are reasonably likely to contaminate food;

- areas subject to flooding;

- areas prone to infestations of pests; and

- areas where waste, either solid or liquid, cannot be removed effectively.

6.3.1.2 Design and layout of food establishment

The design and layout of food establishments should permit adequate maintenance and cleaning. The layout of premises and the flow of operations, including the movements of personnel and material within the buildings, should be such that cross-contamination is minimized or prevented.

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6.3.1.3 Internal structures and fittings

Structures within food establishments should be soundly built of durable materials, which are easy to maintain, clean and, where appropriate, easy to disinfect. They should be constructed of non-toxic and inert materials according to intended use and normal operating conditions. In particular, the following specific conditions should be satisfied, where necessary, to protect the safety and suitability of food:

- the surfaces of walls, partitions and floors should be made of impervious materials that are easy to clean and, where necessary, disinfect;

- walls and partitions should have a smooth surface up to a height appropriate to the operation;

- floors should be constructed to allow adequate drainage and cleaning;

- ceilings and overhead fixtures (e.g. lighting) should be constructed to be shatterproof where appropriate, and finished to minimize the build-up of dirt and condensation and the shedding of particles;

- windows should be easy to clean, be constructed to minimize the build-up of dirt and, where necessary, be fitted with removable and cleanable insect-proof screens; and

- doors should have smooth, non-absorbent surfaces, be easy to clean and, where necessary, disinfect.

Work surfaces that come into direct contact with food should be in sound condition, durable, and easy to clean, maintain and disinfect. They should be made of smooth, non-absorbent materials, and inert to the food, to detergents and to disinfectants under normal operating conditions.

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Establishments and structures covered here include market stalls, street vending vehicles, vending machines and temporary premises such as tents and marquees.

Such premises and structures should be located, designed, and constructed to avoid, as far as reasonably practicable, the contamination of food and the harbouring of pests. Adequate facilities for toileting and washing hands should be provided, where appropriate.

6.3.2 Facilities

6.3.2.1 Drainage and waste disposal facilities

Adequate drainage and waste disposal systems and facilities should be provided and well maintained. They should be designed and constructed so that the likelihood of contaminating food or the water supply is avoided. For plumbing, steps should be taken to prevent backflow, cross-connections, and backup of sewer gases. It is important that drainage does not flow from highly contaminated areas (such as toilets or raw production areas) to areas where finished food is exposed to the environment.

Waste should be collected, disposed of by trained personnel and, where appropriate, disposal records maintained. The waste disposal site should be located away from the food establishment to prevent pest infestation. Containers for waste, by-products and inedible or hazardous substances should be specifically identifiable, suitably constructed and, where appropriate, made of impervious material.

Containers used to hold hazardous substances prior to disposal should be identified and, where appropriate, be lockable to prevent intentional or accidental contamination of food.

6.3.2.2 Cleaning facilities

Adequate, suitably designated facilities should be provided for cleaning utensils and equipment. Such facilities should have an adequate supply of hot and/or cold water, where required. A separate cleaning area should be provided for tools and equipment from highly contaminated areas like toilets, drainage and waste disposal areas. Where appropriate, facilities for washing food should be separate from facilities for cleaning utensils and equipment, and separate sinks should be available for hand washing and food washing.

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Adequate washing and toilet facilities should be available so that an appropriate degree of personal hygiene can be maintained and to avoid personnel contaminating food. Such facilities should be suitably located and should not be used for other purposes such as storage of food or items that contact food. They should include:

- adequate means of washing and drying hands, including soap (preferably liquid soap), wash basins and, where appropriate, a supply of hot and cold (or suitably temperature controlled) water;

- hand washing basins of an appropriate hygienic design, ideally with taps not operated by hands; where this is not possible, appropriate measures to minimize contamination from the taps should be in place; and

- suitable changing facilities for personnel, if needed.

Handwashing basins should not be used for washing food or utensils.

6.3.2.4 Temperature

Depending on the nature of the food operations undertaken, adequate facilities should be available for heating, cooling, cooking, refrigerating and freezing food, for storing refrigerated or frozen foods, and, when necessary, controlling ambient temperatures to ensure the safety and suitability of food.

6.3.2.5 Air quality and ventilation

Adequate means of natural or mechanical ventilation should be provided, in particular to:

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- help control ambient temperatures;

- control odours which might affect the suitability of food; and

- control humidity to ensure the safety and suitability of food (e.g. to prevent an increase in moisture of dried foods that would allow growth of microorganisms and production of toxic metabolites).

Ventilation systems should be designed and constructed so that air does not flow from contaminated areas to clean areas; the systems should be easy to maintain and clean.

6.3.2.6 Lighting

Adequate natural or artificial lighting should be provided to enable the food business to operate in a hygienic manner Lighting should be such that it does not adversely impact the ability to detect defects of, or contaminants in, food or the examination of facilities and equipment for cleanliness. The intensity should be adequate to the nature of the operation. Light fittings should, where appropriate, be protected to ensure that food is not contaminated by breakages of lighting elements.

6.3.2.7 Storage

Adequate and, where necessary, separate facilities for the safe and hygienic storage of food products, food ingredients, food packaging materials and non-food chemicals (including cleaning materials, lubricants, fuels), should be provided. Storage should allow for segregation of raw and cooked foods or allergenic and nonallergenic food.

Food storage facilities should be designed and constructed to:

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- avoid pest access and harbourage;

- enable food to be effectively protected from contamination, including allergen cross-contact, during storage; and

- where necessary, provide an environment which minimizes the deterioration of food (such as by temperature and humidity control).

The type of storage facilities required will depend on the nature of the food. Separate, secure, storage facilities for cleaning materials and hazardous substances should be provided.

6.3.3 Equipment

6.3.3.1 General

Equipment and containers coming into contact with food should be suitable for food contact; designed, constructed and located to ensure that they can be adequately cleaned (other than containers which are single use only); disinfected (where necessary); and maintained or discarded as necessary to avoid the contamination of food, according to hygienic design principles. Equipment and containers should be made of materials that are non-toxic according to intended use. Where necessary, equipment should be durable and movable or capable of being disassembled to allow for maintenance, cleaning, disinfection and to facilitate inspection for pests.

6.3.3.2 Food control and monitoring equipment

Equipment used to cook, heat, cool, store or freeze food should be designed to achieve the required food temperatures as rapidly as necessary in the interests of food safety and suitability, and to maintain food temperatures effectively.

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Where necessary, such equipment should have effective means of controlling and monitoring humidity, airflow and any other characteristics likely to have an effect on the safety or suitability of food.

6.4 Training and competence

Objective

All those engaged in food operations who come directly or indirectly into contact with food should have sufficient understanding of food hygiene to ensure they have competence appropriate to the operations they are to perform.

Rationale

Training is fundamentally important to any food hygiene system and the competence of personnel.

Adequate hygiene training, and/or instruction and supervision of all personnel involved in food-related activities contribute to ensuring the safety of food and its suitability for consumption.

6.4.1 Awareness and responsibilities

Food hygiene training is fundamentally important to the food business. All personnel should be aware of their role and responsibility in protecting food from contamination or deterioration. Personnel should have the knowledge and skills necessary to enable them to handle food hygienically. Those who handle cleaning chemicals or other potentially hazardous chemicals should be instructed in proper use to prevent contamination of food.

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Elements to take into account in determining the extent of training required include:

- the nature of hazards associated with the food, e.g. its ability to sustain growth of pathogenic or spoilage microorganisms, the existence of potential physical contaminants or known allergens;

- the manner in which the food is produced, processed, handled and packed, including the likelihood of contamination;

- the extent and nature of processing or further preparation before consumption of the food;

- the conditions under which the food will be stored;

- the expected length of time before consumption of the food; and

- the use and maintenance of instruments and equipment associated with food.

