Pas 223

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PAS 223:2011
Prerequisite programmes and

design requirements for food
safety in the manufacture and
provision of food packaging
Bought by Mr. Kurt Ross,Grayling Industries, Inc.,on 18/07/2011 21:18 Latest version. Not to be distributed/networked. For multi-user access www.bsigroup.com/license BSI
PAS 223:2011
Publishing and copyright information

The BSI copyright notice displayed in this document indicates when the document
was last issued.
BSI 2011
ISBN 978 0 580 74170 8
ICS 67.020
No copying without BSI permission except as permitted by copyright law.
Publication history
First edition July 2011
BSI July 2011
PAS 223:2011
Contents
Foreword ....................................................................................................... iii
Introduction .................................................................................................. iv
1 Scope .......................................................................................................... 1
2 Normative references ................................................................................ 1
3 Terms and definitions ................................................................................ 2
4 Establishments ........................................................................................... 4
4.1 General requirements . ........................................................................... 4
4.2 Environment . .......................................................................................... 4
4.3 Locations of establishments .................................................................. 4
5 Layout and workspace .............................................................................. 5
5.2 Internal design, layout and traffic patterns ......................................... 5
5.3 Internal structures and fittings .............................................................. 5
5.4 Equipment ............................................................................................... 5
5.5 Temporary/mobile structures . ............................................................... 5
5.6 Storage .................................................................................................... 5
6 Utilities ....................................................................................................... 6
6.2 Water supply ........................................................................................... 6
6.3 Air quality and ventilation ..................................................................... 6
6.4 Compressed air and other gases ........................................................... 6
6.5 Lighting ................................................................................................... 6
7 Waste .......................................................................................................... 7
7.2 Containers for waste .............................................................................. 7
7.3 Waste management and removal ......................................................... 7
7.4 Drains and drainage ............................................................................... 7
8 Equipment suitability and maintenance .................................................. 8
8.2 Hygienic design . ..................................................................................... 8
8.3 Food packaging contact surfaces .......................................................... 8
8.4 Testing and monitoring .......................................................................... 8
8.5 Preventive and corrective maintenance . .............................................. 8
9 Purchased materials and services ............................................................. 9
9.2 Selection and management of suppliers .............................................. 9
9.3 Incoming raw materials . ........................................................................ 9
10 Contamination and migration . ............................................................... 10
10.1 General requirements . ......................................................................... 10
10.2 Microbiological contamination ............................................................ 10
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PAS 223:2011
10.3 Physical contamination ........................................................................ 10

10.4 Chemical contamination . ..................................................................... 10
10.5 Chemical migration . ............................................................................. 10
10.6 Allergen management . ........................................................................ 10
11 Cleaning .................................................................................................... 11
11.2 Cleaning agents and tools ................................................................... 11
11.3 Cleaning programmes .......................................................................... 11
11.4 Monitoring cleaning programme effectiveness ................................. 11
12 Pest control .............................................................................................. 12
12.2 Pest control programmes ..................................................................... 12
12.3 Preventing access . ................................................................................ 12
12.4 Harbourage and infestations ............................................................... 12
12.5 Monitoring and detection .................................................................... 12
12.6 Eradication ............................................................................................ 12
13 Personnel hygiene and facilities ............................................................. 13
13.2 Personnel hygiene facilities and toilets .............................................. 13
13.3 Staff canteens and designated eating areas ...................................... 13
13.4 Workwear and protective clothing ..................................................... 13
13.5 Illness and injuries ................................................................................ 13
13.6 Personal cleanliness .............................................................................. 13
13.7 Personal behaviour ............................................................................... 14
14 Rework ..................................................................................................... 14
14.2 Storage, identification and traceability .............................................. 14
14.3 Rework usage ....................................................................................... 15
15 Withdrawal procedures . ......................................................................... 15
15.2 Withdrawal requirements .................................................................... 15
16 Storage and transport ............................................................................. 16
16.2 Warehousing requirements . ................................................................ 16
16.3 Vehicles, conveyances and containers ................................................ 16
17 Food packaging information and consumer awareness . ..................... 17
18 Food defence, biovigilance and bioterrorism ........................................ 17
18.2 Access controls ...................................................................................... 17
19 Food packaging design and development . ........................................... 18
19.2 Communication and change control ................................................... 18
19.3 Design .................................................................................................... 18
19.4 Specifications ........................................................................................ 19
19.5 Process validation ................................................................................. 19
Bibliography .................................................................................................. 20
ii
BSI July 2011
PAS 223:2011
Foreword
This Publicly Available Specification (PAS) has been prepared by the British
Standards Institution (BSI) to specify requirements for prerequisite programmes
and design to assist in controlling food safety hazards in the manufacture and
provision of food packaging.
This PAS is intended to be used in conjunction with
BSENISO22000to support management systems
designed to meet the requirements specified in
BSENISO22000.
The development of this PAS was sponsored by SSAFE
(Safe Supply of Affordable Food Everywhere).
A Steering Group, consisting of leading global
packaging and food manufacturing companies (listed
below), was led by Neil Marshall on behalf of SSAFE.
The technical authors for PAS 223 were Tracy Burton
and Nancy Schouppe of The Coca-Cola Company.
Acknowledgement is given to the following
organizations that assisted with the development of
this PAS through membership of the Steering Group:
Alpla
Amcor Flexibles
Publishing information
This PAS comes into effect on 1 July 2011.
This PAS has been prepared and published by BSI,
which retains its ownership and copyright. BSI reserves
the right to withdraw or amend this PAS on receipt of
authoritative advice that it is appropriate to do so. This
PAS will be reviewed at intervals not exceeding two
years, and any amendments arising from the review
will be published as an amended PAS and publicized in
Update Standards.
This PAS is not to be regarded as a British Standard,
European Standard or International Standard. In
the event that this PAS is put forward to form the
basis of a full British Standard, European Standard or
International Standard, it will be withdrawn.
Danone
Use of this document
Foundation for Food Safety Certification (FSSC)
It has been assumed in the preparation of this PAS

