CFA Best Practice Guidelines For The Production of Chilled Food

BEST PRACTICE GUIDELINES
FOR THE PRODUCTION OF

CHILLED FOOD
Fourth Edition
2006
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(C) 2006 Chilled Food Association Ltd
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website: www.chilledfood.org
TABLE OF CONTENTS Page
Introduction 3
Scope 4
Management Responsibilities 5
How to use these Guidelines 6
PART 1: GENERAL PRINCIPLES

Section 1.1 Main Hazards 8
1.1.1 Microbiological Hazards 8
1.1.2 Chemical Hazards 9
1.1.3 Physical Hazards 10
1.1.4 Allergens 10
Section 1.2 Control Measures 11
1.2.1. Basic Principles for Control 11
1.2.1.1 Processing parameters 12
1.2.1.2 Intrinsic preservation factors (‘Hurdles’) 14
1.2.1.3 Expected storage conditions, shelf life and usage instructions 15
1.2.2 Determination of the minimum Hygienic Standards for Chilled Products 15
1.2.3. Microbiological Risk Assessment 15
Section 1.3 HACCP 17
1.3.1 Introduction 17
1.3.2 Prerequisites 17
1.3.3 Principles 18
1.3.4 Guidelines for the Application of the HACCP System 18
Section 1.4 HACCP Implementation 25
1.4.1 HACCP in New Product Development 25
1.4.2 Establishing a Safe Raw Materials Supply 26
Section 1.5 HACCP Monitoring, Verification and Documentation 27
1.5.2 Monitoring 27
1.5.2.1 Monitoring at Intake 27
1.5.2.2 Monitoring during processing 28
1.5.2.3 Monitoring of finished products 28
1.5.2.4 Monitoring personnel hygiene 28
1.5.3 Management of non-conformities 28
1.5.4 Verification 29
1.5.4.1 Microbiological criteria 29
1.5.4.2 Sampling and testing 30
1.5.4.3 Environmental monitoring 30
1.5.4.4 Interpretation of data 31
1.5.4.5 Corrective actions and feedback loop 31
1.5.5 Documentation 32
1.5.6 Records 32
Section 1.6 Shelf Life Assessment 33
1.6.2 Shelf life determination 33
1.6.3 Proposed design of shelf life and storage testing studies 34
1.6.4 Assignment of shelf life 35
1.6.5 Use by and best before 35
1.6.6 Monitoring and verification of shelf life 35
PART 2: GMP & GHP

Section 2.1 Decision tree to determine the minimum hygiene status required 38
Section 2.2 Hygiene 41
2.2.1 Basic principles of hygienic manufacturing 41
Section 2.3 Categorisation and Segregation of Production Areas 42
Section 2.4 Tables of General GMP/GHP Requirements 43
th
© CFA Best Practice Guidelines for the Production of Chilled Food, 4 edition 2006 1
Page
PART 3: OTHER REGULATORY REQUIREMENTS
Section 3.1 EC Regulation on Microbiological Criteria for Foodstuffs 62
Section 3.2 Supplier Quality Assurance 63
3.2.1 Principles 63
3.2.2 SQA System Elements 64
3.2.2.1 Specifications 64
3.2.2.2 Auditing 64
3.2.2.3 Certificates of analysis 64
3.2.2.4 Buying from agents and brokers 64
Section 3.3 Traceability 65
3.3.1 Background 65
3.3.2 Guidance Principles 65
Section 3.4 Product Recall 68
3.4.2 Developing a Recall Plan 68
3.4.2.1 People involved 68
3.4.2.2 Information gathering 69
3.4.2.3 Incident classification and action to be taken 69
3.4.2.4 Communication 69
3.4.2.5 Recall closure and evaluation 69
3.4.3. Recall Simulations - Training and Revision 69
APPENDICES
Appendix A Definitions and abbreviations 74
Appendix B Case studies using Decision tree route to Determine Minimum Hygiene Status 81
Required
Appendix C Pre-Employment Medical Screening Questionnaire 94
Appendix D Return to Work Questionnaire 95
Appendix E High Care and High Risk Area Temporary Operatives Pre-employment Training 96
Material
Appendix F CFA Handwash Poster 101
Appendix G Contractor Hygiene Requirements 102
Appendix H Air Quality 104
Appendix I Selected Reading & Other Relevant Guidelines/Codes of Practice 107
Appendix J CFA Mission, Strategy & Guidelines Working Group Membership 110
TABLES
Table 1 Commonly accepted growth boundaries of pathogenic microorganisms 9
Table 2 Control application examples and essential elements 11
Table 3 Lethal rates for Listeria monocytogenes 12
Table 4 Lethal rates for Clostridium botulinum 13
DIAGRAMS
Diagram 1 Logic sequence for the application of HACCP 19
Diagram 2 Example of decision tree to identify CCPs 23
Diagram 3 Example of a HACCP worksheet 24
Diagram 4 Decision tree to determine level of raw material control required 63
FIGURES
Figure 1 Decision tree to determine the minimum hygienic status required for chilled 39
products
Figure 2 Hygiene Areas for Manufacture 40
Figure 3 Chicken Salad – Stages of Traceability 66
Figure 4 Stages of Traceability 67
2 th
© CFA Best Practice Guidelines for the Production of Chilled Food, 4 edition 2006
INTRODUCTION
Chilled foods include a vast range of food products, such as ready-to-eat salads and sandwiches,
ready-to-heat meals, pastas and sauces, pizza, desserts, soups, sauces, dressings and doughs.
These foods may include both raw and heat-processed ingredients. Further heat processing may or
may not be used during the manufacturing process and by the consumer. For these reasons, chilled
foods depend on refrigeration as the primary means of preservation.
A key criterion for chilled foods is that they must be microbiologically safe at the point of consumption.
Pathogens that could result in food borne illness when consumed must be controlled. Within this
context, ensuring the safety and quality of chilled foods is dependent on the integrity of the entire food
chain, from production and harvesting of ingredients, through manufacturing and distribution and
finally storage and preparation by the consumer.
Because of the diversity of raw materials, processing conditions and packaging systems that are used
in the production of chilled foods, it is not possible to establish a "one size fits all" approach to
achieving microbiological safety. Rather the manufacturer must carefully consider a wide variety of
factors and hurdles − raw material quality, hygienic processing, temperature, water activity, acidity,
modified atmosphere − in determining ways to control microbiological growth and thus prevent
spoilage and/or the development of conditions that can lead to food borne illness. Via the choice and
combination of these elements, the manufacturer is able to determine the optimum shelf life for a
product and establish conditions for its use that will ensure safe food products for consumers.
The 2006 revision of the Chilled Food Association (CFA) Best Practice Guidelines for the Production
of Chilled Food provides guidance for manufacturers on the production of a wide spectrum of chilled
foods. The Guidelines are in line with European Union (EU) food hygiene legislation (852/2004/EC),
as well as the Codex Alimentarius Code of Hygienic Practice for Refrigerated Packaged Foods with
Extended Shelf Life (CAC/RCP 46-(1999)) and the Codex Recommended International Code of
Practice – General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3 (1997), Amd. (1999)). As
such, the CFA Guidelines provide the fundamental principles that must be considered when designing
safe manufacturing operations. The Guidelines are also useful when working with local enforcement
authorities to implement legal requirements at the production stage and may assist food business
operators in complying with third party technical standards
While the CFA Guidelines are intended to be as user friendly as possible, it nevertheless must be
recognised that the task of setting up and managing a chilled food operation demands a high level of
expertise to ensure that a facility is properly designed and that appropriate procedures are in place to
achieve the production of safe foods. These procedures involve application of Good Manufacturing
Practices (GMP), Good Hygiene Practices (GHP) and implementation of a Hazard Analysis and
Critical Control Point (HACCP)-based system.
Note that the individual elements of this document cannot be used in isolation.
th
SCOPE
The CFA Guidelines have been designed to cover all chilled prepared foods. However, they are not
intended to cover cook-chill foods used within integrated catering systems.
It is essential that a HACCP-based system be used to identify the specific control requirements
for an individual operation.
On-site catering operations must meet the general hygiene requirements (see Section 2.2).
4 th
MANAGEMENT RESPONSIBILITIES
Food business operators are legally responsible under the Food Safety Act 1990 and EU General
Principles of Food Law (178/2002/EC) for the safety of food products under their control.
New products must have been designed to ensure safety before being presented to customers.
Food business operators must
• understand the principles of HACCP and GMP (see Sections 1.3 and 2.2) and ensure that
they are applied;
• understand hazards and risks and ensure that they are managed;
• ensure that all personnel understand the importance of maintaining the appropriate hygienic
conditions throughout the facility, including appropriate personal hygiene and cleanliness;
• ensure that regular, thorough and planned staff training takes place to reinforce this
understanding
• ensure that systems are in place for removing product from the market if it is not in compliance
with legal requirements.
Within the management team an individual with appropriate knowledge and authority should be
designated to be responsible for all operations, including review and audit related to all aspects of
product safety.
Management must also ensure that there are adequate on- or off-site services, laboratories and
equipment to enable informed decisions regarding
• hygiene of the plant and process;

• quality and safety of raw materials, work-in-progress and finished product;
• assessment of finished product over the known shelf life;
• calibration of instrumentation and equipment.
These services must work to a documented quality management system and use competent
personnel and laboratories that must be proven to be competent in the tests carried out and must use
official methods or validated alternatives.
th
HOW TO USE THESE GUIDELINES
The CFA Guidelines have been designed to cover a wide range of chilled products of varying shelf
lives manufactured under different hygiene conditions. The structure of the Guidelines enables easy
selection of the relevant information for the category of the products covered.
To be effective, the Guidelines must be used in the following way:
− Take into account all essential general information contained in the Guidelines (Part 1 and
Appendices A to H).
− Use the Decision Tree (Figure 1 in Section 2.1) to identify the minimum class of area hygiene
standards required (i.e. Low Risk Area, High Care Area or High Risk Area) – you will need to know
the heat process applied and whether the product is to be heated in pack (i.e. whether
recontamination is possible post process). For foods containing uncooked ingredients the
Decision Tree also takes into account whether the food is intended to be cooked before
consumption.
− Refer to Section 2.4 for the detailed hygiene requirements applicable to the required area
standard.
− If a particular product does not receive the required heat processes set out in the Decision Tree,
the manufacturer must apply product processing design conditions such that product safety is
demonstrable (see Table 2 in Section 1.2 and Intrinsic preservation factors, Section 1.2.1.2).
− If a type of product not specifically excluded from the scope of these Guidelines is not covered,
reference should be made to appropriate national or international codes in conjunction with a
HACCP-based system.
− Where the term “must” is used, this denotes that the conditions referred to are either specifically
required by law, or, in cases where a condition is not specifically legally required, the condition is
considered necessary by CFA to implement requirements of general food hygiene legislation to
ensure food safety. The term “should” indicates that it is desirable to comply with the condition to
which reference is made.
While the Guidelines have been drawn up to illustrate good practice, it is the responsibility of the
manufacturer to demonstrate that hazards are controlled and to document that risks have been
assessed. It is recommended that, where alternative control methods to those given in the Guidelines
are used, documentation be kept to demonstrate the rationale behind the approach taken.
6 th
PART 1
GENERAL PRINCIPLES
th
SECTION 1.1
MAIN HAZARDS
Chilled foods may be manufactured using a wide variety of materials, processes and packaging
systems. Microbiological, chemical or physical hazards may be very different from one product to
another.
HACCP is used to identify hazards in the production of any particular product.
Hazards can be microbiological, chemical or physical, and are very different from one product to
another.
These Guidelines focus on Good Hygienic Practice; therefore microbiological hazards are particularly
considered.
1.1.1 Microbiological Hazards
Chilled foods are very sensitive to microbiological contamination, growth and toxin
development.
To control these hazards the following elements must be taken into account in HACCP
programmes:
− Supplier selection, specifications and control of incoming raw material (see Section 3.2);
− Appropriate raw material storage and stock rotation (first in first out) (see Section 2.3.1.4);
− Product/process design and control measures (see Section 1.2);
− Hygienic processing conditions (see Section 2.2);
− Allocation of appropriate product shelf life and usage instructions (see Section 1.6,
1.2.1.3);
− Maintenance of the chill chain during distribution and sale (see Section 1.2.1.3).
Commonly accepted growth boundaries of pathogenic microorganisms are given in Table 1.
Separate CFA guidance is available covering:
− Hygienic Design
− Microbiological Guidance for Produce Suppliers to Chilled Food Manufacturers
− Microbiological Testing and Interpretation
− Practical Implementation on the EC Regulation on Microbiological Criteria for Foodstuffs
− Water Quality Management
Other elements of Good Hygienic Practice are discussed in detail in subsequent sections.
8 th
Table 1: Commonly accepted growth boundaries of pathogenic microorganisms 1
Microorganism and growth Min Min pH Min aw Aerobic /

boundaries 2 temp anaerobic 3
(°C)
L. monocytogenes -0.41 4.3 0.92 Facultative
4 5 1
B. cereus 4 4.5 0.93 Facultative
Campylobacter jejuni 32 4.9 0.99 Microaerophilic
1
Cl. botulinum Mesophilic/proteolytic 10-12 4.6 0.93 Anaerobic
Cl. botulinum Psychrotrophic/non- 3.3 5.0 0.97 Anaerobic
proteolytic (5% NaCl)
1 1
Cl. perfringens 12 5.5-5.8 0.9351 Anaerobic
E. coli O157:H7 6.5 4.5 0.95 Facultative
Salmonella 6 4.0 0.94 Facultative
6 7
Staphylococcus aureus 5.2 4.5 0.86 Facultative
V. cholerae 10 5.0 0.97 Facultative
V. parahaemolyticus 5 4.8 0.94 Facultative
1
Y. enterocolitica -1.3 4.2 0.96 Facultative
NOTE:
Although not a pathogen, E. coli is often used as an indicator organism. Its commonly accepted
growth boundaries are:
Min temp (°C) Min pH Min aw Aerobic / anaerobic 8
7-8 4.4 0.95 Facultative
1.1.2 Chemical Hazards
Chilled foods, like other food products, are subject to contamination by environmental
contaminants and residues from pesticides or veterinary drugs. Compliance of raw material
with the relevant legislation is essential. Supplier selection, evaluation and follow up are the
best control measures (see Section 3.2).
For further details see CFA’s
− Pesticides Due Diligence Guidelines for Produce Suppliers to Chilled Food Manufacturers
− Veterinary Residues Management Guidance
Chemicals such as cleaning agents, lubricants and pest control materials may also present
on-site chemical hazards. The correct use of food-grade chemicals, where appropriate, and
application of GMP are the best control measures.
1
Microorganisms in Foods. Vol. 5. Microbiological Specifications of Food Pathogens. (1995), ICMSF, Blackie Academic &
Professional; ACMSF Report on Verocytoxin-Producing Escherichia coli (1995), HMSO, London, ISBN 0-11-321909-1.
2
Growth boundaries given under otherwise optimal conditions. Growth criteria will vary according to strain, temperature, and
type of acid, solute and other factors, and will normally be higher in foods. However, variability in measurement, etc., must be
allowed for - a margin of error must be incorporated.
3
It is important to note that even aerobically processed foods may present a risk of growth of anaerobic organisms since they
may have an anaerobic internal environment.
4
No emetic toxin formation at temperature below 10°C
5
Evidence for this limit provided by LL Prokopova (1970) Multiplication and toxigenicity of Bacillus cereus contained in food
products stored under different thermal conditions. Voprosy Pitaniia, 29, 56-61 (in Russian, English summary) and M Raevuori
and C Genigeorgis (1975). Effect of pH and sodium chloride on growth of Bacillus cereus in laboratory media and certain
foods. Applied Microbiology, 29, 68-73.
6
Limits for enterotoxin production, not growth
7
Most serotypes fail to grow at <7ºC
8
It is important to note that even aerobically processed foods may present a risk of growth of anaerobic organisms since they
may have an anaerobic internal environment.
th
1.1.3 Physical Hazards
Physical hazards might include foreign bodies such as metal, glass, wood and bone
fragments. Their control is ensured by raw material quality (specifications, supplier
evaluation) and provisions applied during processing (e.g. metal detectors after packaging,
filters in line).
1.1.4 Allergens
Many foods can be allergenic to some individuals and a very wide range of food and food
components have been identified as actual or potential allergens. Common food allergens
include cow's milk, fruits, legumes (especially peanuts and soybeans), eggs, crustaceans, tree
nuts, fish, vegetables (celery and other foods of the Umbelliferae family), wheat and other
cereals as listed in EU labelling legislation (Directive 2000/13/EC).
Control of allergens must be addressed through HACCP systems. This includes the
identification of the allergens of concern and the consideration of their presence through direct
addition, rework and/or cross contamination. Appropriate labelling must be used.
See the following for additional information regarding legal requirements and practical
management of controls:
'Guidance Notes of the Food Labelling (Amendment) (No. 2) Regulations 2004', November
2005, Food Standards Agency.
http://www.food.gov.uk/multimedia/pdfs/labelamendguid21nov05.pdf
'Guidance on the practical application of Directive 2003/89/EC', June 2004, BRC/FDF.

http://www.brc.org.uk/Downloads/200406%20Directive%202003-89-EC.pdf
10 th
SECTION 1.2
CONTROL MEASURES
1.2.1. Basic Principles for Control
The safety of chilled foods with respect to pathogens must be designed into the product using
formulation, processing parameters and preservation factors. This must be validated, taking
into account
− any variability in the finished product (e.g. pH, aW) and processing, considering worst-case
possibilities
− appropriate hygiene during manufacture (see Section 2);
− expected storage conditions;
− usage instructions.
All of these factors must be taken into account for a safe shelf life to be assigned.
Table 2: Control application examples and essential elements

Hygiene
Microbiological L. monocytogenes
Product Type Essential Control Elements Area
Hazards growth supported?
Standard
• Formulation (e.g. low pH and/or low aW)
• Raw material quality
Ready-to-cook • Hygienic manufacture
No LRA
products made May contain • Shelf life limitation
from uncooked vegetative pathogens • Chilled storage and distribution
and/or cleaned such as L. • Cooking instructions
and/or cooked monocytogenes and • Raw material quality
ingredients, then spore formers • Hygienic manufacture
packed Yes • Shelf life limitation LRA
• Chilled storage and distribution
• Cooking instructions
Ready-to- • Formulation (e.g. low pH and/or low aW)
eat/ready-to- • Raw material quality
reheat products No • Hygienic manufacture LRA
May contain
made from or • Shelf life limitation
vegetative pathogens
containing • Chilled storage and distribution
such as Listeria
uncooked,
monocytogenes and • Raw material quality
decontaminated
spore formers • Hygienic manufacture
and/or cleaned Yes HCA
ingredients, then • Shelf life limitation
packed • Chilled storage and distribution
Ready-to- • Formulation (e.g. low pH and/or low aW)
eat/ready-to- • Ingredients heat process design and control
Must be free from
reheat products No • Hygienic manufacture LRA
vegetative
made from fully • Shelf life limitation
pathogens, but may
cooked • Chilled storage and distribution
contain spore
ingredients
formers if less than • Ingredients heat process design and control
(equivalent to
equivalent to 90ºC • Hygienic manufacture
min 70ºC for 2 Yes HRA
for 10 mins used. • Shelf life limitation
mins), then
packed • Chilled storage and distribution
• Product/process design and control in terms
Must be free from of packaging integrity and control of heat
vegetative treatment, i.e.
pathogens, but may • Shelf life no more than 10 days: equivalent
contain spore
to at least 70°C for 2 mins
formers if less than
Not relevant - • Shelf life >10 days: equivalent to at least
equivalent to 90ºC
Products contamination 90°C for 10 mins or other measures
for 10 mins or other LRA
cooked in pack prevented by demonstrably controlling psychrotrophic C.
measures
cooking in pack botulinum
demonstrably
controlling • B. cereus controls must be in place for
psychrotrophic C. cereal and rice-based products, i.e. raw
botulinum or B. material quality assurance, compositional
cereus not in place factors (e.g. pH, aW), rapid chilling, shelf life
limitation and chilled storage and distribution
th
1.2.1.1 Processing parameters
Where cooking or heating is used as a CCP for the reduction of microorganisms, a

heat process aiming to achieve a 6 log reduction of either vegetative or spore-forming
organisms is required, i.e. either
• Listeria monocytogenes (this treatment will also control other vegetative
pathogens), or
• psychrotrophic (cold growing) Clostridium botulinum (this treatment will not
control other spore-forming pathogens such as Bacillus cereus).
The choice of heat treatment is part of the product and process design (see Figure 1,
page 39).
Commonly accepted lethal rates (i.e. equivalent heat treatments achieving a 6 log
reduction of the target organism) for Listeria monocytogenes and psychrotrophic
Clostridium botulinum are defined in Tables 3 and 4, respectively.
Table 3: Lethal rates for Listeria monocytogenes 9
Temperature (°C) Time (mins, secs) Lethal Rate