Training programmes should also consider the knowledge and skill levels of the personnel being trained. Topics to be considered for training programmes could include the following as appropriate to a person’s duties:

- the principles of food hygiene applicable to the food business;

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- the importance of good personal hygiene, including proper hand washing and wearing, when needed, appropriate clothing, for food safety;

- the GHPs applicable to the food business; and

- appropriate actions to take when food hygiene problems are observed.

In addition, for retail and food service operations, whether personnel have direct customer interaction is a factor in training since it may be necessary to convey certain information about products (such as allergens) to customers.

6.4.3 Instruction and supervision

The type of instruction and supervision needed will depend on the size of the business, the nature of its activities and the types of food involved. Managers, supervisors and/or operators/workers should have sufficient knowledge of food hygiene principles and practices to be able to identify deviations and take necessary action as appropriate to their duties.

Periodic assessments of the effectiveness of training and instruction programmes should be made, as well as routine supervision and verification to ensure that procedures are being carried out effectively. Personnel tasked to perform any activities used in food control should be trained adequately to ensure that they are competent to perform their tasks and are aware of the impact of their tasks on the safety and suitability of the food.

6.4.4 Refresher training

Training programmes should be routinely reviewed and updated where necessary. Systems should be in place to ensure that food handlers and personnel associated with the food business, such as maintenance staff, remain aware of all procedures necessary to maintain the safety and suitability of food. Records should be kept of training activities.

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Objective

To establish effective systems that:

- ensure appropriate establishment maintenance;

- ensure cleanliness and, when necessary, adequate disinfection;

- ensure pest control;

- ensure waste management; and

- monitor effectiveness of cleaning and disinfection, pest control and waste management procedures.

Rationale

To facilitate the continuing effective control of food contaminants, pests, and other agents likely to compromise food safety and suitability.

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6.5.1.1 General

Establishments and equipment should be maintained in an appropriate condition to:

- facilitate all cleaning and disinfection procedures;

- function as intended; and

- prevent contamination of food, such as from pests, metal shards, flaking plaster, debris, chemicals, wood, plastic, glass, paper.

Cleaning should remove food residues and dirt which may be a source of contamination, including allergens. The cleaning methods and materials necessary will depend on the nature of the food business, the food type and the surface to be cleaned. Disinfection may be necessary after cleaning, especially for food contact surfaces.

Attention should be paid to hygiene during cleaning and maintenance operations so as not to compromise food safety and suitability. Cleaning products suitable for food contact surfaces should be used in food preparation and storage areas.

Cleaning and disinfection chemicals should be handled and used carefully and in accordance with manufacturers’ instructions, for example, using the correct dilutions and contact times, and stored, where necessary, separate from food, in clearly identified containers to avoid contamination of food.

Separate cleaning equipment and utensils, suitably designated, should be used for different hygiene zones e.g. food and non-food contact surfaces.

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6.5.1.2 Cleaning and disinfection methods and procedures

Cleaning can be carried out by the separate or the combined use of physical methods, such as heat, scrubbing, turbulent flow, and vacuum cleaning (or other methods that avoid the use of water), and chemical methods using solutions of detergents, alkalis, or acids. Dry cleaning or other appropriate methods for removing and collecting residues and debris may be needed in some operations and/or food processing areas where water increases the likelihood of microbiological contamination. Care should be taken to ensure cleaning procedures do not lead to contamination of food, e.g. spray from pressure washing can spread contamination from dirty areas, such as floors and drains, over a wide area and contaminate food contact surfaces or exposed food.

Wet cleaning procedures will involve, where appropriate:

- removing gross visible debris from surfaces;

- applying an appropriate detergent solution to loosen soil; and

- rinsing with water (hot water where appropriate) to remove loosened material and residues of detergent.

Where necessary, cleaning should be followed by chemical disinfection with subsequent rinsing unless the manufacturer’s instructions indicate that, on a scientific basis, rinsing is not required. Concentrations and application time of chemicals used for disinfection should be appropriate for use and applied according to manufacturers’ instructions for optimal effectiveness. If cleaning is not done effectively to remove soil to permit the disinfectant to contact microorganisms or if sub-lethal concentrations of the disinfectant are used, the microorganisms may persist.

Cleaning and disinfection procedures should ensure that all parts of the establishment are appropriately clean. Where appropriate, programmes should be drawn up in consultation with relevant experts.

Written cleaning and disinfection procedures should be used, where appropriate. They should specify: They should specify:

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- responsibility for particular tasks;

- method and frequency of cleaning and, where appropriate, disinfection; and

- monitoring and verification activities.

6.5.1.3 Monitoring of effectiveness

Application of cleaning and disinfection procedures should be monitored for effectiveness and periodically verified by means such as visual inspections and audits to ensure the procedures have been applied properly. The type of monitoring will depend on the nature of the procedures, but could include pH, water temperature, conductivity, cleaning agent concentration, disinfectant concentration, and other parameters important to ensure the cleaning and disinfection programme is being implemented as designed and verify its effectiveness.

Microorganisms can sometimes become tolerant to disinfecting agents over time. Cleaning and disinfection procedures should follow the manufacturers’ instructions. Periodic review with disinfectant manufacturers/suppliers, where feasible, should be conducted to help ensure the disinfectants used are effective and appropriate. Rotation of the disinfectants could be considered to ensure inactivation of different types of microorganisms (e.g. bacteria and fungi).

While effectiveness of cleaning and disinfecting agents and instructions for use are validated by their manufacturers, measures should be taken for sampling and testing the environment and food contact surfaces (e.g. protein and allergen test swabs, or microbiological testing for indicator organisms) to help verify that cleaning and disinfection programmes are effective and being applied properly. Microbiological sampling and testing may not be appropriate in all cases and an alternative approach might include observation of cleaning and disinfection procedures, including the correct disinfectant concentration, to achieve the necessary results and to make sure protocols are being followed. Cleaning and disinfection and maintenance procedures should be regularly reviewed and adapted to reflect any changes in circumstances and documented as appropriate.

6.5.2 Pest control systems

6.5.2.1 General

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6.5.2.2 Prevention

Establishments should be kept in good repair and condition to prevent pest access and to eliminate potential breeding sites. Holes, drains and other places where pests are likely to gain access should be covered. Roll up doors should close tightly against the floor. Wire mesh screens, for example on open windows, doors, and ventilators, will reduce the problem of pest entry. Animals should, wherever possible, be excluded from the grounds of food-processing establishments.

6.5.2.3 Harbourage and infestation

The availability of food and water encourages pest harbourage and infestation. Potential food sources should be stored in pest-proof containers and/or stacked above the ground and preferably away from walls. Areas both inside and outside food premises should be kept clean and free of waste. Where appropriate, refuse should be stored in covered, pest-proof containers. Any potential harbourage, such as old and unused equipment, should be removed.

Landscaping surrounding a food establishment should be designed to minimize attracting and harbouring pests.

6.5.2.4 Monitoring and detection

Establishments and surrounding areas should be regularly examined for evidence of infestation. Detectors and traps (e.g. insect light traps, bait stations) should be designed and located so as to prevent potential contamination of raw materials, products or facilities. Even if monitoring and detection are outsourced, FBOs should review monitoring reports and, if necessary, ensure they or their designated pest control operators take corrective action (e.g. eradication of pests, elimination of harbourage sites or invasion routes).

6.5.2.5 Control of pest infestation

Pest infestations should be addressed immediately by a qualified person or company and appropriate corrective action taken. Treatment with chemical, physical, or biological agents should be carried out without posing a threat to the safety or suitability of food. The cause of infestation should be identified, and corrective action taken to prevent a problem from reoccurring. Records should be kept of infestation, monitoring and eradication.