that the execution of its provisions will be entrusted
to appropriately qualified and experienced people, for
whose use it has been produced.
Institute of Packaging Professionals/FSAP (Food Safety

Alliance for Packaging)
Kraft Foods
Nestl
Owens-Illinois
ProCert
Rexam
Tetra Pak
The Coca-Cola Company
Unilever
BSI, SSAFE, the Technical Authors and the Steering
Group greatly appreciate the considerable input during
the consultation phase of the development of this PAS
from numerous individuals and organizations around
the world.
Presentational conventions
The provisions of this PAS are presented in roman
(i.e. upright) type. Its requirements are expressed in
sentences in which the principal auxiliary verb is shall.
Commentary, recommendations, explanation and
general informative material are presented in smaller
italic type, using the heading NOTE, and do not
constitute normative elements.
Contractual and legal considerations

This publication does not purport to include all the
necessary provisions of a contract. Users are responsible
for its correct application.
Compliance with this PAS does not in itself confer
immunity from legal obligations.
BSI July 2011
iii
PAS 223:2011
Introduction
BS EN ISO 22000 sets out specific food safety
requirements for any organization in the food chain.
One such requirement is that organizations establish,
implement and maintain prerequisite programmes
(PRPs) to assist in controlling food safety hazards.
This PAS is intended to be used by food packaging
manufacturing organizations to support management
systems designed to meet the requirements for PRPs
specified in BS EN ISO 22000, and it sets out the
detailed requirements for those programmes.
iv
Requirements for design have been included in this PAS

because of the potential food safety risk that can arise
if the food packaging is not suitable for the intended
use. It is essential that the proposed uses of the food
packaging are fully understood so that any food
safety risks can be identified and addressed through
appropriate food packaging design.
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PAS 223:2011
1 Scope
This Publicly Available Specification (PAS) specifies
requirements for establishing, implementing and
maintaining prerequisite programmes (PRPs) and
design requirements to assist in controlling food safety
hazards in the manufacture of food packaging.
This PAS is applicable to all organizations, regardless of
size or complexities, that manufacture food packaging.
This PAS is not designed or intended for use in other
parts of the food chain.
Food packaging manufacturing organizations are
diverse in nature, and not all of the requirements
specified in this PAS apply to an individual
organization. Each organization is required to conduct
a documented food safety hazard and risk assessment
that includes each requirement. Where exclusions are
made or alternative measures are implemented, these
need to be justified by the food safety hazard and risk
assessment.
This PAS is not a management system standard and is
intended to be used by food packaging manufacturing
organizations that wish to implement PRPs in such a
way as to address the requirements specified in BS EN
ISO 22000.
This PAS is intended to be used in conjunction with
BS EN ISO 22000, not in isolation.
NOTE For the purpose of this PAS, the term food
includes beverages.
2 Normative references
The following referenced documents are indispensable
for the application of this document. For dated
references, only the edition cited applies. For undated
references, the latest edition of the referenced
document (including any amendments) applies.
BS EN ISO 22000, Food safety management systems
Requirements for any organization in the food chain
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PAS 223:2011
3 Terms and definitions

For the purposes of this PAS, the following terms and
definitions apply.
The terms and definitions given in BS EN ISO 22000 also
apply.
3.1 certificate of analysis (CoA)

document provided by the supplier that indicates
results of specific tests/analysis, including test
methodology, performed on a defined lot of the
suppliers material
3.2 certificate of conformance (CoC)

document that confirms conformance to relevant
specifications or regulations
NOTE This is sometimes referred to as a certificate of
compliance or declaration of compliance (DoC).
3.3 cleaning
removal of solvents, grease or lubricant, ink residues or
other objectionable matter
3.4 contaminant
any biological or chemical agent, foreign matter or
other substance not intentionally added to the product
that may compromise its safety or suitability
[Adapted from Codex Alimentarius, 2.3]
NOTE Measures for prevention of malicious
contamination are outside the scope of this PAS. For
further information and guidance on approaches to the
protection of food businesses from all forms of malicious
attack, see PAS 96, Defending food and drink. Guidance
for the deterrence, detection and defeat of ideologically
motivated and other forms of malicious attack on food
and drink and their supply arrangements.
3.6 establishment
any building or area in which raw materials,
intermediate materials, chemicals or finished food
packaging are handled, and the surroundings under
the control of the same management
3.7 finished food packaging

physical final output of any kind of production process
that takes place in food packaging manufacturing
organizations
3.8 food packaging

