PAS 220:2008

Specification available to the public

THIS IS A WORKING DOCUMENT

PREREQUISITE PROGRAMS IN FOOD SECURITY

FOR FOOD MANUFACTURING

INTRODUCTION
ISO 22000:2005show specific food safety requirements for organizations in
the food chain. One of such requirements is that the organization must establish,
implementar y mantener programas prerrequisito (PRP) y programas prerrequisitos operacionales
(OPRP) to support the control of food safety hazards. (ISO 22000:2005, clause
7).

This PAS presents the detailed requirements of those programs and aims to be
used to support the management systems designed to meet the specified requirements
in ISO 22000:2005.

The food production operations are diverse in nature and not all
requirements described in this PAS will apply to specific processes or infrastructure. Where
exclusions are made, declarations of compliance with this PAS are not acceptable unless
that the exclusions are justified by documented risk insurance and do not affect
the capacity or responsibility of the Organization to implement a management system of
food security.

SCOPE
This publicly available specification (PAS) specifies the requirements for establishing,
implement and maintain prerequisite programs (PRP) and operational prerequisite programs
(OPRP) to support food safety hazard control.

This PAS is applicable to all organizations, regardless of size or complexity, that

are included in the manufacturing stages of the food chain 'in-house of the
factory" and that wish to implement PRP and O-PRP with the aim of meeting the requirements
specified in ISO 22000:2005.

This PAS is neither designed nor intended for use in other parts of the supply chain.
foods.
This PAS specifies the detailed requirements to be considered in relation to number 7.2.3 of
ISO 22,000, specifically:

a) Construction and arrangement of buildings and support services;

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b) Arrangement of the surroundings, including work areas and facilities for employees;
c) supply of air, water, energy and other services;
d) support services, including disposal of solid and liquid waste;
e) availability of equipment and its ease of cleaning, maintenance and upkeep
estimate;
f) management of purchased materials;
g) measures for the prevention of cross-contamination;
h) cleaning and disinfecting;
i) pest control;
j) personal hygiene.

Additionally, this PAS includes other aspects deemed relevant in the operations of
fabricación:
a) traceability and product withdrawal procedures;
b) storage;
c) product information and warnings for consumers;
d) defense of food, biovigilance, and bioterrorism.

2 Normative References

The following referenced documents are essential for the application of this
document. For dated references, only the cited edition applies. For non-references
closed, the latest edition of the referenced document (including any corrections) applies.

ISO 22000:2005. Food Safety Management Systems. Requirements for any

organization in the food chain, clause 7.

3 Terms and Definitions

For the purposes of this PAS, the following terms and definitions apply.
The terms and definitions provided in ISO 22000:2005 also apply.

3.1 Certificate of Analysis (COA)

Document provided by the supplier which indicates the results of specific tests/analyses.
including methodology of the trial, developed on a defined batch of the product of
provider

3.2 Site Cleaning (CIP)

Cleaning system solely by circulation and/or flow of chemical detergent solutions and
rinses with water by mechanical means on and above the surfaces to be cleaned.

[Link] off-site (COP)

Cleaning of a disassembled equipment in a tank or in an automatic washer using the
circulation of a cleaning solution while maintaining a minimum temperature during the cycle
for cleaning.

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3.4 First in, First out (FIFO)
Rotation of inventory based on the principle of first-in, first-out (FIFO) of expiry dates.
closer

First In First Out (FIFO)

Rotation of stock based on the principle of first in, first out
products received.

3.6 Food Grade

Lubricants and heat transfer fluids that are free of odors or flavors and suitable for use
in food processing where there may be incidental contact between the lubricant and the
food

3.7 Good Manufacturing Practices (GMP)

Set of basic conditions, activities, and requirements specified by the Organization for
provide a hygienic environment for food processing and handling.

3.8 High Care Area

Area subject to additional requirements for hygiene of equipment and personnel aimed at
protect products susceptible to contamination by microorganisms.