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6.5.3.1 General

Suitable provision should be made for the removal and storage of waste. Waste should, as far as possible, be collected and stored in covered containers and should not be allowed to accumulate and overflow in food handling, food storage, and other working areas or the adjoining environment in a manner that compromises food safety and suitability. Personnel responsible for waste removal (including hazardous waste) should be properly trained so they do not become a source of cross-contamination.

Waste storage areas should be easily identifiable, be kept appropriately clean, and be resistant to pest infestation. They should also be located away from processing areas.

6.6 Personal hygiene

Objective

To ensure that those who come directly or indirectly into contact with food:

- maintain appropriate personal health;

- maintain an appropriate degree of personal cleanliness; and

- behave and operate in an appropriate manner.

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Personnel who do not maintain an appropriate degree of personal cleanliness, who have certain illnesses or conditions or who behave inappropriately, can contaminate food and transmit illness to consumers through food.

Food businesses should establish policies and procedures for personal hygiene. FBOs should ensure all personnel are aware of the importance of good personal hygiene and understand and comply with practices that ensure food safety and suitability.

6.6.1 Health status

Personnel known or suspected to be ill or carrying a disease likely to be transmitted through food should not enter any food handling area if there is a likelihood of them contaminating food. Any person so affected should immediately report illness or symptoms of illness to the management.

It may be appropriate for personnel to be excluded for a specific time after symptoms resolve or, for some illnesses, to get medical clearance before returning to work.

6.6.2 Illness and injuries

Some symptoms of illnesses that should be reported to management so that the need for possible exclusion from food handling and/or medical examination can be considered include:

- jaundice;

- diarrhoea;

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- fever;

- sore throat with fever;

- visibly infected skin lesions (boils, cuts, etc.); and

- discharges from the ear, eye, or nose.

Personnel with cuts and wounds should, where necessary, be assigned to work in areas where they will have no direct contact with food. Where personnel are permitted to continue working, cuts and wounds should be covered by suitable waterproof plasters and, where appropriate, gloves. Appropriate measures should be applied to ensure plasters do not become a source of contamination (e.g. plasters of contrasting colour compared to the food and/or detectable using a metal detector or X-ray detector).

6.6.3 Personal cleanliness

Personnel should maintain a high degree of personal cleanliness and, where appropriate, wear suitable protective clothing, head and beard covering, and footwear. Measures should be implemented to prevent cross-contamination by personnel through adequate hand washing and, where necessary, the wearing of gloves. If gloves are worn, appropriate measures should be applied to ensure the gloves do not become a source of contamination.

Personnel, including those wearing gloves, should clean their hands regularly, especially when personal cleanliness may affect food safety. In particular, they should wash hands:

- at the start of food handling activities;

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- immediately after using the toilet; and

- after handling any contaminated material, such as waste or raw and unprocessed foods where this could result in contamination of other food items.

In order not to contaminate food, personnel should wash hands with soap and water and rinse and dry them in a manner that does not recontaminate the hands. Hand sanitizers should not replace hand washing and should be used only after hands have been washed.

6.6.4 Personal behaviour

When engaged in food handling activities personnel should refrain from behaviour which could result in contamination of food, for example:

- smoking or vaping;

- spitting;

- chewing, eating, or drinking;

- touching the mouth, nose, or other places of possible contamination; and

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Personal effects such as jewellery, watches, pins, or other items such as false nails/eye lashes should not be worn or brought into food handling areas if they pose a threat to the safety and suitability of food.

6.6.5 Visitors and other persons from outside the establishment

Visitors to food businesses, including maintenance workers, in particular to food manufacturing, processing or handling areas, should, where appropriate, be instructed and supervised, wear protective clothing and adhere to the other personal hygiene provisions for personnel. Visitors should be guided through a hygiene policy of the business prior to visits and encouraged to report any type of illness/injury that may pose crosscontamination issues.

6.7 Control of operation

Objective

To produce food that is safe and suitable for human consumption by:

- formulating design requirements with respect to raw materials and other ingredients, composition/formulation, production, processing, distribution, and consumer use to be met as appropriate to the food business; and

- designing, implementing, monitoring and reviewing effective control systems as appropriate to the food business.

Rationale

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Control of operation is achieved by having an appropriate food hygiene system in place. The following section describes practices that can assist in the identification and application of appropriate controls, as well as activities that should take place to ensure the operation is under control.

6.7.1 Description of products and processes

After consideration of the conditions and activities of the food business it may be necessary to pay greater attention to some GHPs that are particularly important for food safety. In this case, the following provisions could be considered.

6.7.1.1 Product description

An FBO that is producing, storing, or otherwise handling food should have a description of the food. Products may be described individually or in groups in a manner that does not compromise the awareness of hazards or other factors such as suitability of the products for the purpose intended. Any grouping of food products should be based on them having similar inputs and ingredients, product characteristics (such as pH, water activity (aw)), process steps and/or intended purpose.

The description could include, as appropriate:

- the intended use of the food, e.g. whether it is ready-to-eat or whether it is intended for further processing either by consumers or another business, for example raw seafood to be cooked;

- products intended for specific vulnerable consumer groups, e.g. infant formula or food for special medical purposes;

- any relevant specifications, e.g. ingredient composition, aw, pH, type of preservation method used (if any), or important characteristics associated with the food, such as nay allergens present;

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- instructions provided for further use, for example keep frozen until cooking, cook to a specified temperature for a specified length of time, product shelf-life (use-by date);

- storage of product (e.g. refrigerated/frozen/shelf stable) and transport conditions required; and

- food packaging material used.

6.7.1.2 Process description

The FBO should consider all steps in the operation for a specific product. It may be helpful to develop a flow diagram, which shows the sequence and interaction of all processing steps in the operation, including where raw materials, ingredients and intermediate products enter the flow and where intermediate products, byproducts and waste are released or removed. The flow diagram could be used for a number of similar food products that are produced using similar production or processing steps, to ensure all steps are captured. The steps should be confirmed as accurate by an onsite review of the operation or process. For example, for restaurants, the flow diagram could be based on the general activities from the receipt of ingredients/raw material, storage (refrigerated, frozen, room temperature), preparation before use (washing, defrosting), and cooking or preparation of food.

6.7.1.3 Consideration of the effectiveness of GHPs

Having considered the product and process descriptions, an FBO should determine (using information relevant to hazards and controls from various sources as appropriate) whether the GHPs and other programmes they have in place are sufficient to address food safety and suitability or if some GHPs need greater attention. For example, a cooked meat slicer may require specific and more frequent cleaning to prevent the build-up of Listeria spp. on its meat contact surfaces, or a conveyor belt used in direct contact with the food, such as in sandwich production, may require an increased frequency of cleaning or a specific cleaning programme. When such increased attention on GHPs is insufficient to ensure food safety, it will be necessary to implement a HACCP system (see Hazard Analysis and Critical Control Point [HACCP] System and Guidelines for its Application).

6.7.1.4 Consideration of the effectiveness of GHPs

The FBO should monitor the hygienic procedures and practices as relevant to the business and as applicable to the hazard being controlled. Procedures could include defining methods of monitoring (including defining responsible personnel, frequency, and sampling regime if applicable) and monitoring records to be kept. The frequency of monitoring should be appropriate to ensure consistent process control.

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- bringing the process back into control by, for example, altering temperature or timing, or concentration of disinfectant;

- isolating any affected product and evaluating its safety and/or suitability;

- determining proper disposition of affected product that is not acceptable to market;

- identifying the cause that resulted in the deviation; and

- taking steps to prevent reoccurrence.

Records of corrective actions should be retained.

6.7.1.5 Verification

The FBO should undertake verification activities as relevant to the business, to check that GHP procedures have been implemented effectively, monitoring is occurring, where planned, and that appropriate corrective actions are taken when requirements are not met: Examples of verification activities could include the following, as appropriate:

- review of GHP procedures, monitoring, corrective actions, and records;

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- assessment of the efficacy of cleaning.