any product to be used for containment, protection,
handling, delivery, storage, transport and presentation
of food
NOTE Food packaging may have direct, indirect and no
contact with the food. Direct food contact surfaces or
materials are in contact (i.e. physically touching the
food or in contact with the headspace) or will be in
contact with the food during normal use of the food
packaging. Indirect food contact surfaces or materials
are not in direct contact with the food during normal
use of the food packaging, but there is the possibility
for substances to transfer into the food. Non-contact
surfaces or materials are not in direct contact with the
food during normal use of the food packaging, and
there is no possibility for substances to transfer into the
food. Figure 1 illustrates this concept.
3.9 food packaging withdrawal

removal of nonconforming food packaging from the
market, trade warehouses, distribution centres or
customer operations and warehouses because it does
not meet specified food safety standards or
requirements
3.5 contamination
3.10 intermediate material
introduction or occurrence of a contaminant in the

product or the production environment
physical output of part of the production process that

still requires further processing to create finished food
packaging
NOTE In the context of this PAS, contamination may

also refer to the introduction of non-intentionally
added substances (NIAS).
NOTE For example, a plastic powder, granules or flakes

(including masterbatch), ink, coating, adhesive,
pre-polymer, any semi-finished material and article such
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PAS 223:2011
Figure 1 Food packaging concepts and food contact
Printed boxes
Packing film
Corrugated
board
protective
wrapping
Foodcontaining
bags within
the boxes
Pallet
as a film, sheet or laminate requiring further

processing/reformulation steps to become a finished
material or article. In short, this is any product that is
not a basic chemical and not yet a finished material or
article, and includes part-processed, semi-converted and
converted materials.
3.11 label
printed matter that is, or is intended to be, part of the
finished package conveying specific information about
the contents of the package, the food ingredients and
any storage and preparation requirements
NOTE This includes the package itself, printed matter
that is, or is intended to be, attached to the package or
a sticker used for over-labelling.
3.12 migration
transfer of substances from an external source (e.g.
packaging material, environment) to food
NOTE Transfer of substances can take place by
migration through the substrate, by set-off to the
reverse side and subsequent migration into food, or by
gas phase transfer.
3.13 non-intentionally added substance

(NIAS)
impurity in the materials used in, or a decomposition or
reaction product formed during, the production process
3.14 packing materials

materials used to hold and protect food packaging
during shipping, transport and storage
3.15 set-off
transfer of substances from one side of a material or
product to the other side through direct contact
between the sides caused by the stacking or reeling of
the material or product
3.16 specification
detailed description of the properties and requirements
of a material or product, in particular its technical and
specific suitability
3.17 waste
any substance or object that the food packaging
manufacturing organization discards or intends or is
required to discard
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PAS 223:2011
4 Establishments
4.1 General requirements
4.2 Environment
Establishments shall be designed, constructed and

maintained in a manner fit for the nature and purpose
of the food packaging manufacturing operations to be
carried out, the food safety hazards associated with
those operations and the potential sources of
contamination.
Consideration shall be given to potential sources of

contamination from the local environment.
Buildings shall be of durable construction that presents

no food safety hazard to the food packaging.
NOTE For example, roofs should be self-draining and
not leak.
The effectiveness of measures taken to protect against
contamination of the food packaging shall be
periodically reviewed.
NOTE Local environment includes both internal and

external areas.
4.3 Locations of establishments

The boundaries of establishments shall be clearly
identified.
All areas within the boundaries of establishments shall
be kept in a condition that will protect against
contamination.
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PAS 223:2011
5 Layout and workspace

5.4 Equipment
Internal layouts shall be designed, constructed and

maintained to facilitate good hygiene and
manufacturing practices.
Equipment shall be designed and located to facilitate

good hygiene and manufacturing practices and
monitoring.
The movement patterns of materials, products and

people and the layout of equipment shall be designed
to protect against contamination sources and
unintended mixing of materials or products.
Equipment shall be located to permit access for

operation, cleaning and maintenance.

5.2 Internal design, layout and

traffic patterns
Buildings shall provide sufficient space to allow a
logical flow of materials, products and people through
the production process.
Openings intended for transfer of materials and
products (e.g. transport hoses, conveyors) shall be
designed to prevent entry of foreign matter and pests.
5.3 Internal structures and fittings

Walls and floors shall be washable or cleanable, as
appropriate for the food safety hazards associated with
the food packaging production.
Standing water shall be prevented in areas where food
safety may be impacted.
Drains shall be trapped and covered.
Ceilings and overhead fixtures shall be designed to
prevent build-up of dirt and condensation and shall be
accessible for inspection and cleaning.
In areas where routine cleaning of overhead fixtures
and structures is not feasible or practical, equipment
shall be covered.
External opening doors, windows, roof vents and fans
in production and storage areas shall be closed or
screened (e.g. insect screens, air curtains).
NOTE External openings should be avoided wherever
possible. Where this is not possible, keeping these
openings closed is the preferred option.
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5.5 Temporary/mobile structures