60 43'29" 0.046
61 31'44" 0.063
62 23'16" 0.086
63 17'06" 0.117
64 12'40" 0.158
65 9'18" 0.215
66 6'49" 0.293
67 5'01" 0.398
68 3'42" 0.541
69 2'43" 0.736
70 2'00" 1.000
71 1'28" 1.359
72 1'05" 1.848
73 0'48" 2.512
74 0'35" 3.415
75 0'26" 4.642
76 0'19" 6.310
77 0'14" 8.577
78 0'10" 11.659
79 0'06" 15.849
80 0'05" 21.544
81 0'04" 29.286
82 0'03" 39.810
83 0'02" 54.116
84 0'02" 73.564
85 0'01" 100.000
Notes
These data are based on laboratory studies and are supplied as an example of the necessary process
to achieve a 6-log reduction of Listeria monocytogenes, the most heat-resistant vegetative pathogen
of significance in chilled foods, and, as a consequence, all other vegetative pathogens, such as
Staphylococcus aureus, Campylobacter, E. coli and Salmonella, will also be heat-inactivated (i.e. at
least a 6-log reduction).
9
Heat Resistance of Listeria monocytogenes in Non-dairy Food Menstrua (1989), Technical Memorandum No. 523, Campden
Food and Drink Research Association, Heat Resistance of Listeria monocytogenes in Homogenates of Chicken, Beef Steak
and Carrot (1989) JE Gaze, GD Brown, DE Gaskell and JG Banks, Food Microbiology, 6, 251-259.
12 th
Typical D values 10 for infectious pathogens at 70°C are:
L. monocytogenes 0.3
C. jejuni 0.0001
E. coli (including O157:H7) 0.001
salmonellae 0.01
S. aureus 0.1
V. parahaemolyticus 0.001
Y. enterocolitica 0.01
It is important to note that the values have been extrapolated assuming a linear z-value 11 of 7.5°C and
as a reference 70°C.
Table 4: Lethal rates for psychrotrophic Clostridium botulinum 12

Temperature (°C) Time (mins) Lethal Rate
80 270.3 0.037
81 192.3 0.052
82 138.9 0.072
83 100.0 0.100
84 71.9 0.139
85 51.8 0.193
86 37.0 0.270
87 27.0 0.370
88 19.2 0.520
89 13.9 0.720
90 10.0 1.000
91 7.9 1.260
92 6.3 1.600
93 5.0 2.000
94 4.0 2.510
95 3.2 3.160
96 2.5 3.980
97 2.0 5.010
98 1.6 6.310
99 1.3 7.940
100 1.0 10.000
Notes
These data are based on laboratory studies and are supplied as an example of the necessary process
to achieve a 6-log reduction of psychrotrophic (cold growing) Clostridium botulinum type B 13 .
It is important to note that the values have been extrapolated assuming a linear z-value of 7°C below
90°C and 10°C above 90°C (reference is 90°C).
The typical D value for psychrotrophic C. botulinum at 90°C is 1.5. Most bacterial spores, including
spores from mesophilic C. botulinum and psychrotrophic B. cereus are much more heat resistant than
those from psychrotrophic C. botulinum and will not be inactivated by the pasteurisation treatments
presented in this table.
For example, the D value for Bacillus cereus at 90ºC is 10 (mins), therefore:
3-log reduction requires 30 mins at 90ºC

6-log reduction requires 60 mins at 90ºC
10
D is the time required to reduce the number of microorganisms by a factor 10 at a certain temperature
11
z value = temperature change required to increase/reduce the D-value by a factor 10
12
Taken from Code Voor de Produktie, Distributie en Verkoop van Gekoelde, Lang Houdbare Gepasteuriseerde Maaltijden,
Belgian, Dutch Working Group.
13
There is some evidence that products containing lysozyme or enzymes with lysozyme activity may increase heat resistance of
Clostridium botulinum spores. Additional heat treatments and/or use of other hurdles may be required.
th
The European Food Safety Authority states 14 that “3 minutes at the constant temperature of 105 ºC
can produce 5 log reductions in the population of a high resistant B.cereus strain. Temperatures
higher than 105ºC should protect food from this microorganism in most instances. However, only
canning can ensure complete destruction of B.cereus spores. Other heating processes such as
normal cooking, mild heat application on refrigerated processed food of extended durability or
pasteurisation are not enough to kill all B.cereus spores. These treatments will activate spores, thus
readily triggering germination and enhancing further vegetative cell multiplication. Therefore, a rapid
cooling process is required, followed by storage at temperatures of refrigeration, to avoid the
multiplication of vegetative cells to a level that could endanger the safety of the product."
1.2.1.2 Intrinsic preservation factors (‘Hurdles’)
Refrigeration is the primary factor for the prevention of microbial growth during shelf
life of chilled foods. In addition, other factors are also used to control microbial
growth, such as water activity, pH, storage time, gas atmosphere, inhibitory agents
and redox potential.
The effect of a single factor such as temperature to inhibit a microorganism is

generally determined under conditions where all other factors are optimum. However,
in preserving foods, generally more than one factor is relied upon to control microbial
growth and thus to prevent spoilage and/or food borne disease. Suitable
combinations of factors or hurdles can be devised so that the organisms of concern
can no longer grow/survive in the product. The combination of several factors
('hurdles') to control microbial growth may be synergistic. In such cases the overall
hurdle effect is stronger than the addition of individual hurdles.
Combinations of factors must be chosen depending on the product composition and

processing and storage conditions. Individual factors or combinations of two or more
must be chosen depending on the product composition, processing and storage
conditions. During the evaluation and assessment of their effectiveness it must be
ensured that the chosen hurdle system will not cause unwanted side-effects. The use
of a modified atmosphere to inhibit a target pathogen, for example, may favour others
naturally present at low levels or may inhibit a natural flora which would spoil the
product before growth of pathogens reaches levels presenting a risk for the consumer.
The safety of chilled foods with respect to specific pathogens is defined by the product
(composition) and processing parameters allowing either to reduce them to an
acceptable level and/or to control their growth during storage and distribution.
In the case of psychrotrophic strains of Clostridium botulinum, for example, a shelf life
of more than 10 days can be achieved by different means, either by:
a) Single hurdles and no consideration of initial load of the pathogen.
− heating to a temperature/time combination equivalent to 90°C for 10 minutes;

− adjusting the water activity (aw) to below 0.97;
− lowering the pH to a value below pH 4.8;
or by:
b) Combination of hurdles and no consideration of the initial load of the pathogen.
While the values indicated above represent absolute values for single hurdles,
the safety of the products can also be ensured by the combination of different
hurdles taking benefit of the synergistic effect mentioned above.
14
The EFSA Journal (2004) 175, 1-48, “Bacillus cereus and other Bacillus spp in foodstuffs” Opinion of the Scientific Panel on
Biological Hazards on Bacillus cereus and other Bacillus spp in foodstuffs. (Question N° EFSA-Q-2004-010), Adopted on 26-27
January 2005. http://www.efsa.eu.int
14 th
In both cases (a and b) it is necessary to validate, i.e. to demonstrate the
effectiveness of the approach and hurdle system chosen and the safety of the finished
product.
Predictive models such as Growth Predictor, USDA’s Pathogen Modeling Programme

and ComBase may be used to assess both the effectiveness of preservation
conditions and the effects of modifying product composition and varying
handling/storage conditions on safety.
Whenever there is doubt that the preservation conditions applied might not effectively
control the microorganisms of concern, challenge studies in which specific organisms
are inoculated into products prior to storage must use the worst case conditions of
expected storage and distribution. It is advisable that specialist advice is sought, e.g.
from food Research Associations.
Some tolerances of specific pathogens to various individual factors under otherwise

optimal conditions are given in Table 1.
1.2.1.3 Expected storage conditions, shelf life and usage instructions
Chilled foods are prepared foods that for reasons of safety and/or quality rely on
storage at refrigeration temperatures (generally defined at the national level)
throughout their entire life. Having considered product safety the potential for
presence and subsequent growth of spoilage organisms must also be taken into
account when deciding on the target shelf life and specifying usage instructions.
Knowledge of chill chain performance, in terms of temperature and time, as well as
reasonable consumer handling, must be taken into account when designing chilled
products and establishing their shelf life (see Section 1.5).
1.2.2 Determination of the minimum Hygienic Standards for Chilled Products

Minimum hygiene standards based on different levels of heat treatment, if any, can be
determined using the Decision Tree in Figure 1. The Decision Tree distinguishes between
three hygienic status areas to be applied during manufacturing to eliminate or reduce the risk
of any microbiological hazards arising between the heat treatment, if any, and final packaging:
− Low Risk Area (LRA)

− High Care Area (HCA)
− High Risk Area (HRA)
A detailed description of the requirements in each area is given in Section 2.2.
The hygiene status areas highlighted are the minima for each type of product.
If there is doubt that the conditions applied might not effectively control the microorganisms of
concern, a risk assessment and additional studies must be carried out. If there is still any
doubt about the approach to be taken, expert advice should be sought, e.g. from food
Research Associations.
Deviations from the Decision Tree approach must be validated (see Section 1.2.3.)
Examples of the use of the Decision Tree are given in Appendix B.
1.2.3. Microbiological Risk Assessment
Formal microbiological risk assessment coupled with validation can be used as a tool to
evaluate the impact of all of the above on product safety. However, this demands a very high
level of scientific and technical expertise as well as significant investment in research and
development.
In particular, substantial data are required to carry out microbiological risk assessment,
including regarding:
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− the microbiological quality (current and historical trends and issues) of the particular raw
materials used including in relation to the specific source;
− any pre-treatment to which the raw materials have been subjected and its impact on the
survival and growth of any pathogens that may be present and on the potential for toxin
development in relation to those materials;
− recontamination and growth potential during shelf life.
Specialist, expert advice must therefore be sought to use this approach.
Useful References
Interaction of Factors to Control Microbial Spoilage of Refrigerated Foods, VN Scott, J. Food Prot.,
1989, 52(6), 431-5.
Mechanism of Action of Food Preservation Procedures 1989, GW Gould (Editor) Elsevier Applied
Science London.
Food Preservatives and the Microbiological Consequences of their Reduction or Omission, TA
Roberts, PJ McClure, Proc. Nutr. Soc., 1990, 49(1), 1-12.
Growth Predictor, Institute of Food Research, UK. http://www.ifr.ac.uk/safety/growthpredictor/
Pathogen Modelling Programme, USDA. http://www.arserrc.gov/mfs/PATHOGEN.HTM
ComBase: http://www.combase.cc/
Microbiological Risk Assessment for Food Industry Applications, 2000, CCFRA Guideline No. 28.
Microbiological Testing and Interpretation Guidance, 2005, Chilled Food Association.
16 th
SECTION 1.3
HACCP
Hazard Analysis and Critical Control Points (HACCP) systems manage and control food safety but
cannot make a fundamentally unsafe product safe.
Food safety must be designed into a product at the development stage. See Section 1.4.
This section is adapted from the Codex “Recommended International Code of Practice – General
Principles of Food Hygiene” (CAC/RCP 1-1969, Rev. 4-2003).
1.3.1 Introduction
The HACCP system, which is science-based and systematic, identifies specific hazards and
control measures to assure the safe production of food. HACCP is a tool to assess hazards
and establish control systems that focus on prevention rather than relying mainly on end-
product testing. Any HACCP system is capable of accommodating change, such as advances
in equipment design, processing procedures or technological developments.
HACCP can be applied throughout the food chain from primary production to final
consumption and its implementation should be guided by scientific evidence of risks to human
health. As well as enhancing food safety, implementation of HACCP can provide other
significant benefits. In addition, the application of HACCP systems can aid inspection by
regulatory authorities and promote international trade by increasing confidence in food safety.
The successful application of HACCP requires the full commitment and involvement of
management and the work force. It also requires a multidisciplinary approach; this approach
should include appropriate expertise, for example in agronomy, veterinary health, production,
microbiology, hygiene, medicine, public health, food technology, new product development,
environmental health, chemistry and engineering, according to the particular study. The
application of HACCP is compatible with the implementation of quality management systems,
such as ISO 9001, and is the system of choice in the management of food safety within such
systems.
While the application of HACCP to food safety is considered here, the concept can be applied
to other aspects of food quality.
For definitions concerning HACCP, refer to Appendix A.
For a full explanation of HACCP principles and the latest HACCP updates refer to Codex
General Principles of Food Hygiene: http://www.codexalimentarius.net/web/standard_list.do
For chilled foods, consideration of HACCP most often involves the identification and control of
microbiological hazards, particularly:
− presence (and growth) of infectious pathogens in ready-to-eat raw foods, e.g. Listeria
monocytogenes, salmonellae;
− survival and growth of vegetative and spore-forming pathogens in heat treated foods, e.g.
psychrotrophic Clostridium botulinum, Bacillus cereus.
Control of these organisms is reflected in the Decision Tree in Figure 1 (p38).
1.3.2 Prerequisites
The effective implementation of a food safety control system based on HACCP must be
supported by GMP and GHP, which are commonly known as prerequisite programmes.
Prerequisite programmes (see Section 2.4) may include e.g. (non-exhaustive list):
• building design and layout

• preventative maintenance
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• calibration
• pest control
• foreign body control
• traceability
• training
• supplier quality assurance
1.3.3 Principles
This section sets out the principles of the HACCP system adopted by the Codex Alimentarius
Commission. The second section provides general guidance for the application of the system
while recognising that the details of application may vary depending on the circumstances of
the food operation. 15
The HACCP system consists of the following seven principles:
− Principle 1: conduct a hazard analysis.

− Principle 2: determine the Critical Control Points (CCPs).
− Principle 3: establish critical limit(s).
− Principle 4: establish a system to monitor control of the CCPs.
− Principle 5: establish the corrective action to be taken when monitoring indicates that a
particular CCP is not under control.
− Principle 6: establish procedures for verification to confirm that the HACCP system is
working effectively.
− Principle 7: establish documentation concerning all procedures and records appropriate to
these principles and their application.
1.3.4 Guidelines for the Application of the HACCP System
The application of the HACCP principles is the responsibility of each individual business.
Management awareness and commitment are necessary for implementation of an effective

HACCP system. The effectiveness will also rely upon personnel having the appropriate
HACCP knowledge, skills, training and commitment.
In order to facilitate the successful application and implementation of the HACCP system, the
Food Business Operator (FBO) must have in place prerequisite programs such as good
hygienic practices according to the Codex General Principles of Food Hygiene, the
appropriate Codex Codes of Practice, and appropriate food safety requirements as set out in
these CFA Guidelines.
The HACCP plan must be validated prior to implementation. It must be reviewed and
revalidated when any modification is made in the product, process, or any step.
The application of HACCP principles consists of the tasks identified in the Logic Sequence for
Application of HACCP (Diagram 1).
15
The Principles of the HACCP System set the basis for the requirements for the application of HACCP, while the Guidelines for
the Application provide general guidance for practical application.
18 th
DIAGRAM 1
LOGIC SEQUENCE FOR THE APPLICATION OF HACCP
1. Assemble HACCP Team
2. Describe Product
3. Identify Intended Use
4. Construct Flow Diagram
5. On-site Confirmation of Flow Diagram
List all Potential Hazards

6. Conduct a Hazard Analysis
7. Determine CCPs See Diagram 2
8. Establish Critical Limits for each CCP
9. Establish a Monitoring System for each

CCP
Establish Corrective Actions

10 .
11 . Establish Verification Procedures
12 . Establish Documentation and Record

Keeping
Step 1: Assemble HACCP team
The food operation should assure that the appropriate product specific knowledge and
expertise are available for the development of an effective HACCP plan. Optimally, this may
be accomplished by assembling a multidisciplinary team. Where such expertise is not
available on site, expert advice should be obtained from other sources. The scope of the
HACCP plan should be identified. The scope should describe which segment of the food chain
is involved and the general classes of hazards to be addressed (e.g. does it cover all classes
of hazards or only selected classes).
th
Step 2: Describe the product
A full description of the product should be drawn up, including relevant safety information such
as:
− composition (such as formulation, pH, aw, preservatives, recipe);

− structure (such as multi-layer emulsion type);
− process details (such as mixing method, heat treatment, working method);
− packaging details (such as MAP, VP, aseptic fill or exposed to environment);
− expected performance of chill chain;
− target shelf-life (such as total life, consumer use);
− instructions for use (such as storage temperature, cooking instructions);
− intended use (such as: target population group [children, the elderly], single or multiple
use pack, ready-to-eat or requires heating or cooking by the consumer);
− sensory attributes/requirements.
Step 3: Identify intended use

The intended use should be based on the expected uses, including preparation of the product
by the end user or consumer. In specific cases, vulnerable groups of the population, e.g. those
receiving institutional feeding, may have to be considered.
Step 4: Construct flow diagram
The flow diagram should be constructed by the HACCP team. The flow diagram should cover
all steps in the operation. When applying HACCP to a given operation, consideration should
be given to steps preceding and following the specified operation.
The flow diagram should include as much information as possible about the intended
production process, including any potential alternatives under consideration and any potential
rework routes.
Examples of types of information required on the flow diagram are:

− lists of raw materials/ingredients/packaging;
− ingredients preparations (debagging, chopping, dipping, pre-mixing etc);
− correct sequence of proposed process steps;
− time/temperature conditions proposed for each step, to include potential for delay;
− possibility of rework/recycling (and likely routes, storage times, etc);
− equipment proposed;
− relevant analytical data for formulation and at process stages if parameters vary through
the proposed process (e.g. pH, aw, salt).
Step 5: On-site confirmation of flow diagram
The HACCP team for the intended manufacturing site must confirm that the process defined in
the flow diagram is feasible in routine production and amend the flow diagram where
appropriate.
20 th
Step 6: List all potential hazards and conduct a hazard analysis
The HACCP team should list all the hazards that may be reasonably expected to occur at
each step from primary production, processing, manufacture, and distribution until the point of
consumption.
The HACCP team should next conduct a hazard analysis to identify for the HACCP plan which
hazards are of such a nature that their elimination or reduction to acceptable levels is
essential to the production of a safe food.
In conducting the hazard analysis, wherever possible the following should be included:
− the likely occurrence of hazards and severity of their adverse health effects;
− the qualitative and/or quantitative evaluation of the presence of hazards;
− survival or multiplication of microorganisms of concern;
− production or persistence in foods of toxins, chemicals or physical agents;
− conditions leading to the above.
The HACCP team must then consider what control measures, if any, exist that can be applied
for each hazard.
More than one control measure may be required to control a specific hazard and more than
one hazard may be controlled by a specified control measure.
Step 7: Determine Critical Control Points
There may be more than one CCP at which control is applied to address the same hazard.
The determination of a CCP in the HACCP system can be facilitated by the application of a
HACCP Decision Tree (e.g. Diagram 2), which indicates a logical reasoning approach.
Training in the application of the Decision Tree is recommended.
All control options should be identified and evaluated to determine whether one or any
combination of them would be appropriate for the hazard in question, i.e. validated. With a
product under development the control options identified may be different for alternative
production processes.
If a hazard has been identified at a step where control is necessary for safety, and no control
measure exists at that step, or any other, then the product or process should be modified at
that step, or at any earlier or later stage, to include a control measure.
Step 8: Establish critical limits for each CCP
Critical limits must be specified and validated if possible for each Critical Control Point. In
some cases more than one critical limit will be elaborated at a particular step. Criteria often
used include measurements of temperature, time, moisture level, pH, aw, available chlorine,
and may include sensory parameters such as visual appearance and texture.
Step 9: Establish a monitoring system for each CCP
Monitoring is the scheduled measurement or observation of a CCP relative to its critical limits.
The monitoring procedures must be able to detect loss of control at the CCP. Further,
monitoring should ideally provide this information in time to make adjustments to ensure
control of the process to prevent violating the critical limits. Where possible, process
adjustments should be made when monitoring results indicate a trend towards loss of control
at a CCP. The adjustments should be taken before a deviation occurs. A designated person
with knowledge and authority to carry out corrective actions when indicated must evaluate
data derived from monitoring. If monitoring is not continuous, then the amount or frequency of
th
monitoring must be sufficient to guarantee that the CCP is in control. Most monitoring
procedures for CCPs will need to be done rapidly because they relate to on-line processes
and there will not be time for lengthy analytical testing. Physical and chemical measurements
are often preferred to microbiological testing because they may be done rapidly and can often
indicate the microbiological control of the product. All records and documents associated with
monitoring CCPs must be signed by the person(s) doing the monitoring and by the
responsible reviewing official(s) of the company. See Section 1.5.
Step 10: Establish corrective actions
Specific corrective actions must be developed for each CCP in the HACCP system in order to
deal with deviations when they occur.
The actions must ensure that the CCP has been brought under control. Actions taken must
also include proper disposition of the affected product. Deviation and product disposition
procedures must be documented in the HACCP record keeping.
Step 11: Establish verification procedures
Establish procedures for verification. Verification and auditing methods, procedures and tests,
including random sampling and analysis, can be used to determine if the HACCP system is
working correctly. The frequency of verification should be sufficient to confirm that the HACCP
system is working effectively. Examples of verification activities include:
− review of the HACCP system and its records;
− review of deviations and product dispositions;
− confirmation that CCPs are kept under control.
See Section 1.5.
Step 12: Establish documentation and record keeping
Efficient and accurate record keeping is essential to the application of a HACCP system.
HACCP procedures should be documented. Documentation and record keeping should be
appropriate to the nature and size of the operation.
Documentation examples are:

− hazard analysis;
− CCP determination;
− critical limit determination.
Record examples are:

− CCP monitoring activities;
− deviations and associated corrective actions;
− modifications to the HACCP system.
An example of a HACCP worksheet is attached as Diagram 3.
22 th
DIAGRAM 2
EXAMPLE OF DECISION TREE TO IDENTIFY CCPS
(answer questions in sequence)
Q1 Do preventative control measures exist?
Modify steps in the process or product

Yes No
Is control at this step necessary

Yes
for safety?
No Not a CCP Stop *
Q2 Is the step specifically designed to eliminate

or reduce the likely occurrence of a hazard Yes
to an acceptable level? **
No
Q3 Could contamination with identified

hazard(s) occur in excess of acceptable
level(s) or could these increase to
unacceptable levels? **
Yes No Not a CCP
Stop *
Q4 Will a subsequent step eliminate identified
hazard (s) or reduce likely occurrence to
acceptable level(s)? **
Critical Control Point