Records of GHP verification activities should be kept, where appropriate.

6.7.2 Key aspects of GHPs

Some key aspects of GHPs, such as those described in Sections 6.7.2.1 and 6.7.2.2, could be considered as control measures applied at CCPs in the HACCP system.

6.7.2.1 Time and temperature control

Inadequate time and temperature control, e.g. during cooking, cooling, processing and storage, are among the most common failures of operational control. These allow survival or growth of microorganisms that may cause foodborne illness or food spoilage. Systems should be in place to ensure that temperature is controlled effectively where it impacts the safety and suitability of food.

Time and temperature control systems should take into account:

- the nature of the food, e.g. its aw, pH, and likely initial level and types of microorganisms, such as pathogenic and spoilage microflora;

- the impact on the microorganisms, e.g. time in growth/dangerous temperature zone;

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- the method of packaging and processing; and

- how the product is intended to be used, e.g. further cooking/processing or ready-to-eat.

Such systems should also specify tolerable limits for time and temperature variations. Temperature control systems that impact safety and suitability of food should be validated, and as appropriate, monitored and recorded. Temperature monitoring and recording devices should be checked for accuracy and calibrated at regular intervals or as needed.

6.7.2.2 Specific process steps

There are many individual processing steps for specific foods which contribute to the production of safe and suitable food products. These vary depending on the product and can include key steps such as cooking, chilling, freezing, drying, and packaging.

The composition of a food can be important in preventing microbial growth and toxin production, e.g. in its formulation by adding preservatives, including acids, salts, food additives or other compounds. When formulation is used to control foodborne pathogens (e.g. adjusting the pH or aw to a level that prevents growth), systems should be in place to ensure that the product is formulated correctly and that the controlling parameters are monitored.

6.7.2.3 MicrobiologicalWhere microbiological, physical, chemical and allergen specifications are used for food safety or suitability, such specifications should be based on sound scientific principles and state, where appropriate, sampling parameters, analytical methods, acceptable limits, and monitoring procedures. Specifications can help ensure that raw materials and other ingredients are fit for purpose and contaminants have been minimized.

6.7.2.4 Microbiological contamination

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- by direct contact or indirectly by food handlers;

- by contact with surfaces;

- from cleaning equipment;

- by splashing; or

- by airborne particles.

Raw, unprocessed food, where not considered ready-to-eat, which could be a source of contamination, should be separated from ready-to-eat foods, either physically or by time, with effective intermediate cleaning and, where appropriate, effective disinfection.

Surfaces, utensils, equipment, fixtures and fittings should be thoroughly cleaned and where necessary disinfected after raw food preparation, particularly when raw materials with a potentially high microbiological load such as meat, poultry, and fish have been handled or processed.

In some food operations, access to processing areas may need to be restricted or controlled for food safety purposes. For example, where the likelihood of product contamination is high, access to processing areas should be via a properly designed changing facility. Personnel may be required to put on clean protective clothing (which may be of a differentiating colour from that worn in other parts of the facility), including head and beard covering, footwear, and to wash their hands and where necessary sanitize them.

6.7.2.5 Physical contamination

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6.7.2.6 Chemical contamination

Systems should be in place to prevent or minimize contamination of foods by harmful chemicals, e.g. cleaning materials, non-food grade lubricants, chemical residues from pesticides and veterinary drugs such as antibiotics. Toxic cleaning compounds, disinfectants, and pesticide chemicals should be identified, safely stored and used in a manner that protects against contamination of food, food contact surfaces, and food packaging materials. Food additives and food processing aids that may be harmful if used improperly should be controlled so they are only used as intended.

6.7.2.7 Allergen managementSystems should be in place to take into account the allergenic nature of some foods, as appropriate to the food business. Presence of allergens, e.g. tree nuts, milk, eggs, crustacea, fish, peanuts, soybeans and wheat and other cereals containing gluten and their derivatives (not an inclusive list; allergens of concern differ among countries and populations), should be identified in raw materials, other ingredients and products. A system of allergen management should be in place at receipt, during processing and storage to address the known allergens. This management system should include controls put in place to prevent the presence of allergens in foods where they are not labelled. Controls to prevent cross-contact from foods containing allergens to other foods should be implemented, e.g. separation either physically or by time (with effective cleaning between foods with different allergen profiles). Food should be protected from unintended allergen cross-contact by cleaning and line change-over practice and/or product sequencing. Where cross-contact cannot be prevented despite well-implemented controls, consumers should be informed. Where necessary, food handlers should receive specific training on allergen awareness and associated food manufacturing/processing practices and preventive measures to reduce the risk to allergic consumers.

6.7.2.8 Incoming materials

Only raw materials and other ingredients that are fit for purpose should be used. Incoming materials including food ingredients should be procured according to specifications, and their compliance with food safety and suitability specifications should be verified, where necessary. Supplier quality assurance activities, such as audits, may be appropriate for some ingredients. Raw materials or other ingredients should, where appropriate, be inspected (e.g. visual examination for packages damaged during transportation, use-by-date and declared allergens, or temperature measurement for refrigerated and frozen foods) for appropriate action before processing. Where appropriate, laboratory tests could be conducted to check food safety and suitability of raw materials or ingredients. These tests may be conducted by a supplier that provides a certificate of analysis, the purchaser, or both. No incoming material should be accepted by an establishment if it is known to contain chemical, physical, or microbiological contaminants which would not be reduced to an acceptable level by controls applied during sorting and/or processing where appropriate. Stocks of raw materials and other ingredients should be subject to effective stock rotation. Documentation of key information for incoming materials (e.g. supplier details, date of receipt, quantity etc.) should be maintained.

6.7.2.9 Packaging

Packaging design and materials should be safe and suitable for food use, provide adequate protection for products to minimize contamination, prevent damage, and accommodate proper labelling. Packaging materials or gases, where used, should not contain toxic contaminants, and not pose a threat to the safety and suitability of food under the specified conditions of storage and use. Any reusable packaging should be suitably durable, easy to clean and, where necessary, to disinfect.

6.7.3 Water

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6.7.4 Documentation and records

Appropriate records for the food business operation should be retained for a period that exceeds the shelf-life of the product or as determined by the competent authority.

6.7.5 Recall procedures - removal from the market of unsafe food

FBOs should ensure effective procedures are in place to respond to failures in the food hygiene system. Deviations should be assessed for the impact on food safety or suitability. Procedures should enable the comprehensive, rapid, and effective identification, and removal from the market by the involved FBO(s) and/or return to the FBO by the consumers of any food that may pose a risk to public health. Where a product has been recalled because of the likely presence of hazards that may represent an immediate health risk, other products which are produced under similar conditions which may also present a hazard to public health, should be evaluated for safety and may need to be recalled. Reporting to the relevant competent authority should be required and public warnings considered where a product may have reached consumers and when return of the product to the FBO or removal from the market is appropriate. Recall procedures should be documented, maintained, and modified where necessary based on the findings of periodic field trials.

Provision should be made for removed or returned products to be held under secure conditions until they are destroyed, used for purposes other than human consumption, determined to be safe for human consumption, or reprocessed in a manner to reduce the hazard to acceptable levels, where permitted by the competent authority. The cause and extent of a recall and the corrective actions taken should be retained by the FBO as documented information.

6.8 Product information and consumer awareness

Objectives:

Appropriate information about food should ensure that:

- adequate and accessible information is available to the next FBO in the food chain or the consumer to enable them to handle, store, process, prepare and display the product safely and correctly;

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- the lot or batch can be easily identified and removed/returned if necessary.

Consumers should be given enough information on food hygiene to enable them to:

- be aware of the importance of reading and understanding the label;

- make informed choices appropriate to the individual, including about allergens; and

- prevent contamination and growth or survival of foodborne pathogens by storing, preparing and using food correctly.