Temporary structures shall be designed, located and
constructed to prevent pest harbourage and
contamination.
5.6 Storage
Facilities used to store raw materials, intermediate
materials, chemicals or finished food packaging shall
provide protection from dust, condensation, drains,
waste and other sources of contamination.
Internal storage areas shall be dry and well ventilated.
Monitoring and control of temperature and humidity
shall be applied where necessary.
If raw materials, intermediate materials, chemicals or
finished food packaging are stored outside, measures
shall be in place to manage contamination hazards.
Storage areas shall be designed or arranged to allow
segregation of raw materials, intermediate materials,
chemicals and finished food packaging. Raw materials,
intermediate materials, chemicals and finished food
packaging that are suitable for food contact shall be
segregated from those that are not.
All raw materials, intermediate materials, chemicals and
finished food packaging shall be stored off the floor
and with sufficient distance from the walls to allow
inspection.
Storage areas shall be designed to allow maintenance
and cleaning and to prevent contamination and
deterioration.
Chemicals and other hazardous substances shall be
suitably labelled, secured in closed containers and used
in accordance with manufacturers instructions.
PAS 223:2011
6 Utilities
6.4 Compressed air and other gases
The provision and distribution routes for utilities to and

around production and storage areas shall be designed
to prevent contamination.
Compressed air and other gas systems used in food

packaging manufacturing shall be constructed and
maintained so as to prevent contamination.

potential contamination of the food packaging shall be
The food packaging manufacturing organization shall

establish requirements for gases used for direct food
packaging contact (including those used for
transporting, blowing or drying raw materials,
intermediate materials, finished food packaging or
equipment) and shall monitor accordingly.
6.2 Water supply

The supply of potable water or water suitably treated
to prevent contamination shall be sufficient to meet
the needs of the food packaging production process.
establish requirements for water (including ice or
steam) used for direct food packaging contact or
cleaning and shall monitor accordingly.
Oil used for compressors shall be food grade wherever

there is a potential for contamination.
Requirements for filtration, humidity and microbiology
shall be assessed. Control and monitoring measures
shall be applied as determined by the assessment.
NOTE Filtration of the air should be as close to the
point of use as is practicable.
Non-potable water shall have a separate supply system,

labelled, not connected to the potable water system
and prevented from refluxing into the potable water
system.
6.3 Air quality and ventilation

establish requirements for air used for direct food
packaging contact and shall monitor accordingly.
Suitable and sufficient ventilation (natural or
mechanical) shall be provided to remove excess or
unwanted steam, dust and odours.
Room air supply quality shall be controlled to prevent
airborne microbiological contamination.
NOTE Food packaging such as paper and board could
potentially support microbiological growth if
appropriate controls are not in place.
Ventilation systems shall be designed and constructed
such that air does not flow from contaminated areas to
clean areas.
Ventilation systems shall be accessible for cleaning,
filter changing and maintenance.
6.5 Lighting
The lighting provided (natural or artificial) shall allow
correct operation of the food packaging production
process.
NOTE The intensity of the lighting should be
appropriate to the nature of the operation.
Where there is a food safety hazard (e.g. manufacture
of containers such as jars, cans, bottles or trays), light
fixtures shall be protected to prevent contamination of
raw materials, intermediate materials, chemicals,
finished food packaging and equipment in the case of
breakages.
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PAS 223:2011
7 Waste
7.3 Waste management and removal
Systems shall be in place to identify, collect, remove and

dispose of waste in a manner that prevents
contamination.
Provision shall be made for the segregation, storage

and removal of waste.

7.2 Containers for waste

Containers for waste shall be:
a) clearly identified for their intended purpose;
b) located in a designated area;
c) constructed of impervious material that can be
readily cleaned;
d) closed when not in immediate use, and locked if
hazardous.
BSI July 2011
Waste shall not be allowed to accumulate in production

or storage areas.
Food packaging designated as waste shall be disfigured
or destroyed so that trademarks or food ingredient
information cannot be reused. Removal and destruction
shall be carried out by approved disposal contractors.
retain records of destruction.
7.4 Drains and drainage

Drains shall be designed, located and constructed to
prevent contamination.
PAS 223:2011
8 Equipment suitability and maintenance

Equipment shall be designed to prevent contamination.
8.2 Hygienic design

All parts of equipment coming into contact with food
packaging shall be designed and constructed to
facilitate cleaning and maintenance.
Equipment shall meet established principles of hygienic
design, including:
a) smooth, accessible, cleanable food packaging contact
surfaces;
b) self-draining (for wet processes);
c) use of construction materials compatible with the
intended food packaging, lubricants and cleaning or
flushing agents.
Piping and ductwork shall be cleanable and drainable
and shall not cause condensation or leakage that could
contaminate food packaging.
The effectiveness of equipment used for control of food

safety criteria in the production process shall be
monitored and documented.
8.5 Preventive and corrective

maintenance
A preventive maintenance programme shall be in place.
Valve connections and controls shall have fail-safes to

prevent contamination.
The preventive maintenance programme shall include

all equipment used to monitor and control food safety
hazards.
Equipment components containing metals of known

toxicity (e.g. mercury) shall not be allowed where they
could compromise the food safety of the food
packaging.
NOTE Examples of such equipment include screens and

filters (including air filters), magnets, metal detectors
and X-ray detectors.
8.3 Food packaging contact surfaces
Corrective maintenance shall be carried out in such a

way as to prevent contamination of raw materials,
intermediate materials or finished food packaging on
adjacent equipment.
Food packaging contact surfaces shall be constructed

from materials suitable for the intended use, to prevent
contamination.
Maintenance requests that impact the food safety of

the food packaging shall be given priority.
Inline and online test facilities shall be controlled to

prevent food packaging contamination.
Temporary fixes shall not compromise the food safety

of the food packaging. A request for replacement by a
permanent repair shall be included in the maintenance
schedule.
Equipment used for irradiation processes shall meet the

provisions given in relevant food packaging
specifications.
The procedure for releasing maintained equipment

back into production shall include clean-up and pre-use
inspection.
8.4 Testing and monitoring
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PAS 223:2011
9 Purchased materials and services