Yes No (CCP)
Not a CCP Stop *
* Proceed to the next identified hazard in the ** Acceptable and unacceptable levels
described process need to be determined within the overall
objectives in identifying the CCPs of the
HACCP plans
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DIAGRAM 3
EXAMPLE OF A HACCP WORKSHEET
Product Description
1.
2.
Process Flow Diagram
3. List
Step Hazard(s) Control CCP Critical Monitoring Corrective Records

Measure(s) Limits Procedures Actions
Verification Plan
4.
24 th
SECTION 1.4
HACCP IMPLEMENTATION
1.4.1 HACCP in New Product Development (NPD)
HACCP systems manage and control food safety but cannot make a fundamentally unsafe
product safe.
Food safety must be designed into a product at the development stage using HACCP
principles.
The prerequisites of HACCP – particularly GMP/GHP – must also be in place before a

HACCP system can be successful in securing food safety.
New products must have been designed to ensure safety before being presented to
customers.
Factors to be considered in detail during hazard analysis in NPD include:-
− product formulation including hurdles

− safety of raw materials
− intended use
− processing parameters
− manufacturing areas
− determination of safe shelf life
The sequence of activities in carrying out HACCP for NPD is very similar to that for current
products (see Section 1.3):-
STAGE 1 Describe the proposed product
The description should include the following information:
− composition (such as formulation, pH, aw, preservatives, recipe)

− structure (such as multi-layer emulsion type)
− process details (such as mixing method, heat treatment, working method)
− packaging details (such as MAP, VP, aseptic fill or exposed to environment)
− expected performance of chill chain
− target shelf-life (such as total life, consumer use)
− instructions for use (such as storage temperature, cooking instructions)
− intended use (such as target population group [children, the elderly], single or multiple
use pack, ready-to-eat or requires heating or cooking by the consumer)
− sensory attributes/requirements
STAGE 2 Prepare a Process Flow Diagram
This should include as much information as possible about the intended production process,
including any potential alternatives under consideration and any potential rework routes.
Examples of types of information required on the flow diagram are:
− lists of raw materials/ingredients/packaging

− ingredient preparations (debagging, chopping, dipping, pre-mixing, etc.)
− correct sequence of proposed process steps
− time-temperature conditions proposed for each step, to include potential for delay
− possibility of rework/recycling (and likely routes, storage times, etc.)
− equipment proposed
− relevant analytical data for formulation and at process stages if parameters vary
through the proposed process (i.e. pH, aw, salt, etc.)
th
A team comprising a Quality Manager or Technical Manager and Production
Manager/Supervisor for the intended manufacturing site must confirm that the proposed
process is feasible in routine production.
STAGE 3 Identify hazards associated with each process stage
List all hazards that might reasonably be expected to occur at each process stage.
STAGE 4 Select control measures
List all control points available to eliminate or reduce each hazard to an acceptable level.
Note:
With a development product there may be different control options available for different
production process alternatives (see Stage 2 above). All such options should be listed as
relevant to each process alternative.
− Evaluate the control options to determine whether one or any combination of them would
be appropriate for the hazard in question.
If control cannot be achieved, then all features of product formulation, intended use and
process should be reconsidered to establish whether any modification is available/possible
that will allow control of the hazard. Newly established control measures should be identified
on the record.
Once all control measures for all hazards have been identified, documentation should be
finalised and the team confirm that the product is suitable to advance to full HACCP
assessment and product launch.
1.4.2 Establishing a Safe Raw Materials Supply
Safe products require the understanding of hazards and risks associated with the raw
materials used.
Either
• Raw materials must contain no hazards, or

• Any hazards present must be controlled to an acceptable level by the process.
The level of control required over a raw material depends on the way in which it will be
handled and processed; e.g., herbs going into a product to be cooked may require less
emphasis on microbiological control at the raw material stage than those being used as a
garnish on a ready-to-eat product.
See Section 3.2 for further information.
26 th
SECTION 1.5
HACCP MONITORING, VERIFICATION AND DOCUMENTATION
1.5.1 Introduction
End product specifications must reflect legal requirements for food safety.
Confidence in respect of the implementation of the measures described in the Guidelines and
of those described in HACCP plans for each product is ensured by:
• monitoring actions (measurements, observations) which are implemented, in particular at

each CCP
• verification of the correct implementation of the HACCP plan
• management of non-conformities
• records and document management.
1.5.2 Monitoring
To ensure the correct implementation of GMP requirements and control measures defined in
the HACCP plans, a monitoring plan must be set up, documented and carried out. The plan
should indicate for each point to be monitored:
• the criteria to be monitored

• the persons in charge of the monitoring
• the monitoring frequency
• the sampling procedure
• the monitoring method to be used
• the target level, tolerances and critical limit
• the recording of monitoring results
• the measures to be taken in case of non-conformity
Monitoring methods can comprise actions such as measuring process parameters, checking
process records, analysing samples, visual inspection or auditing.
Analytical methods used must be validated against the appropriate reference method.
Each monitoring activity must be recorded. The record should include:
• the product identification information such as product name, product number or batch
code
• the time of monitoring
• the relevant sampling conditions such as product temperature
• the person who was in charge of the monitoring
• the result, preferably quantified,
• proof that measures were taken in case of nonconformity
Monitoring of CCPs is mandatory and must be done according to documented procedures.
1.5.2.1 Monitoring at Intake
Monitoring at intake allows verification of compliance of raw material with

specifications.
Monitoring frequency of raw materials takes into account the confidence that the user
has in the supplier, based on elements such as supplier auditing, previous test results,
certificates of analysis, or product complaints (see Section 3.2 on Supplier Quality
Assurance).
th
Raw material monitoring should be done before use. Where this is not possible, the
corrective action plan must include handling and disposal of any affected raw material,
work in progress or finished product.
The personnel in charge of the monitoring at intake must be appropriately trained and
qualified. Specific training in organoleptic assessment may be required.
Monitoring of incoming materials may include, for example:
• vehicle cleanliness, vehicle temperature, product temperature

• integrity of the raw material packaging
• raw material labelling
• visual inspection
• absence of foreign bodies
• organoleptic characteristics: appearance, odour, taste
• microbiological analysis of raw material and packaging
• physical and chemical analysis.
Unacceptable raw material must be identified and stored separately for appropriate
disposal.
1.5.2.2 Monitoring during processing
Monitoring during processing may include, for example:
• monitoring in-process material where appropriate

• checking process temperatures and times (such as heating, cooling or
thawing)
• checking the packaging integrity (such as film resistance to the different
treatments, seal integrity, absence of leaks, gas composition)
• monitoring the efficiency of cleaning and disinfection
• monitoring the condition of process equipment.
Unacceptable product or in-process material must be identified and stored separately

for appropriate disposal.
1.5.2.3 Monitoring of finished products
On the condition that all CCPs on raw material and products during processing are
monitored correctly and there are no non-compliances, no particular monitoring of
finished products will be required.
Verification of compliance with specification should be carried out according to a

planned schedule.
1.5.2.4 Monitoring personnel hygiene
Monitoring the hygiene of personnel in production may include, for example:
• visual inspection of cleanliness

• correct wearing of the factory clothing
• respect of hygiene rules and working procedures
• observation of hand washing requirements and monitoring of hand hygiene
• medical screening
1.5.3 Management of non-conformities
Non-conformity occurs when the result(s) of monitoring do not comply with pre-determined
standards defined in product specifications (raw material, in-process products, finished
products) or process specifications. Remedial actions form the basis of the management of
non-conformities.
28 th
The management of non-conformities consists of the following elements:
• Identification of the non-conformity that may be classified into one of three categories:
• critical: non-conformity that presents a safety hazard for the consumer; the result is
outside the critical limit in the HACCP plan;
• major: non-conformity unacceptable for the product quality;
• minor: non-conformity that does not affect the consumer safety or the essential
product quality characteristics.
• Containment of the problem such as segregation of affected product, stopping the
production, or isolation of damaged equipment.
• Remedial actions in order to prevent a reoccurrence of the non-conformity such as
adjusting the process, repairing equipment, retraining personnel or changing work
instructions.
• Disposal of any affected product, if relevant such as its safe reprocessing, reworking, or
destroying.
• Reviewing HACCP and GHP.
• Recording of all the above-mentioned elements.
Non-conformities must be managed by appropriately trained, qualified and authorised

personnel. Responsibilities must be clearly defined by management (see ‘Management
Responsibilities', p5).
1.5.4 Verification
Verification must be regularly performed to demonstrate compliance to Good Manufacturing

Practice and HACCP-based systems. Verification activities should include, for example:
• relevant microbiological and chemical analyses at the stage of raw materials, in-process
products or finished product according to a predetermined sampling plan;
• environmental testing to verify efficiency of cleaning and disinfection;
• audits such as on hygiene, HACCP, suppliers, quality systems, management of non-
conformities;
• revalidation of processes such as the performance of heat-treatment equipment, the rate
of cooling or hurdles used to control the growth of pathogenic organisms.
Particular attention should be paid to the microbiological verification of HACCP. Additional

CFA guidance (‘Microbiological Testing and Interpretation within HACCP’) provides further
detail to that given below.
Microbiological verification of HACCP should include the following elements:
1.5.4.1 Microbiological criteria
Microbiological criteria define the acceptability of a product, a batch of foodstuffs or a

process, based on the absence or presence, or number of microorganisms, and/or
quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch.
It is important to note that raw material/product testing cannot be used as a control

measure. Hazard control in the field and factory is key. Indiscriminate application of
microbiological testing and criteria should be avoided. However, microbiological
criteria are necessary to assist in verifying HACCP plans and in shelf life studies
where storage trials and challenge tests are needed.
See Section 3.1 for further information regarding the EC Regulation on Microbiological
Criteria for Foodstuffs.
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1.5.4.2 Sampling and testing
Microorganisms are rarely distributed homogeneously in a product or a batch. In

particular, pathogens, if present, are usually at low levels. The only way
microbiological testing and associated criteria can be totally reliable is by adoption of
100% inspection with methods of 100% reliability and accuracy. This cannot be done
since current methods are not 100% reliable or accurate and are effectively
destructive.
Examination of a material for indicator or spoilage organisms can provide simple,

reliable and rapid information about processing failure, post-processing
contamination, contamination from the environment and the general level of hygiene.
Where greater confidence is required, a recognised sampling plan may be used,

which includes the sampling procedure and the decision criteria to be applied to a lot,
based on examination of a prescribed number of sample units and subsequent
analytical units of a stated size by defined methods. The sampling plan is determined
by risk assessment taking into account the hygiene status of the product (raw or
cooked, for example) and its intended use (ready-to-eat or to be cooked).
These methods cannot replace examination for specific pathogens where suitable
methods exist and where such testing is appropriate, but usually provide information
in a shorter time than that required for isolation and identification of specific organisms
or pathogens.
Laboratory testing should be undertaken appropriate to both the type of the food and
to the processing it has received. Methods should be:
• reference methods, or
• validated alternative methods
1.5.4.3 Environmental monitoring
Environmental monitoring is used to verify the efficiency of cleaning and disinfection.

It will involve sampling of both product contact and non-contact surfaces after cleaning
and disinfection and may use microbiological samples such as swabs or contact
plates and/or non-microbiological indicator systems such as ATP swabs or rinses.
• Rapid Hygiene Monitoring ATP swabbing and similar rapid hygiene monitoring
systems give a result that can be interpreted before start-up. This is then a
means of monitoring rather than verification. As such testing is relatively
expensive, it is best used to monitor specific CCPs (e.g. cutting knives for cooked
meat in a sandwich plant). Manufacturers of systems will advise on the setting of
standards.
• Microbiological Testing The results of environmental microbiological tests are

not available soon enough to be used for CCP monitoring, but can be used to
verify cleaning and disinfection, to monitor trends and for investigation purposes.
During commissioning of new plant, equipment or processes, including cleaning and

disinfection systems, extensive environmental sampling is an effective means of
confirming that the intended cleaning and disinfection methods are effective (can be
by rapid and/or microbiological testing).
When to Sample
Environmental monitoring should be done after cleaning and disinfection and

immediately before start-up of production. Any surfaces that are not visibly clean at
this point must be re-cleaned before swabbing (swab results do not add any value in
such cases).
30 th
The operator should decide on the points to be swabbed, selecting items that are
particularly difficult to clean and/or have been shown to cause problems in the past.
During commissioning, a large number of items may be tested, the number being
reduced once confidence in cleaning methods is established.
It is good practice to rotate sample points and lines tested as well as the shift, time
and day of sampling.
What to Test For
Microbiological testing will usually be for indicator organisms only (ACC - aerobic
colony count, Enterobacteriaceae, yeasts and moulds).
Specific pathogen testing can also be useful in some circumstances; e.g. testing of
environmental swabs from a High Care or High Risk Area for Listeria spp. on a regular
basis can be used to confirm that this organism is not building up in the environment.
Environmental swabbing is required for ready to eat foods under the EC Regulation
on Microbiological Criteria for Foodstuffs and is strongly recommended in High Care
and High Risk Areas generally.
1.5.4.4 Interpretation of data
Interpretation of test results against microbiological criteria must be based on

knowledge of the product components and the production process.
In addition to interpreting individual results, trend data should be generated.
Some examples regarding the interpretation of microbiological data are given below:
Foodstuffs:
• When an unsatisfactory ACC is encountered, the microorganisms that

predominate should be identified in order to provide a more helpful interpretation.
For example, the inclusion of ingredients such as cheese or salami may contribute
to a high ACC owing to the presence of lactic acid bacteria in these ingredients.
• When sampling fresh fruit and vegetables or products containing them, it is
important to note that testing for Enterobacteriaceae will not provide useful
information since these materials often carry high levels of these organisms as
part of their normal flora.
Environmental:
Standards to be applied will vary according to the type of equipment, its material of
manufacture, its age and its use (e.g. stainless steel surfaces used for cooked meat a
total aerobic count of <100 cfu/100 cm² may be acceptable, whereas a similar surface
used for raw meat may be acceptable at <400 cfu/100 cm²). Enterobacteriaceae
should be absent from product contact surfaces after cleaning. The operator should
decide on standards based on knowledge of product, equipment and cleaning
method.
1.5.4.5 Corrective actions and feedback loop
When tests provide unsatisfactory results, corrective actions defined by HACCP should
be taken. In addition, the cause(s) of the unsatisfactory results should be identified to
prevent its (their) recurrence
Listeria spp. should not (or only rarely) be detected in a High Care or High Risk Area,
even in floor/drain swabs, if cleaning is effective. Action must be taken if positives are
found. This should include, e.g.
• review of cleaning methods
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• reswabbing (after re-cleaning)
• review of product results.
For further detail see Section 1.5.3.
1.5.5 Documentation
Sufficient information must be available to demonstrate control, in particular at the CCPs.
Such information must be filed and may include:
− procedures, data and calculations used to elaborate and validate the processes
(scheduled heat or other preservation treatments, cooling methods);
− if applicable, procedures, data and records establishing the efficacy of hurdles used;
− procedures, data and records relevant to the establishment and validation of the product
shelf life;
− any changes made to the product, processes or other factors used in establishing the
scheduled heat or other treatments;
− documents and records linked with the HACCP plan (including the hazard analysis).
1.5.6 Records
Records are the pieces of evidence showing that the required hygienic quality is achieved and
that the measures implemented according to the HACCP plan are efficient.
Records can also be used for product traceability.
Records can be:
• purchase orders, delivery orders from the supplier

• stock cards
• consignment documents
• monitoring records, such as:
o all CCP records
o for personnel hygiene monitoring, microbiological testing results, personnel
certificates, evaluation/qualification files
o monitoring records at intake (compliance with the specifications)
o temperature records (products, premises, transport vehicles, equipment)
o results of microbiological, chemical and physical testing (products, packaging, fluids,
packaging gas)
o for cleaning and disinfection monitoring, check-list, results of microbiological testing,
results of visual inspection
Adequate documentation and records must be readily available to demonstrate compliance

with these Guidelines, and should be retained according to legal requirements or, if not
specified, for a minimum of one year past the shelf life of the product.
All documents concerning hygiene control, procedures and instructions as well as raw material
specifications, processing and monitoring data sheets should be identified, distributed as
needed, filed and kept up to date.
32 th
SECTION 1.6
SHELF LIFE ASSESSMENT
1.6.1 Introduction
Shelf life is defined as the period of time for which a product remains safe and meets its
quality specifications under expected storage and use conditions. The shelf life determines
the durability date (Use By or Best Before). See Section 1.6.5.
The manufacturer is responsible for setting the shelf life under defined conditions and must
take into account microbiological safety and stability, physical characteristics (such as texture
and colour) and organoleptic quality.
Chilled prepared foods are traditionally short shelf life and the end of shelf life is determined
more by organoleptic than microbiological factors.
However, should the acceptable shelf life for either physical condition or organoleptic
quality exceed that for microbiological safety and stability, the assigned shelf life must
be that determined for microbiological safety and stability.
Safety is not determined by testing. It is paramount that safety is designed into the
product. The only time that pathogen testing is required is during validation of a new
process or in the case of a new material being used. In each case pathogen testing
should be carried out prior to trialling in the factory.
There are technical limits to shelf life for chilled foods in relation to the thermal process used:-
• Maximum 10 days - Listeria monocytogenes is the target organism to be controlled. A 6-

log reduction process is required, for example using a thermal process of at least 70°C for
2 mins, or equivalent. Consideration must be given to the possibility of post-process
contamination.
• More than 10 days – psychrotrophic Clostridium botulinum is the target organism to be
controlled. A 6-log reduction process is required, using a thermal process of at least 90°C
for 10 mins, or equivalent. Consideration must be given to the possibility of post-process
contamination. Non-thermal means of preventing growth are described in Section 1.2,
Intrinsic preservation factors ('Hurdles'). Hurdles can also comprise a combination of
thermal and non-thermal controls. B.cereus should also be considered as a target
organism for long shelf life products. It is managed using raw material controls, rapid
chilling after cooking, storage temperature control and shelf life limitation (see Section
1.2.1.1).
See Lethal Rate tables for Listeria monocytogenes and psychrotrophic Clostridium botulinum
for equivalents (Tables 3 and 4).
This section of the document considers microbiological safety and stability.
1.6.2 Shelf Life Determination
Pathogens must be accounted for by safe product and process design (see Section 1.2).
Identification of the relevant pathogens is critical for the successful assessment of safe shelf
life.
Determination of safe shelf life may involve, for example:

− a review of relevant scientific information, e.g. characteristics of microorganisms;
− use of predictive modelling programs, some of which are publicly available, such as
ComBase, USDA Pathogen Modeling Program or Growth Predictor;
− challenge testing with the relevant pathogens where predictive modelling does not give
sufficient confidence to set a safe shelf life on its own;
− storage trials (see below).
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It is important to recognise that, for many chilled foods, it may be necessary to identify a
combination of factors to assure safety. This will include the heat treatment applied, the
intrinsic properties of the food or mild preservatives that may be added and/or consideration of
shelf life (time and temperature). The assessment of shelf life must take into account storage
conditions, the performance of the chill chain, in terms of temperature and time, as well as
reasonable consumer handling in the market or country of concern. These aspects must be
taken into account as part of HACCP.
Where these do not give sufficient confidence to set a safe shelf life on their own, the
manufacturer should consider the use of challenge testing (CCFRA Technical Manual No 20).
NOTE: Contamination with pathogens such as Salmonella, Listeria monocytogenes,

psychrotrophic Clostridium botulinum and E. coli O157 H7 is expected to be very rare
in products produced following these Guidelines. There is therefore little or no value
in testing for such organisms during shelf life validation studies. Testing will therefore
usually be restricted to indicator and spoilage organisms.
As a minimum, it is recommended that the shelf life of all products must be validated using
storage and microbiological risk assessment as described below.
Shelf life studies and review of the HACCP plan should be carried out in the following
circumstances:-
• new product development, modification or extension

• new process development or modification
• new packaging development
• range extensions
• any change of ingredient/s or packaging to an existing product
• shelf life extensions on existing products
• change of production site
• change or movement of production equipment that could influence the site plan
Challenge testing with relevant pathogens should only be carried out where it is considered
necessary to validate the growth and/or survival characteristics of specific pathogens in a
chilled food product.
1.6.3 Proposed Design of Shelf Life Storage and Testing Studies
Expected storage conditions should be taken into account during
• despatch
• distribution
• retail
• reasonable consumer handling in terms of temperature and time
The performance of the chill chain, including consumer handling and domestic storage, should
be reflected in the test conditions used, e.g.
• storage at 5°C (± 1°C)

• subjecting products to 2 hours’ abuse at a target temperature of 22°C (± 1°C)
• storage at 7°C (± 1°C) for the remainder of the study.
The number of shelf life trial studies required must be decided by the development team and
site quality/technical personnel based on HACCP validation requirements.
Samples must be taken such that they will be representative of the whole run and adequate
for testing. A different product sample must be used for each different test point.
The frequency of testing will be dependent on the target shelf life (the day of
production/packaging is identified as day 0). This should aim to ensure that the product is
34 th
tested at several time points during the storage period (such as beginning of life, end of life
and twice in-between); however this may not be possible for very short shelf life products.
The number of samples required will be determined by the frequency of testing.
Microbiological tests required must be relevant to the food examined and will be determined
by HACCP principles, assessing relevant indicators and spoilage microorganisms.
The testing laboratory must be proven to be competent in the tests carried out and must use
official methods (or validated alternatives).
Shelf life trial protocols must be agreed with the relevant laboratory/ies before samples are
submitted.
1.6.4 Assignment of Shelf Life
The maximum permissible shelf life is determined on the basis of microbiological safety and
stability, physical condition and organoleptic quality, whichever is the shorter. Should the
acceptable shelf life for either physical condition or organoleptic quality seemingly exceed that
for microbiological safety and stability, the assigned shelf life must be that determined for
microbiological safety and stability. The maximum shelf life achievable on the basis of
chemical, physical and organoleptic test results must also be assessed and taken into account
when deciding on the shelf life of the product.
1.6.5 Use By and Best Before
As chilled foods are highly perishable products, in general the date of minimum durability must
be indicated with ‘Use By’. Exceptions may exist but these should be validated through
HACCP plans and must be in accordance with national legislation.
The ‘Use By’ or ‘Best Before’ date is fixed by taking into account:
• the result of shelf life determination test