Rationale

Insufficient product information, and/or inadequate knowledge of general food hygiene, can lead to products being mishandled at later stages in the food chain. Such mishandling can result in illness, or products becoming unsuitable for consumption, even where adequate hygiene control measures have been implemented earlier in the food chain. Insufficient product information about the allergens in food can also result in illness or potentially death for allergic consumers.

6.8.1 Lot identification and traceability

Lot identification or other identification strategies are essential in product recall and also help effective stock rotation. Each container of food should be permanently marked to identify the producer and the lot. TCVN 7087:2013 (CODEX STAN 1-1985, with Amendment 2010) applies.

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6.8.2 Product information

All food products should be accompanied by or bear adequate information to enable the next FBO in the food chain or the consumer to handle, prepare, display, store, and/or use the product safely and correctly.

6.8.3 Product labelling

Pre-packaged foods should be labelled with clear instructions to enable the next person in the food chain to handle, display, store and use the product safely. This should also include information that identifies food allergens in the product as ingredients or where cross-contact cannot be excluded. TCVN 7087:2013 (CODEX STAN 1-1985, with Amendment 2010) applies.

6.8.4 Consumer education

Consumer education programmes should cover general food hygiene. Such programmes should enable consumers to understand the importance of any product label information and following any instructions accompanying products, and to make informed choices. In particular, consumers should be informed of the relationship between time/temperature control, cross contamination and foodborne illness, and of the presence of allergens Consumers should also be informed of the WHO five keys to safer food and educated to apply appropriate food hygiene measures (e.g. proper hand washing, adequate storage and cooking and avoiding cross contamination) to ensure that their food is safe and suitable for consumption.

6.9 Transportation

Objectives

During transportation, measures should be taken where necessary to:

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- protect food from damage likely to render the food unsuitable for consumption; and

- provide an environment which effectively controls the growth of pathogenic or spoilage microorganisms and the production of toxins in food.

Rationale

Food may become contaminated or may not reach its destination in a suitable condition for consumption, unless effective hygiene practices are taken prior to and during transport, even where adequate hygiene practices have been taken earlier in the food chain.

6.9.1 General

Food should be adequately protected during transport6.9.2 Requirements

Where necessary, conveyances and bulk containers should be designed and constructed so that they:

- do not contaminate foods or packaging;

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- permit effective separation of different foods or foods from non-food items that could cause contamination where necessary during transport;

- provide effective protection from contamination, including dust and fumes;

- can effectively maintain the temperature, humidity, atmosphere, and other conditions necessary to protect food from harmful or undesirable microbial growth and deterioration likely to render it unsafe or unsuitable for consumption; and

- allow any necessary temperature, humidity, and other environmental conditions to be checked.

6.9.3 Use and maintenance

Conveyances and containers for transporting food should be kept in an appropriate state of cleanliness, repair and condition. Containers and conveyances for bulk food transport should be designated and marked for food use and used only for that purpose unless controls are taken to ensure that the safety and suitability of the food are not compromised.

Where the same conveyance or container is used for transporting different foods, or non-foods, effective cleaning and, where necessary, disinfection, and drying should take place between loads.

7 Hazard analysis and critical control point (HACCP) system and guidelines for its application

7.1 Introduction to HACCP

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HACCP principles can be considered throughout the food chain from primary production to final consumption, and their implementation should be guided by scientific evidence of risks to human health. Although it is not always feasible to apply HACCP at primary production, some of the principles can be applied and may be incorporated into good practices programmes (e.g. GAPs, etc.). It is recognized that implementation of HACCP may be challenging for some businesses. However, HACCP principles can be applied flexibly in individual operations, and businesses may use external resources (e.g. consultants) or adapt a generic HACCP plan provided by the competent authority, academia or other competent bodies (e.g. trade or industry associations) to the specific site circumstances. As well as enhancing food safety, implementation of HACCP can provide other significant benefits, such as more efficient processes based on a thorough analysis of capability, more effective use of resources by focusing on critical areas, and fewer recalls through identification of problems before product is released. In addition, the application of HACCP systems can aid review by competent authorities and promote international trade by increasing confidence in food safety.

The successful application of HACCP requires the commitment and involvement of management and personnel and the knowledge and/or training in its application for the particular type of food business. A multidisciplinary approach is strongly recommended; this multi-disciplinary approach should be appropriate to the food business operation and may include, for example, expertise in primary production, microbiology, public health, food technology, environmental health, chemistry, and engineering, according to the particular application.

7.2 Principles of the HACCP system

The HACCP system is designed, validated and implemented in accordance with the following seven principles:

Principle 1

Conduct a hazard analysis and identify control measures.

Principle 2

Determine the critical control points (CCPs).

Principle 3

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Principle 4

Establish a system to monitor control of CCPs.

Principle 5

Establish the corrective actions to be taken when monitoring indicates a deviation from a critical limit at a CCP has occurred.

Principle 6

Validate the HACCP plan and then establish procedures for verification to confirm that the HACCP system is working as intended.

Principle 7

Establish documentation concerning all procedures and records appropriate to these principles and their application.

7.3 General guidelines for the application of the HACCP system

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Prior to application of a HACCP system by any FBO in the food chain, that FBO should have in place prerequisite programmes, including GHPs established in accordance with Section 6, Good Hygiene Practices, of this document, the appropriate product and sector-specific Codex codes of practice, and in accordance with relevant food safety requirements set by competent authorities. Prerequisite programmes should be well-established, fully operational and verified, where possible, in order to facilitate the successful application and implementation of the HACCP system. HACCP application will not be effective without prior implementation of prerequisite programmes including GHPs.

For all types of food businesses, management awareness and commitment to food safety are necessary for implementation of an effective HACCP system. The effectiveness will also rely upon management and personnel having the appropriate HACCP training and competency. Therefore, ongoing training is necessary for all levels of personnel, including managers, as appropriate to the food business.

A HACCP system identifies and enhances control of significant hazards, where necessary, over that achieved by the GHPs that have been applied by the establishment. The intent of the HACCP system is to focus control at CCPs. By specifying critical limits for control measures at CCPs and corrective actions when limits are not met, and by producing records that are reviewed before product release, HACCP provides consistent and verifiable control beyond that achieved by GHPs.

A HACCP approach should be customized to each food business. Hazards, control measures at CCPs and their critical limits, CCP monitoring, CCP corrective actions and verification activities can be distinctive for a particular situation, and those identified in a Codex code of practice or other appropriate guidelines might not be the only ones identified for a specific application or might be of a different nature.

The HACCP system should be reviewed periodically and whenever there is a significant change that could impact the potential hazards and/or the control measures (e.g. new process, new ingredient, new product, new equipment) associated with the food business. Periodic review should also be conducted when the application of the HACCP principles has resulted in a determination that no CCPs are needed, in order to assess whether the need for CCPs has changed.

7.3.2 Flexibility for small and/or less developed food businessesThe application of the HACCP principles to develop an effective HACCP system should be the responsibility of each individual business. However, it is recognized by competent authorities and FBOs that there may be obstacles that hinder the effective application of the HACCP principles by individual food businesses. This is particularly relevant in small and/or less developed food businesses. Barriers to the application of HACCP in small and less developed businesses (SLDBs) have been acknowledged, and flexible approaches to the implementation of HACCP in such businesses are available and encouraged. Some approaches may provide ways to adapt the HACCP approach to assist competent authorities in supporting SLDBs, for example, development of a HACCP-based system which is consistent with the seven principles of HACCP but does not conform to the layout or steps described in this section. While it is recognized that flexibility appropriate to the business is important when applying HACCP, all seven principles should be considered in developing the HACCP system. This flexibility should take into account the nature of the operation, including the human and financial resources, infrastructure, processes, knowledge and practical constraints, as well as the risk associated with the produced food. Applying such flexibility, i.e. recording only monitoring results when there is a deviation instead of every monitoring result to reduce unnecessary burden of record keeping for certain types of FBOs, is not intended to impact negatively on the efficacy of the HACCP system and should not endanger food safety.