Purchasing of materials, services and subcontracted
activities that may impact food safety of food
packaging shall be controlled such that the suppliers
used have the capability to meet the specified
requirements.
NOTE Services may include (but are not limited to)
third-party storage and rework by subcontractors.
9.2 Selection and management

of suppliers
There shall be a defined process for the selection,
approval and monitoring of suppliers, including:
a) assessment of the suppliers ability to meet food
safety requirements;
b) description of how suppliers are assessed. The
method used shall be justified by hazard assessment,
including the potential food safety hazard to the
food packaging;
c) assessment by competent persons;
NOTE Examples of a description of how suppliers are
assessed include:
Raw materials shall be inspected, tested or covered by

CoA/CoC to verify conformance to specified
requirements prior to acceptance or use. The method of
verification shall be documented.
Where incoming raw materials are from a recycled
source, measures shall be in place to verify food safety
and traceability requirements are met prior to
acceptance.
Where recycled materials, plant-based materials or
functional (e.g. nanotechnology) additives are used,
there shall be sufficient data to enable hazard
assessment for food contact and safety and
conformance to applicable regulatory requirements,
and all claims shall be documented.
NOTE The inspection frequency and scope may be
based on the hazard presented by the material and the
hazard assessment of the specific suppliers.
Raw materials that do not conform to relevant
specifications shall be handled under a documented
procedure that prevents their unintended use.
Access points to bulk raw materials receiving lines shall
be identified, capped and secured. Discharge into such
systems shall take place only after approval and
verification of the raw materials received.
a) audit of the supplying site prior to accepting

materials for production;
b) appropriate third-party certification.
d) monitoring the performance of the supplier to verify
continued approval status.
NOTE Monitoring may include conformance to
specifications, meeting CoA requirements and
satisfactory audit outcomes.
9.3 Incoming raw materials

Loads on delivery vehicles shall be checked prior to, and
during, unloading to verify that food safety and safety
of raw materials has been maintained during transit
(e.g. seals are intact).
Where tamper-evident seals are used, a verification
process shall be in place to verify conformance to
relevant customer or regulatory requirements.
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PAS 223:2011
10 Contamination and migration

10.4 Chemical contamination
Programmes shall be in place to prevent, detect and

control contamination and allergens. Measures to
prevent microbiological, physical and chemical
contamination shall be included.
Only approved chemicals shall be permitted on site.
Where external product testing is required, it shall be

carried out by an accredited test facility or one that
follows international test facility guidelines. Where
in-house testing is carried out, calibration of equipment
shall be carried out against national standards or other
accurate means.
A register of hazardous materials shall be maintained,

and measures shall be in place to prevent crosscontamination between materials that are suitable for
food contact.
Mixing of raw or intermediate materials shall be

prevented where hazard assessment reveals a food
safety hazard.
10.2 Microbiological contamination
All chemicals on site shall be suitable for the intended

use and shall be controlled to prevent contamination.
NOTE Hazardous materials should include hazardous

chemicals or components with contamination potential.
10.5 Chemical migration

Printed and coated materials shall be handled and
stored in their intermediate and finished states in such
a manner that transfer of substances to the food
contact side via set-off or other mechanism is reduced
to a safe level appropriate for these materials as
defined by hazard assessment.
Where there is a potential for microbiological

contamination, measures shall be implemented to
prevent or control the hazard.
Packing materials (e.g. pallets) shall be made of suitable

material and be clean, dry and free from chemicals that
could potentially contaminate the food packaging
(such as insecticides, fungicides, pesticides or other
chemicals).
10.3 Physical contamination
NOTE In some cases, treatment of pallets may be

necessary to meet regulatory or customer requirements.
Where glass and brittle material are used (for

applications other than the food packaging production
itself) in production or storage areas, periodic
inspection requirements and defined procedures in case
of breakage shall be put in place.
Where there is a potential food safety hazard due to

migration or other transfer mechanism, controls shall
be implemented to prevent or control the hazard.
Glass breakage records shall be maintained where

relevant to food safety.
10.6 Allergen management
NOTE Glass and brittle materials (such as hard plastic

components in equipment, sight glasses on storage
vessels) should be avoided where possible.
Where a potential for contamination from allergens

has been identified, controls shall be implemented to
prevent or control the hazard and to record and label
accordingly.
The use of loose fastenings (e.g. drawing pins and

staples) shall not be allowed in production and storage
areas.
NOTE Components such as inks and oils can sometimes

contain or be derived from allergenic material.
Information should be available from the relevant
supplier to identify any such risks.
Other potential sources of physical contamination (e.g.