• safety margins to be deducted from the maximum shelf life
• determination of day zero
1.6.6 Monitoring and Verification of Shelf Life
Ongoing monitoring and verification of shelf life are necessary to confirm maintenance of the
agreed shelf life for each product.
This can be done by:
• monitoring complaints
• carrying out an annual shelf life assessment (see Section 1.6.2)
• carrying out organoleptic assessment
A representative number of samples covering the whole production run must be taken.
Samples must be stored under the same conditions used to determine the shelf life initially.
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36 th
PART 2
GMP & GHP
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SECTION 2.1
DECISION TREE TO DETERMINE THE MINIMUM HYGIENE STATUS REQUIRED
The Decision Tree (Figure 1) appearing on the following page must be used, together with hazard
analysis and information on any heat processes used, to determine the minimum hygiene standards
applicable to each product in question where no other hurdles are used.
The Decision Tree shows the minimum hygiene status (LRA, HCA, HRA) of the product handling
environment between heat treatment and final packaging. Both the heat treatment (if any) applied
during the processing and any microbiological hazards arising between the heat treatment and the
final packaging must be considered.
Table 2 (Control application examples and essential elements) in Section 1.2 indicates the selection of
minimum hygiene standards where non-thermal hurdles are used to control Listeria monocytogenes.
Good Manufacturing Practice standards as set out in the table are required as the baseline in
the Low Risk Area.
An example of how the standards may be applied in factory organisation is shown in Figure 2.
A detailed description of the requirements in each area (LRA, HCA, HRA) is given in Section 2.2.
The status areas highlighted are minima for each type of product. Higher standards can be used, but
due regard should be paid to the potential for cross-contamination between lower status and higher
status products (e.g. delicatessen products, some of which may contain uncooked components and
others fully cooked) within a single status environment. Expert advice should be sought if necessary.
Deviations from the Decision Tree approach must be validated.
Examples of the use of these Decision Trees are given in Appendix B.
38 th
Figure 1: Decision Tree to determine the minimum hygienic status required for chilled products
EQUIVALENT HEAT MINIMUM

POST-
RISK OF
TREATMENT HYGIENE
EFFECT OF HEAT TREATMENT PROCESS REMAINING HAZARDS TO BE ELIMINATED OR CONTROLLED
DURING LEVEL
CONTAMINATION?
PROCESSING REQUIRED
Vegetative pathogens and Recontamination by pathogens such as Listeria spp. must be

Î YES Î Î HRA
psychrotrophic C. botulinum controlled by strict hygiene to achieve extended shelf life
All components are destroyed while other
Î YES Î 16
≥ 90°C/10 min? more heat-resistant spore- B. cereus may present a hazard for extended shelf life. It is
formers such as B. cereus Î NO Î managed by controlling raw materials, rapid chilling, storage Î LRA
may survive temperature and shelf life
Ð NO
Recontamination by pathogens such as Listeria spp. must be
Vegetative pathogens such Î YES Î controlled by strict hygiene and hurdles against C botulinum Î HRA
as Listeria spp. are must be used to achieve extended shelf life (>10 days).
All components
Î YES Î destroyed but C. botulinum
≥ 70°C/2 min? *
and B. cereus remain a C. botulinum and B. cereus may present a hazard. Hurdles
hazard Î NO Î against C. botulinum must be used to achieve extended shelf Î LRA
life (>10 days).
INTENDED TO BE
Ð NO COOKED BEFORE
CONSUMPTION?
Pathogens may remain from original components or
recontamination. Further contamination needs to be limited
Î NO Î Î HCA
by HCA but shelf life may need to be short unless sufficient
Not all hurdles used (see above)
All types of pathogens
components Î YES Î
remain a hazard
≥ 70°C/2 min? Pathogens may remain from original components or
recontamination. Cooking instructions must be validated.
Î YES Î Î LRA
Shelf life may need to be short unless sufficient hurdles used
(see above)
*
B. cereus is managed by controlling raw materials, compositional factors (see Table 1, p8), rapid chilling, storage temperature and shelf life
Note: this decision tree does not take into account the use of hurdles other than heat treatment. Refer to section 1.2.3 (Microbiological Risk Assessment) and
examples of usage of the decision tree (Appendix B)
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Figure 2: Hygiene areas for manufacture
Low Risk Entry Points HIGH CARE AREA Low Risk Packing
Cooking
Vegetable washing
Intake Sanitised transfer Ready to-Eat
Debox areas Ambient stable transfer e.g. bread Ready-to-Reheat
Raw material storage All Factories
Uncooked ingredient storage and preparation Sealed packaged products for labelling/sealing and
Waste out Entry Points boxing
Raw product assembly (quiche, ready meal pre- Storage and despatch
HIGH RISK AREA
retort sauce cook)
Assembly of ready-to-cook or uncooked products
Cooking
Sanitised transfer (e.g. cans, packaging)
Ready-to-eat
Ready-to-cook Ready-to-reheat
CFA Definition
Low Risk Area High Care Area High Risk Area
Good Manufacturing Practice Chilled area designed to a high standard of hygiene where Physically segregated area designated to a high standard of hygiene
practices relating to personnel, ingredients, equipment and where practices relating to personnel, ingredients, equipment and
environment to minimise contamination by microorganisms environment aim to prevent contamination by pathogenic microorganisms
Product and Factory Fit
Example: Assembly of cooked proteins with some element of uncooked All components fully cooked into the area; the only exception is cheese
Uncooked ready meals vegetables, prepared and washed/treated at/on the barrier into topping (made from pasteurised milk) e.g. on lasagne.
high care
Example:
Ready-to-Cook Sandwiches Ready-to-eat Example: Ready-to-eat
Ready-to-reheat Ready meals Ready-to-heat
Spreads
Cooked meats
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40 © CFA Best Practice Guidelines for the Production of Chilled Food, 4 edition 2006
SECTION 2.2
HYGIENE
2.2.1 Basic Principles of Hygienic Manufacturing
In manufacturing it is critical that the whole supply chain from raw material production to retail
sale operates to guarantee the safety and quality of the final product. Since chilled prepared
foods and their raw materials have limited shelf lives they cannot rely on product testing prior
to delivery and/or processing.
The emphasis must therefore be on effectively managed controls. Each operator in the chain
must work according to GHP/GMP and HACCP principles.
The operations of the suppliers of raw materials must be monitored by the manufacturer to
ensure the suppliers work as agreed and that the raw materials meet the specifications set.
For the chilled food manufacturer, hygienic processing can be summarised by the simple “4 C
principle”:
− Keep Clean
− Cook properly (selecting the thermal process in accordance with the required shelf life –
see Appendices D and E)
− keep Cold
− avoid Cross contamination.
If these principles cannot be followed, there will be a risk of contamination or pathogen growth,
which must then be controlled by other means.
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SECTION 2.3
CATEGORISATION AND SEGREGATION OF PRODUCTION AREAS
Basic legislation and guidance exist at national, EU and Codex Alimentarius level. The CFA
Guidelines are complementary to the legal text, providing additional detail to assist the food
business operator in assuring product safety.
Ensuring hygienic manufacture requires the application of Good Manufacturing Practice,

which includes management of
• raw materials and packaging materials (refer to CFA’s Packaging Hygiene Guidelines);
• premises and facilities;
• equipment;
• personnel and training;
• operational and hygiene controls.
Depending on the type of product that is produced different requirements apply. A Table
distinguishing between the hygiene levels required in these three areas is provided in Section
2.4.
The manufacturing area is separated into three categories according to hygiene requirements:
Low Risk Area, High Care Area and High Risk Area. Premises layout is designed in this way
to control risks of cross contamination.
• A Good Manufacturing Practice (GMP) standard is used throughout the plant and is the
baseline in the Low Risk Area (LRA). For High Care and High Risk Areas specific
additional requirements are to be followed.
• A High Care Area (HCA) is a physically segregated area designed to a high standard of
hygiene where practices relating to personnel, ingredients, equipment and environment
are managed to minimise contamination by microorganisms. Only prepared ready-to-eat
materials washed/treated at the barrier into the area can be brought into it.
• A High Risk Area (HRA) is a physically segregated area designed to a high standard of
hygiene where practices relating to personnel, ingredients, equipment and environment
are managed to prevent contamination by pathogenic microorganisms. Only prepared
ready-to-eat materials that have been decontaminated (i.e. equivalent to a 6 log reduction
of Listeria monocytogenes) are allowed to be brought into this area
Areas should be designed to minimise the potential for build-up of contamination and to
maximise the ease of cleaning and disinfection.
To keep raw materials, in-process products and final products in optimal condition and
protected from cross contamination, storage and processing facilities should always follow the
principles of "one-way-flow" and "first in, first out" and be equipped to maintain temperature,
humidity and ventilation.
The different areas (LRA, HCA, HRA) must be separated.
42 th
SECTION 2.4
TABLES OF GENERAL GMP/GHP REQUIREMENTS
The following is intended to serve as a useful check-list for standards required for the manufacture of chilled prepared food. The list begins with Good
Manufacturing Practices (GMP), which constitute the minimum for hygienic manufacturing practices and which apply to the Low Risk Area (LRA). A reference
to additional requirements for High Care Area (HCA) and High Risk Area (HRA) are indicated, where appropriate.
Colour key:
Green Minimum GMP requirement

Yellow HCA-specific in addition to minimum requirement
Red HRA-specific in addition to minimum requirement
White Applicable in addition to minimum requirement
GMP/GHP REQUIREMENTS
2.3.1 RAW MATERIALS AND PACKAGING MATERIALS
Raw materials and packaging materials must be purchased to agreed specifications and from suppliers who comply with Good Manufacturing Practice and
HACCP, and who can demonstrate compliance with all relevant legislation.
2.3.1.1 Specifications
Raw material specifications, including specification for the packaging materials, should be determined through application of HACCP principles and be validated
during the design phase.
The operator should prepare a specifications manual covering:
− details of the supplier and manufacturing/supply site;

− description of the raw material and its functionality;
− ingredients breakdown;
− labelling requirements;
− microbiological, chemical, physical, organoleptic characteristics of the delivered products;
− target values and critical acceptance limits;
− packaging materials, description of pack type, size and quantity;
− storage and distribution conditions;
− safe handling and use instructions;
In addition, procedures should be available that identify monitoring actions at intake, provisions to be taken in case of non-conformity and the responsibilities of
the supplier and the processor in case of dispute.
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GMP/GHP REQUIREMENTS
2.3.1.2 Supplier evaluation
Suppliers should be selected in order to obtain raw materials of required quality and safety. The supplier evaluation should focus especially on:
− their ability to comply with the specifications manual;

− the existence or not of a quality management system and of the supplier’s monitoring procedures;
− the supplier technical abilities, etc.
To evaluate the suppliers, the processor may use several means, such as sample analysis and/or auditing (see section 3.2) for assessment of their quality
management system).
2.3.1.3 Monitoring at intake
Raw materials must be checked against appropriate critical acceptance limits (see Section 1.5.2.1).
2.3.1.4 Storage
Raw materials must be stored as quickly as possible after delivery in adequate, specifically designated areas and under hygienic conditions that prevent
contamination by microorganisms, insects, rodents, foreign bodies and chemicals and to avoid adverse physical conditions.
Raw materials that are subject to spoilage should be placed without delay in cold storage at the appropriate temperature.
Storage areas must be designed to be easily cleaned, to provide ready access to the stored items and good circulation of air around the stored items.
All temperature and humidity controlled areas should be fitted with monitoring and recording devices and a reliable system (e.g. alarm) designed to signal loss of
control. They should have sufficient capacity to maintain product temperatures during anticipated high ambient temperatures and peak loads.
Documented procedures must specify necessary action to be taken in case of failure.
All batches of raw material must be coded and an appropriate stock control procedure used (see Section 3.3).
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HIGH CARE AREA (HCA) HIGH RISK AREA (HRA)
GMP REQUIREMENTS
REQUIREMENTS REQUIREMENTS
2.3.2 PREMISES AND FACILITIES
2.3.2.1 Surfaces (floors, walls and ceilings)

All surfaces of rooms i.e. walls, ceilings and floors should be sealed All surfaces of rooms, i.e. walls, ceilings and floors, must be sealed and impervious
and impervious to water and must be capable of being cleaned and to water and must be capable of being cleaned and being kept in a dry condition.
being kept in a dry condition.
Floors should be sloped to gullies and drains so that pools of water do not collect. All wall/floor, wall/wall and wall/ceiling junctions should be coved where
possible to facilitate easier cleaning.
Floor drains and gullies must be designed and maintained to Floor drains and gullies must drain away Floor drains and gullies must drain away
prevent back-ups, to be cleanable and properly trapped. Drainage from the High Care Area. from the High Risk Area.
flow should be away from the final product preparation areas.
2.3.2.2 Entrances (doors and windows)

Internal doors should and external doors must be tightly fitting. Doors must be tightly fitting.
Windows should be unopenable or otherwise they must be Windows must be unopenable.
appropriately screened.
2.3.2.3 Lighting
All lighting should be of a suitable intensity and be appropriately guarded.
2.3.2.4 Services
Services must be installed in such a manner as to minimise their Services must be installed in such a manner as to minimise their potential as dust
potential as dust traps. Service pipes (e.g. steam, water) should be traps. Service pipes (e.g. steam, water) must be hygienically lagged to prevent
hygienically lagged to prevent condensation forming on their condensation forming on their surfaces.
surfaces.
Water, steam and ice which is in direct contact with food must be potable, in compliance with the applicable legislation.
Non-potable water used for the generation of steam, refrigeration, fire control and other similar purposes not relating to food must be conducted in separate
systems, readily identifiable and having no connection with or any possibility of reflux into the potable water systems.
Waste water from refrigeration equipment, hand and equipment Waste water from refrigeration equipment, hand and equipment wash facilities, etc.,
wash facilities, etc., should be trapped to drain in such a way as to must be trapped to drain in such a way as to prevent any risk of product
prevent any risk of product contamination. contamination.
Particular attention must be paid to the risk of back-siphoning of condensate water from refrigeration equipment drain systems.
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GMP REQUIREMENTS
2.3.2.5 Temperature control and recording

The temperature and humidity of the storage and production areas must be controlled such that product safety and shelf life are assured; e.g. for chilled products
it may be helpful to maintain production areas at 12ºC or less. The general chilling of an entire area should be used only where it is impractical to have localised
product chilling.
All temperature and humidity controlled areas must have sufficient capacity to maintain product temperatures during anticipated high ambient temperatures and
peak loads. They should be fitted with monitoring and recording devices and a reliable system (e.g. alarm) designed to signal loss of control.
2.3.2.6 Staff facilities

Adequate hand washing facilities must be appropriately sited. Taps must not be hand-operable.
Hand drying facilities must be provided and disposable towels Hand drying facilities must be provided and disposable towels must be used.
should be used.
Cloakrooms and toilets must not open directly into any food handling areas.
2.3.2.7 Air quality

Ventilation and air-handling systems must be hygienically designed. Regard must be made to the location of the plant and any environmental factors that might
present a significant risk of product contamination.
No specific GMP requirements Air supplies to High Care Areas must be Air supplies to High Risk Areas must be
filtered or otherwise treated to remove filtered or otherwise treated to remove
particles to a standard of class H11, particles to a standard of class H11,
dependent on requirements indicated by a dependent on requirements indicated by
HACCP study. a HACCP study.
No specific GMP requirements Air systems must be designed and operated such that condensation and dust are
avoided. The number of air changes and conditioning of air should eliminate
condensation and be capable of achieving the specified conditions for that operation.
No specific GMP requirements Air systems must be managed efficiently by means of frequent inspection of the
equipment including, filters, environmental monitoring of microbial loads in the
assembly room air, and corrective action procedures.
No specific GMP requirements The balance of filtered air flow must maintain the area at a positive pressure with
respect to the raw materials and tray wash areas and away from areas where finished
products are assembled. The number of air changes and conditioning of the air must
minimise condensation. The minimum number of air changes should be six per hour
but will depend on the heat load, overpressure requirements, air loss to other areas
and ventilation requirements of the area. See Appendix H for further details.
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GMP REQUIREMENTS
2.3.3 EQUIPMENT
2.3.3.1 Design and location of equipment

Equipment including fillers, conveyors, transfer belts and packaging equipment must be designed to be cleanable and capable of being decontaminated. See
CFA Hygienic Design Guidelines and various EHEDG guidelines.
Such equipment must be installed and operated such that product assembly can be conducted under consistently good conditions minimising the time for which
product is exposed to the environment.
No specific GMP requirements Equipment must be correctly positioned at the barrier to prevent backward flow of
product and materials and to prevent recontamination.
2.3.3.2 Equipment for handling products in HCA and HRA

Not applicable All equipment and utensils used for handling products after heating must be cleaned
and decontaminated at appropriate intervals.
Not applicable All equipment used for handling products All equipment used for handling products
must be designated to the High Care Area must be designated to the High Risk Area
and be kept separate from that used in and be kept separate from that used in
other areas. other areas.
Not applicable If reusable trays are used, special If reusable trays are used, special
washing and decontaminating equipment washing and decontaminating equipment
must be provided for use in a dedicated must be provided for use in a dedicated
area with appropriate transfer to the High area with appropriate transfer to the High
Care side of the manufacturing operation. Risk side of the manufacturing operation.
All containers must be covered to All containers must be covered to
minimise contamination. minimise contamination.
Not applicable Cleaned and decontaminated utensils, equipment and containers must not pass
unprotected through areas where recontamination could occur.
2.3.3.3 Equipment to monitor CCPs

Performance of all instrumentation monitoring Critical Control Points must be regularly checked, and re-calibrated if necessary, according to a documented
procedure.
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GOOD MANUFACTURING PRACTICE (GMP) REQUIREMENTS
2.3.4 PERSONNEL AND TRAINING
2.3.4.1 Management responsibility

All personnel including management must understand the importance of maintaining the appropriate hygienic conditions throughout the facility. The
management must ensure that staff handling chilled foods are given thorough and planned training in all relevant aspects of chilled food production, storage and
distribution, as well as personal hygiene and cleanliness.
An individual having knowledge and authority must be designated within the management team to be responsible for all operations, including review and audit
relating to all aspects of product safety.
Staff must be trained in the correct operation of hygiene schedules and the correct use of cleaning and decontamination equipment and ingredients, including
chemicals.
Records of training must be maintained for current staff. Detailed job descriptions must be provided for staff carrying out specific jobs.
All employees must be issued with documented company rules with regard to hygiene policy.
Staff handling unpacked foods must be appropriately medically Personnel (including cleaners and service staff) working in High Care or High Risk
screened and be fit for work. See Appendix C. Areas must be medically screened, trained and instructed about the need for a
particularly high standard of personal hygiene at all times.
Hand washing regimes must be rigorously enforced. See section 2.3.4.2.3
Visitors must be informed in advance that they must comply with the same rules and procedures as for employees. They must also be instructed not to handle
equipment, work-in-progress or finished products.
Personnel (including cleaners and service staff) should be Personnel (including cleaners and service staff) working in High Care or High Risk
specially selected, trained and instructed about the need for a Areas should be specially selected, trained and instructed about the need for a
particularly high standard of personal hygiene at all times. particularly high standard of personal hygiene at all times.
2.3.4.2 Protective clothing

Appropriate factory wear, including hair covering, must be provided and worn as directed.
All personal clothing from neck to knee should be covered by an All personal clothing from neck to knee must be covered by an overall or factory coat
overall or factory coat with no outside pockets, with tight cuffs and with no outside pockets, with tight cuffs and which fastens at the neck. Disposable
which fastens at the neck. overalls must conform to this and be fit for the purpose.
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2.3.4.2.1 Overalls
All new overalls and coats should be inspected before use, be free from damage, and from any loose items, e.g. threads, etc., removed. They must be washed
before use.
The laundry process must ensure thermal disinfection, e.g. 71°C (wet temperature) for 3 minutes.
No specific GMP requirements High Care and High Risk Area overalls and coats should be laundered by an approved
laundry that carries out LRA/High Care or Risk Area separation practices. The
separation practices should apply to pre- and post-wash procedures.
No specific GMP requirements The clothing must be transported back to the factory and the High Care or High Risk
Area, fully wrapped.
Overalls and other protective clothing must be maintained in good condition and free from damage, without having loose threads.
Overall and other protective clothing must be changed at least daily and must be of a different colour or coloured trim from those being used in other areas of the
factory.
No specific GMP requirements Overalls must be removed by personnel when leaving the High Care or High Risk
Area and especially when entering the toilets.
No specific GMP requirements Boiler suits are not suitable for High Care or High Risk Areas since it is difficult to
avoid these garments touching the floor during changing.
2.3.4.2.2 Head, hair and beard covers

Suitable hair covering, enclosing all hair ,should be donned before Hair covering should only be removed when leaving the area in order to exit the
entering the Low Risk Area and before overalls are put on. factory and not between GMP and High Care or High Risk Areas, unless a risk
assessment indicates that they should be changed.
In a case where the hat is not capable of enclosing all the hair, a distinctive coloured hairnet of close-weave material must also be worn.
Where metal clips are attached to hairnets, they must not be removable and must be detectable by metal detectors.
Headwear must be laundered daily or be disposable.
Beards and moustaches should be discouraged.
Beards and moustaches must be covered by a snood when any food product is exposed. The snood must be made of close-weave material and be put on
before overalls.
Snoods should be removed after overalls on exiting the production area.
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2.3.4.2.3 Hands and gloves