Small and/or less developed food businesses do not always have the resources and the necessary expertise onsite for the development and implementation of an effective HACCP system. In such situations, expert advice should be obtained from other sources, which may include trade and industry associations, independent experts and competent authorities. HACCP literature and especially sector-specific HACCP guides can be valuable. HACCP guidance developed by experts relevant to the process or type of operation may provide a useful tool for businesses in designing and implementing a HACCP plan. Where businesses are using expertly developed HACCP guidance, it is essential that it is specific to the foods and/or processes under consideration. A comprehensive explanation of the basis for the HACCP plan should be provided to the FBO. The FBO is ultimately responsible for elaboration and implementation of the HACCP system and the production of safe food.

The efficacy of any HACCP system will nevertheless rely on management and personnel having the appropriate HACCP knowledge and skills, therefore ongoing training is necessary for all levels of personnel, including managers, as appropriate to the food business.

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7.4.1 Assemble HACCP team and identify scope (Step 1)

The FBO should ensure that the appropriate knowledge and expertise are available for the development of an effective HACCP system. This may be achieved by assembling a multidisciplinary team responsible for different activities within the operation, e.g. production, maintenance, quality control, cleaning, and disinfection. The HACCP team is responsible for developing the HACCP plan.

Where relevant expertise is not available in house, expert advice should be obtained from other sources, such as trade and industry associations, independent experts, competent authorities, HACCP literature and HACCP guides (including sector-specific HACCP guides). It may be possible that a well-trained individual with access to such guidance is able to implement a HACCP system in house. A generic HACCP plan developed externally may be used by FBOs where appropriate but should be tailored to the food operation.

The HACCP team should identify the scope of the HACCP system and applicable prerequisite programmes. The scope should describe which food products and processes are covered.

7.4.2 Describe product (Step 2)

A full description of the product should be developed, including relevant safety information such as composition (i.e. ingredients), physical/chemical characteristics (i.e. aw, pH, preservatives, allergens), processing methods/technologies (i.e. heat-treatment, freezing, drying, brining, smoking, etc.), packaging, durability/shelf life, storage conditions and method of distribution. Within businesses with multiple products, it may be effective to group products with similar characteristics and processing steps for the purpose of development of the HACCP plan. Any limits relevant to the food product already established for hazards should be considered and accounted for in the HACCP plan, e.g. limits for food additives, regulatory microbiological criteria, maximum allowed veterinary medicines residues, and times and temperatures for heat treatments prescribed by competent authorities.

7.4.3 Identify intended use and users (Step 3)

Describe the use intended by the FBO and the expected uses of the product by the next FBO in the food chain or the consumer. The description may be influenced by external information, e.g. from the competent authority or other sources on ways in which consumers are known to use the product other than those intended by the FBO. In specific cases (e.g. hospitals), vulnerable groups of the population may have to be considered. Where foods are being produced specifically for a vulnerable population, it may be necessary to enhance process controls, monitor control measures more frequently, verify controls are effective by testing products, or conduct other activities to provide a high level of assurance that the food is safe for the vulnerable population.

7.4.4 Construct flow diagram (Step 4)

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- the sequence and interaction of the steps in the operation;

- where raw materials, ingredients, processing aids, packaging materials, utilities and intermediate products enter the flow;

- any outsourced processes;

- where applicable reworking and recycling take place;

- where end products, intermediate products, waste, and by-products are released or removed.

7.4.5 On-site confirmation of flow diagram (Step 5)

Steps should be taken to confirm the processing activities against the flow diagram during all stages and hours of operation and amend the flow diagram, where appropriate. The confirmation of the flow diagram should be performed by a person or persons with sufficient knowledge of the processing operation.

7.4.6 List all potential hazards that are likely to occur and associated with each step, conduct a hazard analysis to identify the significant hazards, and consider any measures to control identified hazards (Step 6/Principle 1)

Hazard analysis consists of identifying potential hazards and evaluating these hazards to determine which of them are significant for the specific food business operation. An example of a hazard analysis worksheet is provided in Figure 2. The HACCP team should list all potential hazards. The HACCP team should then identify where these hazards are reasonably likely to occur at each step (including all inputs into that step) according to the scope of the food business operation. Hazards should be specific, e.g. metal fragments, and the source or reason for presence should be described, e.g. metal from broken blades after chopping. The hazard analysis can be simplified by breaking down complex manufacturing operations and analysing steps in the multiple flow diagrams described in Step 4.

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In conducting the hazard analysis to determine whether there are significant hazards, wherever possible, the following should be considered:

- hazards associated with producing or processing the type of food, including its ingredients and process steps (e.g. from surveys or sampling and testing of hazards in the food chain, from recalls, from information in the scientific literature or from epidemiological data);

- the likelihood of occurrence of hazards, taking into consideration prerequisite programmes, in the absence of additional control;

- the likelihood and severity of adverse health effects associated with the hazards in the food in the absence of control- identified acceptable levels of the hazards in the food e.g. based on regulation, intended use, and scientific information;

- the nature of the facility and the equipment used in making the food product;

- survival or multiplication of pathogenic microorganisms;

- production or persistence in foods of toxins (e.g. mycotoxins), chemicals (e.g. pesticides, drug residues, allergens) or physical agents (e.g. glass, metal);

- the intended use and/or probability of product mishandling by potential consumers that could render the food unsafe; and

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The hazard analysis should consider not only the intended use, but also any known unintended use (e.g. a soup mix intended to be mixed with water and cooked but known to commonly be used without a heat treatment in flavouring a dip for chips) to determine the significant hazards to be addressed in the HACCP plan (see Figure 2 for an example of a hazard analysis worksheet.)

In some cases, it may be acceptable for a simplified hazard analysis to be carried out by FBOs. This simplified process identifies groups of hazards (biological, physical, chemical) in order to control the sources of these hazards without the need for a comprehensive hazard analysis that identifies the specific hazards of concern. There can be drawbacks to such an approach, as the controls can differ for hazards within a group, e.g. controls for pathogenic spore-formers versus vegetative cells of microbial pathogens. Generic HACCP-based tools and guidance documents provided by external sources, for example, by industry or competent authorities, are designed to assist with this step and mitigate concerns about different controls needed for hazards within a group.

Hazards which are such that their prevention, elimination or reduction to acceptable levels is essential to the production of safe food (because they are reasonably likely to occur in the absence of control and reasonably likely to cause illness or injury if present) should be identified and controlled by measures designed to prevent or eliminate these hazards or reduce them to an acceptable level. In some cases, this may be achieved with the application of GHPs, some of which may target a specific hazard (for example, cleaning equipment to control contamination of ready-to-eat foods with Listeria monocytogenes or to prevent food allergens being transferred from one food to another food that does not contain that allergen). In other instances, control measures will need to be applied within the process, for example at CCPs.

Consideration should be given to which control measures, if any exist, can be applied to each hazard. More than one control measure may be required to control a specific hazard. For example, to control L. monocytogenes, a heat treatment may be needed to kill the organism in the food and cleaning and disinfection may be needed to prevent transfer from the processing environment. More than one hazard may be controlled by a specified control measure. For example, a heat treatment can control both Salmonella and E. coli O157:H7 when they are present as hazards in the food.