wooden pallets, tools, rubber seals, personal protective
clothing and equipment, knife blades, hard plastic)
shall be considered.
10
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PAS 223:2011
11 Cleaning
11.3 Cleaning programmes
Cleaning programmes shall be established to maintain

the production equipment and environment in a
hygienic condition.
Cleaning programmes shall specify, as a minimum:

c) cleaning method(s) and frequency;
11.2 Cleaning agents and tools
11.4 Monitoring cleaning programme

effectiveness
Equipment shall be maintained in a condition that

facilitates cleaning.
Cleaning agents shall be clearly identified, stored
separately and used only in accordance with
manufacturers instructions.
a) areas and items of equipment to be cleaned;

b) responsibility for the cleaning tasks specified;
d) monitoring and verification arrangements for the
cleaning.
Cleaning programmes shall be monitored, at

frequencies specified by the food packaging
manufacturing organization, to assess their continuing
suitability and effectiveness.
Cleaning tools shall be of hygienic design and

maintained in a condition that does not present a
potential source of contamination.
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11
PAS 223:2011
12 Pest control
Cleaning, inspection and monitoring procedures shall
be implemented to prevent creating an environment
conducive to pest activity.
12.2 Pest control programmes

have a designated person to manage pest control
activities or deal with appointed expert contractors.
Pest management programmes shall be documented
and shall identify target pests and address plans,
methods, schedules, control procedures and, where
necessary, personnel training requirements.
Programmes shall include a list of chemicals that are
approved for use in specified areas of the
establishment.
12.3 Preventing access
12.5 Monitoring and detection

Pest monitoring programmes shall include the placing
of detectors and traps in key locations to identify pest
activity. A map of detectors and traps shall be
maintained.
Detectors and traps shall be designed and located to
prevent contamination of raw materials, intermediate
materials, finished food packaging and equipment.
Establishments shall be maintained in good repair.

Holes and other potential pest access points shall be
sealed.
Detectors and traps shall be of robust, tamper-resistant

construction. They shall be appropriate for the target
pest.
External doors, windows or ventilation openings shall

be designed to prevent entry of pests.
Detectors and traps shall be inspected at a frequency

intended to identify new pest activity. The results of
inspections shall be analyzed to identify trends in pest
activity.
12.4 Harbourage and infestations

Raw materials, intermediate materials or finished food
packaging found to be infested shall be handled in
such a way as to prevent contamination of other raw
materials, intermediate materials, finished food
packaging or the establishment.
12.6 Eradication
Eradication measures shall be put in place immediately
after evidence of infestation is reported.
Potential pest harbourage (e.g. burrows, undergrowth,

stored items) shall be removed.
Pesticide application shall be restricted to trained

personnel and shall be controlled to prevent food
safety hazards.
Where external space is used for storage, stored items

shall be protected from weather and pest damage (e.g.
bird droppings).
Records of pesticide use shall be maintained to show

the type, quantity and concentrations used; where,
when and how applied; and the target pest.
12
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PAS 223:2011
13 Personnel hygiene and facilities

13.4 Workwear and protective clothing
Requirements for personal hygiene and behaviour

proportional to the hazard posed to the food
packaging shall be established and documented. All
personnel, visitors and contractors shall be required to
comply with the documented requirements.
Personnel who work in or enter into production or

storage areas shall wear work clothing that is fit for
purpose, clean and in good condition.

13.2 Personnel hygiene facilities

and toilets
Personnel hygiene facilities shall be available to
maintain the degree of personal hygiene required by
the food packaging manufacturing organization. The
facilities shall be located close to the points where
hygiene requirements apply and shall be clearly
designated.
According to their size and complexity, food packaging
manufacturing organizations shall:
Work clothing shall not be used for any other purpose

and shall not be stored in the same locker as personal
clothing.
Work clothing shall provide coverage so that hair,
perspiration and loose items cannot contaminate raw
materials, intermediate materials, finished food
packaging or equipment based on a food safety hazard
assessment.
Where gloves are used for food packaging contact,
they shall be clean and in good condition.
Personal protective equipment, where required, shall
be designed to prevent contamination and shall be
maintained in hygienic condition.
13.5 Illness and injuries
a) provide an adequate number and location of means

of washing, drying and, where required, sanitizing
hands (including wash basins, supply of hot and cold
or temperature-controlled water, and soap or
sanitizer);
Personnel, visitors and contractors shall be required to

report relevant infections, conditions or diseases in
accordance with the food packaging manufacturing
organizations requirements.
b) provide an adequate number and location of toilets

of hygienic design, each with hand washing and
drying facilities;
People known or suspected to be infected with, or

carrying, a disease or illness transmissible through food
shall be prevented from handling food packaging.
c) have toilet facilities that do not open directly onto

production areas;
d) have adequate changing facilities for personnel;
e) provide lockers for all personnel who work in
production, laboratory and storage areas.
13.3 Staff canteens and designated

eating areas
Staff canteens and designated areas for food storage
and consumption shall be situated and appropriately
managed to prevent contamination of production
areas.
In production areas, personnel with wounds or burns

shall be required to cover them with specified dressings.
Any lost dressing shall be reported to the direct
supervisor immediately.
13.6 Personal cleanliness

Personnel who are working in production areas shall be
required to wash their hands:
a) before starting any food packaging handling
activities;
b) immediately after using the toilet, eating, smoking
or drinking (other than water);
c) immediately after handling any potentially
contaminated material.
NOTE Hand-cleaning products suitable for food safety
(e.g. odourless) should be used.
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13
PAS 223:2011
Personnel shall be required to refrain from sneezing or

coughing over raw materials, intermediate materials or
finished food packaging. Spitting (expectorating) shall
be prohibited.
Fingernails shall be kept clean and trimmed.
13.7 Personal behaviour

