Food

Safety

Global Standard UNDERSTANDING

FOOD SAFETY PRODUCTION RISK ZONES
ISSUE 9

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UNDERSTANDING PRODUCTION
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© 2022 BRCGS
ISBN: 978-1-78490-456-2

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Contents
1 Introduction
2 Defining the production risk zones
2.1 Products that do not fit the expected production risk zones 8
2.2 The role of cooking instructions 9
2.3 Handling high-risk and high-care products in the same production risk zone 9

3 High-risk areas – specific requirements

3.1 Designation of production risk zones (clause 4.3.1) 11
3.2 Identification of production risk zones on a map (clauses 4.3.2 and 8.1.1) 11
3.3 Physical segregation (clause 8.1.2) 11
3.4 Drainage (clause 8.2.1) 13
3.5 Air flow and ventilation in high-risk areas (clause 8.2.2) 13
3.6 Removable walls (clause 8.2.3) 14
3.7 Maintenance (clause 8.3.1) 15
3.8 Acceptance of equipment into high-risk areas (clause 8.3.2) 15
3.9 Portable equipment (clause 8.3.3) 15
3.10 High-risk changing facilities (clause 8.4.1) 16
3.11 Cleaning procedures (clause 8.5.1) 17
3.12 Acceptable limits for cleaning (clause 8.5.2) 17
3.13 Cleaning equipment (clause 8.5.3) 17
3.14 Waste disposal (clause 8.6.1) 18
3.15 Laundry services (clauses 8.7.1–8.7.2) 18
3.16 Changes of protective clothing (clause 8.7.3) 18
3.17 Documented facility inspections (clause 3.4.4) 18
3.18 Environmental monitoring (clause 4.11.8) 18

4 High-care areas – specific requirements

4.1 Designation of production risk zones (clause 4.3.1) 19
4.2 Identification of production risk zones on a map (clauses 4.3.2 and 8.1.1) 19
4.3 Physical segregation (clause 8.1.3) 20
4.4 Drainage (clause 8.2.1) 20
4.5 Ventilation 21
4.6 Removable walls (clause 8.2.3) 21
4.7 Maintenance (clause 8.3.1) 22
4.8 Acceptance of equipment into high-care areas (clause 8.3.2) 22
4.9 Portable equipment (clause 8.3.3) 23
4.10 High-care changing facilities (clause 8.4.1) 23
4.11 Cleaning procedures (clause 8.5.1) 24
4.12 Acceptable limits for cleaning (clause 8.5.2) 24
4.13 Cleaning equipment (clause 8.5.3) 24
4.14 Waste disposal (clause 8.6.1) 24
4.15 Laundry services (clauses 8.7.1–8.7.2) 25
4.16 Changes of protective clothing (clause 8.7.3) 25
4.17 Documented facility inspections (clause 3.4.4) 25
4.18 Environmental monitoring 25

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5 Ambient high-care areas – specific requirements

5.1 Designation of production risk zones (clause 4.3.1) 26
5.2 Identification of production risk zones on a map (clauses 4.3.2 and 8.1.1) 26
5.2 Documented risk assessment and microbiological control in ambient high-care areas (clause 8.1.4) 27

Appendix 1 Production zone decision trees and definitions 28

Appendix 2 Example products and typical production zones 32

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1 Introduction
This guideline is intended to help sites understand whether the products they produce will require handling in a
high-risk, high-care or ambient high-care area, and how the specific clauses for these areas should be interpreted. It
does not represent an extension of the Global Standard Food Safety Issue 9 (hereafter referred to as the Standard),
new or additional clauses, but is a further explanation of the requirements. It also give examples, showing how the
requirements of the Standard could be implemented.

Global Standard Food Safety first collated all the requirements for high-risk, high-care and ambient high-
care products into a single section (section 8) in Issue 8. This guideline aims to provide greater clarity on the
requirements for products that need to be handled in these areas.

One of the key tasks of any food processor is to ensure that the food safety controls operated within factory areas
are appropriate to the products being produced. Therefore, where a site handles product susceptible to pathogen
contamination, it is vital to understand the risks and implement effective controls that minimise this potential
contamination.

The site therefore needs to consider:

• the pathogens to which its products may be susceptible
• the nature of these pathogens, including the likelihood of their survival and/or growth in the product
• the specific controls used to manage these pathogens, and how these controls are validated, monitored and
consistently maintained.