7.4.7 Determine the critical control points (CCPs) (Step 7/Principle 2)

The FBO should consider which among the available control measures listed during Step 6, Principle 1 should be applied at a CCP. CCPs are to be determined only for hazards identified as significant as the result of a hazard analysis. CCPs are established at steps where control is essential and where a deviation could result in the production of a potentially unsafe food. The control measures at CCPs should result in an acceptable level of the hazard being controlled. There may be more than one CCP in a process at which control is applied to address the same hazard (e.g. the cook step may be the CCP for killing the vegetative cells of a pathogenic spore-former, but the cooling step may be a CCP to prevent germination and growth of the spores). Similarly, a CCP may control more than one hazard (e.g. cooking can be a CCP that addresses several microbial pathogens). Determining whether or not the step at which a control measure is applied is a CCP in the HACCP system can be helped by using a decision tree or a CCP determination worksheet. A decision tree should be flexible, given whether it is for use in production, slaughter, processing, storage, distribution, or other processes.

Other approaches such as expert consultation may be used.

- To identify a CCP, whether using a decision tree or other approach, the following should be considered:

+ Assess whether the control measure can be used at the process step being analysed:

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- Determine whether a control measure at a step is used in combination with a control measure at another step to control the same hazard; if so, both steps should be considered as CCPs.

The CCPs identified could be summarized in tabular format, e.g. the HACCP worksheet presented in Figure 3, as well as highlighted at the appropriate step on the flow diagram.

If no control measures exist at any step for an identified significant hazard, then the product or process should be modified.

7.4.8 Establish validated critical limits for each CCP (Step 8/Principle 3)

Critical limits establish whether a CCP is in control, and in doing so they can be used to separate acceptable products from unacceptable ones. These critical limits should be measurable or observable. In some cases, more than one parameter could have a critical limit designated at a particular step (e.g. heat treatments commonly include critical limits for both time and temperature). Criteria often used include minimum and/or maximum values for critical parameters associated with the control measure such as measurements of temperature, time, moisture level, pH, aw, available chlorine, contact time, conveyor belt speed, viscosity, conductance, flow rate, or, where appropriate, parameters that can be observed, such as a pump setting. A deviation from the critical limit indicates that it is likely that unsafe food has been produced.

Critical limits for control measures at each CCP should be specified and scientifically validated to obtain evidence that they are capable of controlling hazards to an acceptable level if properly implemented7.4.9 Establish a monitoring system for each CCP (Step 9/Principle 4)

Monitoring of CCPs is the scheduled measurement or observation at a CCP relative to its critical limits. The monitoring procedures should be able to detect a deviation at the CCP. Further, the monitoring method and frequency should be capable of timely detection of any failure to remain within critical limits, to allow timely isolation and evaluation of the product. Where possible, process adjustments should be made when monitoring results indicate a trend towards a deviation at a CCP. The adjustments should be taken before a deviation occurs.

Monitoring procedures for CCPs should be capable of timely detection of a deviation from the critical limit to allow isolation of the affected products. The method and frequency of monitoring should take into account the nature of the deviation (e.g. a drop in temperature or a broken sieve, rapid drop in temperature during pasteurization, or a gradual increase in temperature in cold storage). Where possible, monitoring of CCPs should be continuous. Monitoring of measurable critical limits such as processing time and temperature can often be monitored continuously. Other measurable critical limits such as moisture level and preservative concentration cannot be monitored continuously. Critical limits that are observable, such as a pump setting or applying the correct label with appropriate allergen information are rarely monitored continuously. If monitoring is not continuous, then the frequency of monitoring should be sufficient to ensure to the extent possible the critical limit has been met and limit the amount of product impacted by a deviation. Physical and chemical measurements are usually preferred to microbiological testing because physical and chemical tests can be done rapidly and can often indicate the control of microbial hazards associated with the product and/or the process.

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All records and documents associated with monitoring CCPs should be signed or initialled by the person performing the monitoring and should also report the results and timing of the performed activity.

7.4.10 Establish corrective actions (Step 10/Principle 5)

Specific written corrective actions should be developed for each CCP in the HACCP system in order to effectively respond to deviations when they occur. When critical limits at CCPs are monitored continuously and a deviation occurs, any product being produced at the time the deviation occurs is potentially unsafe. When a deviation in meeting a critical limit occurs and monitoring was not continuous, then the FBO should determine what product may have been impacted by the deviation.

The corrective actions taken when a deviation occurs should ensure that the CCP has been brought under control and food that is potentially unsafe is handled appropriately and does not reach consumers. Actions taken should include segregating the affected product and analysing its safety to ensure proper disposition.

External experts may be needed to conduct evaluations regarding the safe use of products when a deviation occurs. It may be determined that the product could be reprocessed (e.g. pasteurized) or the product could be diverted to another use. In other situations, the product may need to be destroyed (e.g. contamination with Staphylococcus enterotoxin). A root cause analysis should be conducted where possible to identify and correct the source of the deviation in order to minimize the potential for the deviation to reoccur. A root cause analysis could identify a reason for the deviation that limits or expands the amount of product impacted by a deviation.

Details of the corrective actions, including the cause of the deviation and product disposition procedures, should be documented in the HACCP records. Periodic review of corrective actions should be undertaken to identify trends and to ensure corrective actions are effective.

7.4.11 Validation of the HACCP plan and verification procedures (Step 11/Principle 6)

7.4.11.1 Validation of the HACCP plan

Before the HACCP plan can be implemented, its validation is needed; this consists of making sure that the following elements together are capable of ensuring control of the significant hazards relevant to the food business: identifying the hazards, critical control points, critical limits, control measures, frequency and type of monitoring of CCPs, corrective actions, frequency and type of verification and the type of information to be recorded.

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Where HACCP guidance developed by external experts, instead of the HACCP team, has been used to establish the critical limits, care should be taken to ensure that these limits fully apply to the specific operation, product, or groups of products under consideration.

During the initial implementation of the HACCP system and after verification procedures have been established, evidence should be obtained in operation to demonstrate that control can be achieved consistently under production conditions.

Any changes having a potential impact on food safety should require a review of the HACCP system, and when necessary, a revalidation of the HACCP plan.

7.4.11.2 Verification procedures

After the HACCP system has been implemented, procedures should be established to confirm that the HACCP system is working effectively. These include procedures to verify that the HACCP plan is being followed and controlling hazards on an ongoing basis, as well as procedures that show the control measures are effectively controlling the hazards as intended. Verification also includes reviewing the adequacy of the HACCP system periodically and, as appropriate, when changes occur.

Verification activities should be performed on an ongoing basis to ensure the HACCP system functions as intended and continues to operate effectively. Verification, which includes observations, auditing (internal and external), calibration, sampling and testing, and records review, can be used to determine if the HACCP system is working correctly and as planned. Examples of verification activities include:

- reviewing monitoring records to confirm that CCPs are kept under control;

- reviewing corrective action records, including specific deviations, product disposition and any analysis to determine the root cause of the deviation;

- calibrating or checking the accuracy of instruments used for monitoring and/or verification;

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- sampling and testing, e.g. for microorganisms - sampling and testing the environment for microbial contaminants and their indicators, such as Listeria; and

- reviewing the HACCP system, including the hazard analysis and the HACCP plan (e.g. internal and/or third-party audits).

Verification should be carried out by someone other than the person who is responsible for performing the monitoring and corrective actions. Where certain verification activities cannot be performed in-house, verification should be performed on behalf of the business by external experts or qualified third parties.

The frequency of verification activities should be sufficient to confirm that the HACCP system is working effectively. Verification of the implementation of control measures should be conducted with sufficient frequency to determine that the HACCP plan is being implemented properly.

Verification should include a comprehensive review (e.g. reanalysis or an audit) of the HACCP system periodically, as appropriate, or when changes occur, to confirm the efficacy of all elements of the HACCP system. This review of the HACCP system should confirm that the appropriate significant hazards have been identified, that control measures and critical limits are adequate to control the hazards, that monitoring and verification activities are occurring in accordance with the plan and are capable of identifying deviations, and that corrective actions are appropriate for deviations that have occurred. This review can be carried out by individuals within a food business or by external experts. The review should include confirmation that various verification activities have been executed as intended.