Fingernails must be clean and short; no nail varnish is to be worn and personnel must refrain from finger licking, nail biting and spitting.
Paper handkerchiefs in a dispenser should be provided at wash hand basins. Operatives must use only these and not cloth handkerchiefs, and must wash
hands after use.
No specific GMP requirements The manual handling of food in High Care and High Risk Areas must be kept to a
minimum.
Appropriate hygienic implements must be used where possible, as an alternative, for handling food. If manual handling is unavoidable, a scrupulous hand
cleaning regime must be enforced, along with refresher training about the need for hand hygiene. See Appendix F for the CFA Handwash Poster.
Hand washing facilities must be adequate for the number of people employed.
Hot water should be stored at 60°C and distributed so that it reaches a temperature of 50°C within one minute at outlets. Cold water storage and distribution
should be at 20°C or below. However, the hottest water temperature that can be withstood is 42.5°C. Therefore water at about 38°C eases compliance. To
achieve this, mixer taps or heaters at the point of use will be required.
Hand- or arm-operated taps are unacceptable. Options include knee-, foot- or photoelectric-cell-operated systems.
Soap should be odourless, bactericidal and liquid, and must not support the growth of pathogens. It should not be assumed that if soaps contain preservative
they will not support the growth of microorganisms.
Soap must be held in a wall-mounted dispenser.
Hands must be washed thoroughly, with particular attention being paid to the fingertips. Refer to CFA’s Handwash Poster for the hand washing procedure.
An alcohol-based hand sanitiser should be applied after the hands have been washed and dried.
Refillable soap dispensers must be washed before filling.
Thorough drying is a vital part of the handwash procedure. Paper towels, a non-hand-operated waste paper bin and alcohol rinses should be located close to
handwash basins.
It is important to be aware that the use of gloves does not reduce the need for hand washing.
Gloves should only be worn where there is a necessity to protect the operative’s hands, to cover wound dressings, or where there is a high measure of
confidence in their hygienic management.
If gloves are used they should be disposable and changed when damaged, at every break or when personnel enter the area. Gloves should be of distinctive
colours and fit for the purpose. If cloth liners are used they must not come into contact with food.
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If non-disposable gloves are necessary they must be washed as thoroughly and frequently as hands and a suitable storage system should be used (e.g. on
pegs).
When using gloves:
1. Wash and sanitise hands

2. Put on gloves, taking care not to tear them
3. Remove gloves when leaving the line or before handling non-food items
4. Always change gloves if there are any holes or tears, and report them to a line manager
5. Dispose of gloves safely
6. Thoroughly wash, dry and sanitise hands before re-applying a new pair of gloves
No specific GMP requirements If gloves are used they must be changed every break period or, where sterile
disposable gloves are used, they must be changed at least every two hours or when
damaged or where personnel leave the production line for any reason.
No specific GMP requirements If reusable gloves are used they must be maintained in a satisfactory, hygienic
condition.
No specific GMP requirements Overalls (and other protective clothing) must be changed at the end of every shift
and footwear properly cleaned and decontaminated.
2.3.4.2.4 Aprons
Aprons should only be worn where there is a necessity to protect the operatives. Aprons must be of a hygienic design and not create a foreign body hazard.
Disposable aprons must be fit for the purpose and must be maintained in a satisfactory, hygienic condition. Non-disposable aprons should be cleaned with the
same frequency as gloves, dried quickly and stored dry using suitable storage systems that hold them off the floor.
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2.3.4.2.5 Footwear
Footwear must be specific to Low Risk Areas and should be a Footwear must be specific to the High Care Footwear must be specific to the High
different colour from that used in other areas of the factory. Area and should be a different colour from Risk Area and should be a different
that used in other areas of the factory. colour from that used in other areas of
the factory.
No additional requirements Footwear must be changed at the High Care Footwear must be changed at the High
Area barrier. Risk Area barrier.
Footwear must be cleaned regularly, the frequency depending on Footwear should be cleaned daily, or more frequently, based on risk assessment.
the degree of soiling.
Footwear cleaning should be carried out as a specific exercise; this may be done during night hygiene.
No specific GMP requirements Footwear may be cleaned using a hose and brush on leaving the area. If cleaned
outside the area, footwear must be brought back into the area covered to protect them
from contamination. The efficacy of this operation should be monitored. If footbaths
are used for aiding in the cleaning of footwear, they must be monitored for visual
cleanliness and disinfectant levels to ensure that they do not become a source of
contamination.
It is best practice to keep boots and floors dry and prevent clothing from becoming wet.
No specific GMP requirements Mechanical boot washers should not be used in High Care or High Risk Areas.
Storage of footwear on pegs, soles uppermost, may be used to help monitoring of cleanliness.
Disposable footwear must be fit for the purpose.
No specific requirements With the exception of hair covering, all With the exception of hair covering, all
clothing must be dedicated to the High clothing must be dedicated to the High
Care Area and stored clean, dry and away Risk Area and stored clean, dry and away
from potential contamination. from potential contamination.
Personal clothing should be completely covered by factory clothing.
No specific GMP requirements High Care Area clothing must only be worn High Risk Area clothing must only be
in this area, must cover personal clothing, worn in this area, must cover personal
and must be removed in the designated clothing, and must be removed in the
area before leaving the High Care Area. designated area before leaving the High
Risk Area.
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GOOD MANUFACTURING PRACTICE (GMP) REQUIREMENTS HIGH CARE AREA (HCA) HIGH RISK AREA (HRA)
2.3.4.2.6 Changing rooms and procedures

No specific GMP requirements All staff working in the High Care Area must enter through a specially designated area
and follow specified procedures for changing into visually distinctive clean overalls
and footwear
No specific GMP requirements Within the changing room there must where necessary be sufficient segregated
space for the removal and hygienic storage of non-High Care Area coats, footwear
and overalls, and High Care footwear and overalls.
No specific GMP requirements A physical barrier between the GMP storage and changing area and High Care
storage and changing area is essential.
Lockers should be on legs to facilitate cleaning underneath.
Lockers should have sloping tops.
2.3.4.2.7 Area entry procedures

The best practice procedure for entering Low Risk Areas is:- The best practice procedure for entering High Care or High Risk Areas is:-
1.Put on your hairnet/hat before entering the changing area 1.Put on your hairnet/hat before entering the changing area
2.Remove outside clothing and footwear 2.Remove GMP or outside clothing and footwear
3.Store outside clothing and footwear in changing area 3.Store GMP or outside clothing and footwear in Low Risk Area
4.Put on designated footwear 4.Step or swing your legs over the bench or barrier into the High Care/Risk Area
5.Wash hands with soap and sanitiser (if second wash omitted). 5.Put on High Care footwear
Refer to CFA Handwash Poster in Appendix F for details. 6.Wash hands with soap and sanitiser (if second wash omitted). Refer to CFA
6.Dry hands thoroughly with disposable paper towel(s) Handwash Poster in Appendix F for details.
7.Put on GMP overall 7.Dry hands thoroughly with disposable paper towel(s)
8.Apply hand sanitiser 8.Put on High Care overall
9.Enter Low Risk Area 9.Apply hand sanitiser
10.Enter High Care/Risk Area
2.3.4.2.8 Area exiting procedures

The best practice procedure for leaving Low Risk Areas is:- The best practice procedure for leaving High Care or High Risk Areas is:-
1.Remove LRA clothing 1.Remove High Care/Risk clothing

2.Remove LRA footwear 2.Remove High Care/Risk footwear
3.Remove hat/hairnet if required 3.Step or swing your legs over the bench or barrier and leave High Care/Risk Area
4.Put on outside clothing/footwear 4.In the Low Risk Area put on LRA/outside clothing/footwear
Do not remove hat/hairnet whilst wearing protective clothing
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2.3.5 OPERATIONAL AND HYGIENE CONTROLS

In all steps of processing, including delays in manufacture, critical temperatures for multiplication of microorganisms (10°C to 60°C) must be avoided. Total
exposure within this temperature range must be limited to 2 hours, unless justified under the principles of HACCP.
Application of HACCP principles may result in a number of control measures, such as:
- heating to maintain temperature above 60°C during a delay in manufacture, e.g. hot vegetables awaiting further processing or a sauce which is being hot
filled.
- active cooling to below 10°C during a delay in manufacture, e.g. raw meat awaiting further processing or cooked pasta that has been chilled prior to
processing.
Remember to consider batch size with respect to the heating or cooling of in-process products, especially during a delay in production.
2.3.5.1 Raw material preparation

The raw materials preparation area must be designed to hold and handle the range of raw material types to be prepared in a hygienic manner, minimising
contamination.
Raw material must be handled and prepared in a manner minimising contamination and microbiological growth.
− Water, steam and ice used as an ingredient or which is in direct contact with food must be potable, in compliance with the applicable legislation.
− All equipment, including sinks, used in the preparation of raw materials should be hygienically designed and be maintained and operated in a hygienic
manner.
− Prepared raw materials, including those that have been thawed, should be processed immediately. If not, they must be held at specified conditions of time
and temperature.
Thawing is a critical process and must be considered within a HACCP plan. When total or partial thawing is required as part of manufacturing, the thawing
conditions must be defined in terms of time and temperature and must be strictly controlled.
− The time and temperature parameters must be selected so as to prevent microbiological growth.
− The risks of contamination from condensation and/or product drip must be considered and controlled.
No specific GMP requirements Only cleaned or cooked raw materials Only cooked raw materials must be
must be transferred into the High Care transferred into the High Risk Area
Area.
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2.3.5.2 Heating
All heating equipment should be hygienically designed and, where appropriate, must be properly instrumented. Vapour and moisture extract systems should be
efficient, hygienically designed and well maintained to minimise the risk of contamination of heated product by condensate or other residue.
As a minimum, heating equipment must be fitted with both direct reading measuring thermometers and continuous recording equipment. The temperature
measuring and recording equipment must be independently calibrated at regular intervals against a nationally recognised standard.
Heat processes must be validated and critical parameters controlled and recorded where appropriate. The heat processes must take account of the worst
conditions likely to occur with respect to heat transfer (for instance, the use of frozen raw materials or the use of large pieces of meat). All parts of the product
must receive a minimum heat process appropriate to the target organism to be controlled and to achieve the projected shelf life. For some raw materials the
required heat process may be detrimental to the nutritional and sensory characteristics of the food and lower temperatures may be used, provided heat
processes of equivalent lethality are applied (see Tables 3 and 4). Achieving designated target temperatures must be monitored by instrumentation of the
heating vessel or by using a calibrated measuring thermometer with an accuracy of ± 0.5°C or as appropriate to the critical limit.
Competent, specially trained personnel should carry out the application of the scheduled heat and other treatments.
It is essential to protect the heated ingredient from recontamination.
When the product is heated in pack, strict precautions must be Not applicable
taken to ensure that only packs that have not been heated and
cooled according to the specified criteria cannot be dispatched.
No specific GMP requirements Where there is a heat process at the point of entry from the Low Risk Area, the
heating equipment must be designed and located so that it can be readily loaded with
raw materials from the Low Risk Area and hygienically unloaded into the HCA or
HRA.
2.3.5.3 Chilling
Chilling of the product must commence as soon as it is practicable after heating, assembly or air drying has been completed. The cooling rate must be such that
significant growth of surviving microorganisms is prevented. Appropriate measures must be used to ensure that the product will not be contaminated, e.g.
chlorination of water, regular cleaning of chiller units.
Finished product must be placed in dedicated chillers designed for the type and amounts of product to be chilled. Product must be chilled to the temperature
required by current food hygiene regulations or below.
Where relevant, packs must be dried as quickly as possible under hygienic conditions.
Manual handling whilst wet should be avoided. Where this is essential, precautions must be taken to ensure that this is done in a hygienic manner.
Documented procedures must specify necessary action to be taken in case of failure.
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2.3.5.4 Assembly and packing

No specific GMP requirements If sealed containers are to be transferred into the High Care or High Risk Area:
• They must be inspected outside the area for evidence of spoilage or physical
damage (e.g. blown cans, torn packs).
• they must be adequately cleaned at the point of transfer, and only after then
should the seal be broken and the product removed in the area.
Documented procedures should be available which should specify action required if

any spoilage is noted.
No specific GMP requirements Care should be taken to ensure that the Care should be taken to ensure that the
risk presented by the introduction of risk presented by the introduction of
packaging and ingredients into the High packaging and ingredients into the High
Care Area is minimised. Risk Area is minimised.
No specific GMP requirements See the CFA Packaging Hygiene Guidelines for Suppliers to the Chilled Food
Industry for standards relating to the production and storage of packaging materials.
No specific GMP requirements Pre-treatment intended to reduce the The room used for assembling final
microbial load of raw materials and product is a High Risk Area and must be
decontamination of raw materials should designed, maintained and operated to
be completed at the point of transfer into the highest standards. ONLY READY-
the High Care Area. ONLY READY-TO-EAT TO-EAT DECONTAMINATED
INGREDIENTS MAY BE BROUGHT INTO INGREDIENTS MAY BE BROUGHT INTO
THIS AREA. THIS AREA.
No specific GMP requirements Time and temperature parameters for the assembly of ingredients must be
determined on the basis of hazard analysis. Any ingredient unlikely to be used
within the specified time must be returned to the chill store. All ingredients must be
used within the maximum specified use life.
No specific GMP requirements After the product packs have been assembled or filled, they must be chilled and
stored under defined safe conditions of time and temperature to control microbial
growth in the contents.
No specific GMP requirements Packaging ingredients must be removed from their outer wrap at the point of transfer
into the area. Any packaging ingredient stored in the area must be held under
conditions that prevent contamination.
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For products cooked in pack, after the packs have been assembled Not applicable Not applicable
and filled, they must be sealed and heated and stored under time
and temperature conditions that prevent significant microbial
growth and outgrowth of spores.
Packs must be checked at regular intervals to verify that they are Not applicable Not applicable
hermetically sealed. Immediate action must be taken to correct
any fault in the packaging machinery or packaging ingredient and
appropriate checks made on product produced since the previous
satisfactory check.
2.3.5.5 Coding and labelling

Finished products must be properly labelled in accordance with legislative requirements and must include the Use By date, temperature and storage conditions,
and if necessary, cooking instructions.
2.3.5.6 Handling of finished product

The storage and distribution temperature must be that which will maintain product safety for the intended shelf life of the product. If the temperature of the
product is the principal means of preservation, that product must be kept at a temperature as low as possible.
The product must be stored so as not to render it injurious to health.
Performance of the proposed distribution chain should be assessed and evaluated.
Regular and effective monitoring of temperatures of storage areas, transport vehicles and store display cases should be carried out. This monitoring should take
place, in particular, when the transport vehicle is loaded or unloaded.
Particular attention should be paid throughout storage and distribution:

− to periods of defrosting of refrigeration units;
− to temperature abuse;
− to overloading the cold storage facility; and
− to anything that could damage the containers and/or packaging material.
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2.3.5.7 Cleaning and disinfection

Adequate separate equipment washing facilities must be installed. Dedicated equipment washing facilities must be installed.
Consideration should be given to adequate extraction from Equipment washing facilities should be Equipment washing facilities should be
equipment washing facilities, thus reducing potential condensation placed in a segregated room within the placed in a segregated room within the
problems and ensuring that aerosols do not contaminate the High Care Area. Alternatively, cleaning High Risk Area. Alternatively, cleaning
product. should be carried out after production should be carried out after production has
has finished. finished.
Spillages and accumulation of debris should be minimised by the adoption of appropriate practices.
There must be a regularly reviewed, comprehensive, fully evaluated, confirmed and documented hygiene cleaning schedule for all equipment and the
environment, written by technical/production personnel and cleaning chemical representatives or other suitably qualified personnel. Cleaning methods must be
specified and documented by the hygiene supervisor.
There should be a clean as you go system to prevent gross build-up There must be a clean as you go system to prevent gross build up of soiling,
of soiling, followed by comprehensive cleaning at the end of the followed by comprehensive cleaning at the end of the production cycle.
production cycle.
Standards of cleaning, including laundering of protective clothing, must be compatible with the hygiene standards needed for the particular area.
Methods used for ‘clean as you go’ should not generate aerosols which could contaminate adjacent lines or cross contaminate chemicals. It is important to keep
the area as dry as possible.
There should be a pre-determined sequence of cleaning; for example:-
1. Remove gross debris from the area

2. Clean walls, ceilings, drains and floors
3. Clean equipment and food contact surfaces
4. Final cleaning and sanitising of equipment, ensuring that the sanitiser has the required contact time
The post-production cleaning schedule should include details for such cleaning.
Staff must be trained in the correct operation of hygiene schedules and the correct use of cleaning and decontamination equipment and ingredients, including
chemicals.
No specific GMP requirements Dedicated equipment washing facilities Dedicated equipment washing facilities
and tools must be installed and the and tools must be installed and the
cleaning equipment must be dedicated cleaning equipment must be dedicated to
to the High Care Area. It is important to the High Risk Area. It is important to
separate equipment washing from the separate equipment washing from the High
High Care Area. Risk Area.
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Brushes suitable for dry areas must have plastic or aluminium handles with bonded plastic bristles. They should be colour-coded or designed for specific areas
or uses. Brushes used in wet areas must either be stored in sanitiser, which is monitored between uses on a regular basis, or be cleaned after use in detergent
steriliser and stored dry. The sanitiser level and activity must be monitored regularly to ensure efficacy.
Mops, squeegees, cloths, condensation removal equipment and hoses are recognised as particular sources of contamination with Listeria, and wherever
possible these should not be used, or, if essential, must be cleaned and decontaminated frequently.
Squeegees suitable for wet areas must have plastic or aluminium handles with removable blades. They should be colour-coded or designed for specific areas or
uses, and must either be kept in sanitiser, which is monitored between uses on a regular basis, or kept in a clean and dry condition and stored off the floor.
Squeegees which have a sponge-like structure must not be used.
Waste bins must be cleaned and sanitised on a regular basis. Waste bins must be dedicated to High Waste bins must be dedicated to High Risk
Care Areas, and must be cleaned and Areas, and must be cleaned and sanitised
sanitised on a regular basis. on a regular basis.
High pressure hoses should preferably not be used, but if All hoses can produce aerosols, therefore high pressure hoses must only be used
necessary should be used only by designated trained personnel by designated trained personnel between production periods. They must not be
between production periods. They should not be used to clean used to clean drains without subsequent decontamination of the whole area. Low
drains without subsequent decontamination of the whole area. pressure hoses should only be used between production periods. Low pressure
hoses and ring mains systems should be strictly controlled in their use. High
pressure washing must be restricted to non-production times, and ideally, should
not be used at all in High Care or High Risk Areas.
No specific GMP requirements All hoses should be monitored as a possible source of contamination and, if
possible, should not go over lines or equipment or be allowed to touch the floor
when in use or in storage. After use they may be stored in detergent/sanitiser, which
is regularly monitored.
No specific GMP requirements Vacuum cleaners must be dedicated to High Care Areas and be fitted with
microbiological filters.
Regular monitoring of the cleanliness of food contact surfaces Monitoring the cleanliness of food contact surfaces must be carried out immediately
should be carried out immediately before production commences. before production commences. This must be supported by regular microbiological
(see Section 1.5.4.3) validation. Environmental monitoring for Listeria spp. Is strongly recommended.
(see Section 1.5.4.3)
Cleaned and decontaminated utensils, equipment and containers All equipment and utensils used for handling products after heating must be cleaned
should not pass through areas where recontamination could occur. and decontaminated at appropriate intervals.
2.3.5.8 Pest control

Effective pest control arrangements must be in place throughout the plant.
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2.3.5.9 Waste management

Food waste and other refuse should be disposed of as quickly as possible and must not accumulate in food rooms except when unavoidable for the proper
functioning of the business.
Adequate provision must be made for the removal and storage of food waste and other refuse. Steps must be taken to ensure that food waste and other refuse
does not present any risk of contamination. It must be deposited in closable containers specially designed and marked for this use. These containers must be of
an appropriate construction, kept in sound condition and be easy to clean and disinfect.
Refuse stores must be designed and managed in such a way as to enable them to be kept clean and minimise pest access.
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PART 3
Other Regulatory Requirements
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SECTION 3.1
EC REGULATION ON MICROBIOLOGICAL CRITERIA FOR FOODSTUFFS
The European Commission Regulation on Microbiological Criteria for Foodstuffs (2073/2005) came
into force in January 2006 and defines microbiological criteria across the EU for a wide range of food
products.
The European Commission and Food Standards Agency recognise that microbiological testing per se
is not a control measure and in itself does not ensure food safety, whereas the implementation of
GMP and HACCP do. The emphasis of the Regulation is therefore on GMP and HACCP
implementation, with HACCP verification testing by the FBO.
Guidance on practical implementation of the Regulation has been produced by CFA in conjunction
with other organisations, and with input from FSA. For further details see:
www.chilledfood.org/content/guidance.asp
To summarise, the Regulation
Relates microbiological criteria to GMP/GHP and HACCP by requiring a preventative approach

such as employing good hygienic practices and a system based on HACCP principles to be in
place in food businesses. Food testing against the appropriate criteria set out in the Regulations
needs to be undertaken when verifying or validating HACCP.
Stipulates a certain level of sampling for official control purposes and by the FBO for carcases,
minced meat, meat preparations, meat products to be cooked and mechanically separated meat
(one product per week, per plant). Otherwise, sampling of foods is to be determined by the FBO
on a HACCP and hygiene control basis.
Requires that if testing against the Food Safety Criteria is conducted by a Port Health Authority or
for other official control purposes (e.g. to assess the acceptability of a certain batch of foodstuffs
or a process) then the sampling plan set out in Annex I, Chapter 1 of the Regulation be respected
as a minimum.
States that it is for the FBO to determine whether a food is ready-to-eat. Products intended to be
re-heated before consumption are not considered to be ready-to-eat.
Does not require a company having implemented GMP, HACCP and supporting systems and
following the shelf life assessment approach set out in Annex II of the Regulation to have to carry
out Listeria monocytogenes challenge testing.
Allows alternative methods to those prescribed in the Regulation to be used only if they have been
validated against the prescribed reference method.
States that if the Food Safety Criteria given in Annex I, Chapter 1 of the Regulation are exceeded,
the product is deemed unsafe and action specified in Regulation 178/2002 (the General Food
Law) must be taken. If the product is no longer within the control of the FBO it is the responsibility
of the brand owner to inform the competent authority and to withdraw the product from the market.
The competent authority may also require recall of the product from the market.
Process Hygiene Criteria (Annex I, Chapter 2) are quality-related, and action (i.e. notification) is
not required under Regulation 178/2002. However, corrective action is required in terms of
controlling the process and/or raw material chain.
The European Commission has stated that regarding Listeria monocytogenes for ready-to-eat foods,
the objective is to keep levels below 100 cfu/g during the shelf life of food, ‘according to scientific
opinion’. If a product's shelf life has been determined in accordance with the approach set out in
Annex II of the Regulation and the level of 100 cfu/g can be demonstrated not to be reached during
the shelf life (e.g. by using historical end of life data), zero tolerance does not apply and detection
does not require notification. See Section 1.6 regarding the determination of shelf life.
Further information:
CFA/BRC Guidance on the Practical Implementation of the EC Regulation on Microbiological