For example:
‘L. monocytogenes is hardy; it is salt-tolerant and not only can survive in temperatures below 1°C, but also grow
in these conditions, unlike many other pathogens. It is also notable for its persistence in food-manufacturing
environments. The bacterium is ubiquitous in the environment and can be found in moist environments, soil,
and decaying vegetation.’ Food and Drug Administration. Bad Bug Book, Foodborne Pathogenic Microorganisms and
Natural Toxins (Second Edition) [Listeria monocytogenes, p.99]. 2012.

The expectations for factory hygiene, finish of buildings, equipment, protective clothing and staff hygiene should
reflect the potential risks to the product and obviously the higher the risk associated with a particular product, the
greater the controls required.

Within the Standard, particular attention is focused on products that are chilled or frozen ready-to-eat foods, and
a small group of ambient, ready-to-eat products, all of which have been associated with food poisoning incidents.
One of the primary techniques used by the Standard is to identify factory areas with different risks. This helps to
ensure the appropriate food safety controls are in place and can:
• define the minimum hygiene and environmental standards to prevent pathogen contamination of these foods
after the final process step
• identify restrictions to movement of personnel, materials or equipment between areas.

Within the Standard these areas are classed as high-risk, high-care and ambient high-care areas. Full definitions of
‘high-risk’, ‘high-care’ and ‘ambient high-care’ can be found within Appendix 2 of the Standard - a summary can be
found in the Definitions section of this title. As an aid to understanding these definitions we include two decision
trees in Appendix 1 of this guideline.

BRCGS would like to thank Richard Leathers from Campden BRI and Karin Goodburn from the Chilled Food
Association for their help reviewing this publication.

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2 Defining the production risk zones

Most food processing activities consist of taking a raw material or an unprocessed food product and processing it
to make a product that is closer in condition to that required for consumption. Processing can be as simple as the
washing or grading of vegetables, or as complicated as the creation of a ready meal. Usually, the closer a product is
to becoming consumer-ready, the more demanding the environmental standards are.

The terms ‘high-risk’ and ‘high-care’ have been used in the BRCGS Standards for many years to define areas where
chilled or frozen foods, which are particularly vulnerable to microbiological contamination, are handled. In addition
to this, Issue 7 introduced ‘ambient high-care’ areas to reflect the lessons learned from outbreaks associated with a
range of ambient products that had not previously been considered a concern, such as chocolate, peanut butter and
raw flour.

The aim of these requirements is to define the minimum hygiene and environmental standards to prevent pathogen
contamination of these foods after the microbiological kill or reduction process step. This expected outcome is
summarised by the statement of intent which states:

The site shall be able to demonstrate that production facilities and controls are suitable to prevent pathogen
contamination of products.

The guidelines for defining products to be considered for processing in high-risk, high-care or ambient high-care
areas are principally based on:
• the ability of the finished product to support the growth of pathogens (e.g. Listeria species)
• the survival of pathogens on the finished product that could subsequently grow during the normal storage or use
of the product (e.g. if a frozen product is defrosted but not immediately consumed)
• the protection that a food may provide to a pathogen (e.g. fatty foods afford protection to Salmonella, enabling
food poisoning to result from a very low level of contamination. This is known as a low effective dose).

On this basis high-care, high-risk or ambient high-care zones are applicable for the handling of products that fulfil
all of the conditions in Table 1.

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Applicable production risk zones

High-risk* High-care* Ambient
high-care*
Products are open and therefore vulnerable to contamination
(i.e. neither packaged nor enclosed within equipment).

Products are ready to eat or heat (i.e. there is no intended

final microbiological kill step undertaken by the customer or
consumer to make the products safe to eat) or are likely to be
consumed without adequate cooking**.

Finished products are vulnerable to the growth of pathogens (i.e.

the characteristics or formulation of the products are suitable to
support growth, such as water activity, absence of preservatives,
suitable pH) or to the survival of pathogens that could
subsequently grow during normal storage or use.

Finished products are vulnerable to the survival of vegetative

pathogens that could subsequently cause food poisoning due
to growth, or the protection of the pathogen by the food matrix
resulting in low effective doses.

Finished product is chilled or frozen to preserve food safety.

Finished product is stored at ambient temperature.

All components (e.g. ingredients) have received a full cook prior

to entry to the area.

Microbiologically susceptible components (e.g. ingredients) have

received a process that reduces contamination to an acceptable
level prior to entry to the area.

Products are processed on site from a raw material that is prone

to contamination by a vegetative pathogen.

* For a product to be considered as high-risk, high-care or ambient high-care, it must fulfil all of the criteria in the appropriate column.
** see section below on validated cooking instructions.