7.4.12 Establish documentation and record keeping (Step 12/Principle 7)

Efficient and accurate record keeping is essential to the application of a HACCP system. HACCP procedures should be documented. Documentation and record keeping should be appropriate to the nature and size of the operation and sufficient to assist the business to verify that the HACCP controls are in place and being maintained. Expertly developed HACCP guidance materials (e.g. sector-specific HACCP guides) may be utilized as part of the documentation, provided that those materials reflect the specific food operations of the business.

Examples of documentation include:

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- hazard analysis and the scientific support for the hazards included or excluded from the plan;

- CCP determination;

- critical limit determination and the scientific support for the limits set;

- validation of control measures; and

- modifications made to the HACCP plan.

Examples of records include:

- CCP monitoring activities;

- deviations and associated corrective actions; and

- verification procedures performed.

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7.4.13 Training

Training of personnel in food businesses, government and academia in HACCP principles and applications is an essential element for the effective implementation of HACCP. As an aid in developing specific training to support a HACCP plan, working instructions and procedures should be developed which define the tasks of the operating personnel in charge of each CCP. Training programmes should be designed to address the concepts at a level appropriate for the knowledge and skill level of the personnel being trained. Training programmes should be reviewed periodically and updated where necessary. Re-training may be needed as part of corrective actions for some deviations.

Cooperation between food business operations, trade groups, consumer organizations, and competent authorities is vitally important. Opportunities should be provided for the joint training of FBOs and competent authorities to encourage and maintain a continuous dialogue and create a climate of understanding in the practical application of HACCP.

Annex A

 (informative)

Comparison of control measures with examples

Control measures applied as good hygiene practices (GHPs)

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Scope

General conditions and activities for maintaining hygiene, including creating the environment (inside and outside the food business) so as to ensure production of safe and suitable food.

Generally, not specific to any hazard but results in reduction of likelihood of hazards occurring. Occasionally a GHP activity may target a specific hazard, and this may be a GHP that requires greater attention (e.g. cleaning and disinfection of food contact surfaces for control of Listeria monocytogenes in a ready-to-eat food processing environment).

Specific to production process steps and a product or group of products, and necessary to prevent eliminate or reduce to acceptable level a hazard determined as significant by the hazard analysis.

When identified?

After consideration of the conditions and activities necessary to support the production of safe and suitable food.

After a hazard analysis has been completed, for each hazard identified as significant, control measures are established at steps (CCPs) where a deviation would result in the production of a potentially unsafe food.

Validation of the control measures

Where necessary, and generally not carried out by FBOs themselves (TCVN 12947:2020). Validation data provided by competent authorities, published scientific literature, information provided by manufacturers of equipment/food processing technology etc. is adequate e.g. cleaning compounds/products/equipment should be validated by the manufacturer and it is generally sufficient for the FBO to use cleaning compounds/products/equipment according to manufacturers’ instructions. The FBO should be able to demonstrate it can follow manufacturers’ instructions.

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Criteria

GHPs may be observable (e.g. visual checks, appearance) or measurable (e.g. ATP tests of equipment cleaning, concentration of disinfectant), and deviations may require an evaluation of the impact on safety of the product (e.g. whether the cleaning of complex equipment such as meat slicers is adequate).

Critical limits at CCPs which separate acceptability from unacceptability of the food:

- measurable (e.g. time, temperature, pH, aw), or

- observable (e.g. visual checks of conveyor belt speed or pump settings, ice covering product).

Monitoring

When appropriate and necessary, to ensure procedures and practices are applied properly.

Frequency dependent on the impact on the product’s safety and suitability.

Necessary to ensure critical limit is met:

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- if not continuous, at appropriate frequency that ensures to the extent possible the critical limit has been met.

Corrective actions when deviation has occurred

- For procedures and practices: necessary

- For products: usually not necessary. Corrective action should be considered on a case- by-case basis, as failure to apply some GHPs, such as failure to clean between products with different allergen profiles, not rinsing after cleaning and/or disinfecting (where needed) or post maintenance equipment checks indicating missing machinery parts, may result in action on product.

- For products: necessary pre-determined actions.

- For procedures and practices: necessary corrective actions to restore control and prevent reoccurrence.

- Specific written corrective actions should be developed for each CCP in the HACCP plan in order to effectively respond to deviations when they occur.

- The corrective actions should ensure that the CCP has been brought under control and food that is potentially unsafe is handled appropriately and does not reach consumers.

Verification

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Necessary: scheduled verification of implementation of control measures, e.g. through record review, sampling and testing, calibration of measuring equipment, internal audit.

Record keeping (e.g. monitoring records)

When appropriate and necessary, to allow the FBO to assess whether GHPs are operating as intended.

Necessary to allow the FBO to demonstrate ongoing control of significant hazards.

Documentation (e.g. documented procedures)

When appropriate and necessary to ensure GHPs are properly implemented.

Necessary to ensure the HACCP system is properly implemented.

Figure 1 - Logic sequence for application of HACCP

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Step*

Identify potential hazards introduced, controlled, or enhanced at this step

B = biological

C = chemical

P = physical

Does this potential hazard need to be addressed in the HACCP plan?

Justify your decision for column 3

What measure(s) can be applied to prevent or eliminate the hazard or reduce it to an acceptable level?

Yes

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(1)

(2)

(3)

(4)

(5)

B

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C

P

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B

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C

P

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B

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C

P

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* A hazard analysis should be conducted on each ingredient used in the food; this is often done at a “receiving” step for the ingredient. Another approach is to do a separate hazard analysis on ingredients and one on the processing steps.

Figure 3 - Example of a HACCP worksheet

Critical control points (CCPs)

Significant hazard(s)

Critical limits

Monitoring

Corrective actions

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Records

What

How

When (frequency)

Who

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BIBLIOGRAPHY

Foreword

Introduction

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2 Normative references

3 Definitions

4 General principles

5 Management commitment to food safety

6 Good hygiene practices

6.1 Introduction and control of food hazards

6.2 Primary production

6.3 Establishment – Design of facilities and equipment

6.4 Training and competence

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6.6 Personal hygiene

6.7 Control of operation

6.8 Product information and consumer awareness

6.9 Transportation

7 Hazard analysis and critical control point (HACCP) system and guidelines for its application

7.1 Introduction

7.2 Principles of the HACCP system

7.3 General guidelines for the application of the HACCP system

7.4 Application

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1) See TCVN 12947:2020, Guidelines for the Validation of Food Safety Control Measures. TCVN 12947:2020 corresponds to CXG 69-2008 Guidelines for the validation of food safety control measures in terms of specifications.

2) See TCVN 10168:2013 (CAC/RCP 49-2001) Code of Practice Concerning Source Directed Measures to Reduce Contamination of Food with Chemicals.

3) Refer to TCVN 9632:2016 (CAC/GL 21-1997, Revised 2013) Principles and Guidelines for the Establishment and Application of Microbiological Criteria Related to Foods

4) See CXC 80-2020, Code of practice on food allergen management for food business operators

5) See Microbiological Risk Assessment Series 33: Safety and quality of water used in food production and processing.

6) TCVN 10167:2013 (CAC/RCP 47-2001) Code of Hygienic Practice for the Transport of Food in Bulk and Semi-Packed Food.

7) FAO/WHO Guidance to governments on the application of HACCP in small and/or less-developed food businesses.

8) FBOs may take advantage of risk assessments and risk management matrices established by a competent authority or by international expert groups such as JEMRA.

9) See TCVN 12947:2020, Guidelines for the Validation of Food Safety Control Measures.

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11) TCVN 9632:2016 (CAC/GL 21-1997, Revised 2013) Principles and Guidelines for the Establishment and Application of Microbiological Criteria Related to Foods