3.9 Indirect contact with the product

Surfaces from which liquids could drain, leak, diffuse or be carried to
interior of the product or the container that holds it; surfaces that touch the product
contact surfaces or containers during the normal operation of the equipment.
Note: it also includes surfaces such as utensils and scraping product.

3.10 Label
Printed material that is part of the finished packaged product that carries information
specific about the contents of the packaging, the ingredients, and storage conditions
and preparation.
Note: this includes, but is not limited to:
a) the packaging itself, printed material that accompanies the packaging, or a sticker used on
the label;
b) Multi-packages which have an internal label on the individual product or a
combined outer label for the total content.

3.11 Cross-contact during preparation

Allergens which are not part of the established formulation, introduced into the products.
during its preparation.
Note: Cross-contact during preparation may apply to both:
a) traces of products from a previous production run which are not adequately
removed from the production line due to technical limitations;
b) when contact likely occurs, in the normal manufacturing process, with products
or ingredients that are produced in separate lines, or in the same or adjacent areas of
process.

3.12 Contact with the product

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All surfaces that come into contact with the product or with the primary packaging during the
normal operation.

3.13 Product Withdrawal

Removal of a non-conforming product from the market, commerce, and storage facilities,
customer distribution and/or storage centers because they meet the standards
specified.

3.14Sanitization
All actions related to cleaning or maintaining hygienic conditions of
the facilities cover everything from the specific cleaning/disinfection of the equipment to the
cleaning activities inside the facilities (including cleaning activities of
buildings, structures, and floors

3.15Specifications
Detailed documented description or enumeration of the parameters, including tolerances or
permissible variations, which are required to achieve a defined level of acceptability
or quality.

3.16 Traceability
Ability to trace a specific batch of ingredients/components to a product which
contains; and trace a finished product to the recipient(s) or primary consumer(s)
externals.

3.17Zoning
Demarcation of an area within a facility where a specific operation, practices
hygienic or other measures can be applied to minimize the potential for contamination
cross microbiological.
Note: examples include: changing clothes upon entry/exit, positive air pressure, guidelines
modified traffic flow

4. Construction and arrangement of Buildings

4.1 General Requirements

Buildings must be designed, constructed, and maintained appropriately.
nature of the processing operations carried out, the security risks
food-related operations, and the potential sources of contamination from the
surroundings of the plant.

4.2 Surroundings
Potential sources of local environmental contamination must be considered.
Note: food production should not take place in areas where substances
potentially harmful substances could enter the product.

The effectiveness of the measures taken to protect against potential pollutants

It must be reviewed periodically.

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4.3 Localization of the establishments
The site boundaries must be controlled.

The site must be kept in proper order. The vegetation must be controlled or removed.
Access routes, gardens, and parking areas must be drained to prevent water stagnation.
and must be preserved.

The potential nesting of pests (for example burrows, weeds, stored items)
it must be removed.
Where outdoor areas are used for storage, the stored items must
to be protected from weather and pest damage.
Buildings must be constructed of durable materials that do not pose a risk to the
product.
The roof must drain on its own and not have any dripping.

5 Arrangement of workspaces and surroundings

5.1 General Requirements
The internal layout of the plant must be designed, built, and maintained to facilitate the
good hygiene and manufacturing practices. The internal movement patterns of materials,
products and personnel, and the arrangement of the equipment must protect from potential sources of
contamination

5.2 Internal Design, distribution patterns and traffic

Buildings must provide an adequate space, with a logical flow of materials, products and
personal, and the physical separation of raw material areas from processing areas.

5.3. Internal structures and couplings

Walls and floors of processing areas must be washable or cleanable, as appropriate for the
process or product risk. The materials must be resistant to cleaning systems
applied
Floor-wall joints and corners should be rounded in processing areas.
In wet process areas, the floors must be sealed and drained. The drains must have
traps and being sealed.
The roofs and elevated structures must be designed to minimize the accumulation of dirt.
and the condensation.
The outward-opening windows, the exhausts or fans, where present, must
insect nets.
The exterior doors must be closed when not in use.

