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 areas2), locating near
facilities emitting toxic or offensive odours which could taint foodstuffs or
near sources of contaminated water such as discharge of wastewater from
industrial production or runoff from agricultural land with high faecal
material or chemical residues, unless there is a measure to reduce or prevent
the contamination of food.
6.2.2
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
Microbiological3) physical, chemical and allergen
specifications
Where
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 management4)
Systems 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). The type of conveyances or containers
required depends on the nature of the food and the most appropriate conditions
under which it should be transported.
6.9.2
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 businesses7)
The 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 control8);
- 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 implemented9). Validation of critical
limits may include conducting studies (i.e. microbiological inactivation
studies). FBOs may not always need to conduct or commission studies themselves
to validate critical limits. Critical limits could be based on existing
literature, regulations or guidance from competent authorities, or studies
carried out by a third party, e.g. studies conducted by an equipment
manufacturer to determine the appropriate time, temperature and bed depth for
dry roasting tree nuts. Validation of control measures is further described
more fully in TCVN 12947:2020.
7.4.9
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 11) (pathogens or their indicators),
chemical hazards such as mycotoxins, or physical hazards such as metal
fragments, to verify product safety;
- 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