A documented policy shall describe the behaviour
required of personnel in production and storage areas.
The policy shall, at a minimum, cover:
a) permissibility of smoking, drinking (other than
water), eating and chewing in designated areas only;
b) control measures to prevent hazards presented by
permitted jewellery;
NOTE Permitted jewellery includes specific types of
jewellery that may be worn by personnel in
processing and storage areas because of religious,
ethnic, medical and cultural imperatives.
c) permissibility of having personal items, such as
smoking materials and medicines, in designated
areas only;
d) prohibition of the use of nail polish, false nails and
false eyelashes;
e) control measures to restrict writing implements or
loose items in areas where they could contaminate
raw materials, intermediate materials or finished
food packaging;
f) maintenance of personal lockers so that they are
kept free from rubbish and soiled clothing;
g) prohibition of storage of food packaging contact
tools in personal lockers.
14 Rework
Rework shall be stored, handled and used in such a way
that the food safety performance of food packaging,
quality, traceability and regulatory compliance are
maintained.
NOTE In this PAS, the term rework includes materials
intended for onsite processing.
14.2 Storage, identification and

traceability
Stored rework shall be segregated and protected
against contamination.
Rework shall be clearly identified and labelled to allow
traceability. Traceability records for rework shall be
maintained.
The rework classification or the reason for rework
designation shall be recorded (e.g. finished food
packaging name, production date, shift, production
line of origin).
14.3 Rework usage

Where rework is to be incorporated back into the
production process, the acceptable quantity, type and
conditions of rework use shall be specified. The method
of addition, including any necessary preprocessing
stages, shall be defined.
Measures shall be in place to prevent rework processes
allowing raw materials, intermediate materials or
finished food packaging to be contaminated with
materials not intended for food contact.
Validation records shall be kept to demonstrate that
conformance to regulatory and customer requirements
is maintained by following the specified rework
process.
14
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PAS 223:2011
15 Withdrawal procedures
15.2 Withdrawal requirements
Systems shall be in place to identify, locate and remove,

from all necessary points of the supply chain, food
packaging failing to meet required food safety
standards.
A list of key contacts in the event of a withdrawal shall

be maintained and shall be accessible at all times.
NOTE Refer to BS EN ISO 22000, Clause 7.10.3,

Handling of potentially unsafe products, and Clause
7.10.4, Withdrawals.
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A procedure shall be in place to notify affected

customer(s) immediately of withdrawal situations.
Where food packaging is withdrawn due to immediate
health hazards, the food safety of other food
packaging produced under the same conditions shall be
evaluated.
15
PAS 223:2011
16 Storage and transport

16.2 Warehousing requirements
Raw materials, intermediate materials and finished

food packaging shall be stored in clean, dry, wellventilated spaces protected from dust, condensation,
fumes, odours or other sources of contamination.
Effective control of warehousing temperature, humidity

and other environmental conditions shall be provided
where required by food packaging or storage
specifications.

Waste and chemicals (cleaning products, lubricants and

pesticides) shall be stored separately.
A separate area or other means of segregating food
packaging materials identified as nonconforming shall
be provided.
Specified stock rotation systems that meet customer,
food safety and regulatory requirements shall be
observed. Stock shall be used in the correct order and
within the allocated shelf-life.
16.3 Vehicles, conveyances and containers

Vehicles, conveyances and containers shall be
maintained in a state of repair, cleanliness and condition
consistent with requirements given in relevant
specifications and contracts.
Vehicles, conveyances and containers shall provide
protection against damage or contamination of the
food packaging.
Control of temperature and humidity shall be applied,
recorded and accessible where required.
All delivery vehicles and shipping containers shall be
subject to a documented hygiene and integrity check
prior to loading.
Food packaging shall be protected from contamination
during loading operations. Where required by the food
packaging manufacturing organization, bulk containers
shall be dedicated to a specified food packaging
material.
Where specified by regulatory or customer
requirements, outer wrapping and delivery vehicles shall
be equipped with unique non-toxic, supplieridentifiable, tamper-evident seals to indicate any
violation or attempted violation.
16
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PAS 223:2011
17 Food packaging
information and consumer
awareness
18 Food defence,
biovigilance and
bioterrorism
Where food packaging is printed with food safety

information, measures shall be in place to prevent
misprinting and verify that the information is compliant
with all customer and regulatory requirements.
Each food packaging manufacturing organization shall

assess the hazard posed by potential acts of sabotage,
vandalism or terrorism and shall put in place
proportional protective measures.
NOTE Food safety information includes (but is not

limited to) ingredient lists, allergen statements,
identification codes and instructions for use.
NOTE 1 This should include consideration of transport

and distribution, as well as onsite activities. It should
include points such as:
Controls shall be in place to prevent the use of obsolete

printing media (e.g. preprinted material, printing
plates).
Manufacturing, rework, storage and distribution
processes shall be designed and implemented to
prevent mixing of food packaging with different food
safety information within a given batch.
a) building and infrastructure design to prevent

unauthorized entry;
b) reference checks for personnel;
c) control of confidential information;
d) security of storage and production areas;
e) management of security incidents.
NOTE 2 For further information and guidance on
approaches to the protection of food businesses from
all forms of malicious attack, see PAS 96, Defending
food and drink. Guidance for the deterrence, detection
and defeat of ideologically motivated and other forms
of malicious attack on food and drink and their supply
arrangements.
The site security assessment shall be kept up to date.
Personnel shall be trained in site security measures.
18.2 Access controls

Potentially sensitive areas (e.g. production areas, utility
services) within the establishment shall be identified,
mapped and subject to access control.
NOTE Where feasible, access should be physically
restricted by use of locks, electronic key card or
alternative systems.
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17
PAS 223:2011
19 Food packaging design and development