5.4 Equipment installation

The equipment must be designed and installed in order to facilitate good hygiene practices and the
monitoring.
The equipment must be installed to allow access for operation, cleaning, and
maintenance.

5.5 Laboratories
The line and the facilities for online testing must be controlled to minimize the risk of
product contamination.

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Microbiology laboratories must be designed, located, and operated in order to prevent the
contamination of personnel, the plant, and the products. They should not be opened directly over
the production area.

5.6 Temporary/mobile installations and vending machines

Temporary structures must be designed, located, and constructed to avoid nesting.
of pests and the potential contamination of products.

Additional dangers associated with temporary structures and vending machines must
to be evaluated and controlled.

5.7 Storage of food, ingredients, and non-food chemicals

The facilities used for the storage of ingredients, packaging material and
Products must provide protection against dust, drips, condensation, waste, or others.
sources of pollution.

Storage areas must be dry and well-ventilated. Temperature control and the
humidity should be applied where needed.

All materials and products must be stored off the floor, and with sufficient
space between the material and the walls to allow for inspection and control activities
pests are carried out.

Exceptions for bulk materials or crops must be documented in the System of

Food Safety Management of Facilities

The storage area must be designed to allow maintenance and cleaning, prevent
pollution and minimize deterioration.

A separate, secure storage area (closed or access controlled) must be provided.

for cleaning materials, chemicals, and other harmful substances.

6 Services – air, water, energy

6.1 General requirements
The supply and distribution routes for the services for and around processing and the
storage areas must be designed to minimize the risk of contamination
product. The quality of services must be monitored to minimize the risk of
product contamination.

6.2 Water Supply

The supply of drinking water must be sufficient to meet the needs of the process(es) of
production. Facilities for storage, distribution and, where necessary, control of
The water temperature must be designed to meet the specified quality requirements.
of the water.
Note: drinking water should comply with the guidelines of the World Health Organization
for water quality for human consumption.

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The water used as an ingredient of the product, including ice or steam, or in contact with the
products or surfaces of the product must meet the quality and microbiological requirements
relevant to the product.

Water for applications where there is a risk of indirect contact with the product (for example,
jacketed mixers, heat exchangers) must meet quality requirements and
relevant microbiologicals for the application.
Non-potable water must have a separate system, marked, not connected to, and prevent backflow.
within the drinking water system.

Where the drinking water supply is chlorinated, inspections must ensure that the level of
Residual chlorine at the points of use remains within the limits specified.
relevant.
Water pipes must be capable of being disinfected.

6.3 Chemicals for boilers

Chemicals for boilers, if used, must be:
approved as food additives that meet the specifications for additives
relevant; or
b) additives that have been approved by the respective regulatory authority as safe for
to be used in water intended for human consumption.

Chemicals for boilers must be stored in a separate, secure area (closed or ...
controlled access) when not used immediately.

6.4 Air quality and ventilation

The Organization must establish requirements for filtration, humidity (%HR), and microbiology of
air used as an ingredient for direct contact with the product. Where the temperature
and/or humidity are considered critical by the Organization, a control system must be
installed and effectively monitored.

Ventilation (natural or mechanical) must be provided to remove excess vapor.

desired, dust or odors, and to facilitate drying after wet cleaning.

The air in the enclosure should not provide a source of microbiological contamination. In areas where
the products are exposed to support growth or survival, protocols for the
monitoring and control of air quality must be established through the evaluation of
risk.

Ventilation Systems must be designed and constructed in such a way that air does not flow from
contaminated areas or raw material areas to clean areas. The pressure differences
specified must be maintained. The systems must be accessible for cleaning, changing
of filters and maintenance.

The physical integrity of the outdoor air intake should be reviewed annually.