Criteria for Foodstuffs
CFA Microbiological Testing and Interpretation Guidance
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SECTION 3.2
SUPPLIER QUALITY ASSURANCE
3.2.1 Principles
Raw material quality is critical for chilled foods since they are often delivered from the supplier
in the condition in which they will be used in the final product, e.g. cooked chicken and pre-cut
fresh vegetables.
Safe products require the understanding of hazards and risks associated with the raw
materials used.
Either:-
• Raw materials must contain no hazards, or

• Any hazards present must be controlled to an acceptable level by the process
The level of control required over a raw material depends on the way in which it will be
handled and processed, e.g. herbs going into a product to be cooked may require less
emphasis on microbiological control at the raw material stage than those being used as a
garnish on a ready-to-eat product.
Using the Decision Tree below (Diagram 4) will allow targeting of supplier quality assurance
(SQA) resources at the raw materials that are most critical to operation and products.
DIAGRAM 4
DECISION TREE TO DETERMINE LEVEL OF RAW MATERIAL CONTROL REQUIRED
Is there a hazard associated with

Î NO Î Proceed to next raw material
Q1 the raw material?
Ð
YES
Ð
Q2 Are you or the consumer going to
process this hazard out of the Sensitive raw material. High
Î NO Î
product or reduce it to an level of control required.
acceptable level?
Ð
YES
Ð
Q3 Is there a cross-contamination risk
to the facility or to other products Î NO Î Proceed to next raw material
that will not be controlled?
Ð
YES
Ð
Sensitive raw material. High level
of control required.
To ensure that raw materials meet requirements regarding quality and safety, the following
aspects need attention:
• A system ensuring consistent supplier selection and ongoing supplier performance;

• Specifications containing all parameters that are relevant for quality and safety;
• Transport, storage and traceability of raw materials;
• Verification of these points.
th
3.2.2 SQA System Elements
3.2.2.1 Specifications
Process diagrams, descriptions of processing, and site plans are also helpful to the
HACCP team in ensuring that all hazards of concern in the raw material have been
identified.
All raw and packaging materials must have written specifications that detail critical
parameters.
The supplier should formally agree to the specifications before actual supply of raw
materials (based on test supplies).
The microbiological specification defined for the various raw materials depends on
their intended use. If ingredients have been pre-treated at the supplier (e.g. blanched,
frozen vegetables), this should be reflected in a tighter microbiological specification
compared with fresh vegetables. For fresh-cut vegetables and herbs, intended to be
eaten raw, management of hazards is based on minimisation of microbial and other
contamination during growing and harvesting of fresh produce. This is assured
through GAP (Good Agricultural Practice) as well as management systems that limit
contamination and growth of (pathogenic) microorganisms from farm to consumption
(e.g. Eurep GAP).
The microbiological specification should consist of the following components: relevant

microorganisms or their toxins/metabolites, the analytical methods, the sampling plan
and the microbiological limits.
3.2.2.2 Auditing
SQA audits are important to the safety and quality of products therefore they must be
carried out effectively.
The frequency of audits should be determined using a risk assessment basis; critical
raw material suppliers (e.g. cooked meat to be used without any further processing)
are audited most frequently. Third party inspections or self audit questionnaires or a
combination of all three approaches can be used.
If third party inspections are to be used, the inspection body must be independently
accredited, e.g. to EN 45011.
3.2.2.3 Certificates of analysis
Certificates of analysis can form a useful part of the SQA system, but owing to the
limitations of end product inspection and testing, they should not be the only way of
verifying that the finished product is free from the hazard/s.
You should ensure that analyses are performed only by laboratories competent to
carry out the tests and provide accurate results.
3.2.2.4 Buying from agents and brokers
You must know how your raw materials have been processed and handled at every
stage. It is important that you obtain the appropriate documented assurance from any
agent used, and possibly from the supplier via the agent. You must ensure that
appropriate control is built into your own operation to cope with the worst-case
scenario.
64 th
SECTION 3.3
TRACEABILITY
3.3.1 Background
Multicomponent minimally processed products such as chilled prepared foods require

exceptional levels of control from the sourcing year-round of seasonal perishable raw
materials, processing into complex short shelf life products and their distribution for retail sale.
Traceability is a fundamental part of all Quality Management Systems. For example, ISO 9000
standards require documented procedures aiming at product identification, from purchasing of
the starting materials throughout the whole production process and shipment.
Good traceability systems are able to identify rapidly
• the suppliers of components of raw materials and ingredients, and

• feed fed to food producing animals used by a business.
Traceability systems can be used not only to trace forward from a particular raw
material/ingredient to identify a product in which it was used, but also to trace back from a
product to identify the sources of its components. Both aspects are vital in effectively
identifying and managing quality and other problems.
From 1 January 2005 all EU food and feed businesses, regardless of size, have been required
to implement limited traceability systems into their business. Traceability systems must be
able to identify immediate raw material suppliers and finished product purchasers. Businesses
importing food from outside the EU are also required to keep records of their suppliers. Such
information must be made available to enforcement authorities on demand.
These requirements are set out in Article 18 of Regulation (EU) 178/2002 17 laying down the
general principles and requirements of food law and procedures in matters of food safety.
3.3.2 Guidance Principles
Suppliers to CFA Members must have traceability systems in place that allow them to trace
back to the ultimate source of their raw materials. Members’ operating units must have
systems in place that allow them to trace raw materials to their suppliers and to trace finished
products to the next point of delivery in the supply chain.
A high level of traceability throughout the food chain is possible only if each operator
establishes traceability within its own operation. Food business operators must therefore
adhere to the following principles:
• Obtain documentation and/or labelling accompanying supplies of foods, of food contact

materials and of other products purchased.
• No food business operator should accept raw materials or other products that are of
uncertain origin or which are not batch coded.
• Maintain in-process paperwork to track raw material usage.
• Define and identify the lots of products manufactured.
• Define and establish a clear link between goods coming in and products going out.
• Record the names and addresses of their suppliers and customers and grade of
products, identify transport, define and identify the lots of raw materials as well as of
goods delivered.
• Document this information, especially all relevant safety information based on risk control
pertaining to the lots of raw materials received or to the manufactured goods.
• Guarantee that all documented information is reliable and readily available.
17
Official Journal of the European Communities, L 31, 1.2.2002, p. 1.
th
This cascade approach must be used in the whole food chain. This means that all the
operators in a particular part of the food chain need to use the same principles of traceability.
An example of traceability documentation that should be generated during production is

shown below (Figures 3 and 4).
Figure 3
66 th
Figure 4
Further information:
'An introduction to traceability for your food business', Sept 2003, FSA.
http://www.food.gov.uk/multimedia/pdfs/introtracebus.pdf
th
SECTION 3.4
PRODUCT RECALL 18
3.4.1 Introduction
The Commission Regulation on the general principles of food law (178/2002)17 came into
force on 1 January 2005. One of its requirements is that FBOs withdraw from the market any
food that is unfit or injurious to health and notify the competent authority.
A product recall is conducted to remove unsatisfactory product from the marketplace or to

protect public health and safety. It may be initiated as a result of findings from the food
business itself or information obtained from suppliers, retailers, wholesalers, governmental
health authorities or consumers.
All food business operators in the wholesale supply, manufacture or importation of food must
be capable of rapidly and effectively managing product recalls. This applies in particular to
chilled food, where products move rapidly from production to consumption.
A recall action removes from sale, distribution and consumption foods that may be of
unsatisfactory quality or may pose a safety or health risk to consumers 19,20 . In general, two
levels of recall may be considered:
− trade recall (withdrawal): the recovery of the product from distribution centres and
wholesalers; it may also involve recovery of product from hospitals, restaurants, other
major catering establishments, as well as other food processors;
− consumer (public) recall: in addition to a trade recall, the recovery of any affected product
in the possession of consumers.
For short shelf life chilled foods, recall may present practical difficulties. However, a detailed
written recall plan should be prepared describing step-by-step the procedure to be followed.
While this section is limited to product recall for food safety reasons, a food business operator
may consider managing a market withdrawal or stock recovery in the same way as a recall.
3.4.2 Developing a Recall Plan
Establishing a recall plan requires consideration of:
• people involved, their responsibilities and contact details

• information to be gathered
• incident classification and action to be taken
• communication
• corrective actions (See Section 1.5.3)
• recall closure and evaluation
3.4.2.1 People involved
Recall coordinator
One person should be identified as the recall coordinator to prepare for and coordinate
all activities related to a recall. Preferably this should be the FBO’s senior quality
manager. The recall coordinator should be knowledgeable about every aspect of the
operation, including purchasing, processing, quality assurance, distribution, and
consumer complaints. The recall coordinator is responsible for preparing and updating
18
Regulation (EC) 178/2002 of the European Parliament and the Council of 28 January 2002 laying down the general principles
and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food
safety (Official Journal of the European Communities, L31, p1)
19
FSA Guidance on the General Food Law Regulation 178/2002
20
Guidance on the Implementation of Articles 11, 12, 16, 17, 18, 19 and 20 of Regulation (EC) No 178/2002 on General Food
Law, December 2004: http://europa.eu.int/comm/food/food/ foodlaw/guidance/guidance_rev_7_en.pdf
68 th
a recall plan and reporting to top management at regular intervals about its readiness
and effectiveness.
Incident management team
In particular for short shelf life products, speed is critical; therefore the initial team
should be small and with decision making authority to enable rapid action to be taken.
Senior management personnel should be nominated to represent the principal areas

involved in a recall. The incident management team must be authorised to make
decisions in carrying out a recall and to communicate to all stakeholders involved.
Typically, an incident management team should consist of the recall coordinator and
the managing director. Other representatives may be required from, for example:
• quality
• manufacturing
• warehousing and distribution
• purchasing
• sales and/or marketing
• legal
• public relations
• other resources as required
In small business operations, the committee may consist of just one or two people,
each having a number of the above responsibilities.
The responsibilities of each team member in regard to a recall must be clearly defined
in the product recall plan. For example, the recall coordinator is responsible for
maintaining the incident contact list, notifying the health authorities, and the head of
public relations for preparing a media statement if necessary.
3.4.2.2 Information gathering
Prior to making a recall decision, gather information on the affected product, such as:
• product name and description, including package size and type;

• lot identification;
• the remaining shelf life of the affected product and whether it may have been
frozen by the consumer in accordance with labelled instructions - this will
indicate the timescale and feasibility of any recall and the type of
communication required;
• batch size, date and amount released;
• distribution and amounts of the product in each part of the chain: within the
business, wholesale, foodservice, retail, consumer, nationally, within the EU,
exported outside the EU;
• production records of the batch(es) concerned;
• potential for the same problem or type of contamination occurring in other
products;
• name and contact information of the person reporting the incident, and the
date of the report;
• date of the incident;
• nature of the incident;
• number of similar reports received (for example, from customer/consumer
complaint records);
• results of tests and other investigations on suspect or other samples.
th
3.4.2.3 Incident classification and action to be taken
The identification and characterisation of hazards related to the reported incident,

assessment of exposure to these hazards and the risks involved will determine the
level of action required including the decision whether or not to notify the authorities
and/or recall the affected product. External expert advice may be needed to
determine the seriousness of the hazard and the risks involved.
Depending on the nature of the hazard and the possible risks, incidents may be
classified according to:
− Class I incident, where there is a reasonable probability that the use of the
product will cause serious, adverse health consequences.
− Class II incident, where there is a remote probability of adverse health
consequences from the use of the product.
− Class III incident, where the use of the product will not cause adverse health
consequences.
Based on the information from the incident classification, decisions are taken on
whether or not to recall the affected products, as indicated below.
Class Product has not left the immediate Product on the market
control of the FBO
I Withdrawal Recall and notification
II Withdrawal Withdrawal or recall in consultation with the
authorities, i.e. includes notification
III Withdrawal at the discretion of the FBO Withdrawal or recall at the discretion of the FBO
The decision must be justified, documented and communicated appropriately.
The means of controlling and disposing of, or correcting the defect in the stock
returned during a recall should be specified in the recall plan. This may include
actions such as destroying, relabelling or reworking products. All actions must be
documented.
3.4.2.4 Communication
The recalling company is responsible for promptly notifying each of its affected
consignees about the details of the recall in line with national legislation and/or
customer requirements.
If it is decided to carry out a public recall, the authorities must be notified in a co-
ordinated way, preferably by the brand owner.
3.4.2.5 Recall closure and evaluation
A recall will be terminated by a recall status report summarising and documenting the
facts and the actions taken. If possible, the report details the effectiveness of the
recall in terms of recovered product.
The report should be communicated to the incident management team and other
relevant personnel to ensure that all issues, including the design of the recall process
are addressed.
3.4.3. Recall Simulations - Training and Revision
In order to evaluate its recall process, a company must conduct periodic, documented recall
simulations. A simulated recall should involve the selection, without prior notice, to personnel
involved in the simulated recall, of at least one lot of product that has been placed on the
market. A hypothetical reason for recalling the product should be specified and the recall plan
70 th
followed to establish a strategy for recalling the product. The simulation should proceed at
least to the point at which communication is to be made beyond the firm’s organisational limit.
However, even if the simulation is stopped at this point, full details of who will be contacted at
that point and how contact will be established should be specified.
If problems are identified during a recall simulation, the recall plan and procedures must be
revised accordingly.
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72 th
APPENDICES
th
APPENDIX A
DEFINITIONS AND ABBREVIATIONS
Barrier: the point of separation between two different hygiene areas.
Challenge testing: deliberate inoculation of relevant microorganisms into a food product to

determine the product's ability to support survival, growth or inactivation of the organism
during storage at defined temperature(s).
Chilled food: A prepared food that for reasons of safety and/or quality is designed to be
stored at refrigeration temperatures (at or below 8°C) throughout its entire life.
Chiller: Equipment designed to reduce rapidly the temperature of product to a specified chill
temperature.
Chilling: Rapid reduction of temperature, normally to a specified value.
Chill store: A facility regulated to maintain product at a specified chill temperature.
'Clean-as-you-go': Maintenance of work areas in a clean and tidy manner at all times.
Cleaning: the removal of soil, food residue, dirt, grease or other objectionable matter.
Container: (i.e. primary package): any box, tin, plastic or other receptacle, or wrapper in
direct contact with the food product.
Contaminant: Any biological or chemical agent, foreign matter, or other substance not
intentionally added to food which may compromise food safety or suitability.
Contamination: The introduction or occurrence of a contaminant in a food product,

ingredient or environment.
Decontamination: Removal or reduction of contaminant(s) to an acceptable level for

safety or quality, i.e. destruction of Listeria monocytogenes in a product by heat
and/or chemicals or other validated means equivalent to at least a 6 log reduction.
Recontamination: The post-process introduction of a contaminant into a food

product.
Cook-chill foods: Foods produced by a catering system based on cooking followed by

chilling, storage in controlled low temperature conditions (0°C to 3°C) and subsequent
reheating immediately before consumption.
Cooking: Heating by the consumer so that all parts of a food or food ingredient reach a
minimum time/temperature equivalent of 70°C for 2 minutes, i.e. a 6 log reduction of Listeria
monocytogenes. Validation of preparation instructions should assure that these time and
temperature requirements are met.
Cooling equipment: equipment to reduce a product's temperature.
Control (verb): to take all necessary actions to ensure and maintain compliance with criteria
established in the HACCP plan.
Control (noun): the state wherein correct procedures are being followed and criteria are
being met.
Control measure: any action and activity that can be used to prevent or eliminate a food
safety hazard or reduce it to an acceptable level.
74 th
Corrective action: any action to be taken when the results of monitoring at the CCP indicate
a loss of control.
Critical Control Point (CCP): a step at which control can be applied and is essential to
prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Critical limit: a criterion that separates acceptability from unacceptability.
Decontamination: see 'contamination'.
Deviation: failure to meet a critical limit.
Disinfection: the reduction, by means of chemical agents and/or physical methods, of the
number of microorganisms in the environment, to a level that does not compromise food
safety or suitability.
Domestic cooking: Heating by the consumer so that all parts of a food or food ingredient
reach a minimum time/temperature equivalent of 70 °C for 2 minutes. Validation of preparation
instructions must be carried out to ensure that these time and temperature requirements are
met where heating is required to assure the safety of the product.
Domestic reheating: Heating by the consumer to a temperature suitable for organoleptic

purposes, where its application is not required to assure safety of the product.
Establishment: any building or area in which food is handled and the surroundings under the
control of the same management.
FBO: see ‘Food business operator’.
Filling and sealing: operation consisting of placing a food product in a container and closing
it.
Flow diagram: a systematic representation of the sequence of steps or operations used in

the production or manufacture of a particular food item.
Food or foodstuff: (As defined by EU Regulation) any substance or product, whether

processed, partially processed or unprocessed, intended to be, or reasonably expected to be
ingested by humans. Includes drink, chewing gum and any substance, including water,
intentionally incorporated into the food during its manufacture, preparation or treatment. It
includes water after the point of compliance. Does not include feed, live animals unless they
are prepared for placing on the markets for human consumption, plants prior to harvesting,
medicinal products, cosmetics, tobacco and tobacco products, narcotic or psychotropic
substances, residues and contaminants.
Food business: any undertaking, whether for profit or not and whether public or private,
carrying out any of the activities related to any stage of production, processing and
distribution of food.
Food business operator (FBO): the natural or legal persons responsible for ensuring that
the requirements of food law are met within the food business under their control.
Food handler: any person who directly handles packaged or unpackaged food, food
equipment and utensils, or food contact surfaces and is therefore expected to comply with
food hygiene requirements.
Food hygiene: all conditions and measures necessary to ensure the safety and suitability of
food at all stages of the food chain.
Food safety: assurance that food will not cause harm to the consumer when it is prepared
and/or eaten according to its intended use.
th
Food suitability: Assurance that food is acceptable for human consumption according to its
intended use.
Good Manufacturing Practice (GMP): The requirements set out within Section 2.2.
Hazard: a biological, chemical or physical agent in, or condition of, food (or feed) with the
potential to cause an adverse health effect.
Hazard analysis: the process of collecting and evaluating information on hazards and
conditions leading to their presence to decide which are significant for food safety and
therefore should be addressed in the HACCP plan.
Hazard Analysis Critical Control Point (HACCP): a system that identifies, evaluates, and
controls hazards which are significant for food safety.
HACCP plan: a document prepared in accordance with the principles of HACCP to ensure
control of hazards which are significant for food safety in the segment of the food chain (e.g.
chilled foods) under consideration.
Heating: Heating by the manufacturer so that all parts of a food or food ingredient reach the
correct target time/temperature conditions or their equivalents appropriate to microorganisms
to be controlled for the projected shelf life. See Table 3 and 4.
Hermetically sealed container: containers that are designed and intended to protect the
contents against the entry of viable microorganisms after closing.
High Care Area (HCA): an area designed to a high standard of hygiene where practices
relating to personnel, ingredients, equipment and environment are managed to minimise
microbiological contamination of a ready-to-eat or ready-to-reheat product containing
uncooked ingredients. Specific requirements for High Care Areas are given in Section 2.2.
High Risk Area (HRA): an area designed to a high standard of hygiene where practices
relating to personnel, ingredients, equipment and environment are managed to minimise
microbiological contamination of a ready-to-eat or ready-to-reheat product comprising only
cooked ingredients. Specific requirements for High Risk Areas are given in Section 2.4.
Hurdle: microbial growth limiting, retarding or preventative factor.
Hurdle technology: the use of a combination of factors to effect control of microbial growth.
Hygiene schedule: Documentation of procedures appropriate for dismantling or clean-in-

place, cleaning and decontaminating (including methods, dosages and chemicals), the
frequency of use or equipment and the monitoring procedures to assure compliance with
hygiene requirements. The schedule includes in-plant environmental screening and also
documentation for personnel hygiene systems.
Lethal rate: Lethal rate is an expression of the rate at which a target organism is killed at any
given temperature, relative to the rate at which it is killed at a reference temperature.
Low Risk Area (LRA): an area where GMP standards (see Section 2.4) are in place.
Microbiological criterion: defines the acceptability of a product or a food lot, based on the
absence or presence, or number of microorganisms including parasites, and/or quantity of
their toxins/metabolites, per unit(s) of mass, volume, area or lot.
Modified atmosphere: atmosphere in a packaged product (vacuum or gas) that differs from
the ambient atmosphere.
76 th
Monitor: the act of conducting a planned sequence of observations or measurements of
control parameters to assess whether a CCP is under control.
On-site catering operations: operations producing food and/or drink for consumption on-
site.
Organoleptic: relating to an attribute of a product perceptible by the sense organs, e.g.