All applicable food safety requirements from regulatory
authorities and any additional customer requirements
shall be identified and addressed in the design process.
19.2 Communication and change control
NOTE Figure 2 illustrates an example of information

flows along the food packaging supply chain.
New technology and new manufacturing processes that
may impact the food safety performance of the food
packaging shall not be introduced without notification
of the affected customer(s) in accordance with
contractual obligations.
19.3 Design

have in place a procedure to obtain the information
necessary to design food packaging suitable for its
intended use.
Complete and accurate supporting documents

confirming the suitability of the materials for the
intended application shall be available for all
intermediate materials used to manufacture the food
packaging.
There shall be a process in place to verify that changes

in requirements are communicated along the food
packaging supply chain.
Intermediate material composition, finished food

packaging composition and migration data (where
applicable) shall be available to demonstrate
Figure 2 Information flows along the food packaging supply chain

Information
on potential
migrants
Raw material
manufacturers
Finished pack
migration
information
(CoC)
Packer/Filler
Packaging
manufacturer
Information on
use food type,
use conditions
Finished
goods (use
information
on pack)
Information on
use food type,
use conditions
Final
consumer
Food safety
issues
NOTE 1 Several materials may be used by a food

packaging manufacturing organization to produce the
finished food packaging (e.g. plastic film, paper, ink,
adhesive).
NOTE 2 Several finished articles may be used by the
packer/filler to produce the finished pack:
e.g. 1. bottle, label, closure;
e.g. 2. carton box, inner liner.
18
BSI July 2011
PAS 223:2011
conformance to relevant food safety regulatory and

customer requirements in the countries where the end
product is intended to be used, where known.
Compliance data (e.g. migration data) shall include the
intended conditions under which the food packaging is
to be used.
19.4 Specifications
Food safety requirements and specifications shall be
developed and maintained, and a process shall be in
place to verify that these specifications are agreed by
the food packaging manufacturing organization and
the customer(s).
19.5 Process validation

Validation data (e.g. information from production trials
or testing) shall be available to demonstrate that the
manufacturing process is capable of producing food
packaging to accepted specifications and that the
specified transport conditions to the customer(s) do not
compromise the food safety or functionality of the
food packaging.
NOTE Previous validation data may be used for new
food packaging and processes if they are similar to
existing ones.
Specifications shall include all food safety-relevant

parameters.
BSI July 2011
19
PAS 223:2011
Bibliography
For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced
document (including any amendments) applies.
Standards publications
PAS 96, Defending food and drink. Guidance for the
deterrence, detection and defeat of ideologically
motivated and other forms of malicious attack on food
and drink and their supply arrangements
Further reading
BIP 2078, Managing food safety the 22000 way
ISO/TS 22003, Food safety management systems
Requirements for bodies providing audit and
certification of food safety management systems
ISO/TS 22004:2005, Food safety management systems
Guidance on the application of ISO 22000:2005
Other publications
Codex Alimentarius, Recommended international code
of practice General principles of food hygiene
20
BSI July 2011
ISBN 978-0-580-74170-8
British Standards Institution

389 Chiswick High Road
London W4 4AL
United Kingdom
www.bsigroup.com
9 780580 741708

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Bought by Mr. Kurt Ross,Grayling Industries, Inc.,on 18/07/2011 21:18 Latest version. Not to be distributed/networked.

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Publishing and copyright information

BSI July 2011

BSI July 2011

10.3 Physical contamination ........................................................................ 10

BSI July 2011

Use of this document

Foundation for Food Safety Certification (FSSC)

It has been assumed in the preparation of this PAS

Institute of Packaging Professionals/FSAP (Food Safety

Contractual and legal considerations

BSI July 2011

Requirements for design have been included in this PAS

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3 Terms and definitions

3.1 certificate of analysis (CoA)

3.2 certificate of conformance (CoC)

3.7 finished food packaging

3.8 food packaging

3.9 food packaging withdrawal

3.10 intermediate material

introduction or occurrence of a contaminant in the

physical output of part of the production process that

NOTE In the context of this PAS, contamination may

NOTE For example, a plastic powder, granules or flakes

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Figure 1 Food packaging concepts and food contact

as a film, sheet or laminate requiring further

3.13 non-intentionally added substance

3.14 packing materials

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Establishments shall be designed, constructed and

Consideration shall be given to potential sources of

Buildings shall be of durable construction that presents

NOTE Local environment includes both internal and

4.3 Locations of establishments

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5 Layout and workspace

Internal layouts shall be designed, constructed and

Equipment shall be designed and located to facilitate

The movement patterns of materials, products and

Equipment shall be located to permit access for

The effectiveness of measures taken to protect against

5.2 Internal design, layout and

5.3 Internal structures and fittings

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5.5 Temporary/mobile structures

6.4 Compressed air and other gases

The provision and distribution routes for utilities to and

Compressed air and other gas systems used in food

The effectiveness of measures taken to protect against

The food packaging manufacturing organization shall

6.2 Water supply

Oil used for compressors shall be food grade wherever

Non-potable water shall have a separate supply system,

6.3 Air quality and ventilation

Foundation for Food Safety Certification (FSSC)

Institute of Packaging Professionals/FSAP (Food Safety

a) audit of the supplying site prior to accepting