6.5 Compressed air

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The compressed air intended for direct or incidental contact with the product
including the air used for the transport, blowing, or drying of materials, products or
The equipment must come from an approved source, filtered, and free of dust, oil, and moisture.
NOTE It is recommended to use oil-free compressors.

The filtration, humidity (RH%), and microbiology requirements must be specified.

NOTE The air filter should be as close to the point of use as possible.

6.6 Lighting
The provided lighting (natural or artificial) must allow personnel to operate effectively.
hygienic.

NOTE The intensity of the lighting must be appropriate to the nature of the operation.

The lamp holders and other similar arrangements must be protected to ensure that the
materials, products, or equipment are not contaminated in case of breakage.

7 Waste disposal
7.1 General requirements
Systems must be implemented to ensure that waste materials are identified.
collected, removed, and disposed of in such a way that prevents contamination of the
products or production areas.

7.2. Containers for waste substances and those not suitable for consumption
The containers for waste substances that are not suitable for consumption or are harmful must:
a) be clearly identified for their intended purpose;
located in a designated area;
c) closed when not in immediate use and closed and secured if they contain substances
damaging;
d) constructed with a material that allows for easy cleaning and disinfection;

7.3 Waste management and removal

Provisions must be made for the segregation, storage, and removal of the
waste.
The accumulation of waste in handling or storage areas must not be allowed.
foods. The removal frequencies should be managed to avoid accumulations such as
minimum daily.
The materials and products that are marked and designated as waste must be
disfigured or destroyed to ensure that the labels and logos cannot be reused.
The removal and destruction must be carried out by approved contractors for handling
waste. The organization must maintain records of the destruction. The retention period
It must be specified in the food safety management system.

7.4 Siphons and drains

The siphons must be designed, constructed, and located in such a way that the risk of
contamination of materials or products should be avoided. The drains must have sufficient

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ability to remove the expected flow loads. The drains should not pass over the lines.
of process.

The floors must be sloped to allow for effective drainage in wet areas.
stagnant ones must be avoided.
The drainage channels must be covered by a grid. The direction of the drainage flow does not
it must go from a contaminated area to a clean area.

8 Appropriate equipment, cleaning and maintenance

8.1 General requirements
Equipment in contact with food must be designed and constructed to facilitate cleaning.
disinfection and maintenance. Contact surfaces should not be affected or have an effect.
for the cleaning product or system to be used.

The food contact equipment must be designed to be removed or dismantled to

allow for cleaning or maintenance. It should be built of durable materials that withstand
a repeated cleaning.

8.2 Sanitary design

The team must comply with the established principles for sanitary design including:
a) separation of raw materials/final product/ready-for-consumption product;
b) smooth, accessible, and cleanable surfaces that drain by themselves in humid areas of
process
c) use of materials compatible with the products to be processed and cleaning agents;
d) unperforated structure by holes, nuts, bolts.

Pipes and ducts must be cleanable, rinsable, and without closed ends.
The equipment must be designed to minimize contact between the operator's hands and the
products.

8.3 Surfaces in contact with the products

The surfaces in contact with the product must be made of materials designed for
the use in food. They must be waterproof and free from corrosion or oxidation.

8.4 Temperature control and monitoring equipment

The equipment used for thermal processes must be able to meet the conditions of gradient and
temperature maintenance given in the relevant product specifications.
The equipment must allow for temperature control and monitoring.

8.5 Cleaning of the Plant, utensils and equipment

Dry and wet cleaning programs must be documented to ensure that everything is covered.
The utensils and equipment should be cleaned at defined frequencies.
Programs must specify what will be cleaned, the responsibility, the cleaning method.
(for example CIP-COP), requirements for removal, disassembly and methods to verify the
effectiveness of the cleaning.