texture, flavour, aroma, colour.
Packaging: any operation consisting of placing the food in containers (i.e. primary
packaging) or placing the food containers in further packaging materials.
Packaging materials: materials such as cardboard, paper, glass, plastic film, metal, etc.,
use to manufacture containers or packaging for refrigerated packaged food.
Packaging - Primary: material in direct contact with food.
Packaging – Secondary: material not in direct contact with food.
Pasteurisation value: the length of time at a given temperature required to obtain a specified
level of destruction of a microorganism whose heat resistance characteristics are known. The
heat resistance of a microorganism is characterised by D and z values defined as follows:
- D = time (in minutes) to achieve a 90% or one log reduction of a microbiological
population at a given temperature;
- z = the number of degrees required for the thermal destruction curve to transverse
one log cycle (expressed in degrees Celsius or Fahrenheit).
Pasteurised food ingredient: Where a legal standard is applied to pasteurisation, e.g., milk,
cream and eggs, such ingredients may be considered as heated for the purpose of these
Guidelines.
Placing on the market: the holding of food or feed for the purpose of sale, including offering
for sale or any other form of transfer, whether free of charge or not, and the sale, distribution,
and other forms of transfer themselves.
Pre-distribution storage: Storage on-site under conditions controlled by the manufacturer.
Primary preparation: Cleaning and trimming of raw materials.
Primary production: those steps in the food chain up to and including, for example,
harvesting, slaughter, milking, fishing.
Rapid cooling: lowering the temperature of the food in a way such that the critical zone for
microbiological proliferation (60°C-10°C) is passed through as rapidly as possible and the
specified temperature is attained.
Raw material: individual components as received at the factory, used in the preparation of a
final product.
Recontamination: see 'contamination'.
Ready-to-cook (RTC) Food: food designed by the producer or manufacturer as requiring

cooking or other processing effective to eliminate or reduce to an acceptable level
microorganisms of concern.
Ready-to-eat (RTE) Food: food intended by the producer or the manufacturer for direct
human consumption without the need for cooking or other processing, effective to eliminate or
reduce to an acceptable level microorganisms of concern.
th
Ready-to-reheat (RTRH) Food: food designed by the producer or manufacturer as suitable
for direct human consumption without the need for cooking,, but which may benefit in
organoleptic quality from some warming prior to consumption.
Recall: the action taken to remove from sale, distribution and consumption foods that may
pose a safety or health hazard to consumers. In general, two levels of recall may be
considered:
− Trade recall ('withdrawal'): the recovery of the product from distribution centres and
wholesalers; it may also involve recovery of product from hospitals, restaurants, other
major catering establishments, as well as other food processors;
− Consumer ('public') recall: in addition to a trade recall, the recovery of any affected
product in the possession of consumers.
Refrigerated food: food that is kept at cold storage temperatures to maintain its safety,
quality and suitability, for the intended shelf life.
Refrigerated storage facility: facility designed to keep refrigerated foods at the intended
temperature.
Reheating: heating by the consumer to a temperature suitable for organoleptic purposes,

where its application is not required to assure safety of the product.
Retail: the handling and/or processing of food and its storage at the point of sale or delivery
to the final consumer, and includes distribution terminals, catering operations, factory
canteens, institutional catering, restaurants and other similar food service operations, shops
supermarkets distribution centres and wholesale outlets.
Risk: a function of the probability of an adverse effect and the severity of that effect,
consequential to a hazard(s) in food.
Secondary preparation: size reduction of raw materials following primary preparation.
Shelf life: the period during which the product maintains its microbiological safety and
sensory qualities at a specific storage temperature. It is based on identified hazards for the
product, heat or other preservation treatments, packaging method and other hurdles or
inhibiting factors that may be used.
Shelf life testing: assessment of shelf life using storage trials and/or challenge testing.
Step: a point, procedure, operation or stage in the food chain including raw materials, from
primary production to final consumption.
Stock recovery: a company’s removal or correction of product that has not been marketed or
that has not left the direct control of the firm. For example, product located on premises
owned by, or under the control of, the firm, and no portion of its lot(s) has been released for
sale or use.
Storage trial: storing a product at predetermined times and temperatures as part of shelf life
determination.
Traceability: the ability to trace and follow a food, feed, food-producing animal or substance
intended to be, or expected to be incorporated into a food or feed, through all stages of
production, processing and distribution.
Trade recall: see 'Recall'
Use By date: the date after which the product should not be consumed. It is determined from
the date of production, utilising the product shelf life, building in a margin of safety as
determined by the manufacturer.
78 th
Vacuum packaging: Partial or total removal of air from packaging.
Validation: Obtaining evidence that the elements of the HACCP plan are effective.
Verification: the application of methods, procedures, tests and other evaluations, in addition
to monitoring, to determine compliance with the HACCP plan.
Water:
Clean water
Water that does not compromise food safety in the circumstances of its use.
Ground water
Water that has percolated through the soil from the surface and is available in porous
rock beneath the surface.
Potable water
Water that is of drinking water standard as defined in the legislation European

Communities (Quality of Water Intended for Human Consumption) Regulations 1998.
Surface water
Rivers, lakes, ponds, reservoirs, uncovered storage tanks, etc, where the water
source is open to the environment.
Withdrawal: a company’s removal or correction by its own volition of a distributed product

that involves no health hazard, and that is initiated for two reasons:
− The product has a quality defect (e.g. colour or texture) or is underweight or has
labelling irregularities that do not pose a potential risk to public health and safety.
− As a precaution pending further investigation and – if a risk to public health or safety
is established – leading to recall.
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80 th
APPENDIX B
Case Studies using Decision Tree Route to Determine

Minimum Hygiene Status Required
th
EXAMPLE 1: COLESLAW
CATEGORY OF FOOD: READY-TO-EAT UNCOOKED PREPARED FOOD
PART 1
EXAMPLE PROCESS FLOW DIAGRAM
Vegetable Dry
LRA Vinegar
Ingredients Ingredients
Mix
Adjust pH <4
Deposit
Pack, Seal
Label
Cool <5°C
Despatch
82 th
EXAMPLE 1: COLESLAW
CATEGORY OF FOOD: READY-TO-EAT UNCOOKED PREPARED FOOD
PART 2
DECISION TREE ROUTE
What is the treatment applied?
All Components
≥90°C/10 mins?
Ð
NO
Ð
All Components
≥70°C/ 2 mins?
Ð
NO
Ð
Intended to be
Not all Components
Î YES Î cooked before Î NO Î LRA
≥70°C/ 2 mins?
consumption?
Minimum Hygiene Status Required LRA
Finished Product Main Pathogen Hazards Refer to Decision Tree (Section 2.1)
Finished Product Pathogen Control Measures LRA

pH<4
Temperature
Refer to ‘Hurdles’ (section 1.2) and
Table 1
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EXAMPLE 2: CHEESE-TOPPED LASAGNE
CATEGORY OF FOOD: READY-TO-REHEAT CHILLED COOKED FOOD
PART 1
Cheese Topping
GMP <10 °C
Pasta Béchamel Sauce Meat Fill
(Pasteurised Milk
Cheese)
Cook Cook Cook

>70 °C/2 min but >70 °C/2 min but >70 °C/2 min but
<90°C/10 mins <90°C/10 mins <90°C/10 mins
Cool
HRA <5°C
Assemble
Cool
<5°C
Top
Pack, Seal
LRA
Sleeve
Despatch
84 th
EXAMPLE 2: CHEESE-TOPPED LASAGNE
PART 2
DECISION TREE ROUTE
All components
≥ 90°C/10
mins?
Ð NO
Not all
Product heat treated
Components Î YES Î Î NO Î HRA
in pack?
≥70°C/ 2 mins?
Minimum Hygiene Status Required: HRA
Finished Product Main Pathogen Hazards: Listeria spp. from potential

recontamination
Finished Product Pathogen Control Measures: Surviving spore formers, e.g. C.

botulinum and B. cereus
HRA
Pasteurisation > 70ºC for 2 mins
Shelf life 10 days maximum
Chilled storage temperature
th
EXAMPLE 3: SANDWICHES
CATEGORY OF FOOD: READY-TO-EAT PREPARED FOOD (INCLUDING

COOKED AND RAW INGREDIENTS)
PART 1
Salad +
Protein pH-Adjusted
Vegetable
HCA Ingredients Dressing Bread Butter
Ingredients
<5°C <10°C <15°C <15°C
<10°C
Assemble
Spread
Deposit
Pack, Seal
Cool <5°C
Label
LRA Despatch
86 th
EXAMPLE 3: SANDWICHES
CATEGORY OF FOOD: READY-TO-EAT PREPARED FOOD (INCLUDING

COOKED AND RAW INGREDIENTS)
PART 2
DECISION TREE ROUTE
All Components
≥90°C/ 10 mins?
Ð
NO
Ð
All Components
≥70°C/ 2 mins?
Ð
NO
Ð
Some Components Intended to be cooked
Î YES Î Î NO Î HCA
≥70°C/ 2 mins? before consumption?
Minimum Hygiene Status Required HCA
Finished Product Pathogen Control HCA

Measures Ingredients specification
Shelf life limitation
Temperature
Refer to ‘Hurdles’ (Section 1.2)
th
EXAMPLE 4: IN-PACK PASTEURISED LASAGNE
PART 1
EXAMPLE PROCESS FLOW
Precooked Cheese
LRA Pasta Béchamel Sauce Meat Fill
and Crumb Topping
Cook Cook Cook

>70 °C/2 min but >70 °C/2 min but >70 °C/2 min but
<90°C/10 mins <90°C/10 mins <90°C/10 mins
Cool
<5 °C
Assemble in pack
Top and seal
Pasteurise in pack
>90ºC for 10 mins
Chill <5ºC
Label
Store
Despatch
88 th
EXAMPLE 4: IN-PACK PASTEURISED LASAGNE
PART 2
DECISION TREE ROUTE
All components
≥ 90°C/10 mins?
Ð
NO
Ð
All components Product heat

Î YES Î treated in
≥ 70°C/2 mins? Î YESÎ LRA
pack?
Finished Product Pathogen Control Measures In-pack pasteurisation > 70°C/2 min
Shelf life 10 days maximum
Chilled storage
th
EXAMPLE 5: MIXED LEAF SALAD
CATEGORY OF FOOD: RAW PREPARED READY-TO-EAT PRODUCT
PART 1
Whole Lettuce Raw Whole Peeled Whole Peeled Pre-packed

LRA
(Various) Beetroot Onion Dressing Sachet
Trimming Inspect Inspect
Cut
Wash Wash Wash Debox

HCA
Drain Cut Drain
Spin dry Grate
Drain
Fill into pack
MAP and seal

LRA
Despatch 5ºC
90 th
EXAMPLE 5: MIXED LEAF SALAD
CATEGORY OF FOOD: RAW PREPARED READY-TO-EAT PRODUCT
PART 2
DECISION TREE ROUTE

All
components
≥ 90°C / 10
min?
Ð
NO
Ð
All
components
≥ 70°C / 2
min?
Ð
NO
Ð
Not all
Intended to be
components
Î YES Î cooked before Î NO Î HCA
≥ 70°C / 2
consumption?
min?
Minimum Hygiene Status Required: HCA
Finished Product Main Pathogen Hazards: Listeria spp. from potential

recontamination
Surviving spore formers, e.g. C.
botulinum and B. cereus
Finished Product Pathogen Control Measures: Washing prior to packing

HCA
Chilled storage temperature
th
EXAMPLE 6: CHEESE & TOMATO PIZZA
CATEGORY OF FOOD: PREPARED FOOD (INCLUDING COOKED AND RAW

INGREDIENTS) TO BE COOKED BY THE CONSUMER BEFORE EATING
PART 1
Pre-
Protein Vegetable Grated
Cooked prepared
LRA Ingredients Ingredients Cheese
Dough Tomato
<5°C <10°C <10°C
Base Sauce
<15°C
Spread
Deposit
Pack, Seal
Cool <5°C
Label
Despatch
92 th
EXAMPLE 6: CHEESE & TOMATO PIZZA
CATEGORY OF FOOD: PREPARED FOOD (INCLUDING COOKED AND RAW

INGREDIENTS) TO BE COOKED BY THE CONSUMER BEFORE EATING
PART 2
DECISION TREE ROUTE
All Components
≥90°C/ 10 mins?
Ð
NO
Ð
All Components
≥70°C/ 2 mins?
Ð
NO
Ð
Some Components Intended to be cooked
Î YES Î Î YES Î LRA
≥70°C/ 2 mins? before consumption?
Finished Product Pathogen Control Appropriate cooking instructions

Measures
th
APPENDIX C
PRE-EMPLOYMENT MEDICAL SCREENING QUESTIONNAIRE
FULL NAME:
DATE OF BIRTH:
DATE OF ENGAGEMENT:
Have you now, or have you over the last seven days, suffered from diarrhoea and/or
vomiting? YES/NO
1. At present, are you suffering from:
i) Skin trouble affecting hands, arms or face? YES/NO
ii) Boils, styes or septic fingers? YES/NO
iii) Discharge from eye, ear or gums/mouth? YES/NO
2. Do you suffer from:
i) Recurring skin or ear trouble? YES/NO
ii) A recurring bowel disorder? YES/NO
3. Have you ever had, or are you now known to be a carrier of typhoid or YES/NO
paratyphoid?
4. In the last 21 days have you been in contact with anyone, at home or abroad,
who may have been suffering from typhoid or paratyphoid? YES/NO
5. Have you been abroad in the last three weeks? YES/NO
If YES, were you ill? YES/NO
SIGNATURE OF EMPLOYEE:-
SIGNATURE OF MEDICAL PRACTITIONER:

(or other suitably qualified person)
94 th
APPENDIX D
RETURN TO WORK QUESTIONNAIRE
This is a sample form for completion by any employee who has been absent from work, suffering from
illness (whether they have had time off work or not) and after any overseas travel.
It should also be completed if an employee has suffered symptoms of illness referred to.
The employee must not enter the factory without having completed the form and it having been
reviewed by a Supervisor or other member of staff responsible for the medical status of staff.
Name: Shift:
Job Title: Department:
Period of absence: From: To: Manager/Supervisor:
Section 1: Reason for Absence
Please circle your answers to the following questions:
Works
Foreign travel Notified Sick Maternity
accident
Country:
Illness while away or since return?
Authorised Unauthorised Bereavement Other
In the case of any of the individual having visited a Red Zone country, they should not handle
food until cleared by an occupational health professional.
Section 2: Symptoms/Exposure
Tick those relevant:
Diarrhoea Vomiting
Enteric fever (typhoid/paratyphoid) Other type of Salmonella infection
Stomach or bowel disorder Gastroenteritis
Cholera (Vibrio) Hepatitis/jaundice
VTEC E. coli (e.g. O157) Dysentry (Shigella)
Skin condition (e.g. eczema, scaling, Sore throat
septic cuts, boils)
Bronchitis/productive cough Boils/infected wound
Disease/discharge eyes, nose, ears, Food poisoning
mouth/gums
Have you been in contact with anyone suffering any of the above?
In the case of any of the above the individual should not handle food until cleared by an
occupational health professional.
Section 3: Investigation Notes
Are you taking any medication Yes/No

If yes, state what medication and any potential side effects
Have you completed a stool test?
Section 4: Action Taken
No action required
Appointment with Human Resources Date:
Appointment with Occupational Health Date:
th
APPENDIX E
HIGH CARE & HIGH RISK AREA TEMPORARY OPERATIVES

PRE-EMPLOYMENT TRAINING MATERIAL
Personal Responsibility
If you are employed as a food handler you are responsible for helping to ensure that food reaches
consumers in a condition that doesn't harm them. You must remember that you are making food for
people to eat, and their well being and safety depends on you.
Good hygiene is necessary for your company, and for job security, and is required by law.
Harm can mean food poisoning by bacteria and viruses (germs), poisoning by chemicals (e.g.
cleaning materials), or physical damage from foreign bodies (e.g. glass).
Food Poisoning Bacteria and Viruses (Germs)
Germs are organisms that are so small you can't see them, but if not controlled can be found
everywhere. Food poisoning bacteria and viruses can't be allowed in chilled ready-to-eat foods.
Important food poisoning organisms include:-
Salmonella
E. coli O157
Listeria monocytogenes
Staphylococcus. aureus
Campylobacter
Clostridium perfringens
Bacillus cereus
Clostridium botulinum (botulism bacteria)
some viruses
These can be found in a variety of places including:-
• Animals (e.g. food animals, birds, pets, pests and food animals)
• Raw food (e.g. raw meat, poultry, vegetables)
• Raw milk
• Soil, dirt and dust
• Human beings - intestines, skin (e.g. hands, cuts), nose, mouth and hair
• Clothing and footwear
• Water, especially lying open in pools or puddles
• Air
• Surfaces (e.g. floors, walls, factory equipment, dirty cleaning
equipment, outer packaging, gloves)
• Waste (e.g. trimmings, reject materials)
• Toilet areas
Food poisoning usually causes a stomach upset - vomiting and diarrhoea, but it can sometimes be
more serious than this, even causing death.
Chemicals
Chemicals in food factories are needed for cleaning, disinfecting and keeping machinery working
properly. If chemicals are used wrongly (e.g. too much, in the wrong place, mixed with other chemicals
or not washed off as instructed) they become poisonous and may harm you or the consumer.
96 th
Examples include:-
• cleaning chemicals
• disinfectants
• lubricants
• perfume
Foreign Bodies
Foreign bodies lead to dissatisfied consumers who feel their well-being has been affected. They may
also cause harm, e.g. glass.
Examples of foreign bodies include:-
• glass and hard plastics

• nuts, bolts and electrical wire
• pieces of packaging material
• bones or shells
• wood
• jewellery
• cigarette ends
• plasters
• contact lenses and glasses
• cleaning equipment (e.g. brush bristles, cloths)
• hair
• make up and nail varnish
• flies and insects
WHAT YOU MUST DO TO AVOID THESE PROBLEMS
Always follow factory rules and instructions

Prevent contamination
Don't let bacteria, foreign bodies or chemicals get onto the food
DO
9 Always wear protective clothing provided

9 Change protective clothing when instructed, following the factory procedures
9 Wash hands thoroughly as instructed, especially after using the toilet, after handling waste, after
handling raw materials and before touching ready-to-eat foods
9 Report any septic boils and cuts to your immediate manager
9 Cover cuts and blemishes with a blue waterproof plaster as blue is easily seen
9 Report sickness and/or diarrhoea to your manager; this includes contact with other people who
have had sickness or diarrhoea
9 Store chemicals and cleaning equipment away in separate storage areas before handling foods
9 Be careful in your use of water - it can spread germs; use it only as instructed
9 Ensure that equipment is always clean
9 Stick to the Company's hygiene rules
DON'T
8 Start work if suffering from vomiting or diarrhoea

8 Start work before you have washed your hands
8 Wear jewellery or watches, except as allowed by the Company
8 Smoke except in special areas allowed by the Company
th
8 Sneeze or cough over food - if you have to wipe or blow your nose use a disposable tissue and
then wash your hands
8 Scratch or touch skin or hair
8 Bite your nails, or lick your fingers
8 Spit
8 Eat in the factory
8 Allow anything that has been on the floor to be packed as food or come Into contact with food
8 Use dirty containers or utensils
8 Use hoses near open product and never spray floors or packaging with water
Prevent the Growth of Bacteria
Sometimes you don't even need germs to grow to cause food poisoning. Examples of these are E. coli
O157, viruses, Campylobacter and even Salmonella. However, food poisoning is often caused when
bacteria are allowed to grow to high numbers. To do this they need moisture, warmth and time. The
growth of bacteria slows down a lot at less than about 8°C and more than about 50°C. If conditions are
right, they can double their numbers as often as every 20 minutes. This means that one germ can
grow to nearly 17 million by the end of a shift. This is more than enough to cause food poisoning. It is
particularly important to cover and move food to chilled store rooms quickly.
A low temperature, even freezing, will not kill germs but will slow their growth right down.
DO
9 Keep things that are meant to be cold, cold (usually 5°C or less)
9 Chill products which need to be chilled as soon as possible
9 Keep things that are meant to be hot, hot (usually 63°C or more)
9 Keep things dry if instructed to do so
9 Keep things clean
9 Clean as you go
9 Report faulty refrigeration or other equipment to your manager
DON'T
8 Leave food at room temperature (in the danger zone (8-50°C), or outside the factory
8 Take food out of the fridge before directed
8 Leave fridge doors open
8 Use water unnecessarily in 'dry areas'
8 Neglect difficult to clean areas when cleaning - these may provide breeding ground for germs
Destroying Germs
Cooking is usually carried out to destroy germs. Always ensure that cooking instructions are followed.
DO
9 Always heat or cook foods to the temperatures and times required

9 If there seems to be a problem with cooking report it immediately to your supervisor
DON'T
8 Ever allow inadequately heated foods to be packed
98 th
OPERATIVES ONLY
SELECTION QUESTIONNAIRE - FOOD HYGIENE AWARENESS
Name............................................................................................................
Date..............................................................................................................
Questions. Please give your answers in the space provided.
Q1. Why should food be stored in a fridge?
Q2. Why is special clean protective clothing worn?
Q3. Why is it important to keep the factory clean?
Q4. When should you wash your hands?
Q5. Why should wounds and skin blemishes be covered?
Q6. Why are blue coloured plasters used?
Q7. What are the key conditions needed for germs to grow?
Q8. How do you stop germs growing?
Q9. What is the main way we destroy germs?
Q10. What must you do if you drop food on the floor?
Q11. Why must cooked foods be protected from contact with raw materials?
Q12. What must you do if equipment is faulty?
Q13. What must you do if you have vomiting or diarrhoea?
Q14. Name two common symptoms of food poisoning?
Q15. List three types of foreign bodies or chemical contamination?
© CFA Best Practice Guidelines for the Production of Chilled Food, 4 edition
th
2006 99
FOR SELECTION PERSONNEL ONLY
SELECTION QUESTIONNAIRE - FOOD HYGIENE AWARENESS
Q1 Why should food be stored in a fridge?