8.6 Corrective and Preventive Maintenance

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A preventive maintenance program must be implemented.
The preventive maintenance program must include the inspection of meshes, filters (including
air filters) and magnets.
Corrective maintenance must be carried out in such a way that there is no risk of
contamination of the production lines and auxiliary equipment.
Maintenance requests that have an impact on product safety must be
prioritized.
Temporary repairs must not jeopardize the safety of the product, and must be
replaced by permanent repairs as quickly as possible. The strings, tapes, cables,
Wires or rubber bands should not be used in temporary repairs.
Lubricants and heat transfer fluids must be food grade where there is a
potential for direct or indirect contact with the product.
The procedure for releasing the equipment to production after maintenance must
include cleaning and disinfection where specified in the disinfection procedures of the
process and inspection prior to use.

The requirements of good manufacturing practices in local areas must be applied to the areas
of maintenance and the maintenance activities in process areas. The staff of
maintenance must be trained in the risks related to the product associated with their activities.

8.7 Calibration
The measurement and monitoring equipment used to maintain or verify product safety
must be identified.
The identified equipment must be calibrated at specific intervals against known standards.
valid and traceable, and maintained in such a way that the calibration state is protected.
When it is found that a team is out of calibration, it must be recalibrated or removed from use.
The potential impact of measurement errors on the product must be determined.
Calibration records must be maintained.

9. Management of purchased materials.

9.1. General Requirements
The purchase of materials that may impact food safety must be
controlled to ensure that the suppliers used meet the specified requirements. The
the conformity of the incoming materials with the specified purchase requirements must
to be verified.

9.2. Selection and management of suppliers.

There must be a defined process for the selection, approval, and monitoring of suppliers.
including:

a) ensuring the provider's capacity to meet expectations, requirements and

quality and food safety specifications:

b) a description of how suppliers are assured.

NOTE: Examples of how suppliers are ensured include:

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a) audit of the supplier's facilities prior to the acceptance of materials for the
production;
b) appropriate third-party certifications.

The method used must be justified with a risk analysis, including the potential risk.
about the final product.

c) monitoring the supplier's performance to ensure continuous approval status

compliance with the specification, adherence to the certificate of analysis requirements
(COA), satisfactory audit results).

9.3. Requirements for incoming materials (raw materials/ingredients/packaging)

Delivery vehicles must be checked before and during unloading to verify that the
the quality and safety of the material have been maintained during transport (e.g., intact seals,
absence of infestation, existence of temperature records, etc.
The materials must be inspected, tested, or covered by a certificate of analysis.
(COA) to verify conformity with the specified requirements prior to use. The method of
verification must be documented.
Materials that do not conform to the specifications must be handled accordingly.
with a documented procedure that ensures to prevent its unintended use.
The access points to the raw material reception lines must be identified.
covered and closed.
The download to such systems must be carried out only after approval and
verification of the material to be received.

10. Measures for the prevention of cross-contamination.

10.1 General requirements.
Programs should be established to prevent, control, and detect pollution. They must
include measures to prevent physical, chemical, and microbiological contamination.

10.2. Cross Microbiological Contamination

The areas where there is potential for cross-microbiological contamination (through the air or by
Traffic pattern causes must be identified and a segregation plan must be implemented.
A risk analysis must be carried out to determine possible sources of contamination, the
product susceptibility, and the appropriate control measures for the mentioned areas,
the following way:

a) separation of the raw form of finished or ready-to-consume products;

b) structural segregation - physical barriers/walls/separate buildings;

c) access controls that include the requirement to change clothing into work attire
suitable;

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d) traffic patterns - people, materials, equipment, and tools (including the use of
tools for exclusive dedication)

e) air pressure differentials.

10.3 Allergen management.

All allergens present in the product, either by design or by cross-contact.
Potential during manufacturing must be declared. The declaration must be on the label.
of products for consumption, and on the label or in the corresponding documentation for the
products intended for further processing.
The products must be protected from unintentional cross-contact with allergens by
through proper cleaning practices of the line when changing products and a
adequate determination of the production sequence.
Reprocessed foods containing allergens should only be used in products that
contain by design the same allergens.
Workers who handle food must receive specific training in prevention of
allergens and in the associated manufacturing practices.

10.4 Physical and chemical pollution.

When using glassy or brittle materials, inspection requirements must be established.
periodic and defined procedures in case they break.

NOTE: Glassy and brittle materials (such as plastic components of the

Teams should be avoided when possible.

Records of broken glass must be kept.

Basado en la evaluación de riesgos, deben tomarse medidas para prevenir, controlar o detectar la
potential pollution.

NOTE: Examples of such measures include:

a) appropriate covers over the equipment or containers for exposed materials or products;
b) use of sieves, magnets, meshes or filters;
c) use of detection and rejection devices such as metal detectors or X-rays.

11. Cleaning and disinfection

11.1 General requirements
Cleaning and disinfection programs must be established to ensure that the equipment and the
food processing environments are maintained in a hygienic condition. The
programs should be monitored to ensure their effectiveness and continued relevance.

11.2 Agents and tools for cleaning

The facilities and equipment must be maintained in conditions that facilitate cleaning.
wet or dry and disinfection.
Cleaning agents and chemicals must be clearly identified and be food grade.
store separately and use only according to the instructions of the
manufacturer.

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Cleaning tools and equipment must be of hygienic design and maintained in a
a condition that does not represent a potential source of foreign material.

11.3 Cleaning Programs

Programs must be established and validated to ensure that all parts of the facilities and
the equipment is cleaned according to a schedule, including the cleaning of the equipment
cleaning.

Cleaning programs must specify at a minimum:

a) Areas, equipment items and utensils to be cleaned;

b) responsibilities associated with the specified tasks;
c) methods and frequency of cleaning;
d) verification and monitoring activities;
e) inspections after cleaning and before the start of operations.

11.4 Cleaning in Place (CIP) Systems

CIP systems must be separated from active product lines.
The parameters of the CIP systems must be defined and monitored (including the type, the
concentration, contact time, and temperature of any chemical used.

11.5 Monitoring the effectiveness of disinfection

Cleaning and disinfection programs must be monitored with the frequency specified by
the organization to ensure its convenience and effectiveness, to ensure its effectiveness and
convenience.

12. Pest control

12.1 General requirements
Inspection and monitoring procedures for the hygiene of facilities must be established.
cleaning and incoming materials to prevent the creation of an environment that leads to
presence of pests.

12.2 Pest control programs

The facilities must have a person assigned to managing control activities.
pests and/or to deal with expert contractors.
Pest management programs must be documented and must include plans, methods,
schedules, control procedures when necessary, and requirements of
training.
Los programas deben incluir una lista de los químicos que estén aprobados para el uso en áreas
specific to the facilities.

12.3 Prevention of access

Buildings must be kept in good condition. Gaps, leaks, and other potential points
access for pests must be sealed.
External doors, windows, or ventilation openings should be designed to minimize the
potential entry of pests.

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NOTE: For example, windows or ventilation openings must have wire meshes and
stay closed when not in use.

12.4 Nesting and infestations

Storage practices must be designed to prevent food availability and
water for pests.
The infested material must be handled in such a way as to prevent the
contamination of other materials, products, or facilities.

12.5 Monitoring and detection

Pest monitoring programs must include the placement of bait stations in
key locations to identify pest activity. A map of the bait stations must
to remain. The bait stations must be designed and located in such a way that they
prevent potential contamination of materials, products, or facilities.
Las estaciones de carnada deben ser de construcción robusta, resistente a los daños. La carnada
The used one must be appropriate for the target pest.
The bait stations should be inspected with a frequency aimed at identifying
new pest activity. The inspection results must be analyzed to identify
threats.

12.6 Eradication
Action must be taken on evidence of infestations as soon as it is reported.
The application and use of pesticides must be restricted solely to trained operators and
It must be controlled to avoid the risk to the safety or quality of the product.
Records of pesticide use must be maintained that show the type, quantity, and
concentrations used; where, when and how they were applied and the target pest.