A1 To slow the growth of germs
Q2 Why is special clean protective clothing worn?

A2 To protect food from contamination.
Q3 Why is it important to keep the factory clean?

A3 To prevent the spread of germs.
Q4 When should you wash your hands?

A4 Before you handle food.
Q5 Why should wounds and skin blemishes be covered?

A5 To prevent contamination of food from germs on/in them.
Q6 Why are blue coloured plasters used?

A6 They are easy to see if they fall off.
Q7 What are the key conditions needed for germs to grow?

A7 Warmth (must give this point), food, water.
Q8 How do you stop germs growing?

A8 Refrigeration (must give), heat, drying.
Q9 What is the main way we destroy germs?

A9 Heat.
Q10 What must you do if you drop food on the floor?

A10 Ensure it is not used.
Q11 Why must cooked foods be protected from contact with raw materials?
A11 To prevent contamination
Q12 What must you do if equipment is faulty?

A12 Report it to your manager.
Q13 What must you do if you have vomiting or diarrhoea?

A13 Preferably, stay at home, but at least report it to your manager before starting work.
Q14 Name two common symptoms of food poisoning

A14 Diarrhoea, vomiting.
Q15 List three types of foreign bodies or chemical contamination

A15 See training material.
100 th
APPENDIX F
CFA HANDWASH POSTER
This poster is available from CFA in A4 and A3, printed in three colours on splashproof Permasilk.
th
APPENDIX G
CONTRACTOR HYGIENE REQUIREMENTS
1. Contractors must complete a hygiene questionnaire and comply with the Department of
Health's Fitness to Work guidelines as food handlers if carrying out work in a factory or store
area.
2. Any contractor potentially not complying must report to his manager before starting work, who
must then notify their contact with the food manufacturer. A decision must then be made by
the company whether to allow the contractor on site.
3. Contractors must declare prior to entering the plant whether they have previously been
working in an environment that may prejudice food safety in the plant, e.g. abattoir/raw meat
plant/waste disposal plant.
4. No contractor should commence work without prior consent from the appropriate factory
manager or Central Stores Superintendent. The contractor should be made aware of any
specific hygiene and/or safety requirements.
5. Personal hygiene is of the utmost importance. Contractors must observe company hygiene
rules, including specific clothing requirements.
6. Any cuts/sores must be kept covered with a blue (metal detectable) waterproof dressing.
7. Head coverings, including hairnets, must be worn. Hair coverings must enclose all the hair
and must cover the ears. Where appropriate, beards snoods must be worn.
8. No jewellery is permitted apart from one plain ring and two sleeper earrings. Watches are not
permitted.
9. Hands must be washed after visiting the toilet or using a tissue and before handling equipment
where food is exposed.
10. Eating or chewing of any foodstuffs is not allowed in any factory area including the Central
Stores. Food and drink are to be consumed only in the canteens.
11. Spitting is not permitted.
12. Smoking is not permitted across the site. Smoking is allowed only in designated smoking
areas.
13. Contractors must not handle raw materials, product or packaging at any stage of production
without permission.
14. All accidents on Company property involving contractors should be reported to the Company's
safety officer.
15. All tools and equipment used by contractors must be kept in a clean and tidy condition and not
present a food safety hazard to product or plant. Tools must not be placed on raw materials
or products in factories or stores, nor on equipment that is in use. All tools must be accounted
for when leaving the Company’s site.
16. When welding, drilling or cutting, contractors should ensure that there is no possibility of
debris from these operations contaminating raw materials, product or other machinery.
17. The area of operation should be screened where necessary and/or contractors should request
appropriate Company personnel to remove raw materials or product from the working area.
102 th
18. All swarf, clippings and debris from contractual work must be swept up and removed from the
stores or factories in a suitable sealed container after the work has been completed. The
waste should then be disposed of into a clean away bin or if glass into the red glass bin on the
site.
19. All oils, lubricants and other fluids must be kept in sealed containers and not allowed to
contaminate raw materials or product in the factory or stores. They must be food safe where
specified.
20. Contractors must go directly to and from their place of work and may not enter other areas
without prior authorisation.
th
APPENDIX H
AIR QUALITY
It is not possible to eliminate completely the risk of microbial contamination of a prepared foodstuff.
However, High Care and High Risk Area operations and systems must be designed and managed
with the aim of preventing contamination.
Many factors can contribute to food contamination by microorganisms during production, such as: raw
materials, equipment, personnel and the air in the food production environment. Air can act as a
source of contamination from outside the processing area, or as a transport medium, moving
contamination from other sources within the processing area, such as personnel, drains and overhead
structures. Control of airborne microbiological contamination can be achieved with the use of well-
designed hygienic air handling systems provided that the production process and the nature of the
associated risks are fully understood, and maintenance of the air movement equipment is in place.
Air quality control systems are primarily designed to prevent product contamination by spoilage
organisms or particles that may act as a transport vehicle for microbiological contamination; however,
other considerations may also need to be taken into account for example, the requirement for
temperature and relative humidity control, prevention of air turbulence and maintenance of personnel
comfort. Directional air flow to ensure that air moves to aerosol generating areas and such locations
as personnel entry zones should be considered.
The specification of requirements for individual air handling systems depends to some extent on the
risk category of the food product, the target microorganisms to be controlled, and the environment
surrounding the higher risk (High Care or High Risk) Area. Hazard analysis must be carried out to
determine the standards required for each circumstance. For example, high efficiency air filtration is
not essential where the supply air is not a significant factor in dispersing contamination, or where the
level and type of contamination on the materials handled are such that any contribution from the air is
relatively insignificant. Similarly, air filtration alone cannot guarantee room cleanliness - air movement,
room design and activity within the controlled environment are of great importance. However, in all
cases, air quality from mechanical ventilation systems must be controlled so that it does not become a
factor limiting product hygiene, and procedures must be established to manage and service the air
handling system. To control the intake of atmospheric pollution F7 grade rigid cassette filters are
essential, and should be considered a minimum air filtration level.
The air handling system must be designed so that it does not become contaminated, either during
operation or by any cleaning operations within the production area. Condensation within the ductwork
must be prevented and the ingress of other forms of water vapour during the normal operation or
cleaning of the controlled space must not be allowed, as this may promote microbial growth in the
system. Compliance with the requirements for the control of Legionnaires’ Disease must be implicit in
any system design.
It is vital to avoid drawing in contaminated air such as aerosols from cooling equipment, combustion
gases, waste areas, etc., and exhaust fumes. Air intakes must therefore be sited to avoid such
sources.
To prevent air from lower-risk areas entering and contaminating the higher-risk (High Care or High
Risk) Area, continuous room pressurisation is essential to ensure correct air flows. Air flow must be
from higher- to lower-risk operations. The degree of pressurisation will depend on the nature of the
operation and the number of openings that need to be protected. Openings and access should be
kept to a minimum to control air loss to an acceptable level whilst maintaining air flow, air change rate
and a positive differential pressure. Low levels of differential pressure are difficult and expensive to
monitor and it is easier to measure air movement out of High Care/High Risk areas. A minimum air
movement of 1m/s is recommended. This air movement must be maintained under all controlled
process conditions.
104 th
A restricted High Care space or enclosure within a process room can be achieved by air filtration and
air flow to surround the product when it is not practical or necessary to have the complete room as a
High Care or High Risk Area. This design is known as a ‘mini-environment.’
It must be emphasised that the important feature of room pressurisation is that air must flow at all
times from higher to lower risk, not the room pressurisation itself. Only a small amount of
overpressure, measured in Pascals, is sufficient. The influence of access to ambient air from GMP
areas such as dispatch should be controlled. Outside weather conditions such as wind can pressurise
GMP areas and influence corridor and even High Care areas; thus access control is critical.
As air quality may be an essential element in food safety and must be taken into account in the risk
assessment, specialist expert advice should be taken.
Further Reading
Guidelines on Air Quality Standards for the Food Industry, Guideline No. 12, Campden and
Chorleywood Food Research Association, Issue 2, 2005.
The Minimisation of Microbic Pollution Risk in the Food Industry, Dr F Mariani, Swiss Contam. Control,
1990, 3(4a), 355-7
Ventilation and Air Conditioning, Chartered Institute of Building Services Engineers (CIBSE), 2001,
ISBN: 1 903287 16 2. www.cibse.org
Useful Technical Information
A level of 19-20 litres of outside air per second, per person, should be allowed. The minimum
standard is 8 ℓ/s/person. (CIBSE).
A minimum of 10-12 air changes per hour is recommended to help control relative humidity and
temperature, but will depend on the nature of the process.
The amount of outside air make-up required will depend on the level of room overpressure required.
A suggested maximum air velocity of 2.5 m/s should not be exceeded across the air handling unit
cooling coils (if installed) in order to prevent condensate droplets from being carried over into the
system and hence supporting microbial growth within the unit. If this is considered to be a risk, then
design steps must be taken to eliminate it.
Where a mini “High Care” environment is installed, a minimum target air velocity (in the absence of
turbulence) of 0.3 m/s over the product is recommended.
Heating, Ventilation and Air Conditioning (HVAC) type filters are used to remove particulates from the
air. Refer to the following table for filter classifications (EN 779 and EN 1822).
For High Care Areas, if there is a hazard of microbiological contamination from the air supply to the
process room, filtration standards of F7 to H 11 are recommended; however, the exact specification
required will depend upon the analysis of risk. It is essential that such filters be installed with suitable
pre-filtration for maximum filter life and that the filter system is leakproof.
th
AIR FILTER TEST REFERENCE CHART
General Filter Filter Test Reference Filter Test Type and Application for the
and Classification Food Industry
Type
EN779 Average value for collection of large particles
using synthetic test dust. Filter used to prevent
arrestance
mechanical air movement system fouling and
Primary filters G1 <65 as pre-filters to secondary and semi-HEPA
filters.
to collect G2 65<80
coarse G3 80>90
dust G4 >90
EN779 Average percentage value test using the dust in
atmospheric air. Filters installed to keep
efficiency %
general food processing areas clean and free
Secondary filters F5 40<60 from airborne pollution (minimum F7). Some
high care use according to risk assessment.
to collect and retain F6 60<80
small particulate F7 80<90
dust F8 90<95
F9 >95
EN1822 Filters installed for high care/high risk food
process applications.
Very small minimum MPPS %
particulate H10 85
Filters tested for maximum penetration using
air filters of the H11 95 various sizes of particles in an aerosol form to
semi HEPA & HEPA H12 99.5 challenge the filter. Filter with lowest
penetration is most efficient.
type for specific H13 99.95
particulate control. H14 99.995
Highly efficient U15 99.9995 Filters used for laboratory work, in cabinets and
some mini environments.
air filters U16 99.99995
EN 1822 aerosol for MPPS
ULPA type U17 99.999995
MPPS - Most Penetrating Particle Size

HEPA - High Efficiency Particulate Air (filters)
ULPA - Ultra Low Penetration Air (filters)
(BS) EN779 arrestance and efficiency test references are based on average percentage values.
Primary and secondary filters are at their lowest efficiency when they are new, and at their most
efficient at the end of their useful life. (BS) EN 1822 tested filters offer a guarantee of minimum
performance when newly installed as stated above.
106 th
APPENDIX I
SELECTED READING
OTHER RELEVANT GUIDELINES/CODES OF PRACTICE
Chilled Food
Guidelines for Good Hygienic Practice in the Manufacture of Chilled Foods. (1997). 3rd Edition.
Chilled Food Association. ISBN 1 901798 00 3
High Risk Area Best Practice Guidelines. (2001). 2nd edition. Chilled Food Association. ISBN 1 901798
06 2
Microbiological Guidance for Produce Suppliers to Chilled Food Manufacturers. (2002). Chilled Food
Association. ISBN 1 901798 03 8.
Codex Alimentarius Code of Hygienic Practice for Refrigerated Packaged Foods with Extended Shelf
Life - CAC/RCP 46- (1999).
Evaluation of Product Shelf-life for Chilled Foods. (2004). Guidelines No. 46. CCFRA. ISBN 0-904942-
65-5
Microbiology
Microbiological Testing and Interpretation Guidance (2005), Chilled Food Association, ISBN 978-1-
901798-10-4, www.chilledfood.org/content/guidance.asp
‘Guidance on the Practical Implementation of the Microbiological Criteria Regulations’ (2005) Chilled
Food Association. ISBN 978-901798-12-8, www.chilledfood.org/content/guidance.asp.
General Hygiene
Recommended International Code of Practice - General Principles of Food Hygiene - CAC/RCP 1-

1969, Rev. 3 (1997), Amd (1999)
Guidelines on the Application of the Principles of Risk Assessment and Risk Management to Food
Hygiene Including Strategies for their Application. (1995) Codex Committee on Food Hygiene, CX/FH
95/8
Hygienic Design Guidelines. (2002). 1st edition. Chilled Food Association, UK. ISBN 1 901798 07 0.
Packaging Hygiene Guidelines for Suppliers to the Chilled Food Industry. (1999). 1st edition. Chilled
Food Association. ISBN 1 901798 05 4.
Water Quality Management: Guidance for the Chilled Food Industry. (2005). 2nd edition. Chilled Food
Association. ISBN 978-1-901798-09-8.
Effective Microbiological Sampling of Food Processing Environments. (1999). Guideline No. 20.
Campden and Chorleywood Food Research Association.
Hand Hygiene, Babb, J (1998), Minute 30/98, 18 July 1998 CFA Technical Committee meeting,
CFA/204/98. Chilled Food Association.
European Hygienic Engineering Design Group: www.ehedg.org
Specific Product Types
Microbiological Guidance for Produce Suppliers to Chilled Food Manufacturers. (2002). Chilled Food
Association. ISBN 1 901798 03 8.
th
A Code of Practice for the Manufacture of Vacuum and MAP Chilled Foods. (1996). CCFRA Guideline
No.11. Campden & Chorleywood Food Research Association
Code of Practice for Sous Vide Catering Systems. (1991). Sous Vide Advisory Committee, c/o
Multivac Ltd, Swindon.
Retail Guidelines: Refrigerated Foods in Reduced Oxygen Packages. US Association of Food & Drug
Officials. New York.
Code for the Safe Running of Salad Bars. (1991). Food Safety Advisory Centre/IEHO.
Code of Hygienic Practice for Refrigerated Packaged Foods with Extended Shelf-Life - CAC/RCP 046-
1999.
Temperature
A guide to the General Temperature Control Regulations 1995 Food Safety. Department of Health,
London. http://archive.food.gov.uk/dept_health/archive/busguide/foodsafe/temrch.htm
Guidelines on the Food Hygiene (Amendment) Regulations 1990. Part II: Methods of Measuring and
Monitoring Temperature. (1991). HMSO, London.
A Guide to the International Carriage of Perishable Foodstuffs (ATP). (1988). Department of

Transport, London.
Recommendations for the Chilled Storage of Perishable Produce. (2000). International Institute of
Refrigeration, Paris.
Quality Management Systems
ISO 9000 series. International Standards Organisation.
BS 5750, Parts 1 to 3. (1987). British Standards Institution.
BS 5750, Part 4. (1990). British Standards Institution.
Quality Systems for the Food and Drink Industries. Guidelines for the Use of ISO 9002:1987 in the
Manufacture of Food and Drink (EN 29002:1987; BS 5750 Part 2:1987). (1989). Leatherhead Food
International.
Laboratory Practice
A Code of Practice for Microbiology Laboratories Handling Food Samples. (1996). Guideline No. 21.
Campden and Chorleywood Food Research Association.
Manual of Microbiological Methods for the Food and Drink Industry. (2003). Campden and
Chorleywood Food Research Association.
'Guidelines for Challenge Testing', (1987), Campden and Chorleywood Food Research Association.
Medical Screening
Health Surveillance and Management Procedures for Food-Handling Personnel. (1989). World
Health Organisation Technical Report Series 785, WHO, Geneva.
Notes on the Control of Gastrointestinal Infections, Infestations and Bacterial Intoxications in the UK.
(1990). Communicable Disease Report Supplement 1, PHLS.
Food Handlers: Fitness to Work, Aug. 1994, Department of Heath, London
108 th
Food Handlers Fitness to Work: Guidelines for Food Business Managers. Department of Health
(1996), H16/014 718 2P 107k, London, UK.
Miscellaneous
Veterinary Residues Management Guidance. (2004). Chilled Food Association. ISBN 1 901798 08 9
General Guidelines for Microwaveable Products. (1991). Food and Drink Federation (available via
Chilled Food Association).
IFST (Institute of Food Science and Technology) "Food and Drink Manufacture - Good Manufacturing
Practice A Guide To Its Responsible Management".
Due Diligence Guidance on the Agricultural Use of Pesticides for Suppliers to Chilled Food
Manufacturers. (2002). Chilled Food Association, UK. ISBN 1 901798 02 X
The Control of legionella bacteria in water systems: Approved Code of Practice and Guidance. HSE
(2001), ISBN 0 7176 1772 6, ref. L8, HSE Books, PO Box 1999, Sudbury, Suffolk, CO10 2WA
Guidelines on Air Quality Standards for the Food Industry, 2nd edition, CCFRA (2005), Guideline No.
12, Campden & Chorleywood Food Research Association
th
APPENDIX J
CFA MISSION, STRATEGY AND WG MEMBERSHIP
CFA’s mission is to promote and defend the reputation of the chilled food industry through the
development and communication of standards of excellence in the production and distribution of
chilled food.
CFA’s strategy
• Is to promote its standards to regulatory bodies, policymakers and other stakeholders

• CFA Members promote CFA standards throughout their supply base
• CFA catalyses action on issues broader than the chilled food sector alone
CFA membership is open to chilled food manufacturers and chilled component/raw material suppliers
who commit to meet CFA Guidelines standards and are UKAS audit accredited to a minimum of BRC
Foundation Level or the International Food Standard.
For current membership, see CFA’s website: www.chilledfood.org
Guidelines Working Group Members
Miss Kaarin Goodburn Chilled Food Association

Mr Garry Chapman Del Monte Fresh Produce (UK)
Mrs Bridgette Clarke Geest
Mrs Caroline Millman Greencore
Mrs Shaheen Adatia Kerry Foods
Dr Sheila Benson Uniq
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BEST PRACTICE GUIDELINES

FOR THE PRODUCTION OF

Mail, telephone, fax & email

TSO Accredited Agents

And through good booksellers

(C) 2006 Chilled Food Association Ltd

Chilled Food Association Ltd

PART 1: GENERAL PRINCIPLES

PART 2: GMP & GHP

Food business operators must

• hygiene of the plant and process;

To be effective, the Guidelines must be used in the following way:

HACCP is used to identify hazards in the production of any particular product.

1.1.1 Microbiological Hazards

Commonly accepted growth boundaries of pathogenic microorganisms are given in Table 1.

Separate CFA guidance is available covering:

Microorganism and growth Min Min pH Min aw Aerobic /

1.1.2 Chemical Hazards

For further details see CFA’s

'Guidance on the practical application of Directive 2003/89/EC', June 2004, BRC/FDF.

1.2.1. Basic Principles for Control

Table 2: Control application examples and essential elements

Where cooking or heating is used as a CCP for the reduction of microorganisms, a

Temperature (°C) Time (mins, secs) Lethal Rate

Table 4: Lethal rates for psychrotrophic Clostridium botulinum 12

3-log reduction requires 30 mins at 90ºC

1.2.1.2 Intrinsic preservation factors (‘Hurdles’)

The effect of a single factor such as temperature to inhibit a microorganism is

Combinations of factors must be chosen depending on the product composition and

a) Single hurdles and no consideration of initial load of the pathogen.

− heating to a temperature/time combination equivalent to 90°C for 10 minutes;

b) Combination of hurdles and no consideration of the initial load of the pathogen.

Predictive models such as Growth Predictor, USDA’s Pathogen Modeling Programme

Some tolerances of specific pathogens to various individual factors under otherwise

1.2.1.3 Expected storage conditions, shelf life and usage instructions

1.2.2 Determination of the minimum Hygienic Standards for Chilled Products

− Low Risk Area (LRA)

A detailed description of the requirements in each area is given in Section 2.2.

1.2.3. Microbiological Risk Assessment

Specialist, expert advice must therefore be sought to use this approach.

Microbiological Testing and Interpretation Guidance, 2005, Chilled Food Association.

For definitions concerning HACCP, refer to Appendix A.

• building design and layout

The HACCP system consists of the following seven principles:

− Principle 1: conduct a hazard analysis.

1.3.4 Guidelines for the Application of the HACCP System

Management awareness and commitment are necessary for implementation of an effective

LOGIC SEQUENCE FOR THE APPLICATION OF HACCP

1. Assemble HACCP Team

3. Identify Intended Use

4. Construct Flow Diagram

5. On-site Confirmation of Flow Diagram

List all Potential Hazards

7. Determine CCPs See Diagram 2

8. Establish Critical Limits for each CCP

9. Establish a Monitoring System for each

Establish Corrective Actions

11 . Establish Verification Procedures

12 . Establish Documentation and Record