13 Facilities and personal hygiene of workers.

13.1 General requirements
Standards for personal hygiene and behavior must be determined and documented.
workers depending on the risk they pose to the production area or the
Product. All staff, visitors, and contractors must be required to comply with the
documented requirements.

13.2 Toilets and installations for personal hygiene

Facilities for personal hygiene must be available to ensure the level of hygiene.
personal required by the organization must be maintained. The facilities must be located
look for the points where personal hygiene requirements apply, and they must be clearly defined.
designated.

NOTE Where appropriate, the facilities should provide:

a) quantities, locations, and suitable means for hygienic hand washing and drying
when required, disinfection (including sinks, provision of hot, cold water or
controlled temperature, soap and/or disinfectant;
b) siphons designated for hand washing that must be separate from the siphons.
used for food use and those used for equipment cleaning stations. The
valves should not be operated manually;

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c) an adequate number of sanitary facilities with appropriate hygienic design, each equipped with installations
to wash, dry, and where required, disinfect hands;
d) sanitary facilities, shower rooms and other hygiene facilities for workers that do not
they are directly open to production, packaging, or storage areas;
e) adequate facilities for staff to change clothes. The staff that handle
food must have the possibility of being moved from the facilities for changing clothes
to the production areas without going outside.

13.3 Casinos and designated areas for staff meals

The casinos and the areas designated for the storage and consumption of food must
position themselves in such a way that the potential for cross-contamination in production areas is
minimize.
The staff casinos must be managed to ensure storage and preparation.
hygienic food handling, as well as hygienic storage and serving of food
prepared. The storage conditions, cooking, and time constraints and
The temperature to keep food must be specified.
The food brought by the workers must be stored and consumed only in areas
designated.

13.4 Work and protective clothing

Personnel who work in or enter areas where products or materials are handled must
use appropriate work clothing for this purpose, clean and in good condition.
Clothing intended for food protection or hygiene purposes should not be used.
for no other purpose.
Work clothing should not have pockets or external buttons.
NOTE Zippers and snap closures are acceptable.

Work clothing must be washed at intervals and according to appropriate defined standards.
for the expected use of it.
Work clothing must provide adequate coverage to prevent hair and sweat from
etc., cannot contaminate the product.
The hair, beard, and mustache must be protected (e.g., completely covered) with the
appropriate protections unless the risk analysis indicates otherwise.
Where gloves are used for contact with food, they must be clean and in good condition.
conditions.
NOTE The use of latex gloves should be avoided where possible

The shoes used in processing areas must be completely closed and

made with non-absorbent materials.
When required, the personal protective equipment must be designed to prevent the
product contamination and must be kept in a hygienic condition.

13.5 Health status

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Workers should undergo a medical examination prior to being assigned to operations.
where there is contact with food (including on-site food services), unless
that the risk analysis indicates something different.
Additional medical examinations must be conducted at intervals defined by the organization.
subject to the existing legal restrictions in the country of operation.
Any person suspected of being infected or a carrier of a
Infection or foodborne illness must have restricted access to areas where
handle food.

13.6 Diseases and wounds

Where permitted by law, workers should be required to report to management the
following conditions, for their possible exclusion from areas where food is handled:
jaundice, diarrhea, vomiting, fever, sores in the throat accompanied by fever, skin lesions
visibly infected (burns, cuts, or lacerations) and discharge from the ears, nose, or the
eyes.
In areas where food is handled, it must be required that people with burns or
wounds should be covered with specified protections. Any lost protection must
report immediately to the supervisor.
NOTE The mentioned protections must be bright colored and detectable as metals
when appropriate.

13.7 Personal hygiene

Staff must be required to wash their hands and, when necessary, to disinfect them.
a) before starting any food handling activity;
b) immediately after using the toilet or blowing one's nose;
c) immediately after handling any potentially contaminated material.
Staff should be required to refrain from sneezing or coughing on materials or products.
Spitting (expectoration) should be prohibited.
Fingernails should remain clean and trimmed.

13.8 Staff Behavior

A policy must be established and documented that describes the required behavior for the
staff located in the processing, packaging, and storage areas. This
policy must cover at least:
a) authorization to smoke, eat, or chew gum only in the designated areas;
b) control measures to minimize the risks presented by the allowed jewelry;

NOTE The allowed jewelry includes specific types of jewelry that may be used by the
personnel in the areas of processing and storage, taking into account religious imperatives,
ethnic, medical, and cultural.

c) authorization to carry personal belongings, including medications, only in areas

designated;
d) prohibition of the use of nail polish, false nails, and false eyelashes;
e) prohibition of carrying pens and pencils behind the ears;
f) maintenance of personal lockers in such a way as to avoid the presence of garbage and
dirty clothes

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g) prohibition of storing tools and equipment that come into contact with the product in the
personal lockers.

14 Product Withdrawal Procedures

14.1 General requirements

Systems must be established to ensure that products identified as non-compliant
with the required food safety standards can be identified, located and
removed and all necessary points from the supply chain.

14.2 Product Withdrawal Requirements

A list of key contacts for the event of a retreat must be maintained.
Where products are withdrawn due to direct threats to health, safety of
other products made under the same conditions must be evaluated. The need for
public warnings must be considered.
The recalled products must be kept under supervision until the method is determined.
Final disposition. The withdrawn products must not be used for reprocessing.
The effectiveness of the withdrawal and traceability system must be tested by a withdrawal simulation.
carried out annually.

15 Storage
15.1 General requirements
The materials and products must be stored in dry, well-ventilated, and protected spaces.
from dust, condensation, smoke, odors or other sources of pollution. The materials must
remove from storage for use in the correct order of inventory rotation.

15.2 Warehouse Requirements

There should be control of temperature, humidity, and other environmental conditions of the
warehouse where required by the product specifications or storage.
Waste materials and chemicals (cleaning products, lubricants, and pesticides) must
store separately.

NOTE Wherever possible, storage spaces should allow for segregation of

raw materials, work in progress, and finished products.

A separate area or other means to segregate materials identified as non-conforming

must be provided.

Specific inventory rotation systems (FIFO/FEFO) must be observed.

Forklifts powered by gasoline or diesel should not be used in areas of
storage of food ingredients or finished product.

15.3 Vehicles, carriers, and containers

The vehicles, transporters, and containers must be kept in a state of complete
operation, cleaning, and conditions consistent with the requirements given in the
relevant specifications.

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Vehicles, transporters, and containers must provide protection against damage or
product contamination. Temperature and humidity control must be applied and
register when required by the organization.

Where the same vehicles, carriers, and containers are used for products
nutritional and non-nutritional, a cleaning must be carried out between each load.

Bulk containers must be dedicated solely to food use. Wherever it is

required by the organization, the bulk containers must be dedicated to one material
specific.

16. Product information / consumer warnings.

16.1 General requirements
The products must be accompanied by sufficient information to ensure that the
next person in the food chain can store, display, prepare and use them
safe and correct way.

16.2 Product Information

The information must be presented to consumers in a way that allows them to understand the
importance of the information provided and making decisions with information.

NOTE The information may be included on the label or by other means and may include instructions.
for the storage, preparation, and serving applicable to the product.

16.3 Labeling of pre-packaged foods

The label must provide clear instructions for storage, preparation, and use of the
product when necessary.
Procedures must be established to ensure the correct application of labels to the
products.

17. Defense of food

17.1 General requirements
Each installation must analyze the risk to the products arising from acts of sabotage.
vandalism or terrorism and must implement the corresponding protection measures.

NOTE For further guidance and information regarding approaches to business protection
on food against all malicious attacks, see PAS 96:2008

17.2 Access controls

The potentially sensitive areas within the organization's facilities must be
identified, mapped, and subject to access control.
NOTE When possible, physical access should be restricted through locks,
electronic cards or alternative systems.

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