Table 1: Conditions requiring high-risk, high-care or ambient high-care zones

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It is important to note that the high-risk, high-care or ambient high-care production area usually applies only to part
of a factory’s production process; usually following a microbiological reduction or kill step and until the products
are enclosed in packaging.

Products manufactured in these areas are further separated on the basis of whether processing has eliminated
pathogens such as Listeria through cooking or reduced their likely incidence through other control measures
such as the chlorine washing of vegetables and whether the final products are stored at chilled, frozen or ambient
temperatures.

Examples of typical products and the applicable final processing zones are given in Appendix 2.

2.1 Products that do not fit the expected production risk zones
Whilst the Standard specifically focuses on the requirements for high-risk, high-care and ambient high-care zones,
low-risk does not mean no risk. The expectations for factory hygiene, finish of buildings, equipment, protective
clothing, staff hygiene etc. must still reflect the potential risks to the product and need to be appropriate.

In particular, a risk assessment may identify products that do not fall within the Standard’s definitions for high-risk,
high-care or ambient high-care but still have significant pathogen risks which need to be correctly managed. For
example, raw milk cheese, raw oysters, and meat or fish that will be consumed raw do not have a microbiological
kill or reduction step within the production process, but all these products require high standards of hygiene and
pathogen control, including segregation, good process flows and hygiene. In these situations the site still has a
responsibility to develop appropriate controls and a factory environment suitable to produce safe food.

The following clauses are likely to be especially important in maintaining and monitoring product safety:
• 4.3.4 (movement of personnel and materials)
• 4.11.1–4.11.2 (methods and standards of cleaning)
• 4.11.8 (environmental monitoring)
• 5.6 (Product inspection, on-site product testing and laboratory analysis)

Similarly, there may be instances where a site manufactures a product that would generally be considered
high-risk, high-care or ambient high-care but validation shows that this specific product is not susceptible to
pathogen contamination and/or growth (e.g. due to the intrinsic characteristics of that specific product). In these
circumstances the auditor would expect to see a thorough validation study demonstrating and justifying the
controls required. Yoghurts, for example, will have variable pH values which may or may not make them susceptible
to Listeria and therefore manufacture may be high-care or low-risk as applicable.

On the contrary to the above, a site may manufacture a product that would generally be considered low risk as the
majority of the operation is enclosed but the very last step in the process may change the risk categorisation. An
example of such a situation is dairy based ice-creams. There have been a number of product recalls associated with
ice cream contaminated with pathogens such as Listeria spp. It is therefore vital that sites manufacturing dairy based
ice-cream products operate suitable controls to prevent adverse microbiological contamination, which is often
achieved using high-care production risk zones (see Appendix 2 of the Standard).

A large proportion of the ice cream manufacturing process is completed in enclosed product areas (e.g. in pipework)
and high-care facilities are not required for these areas. Where the product is open (i.e. exposed to the factory
environment), the site must operate suitable processes to prevent product contamination. Many sites have therefore
concluded that high-care facilities are appropriate for their product range. However, if a site concludes that high-
care production zones are not necessary and a low-risk zone can be used, then this must be supported by justifiable
evidence. In this situation, the chosen risk zone must be supported by a risk assessment in the HACCP plan (i.e. the
plan must include a thorough risk assessment which considers the potential pathogen contamination risks and a
demonstration of how these will be mitigated).

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Simply stating that a product is frozen is not considered a thorough risk assessment. Pathogen test results (product
and/or environmental monitoring) can be useful to demonstrate that the controls are working effectively, but they
are not considered an alternative to a thorough risk assessment as they demonstrate the absence of pathogens
rather than identifying the correct controls. In the absence of this risk assessment, the expectation is that a high-
care zone will be operating.

Regardless of the production zone, sites are also expected to meet any specific legislation in the countries where
the product is intended to be sold.

Additionally there may be situations where a site manufactures a product where a robust scientific-based validation
may show that the product is low risk as this specific product is not susceptible to pathogen contamination and/
or growth however based on evidence of expected reasonable use/misuse they would be considered high-risk,
high-care or ambient high-care (reference clause 2.4.1). Examples would be raw cookie dough, breaded chicken
and cooked crustaceans. Due to the product appearance and known consumer usage of such products i.e. eating
the product without any further heating or full cook, cooking instructions alone are not considered as a valid
justification for a lower-risk production zone for such products.

All the scenarios detailed above demonstrate the need to assess all factory controls, including high-risk, high-care
and ambient high-care facilities, based on the specific product details, rather than on generalisations about the
product category.

Where a site produces a product that does not fit with the typical production risk zone for that type of product, it is
recommended that the site discusses this with its certification body in advance of the audit.

2.2 The role of cooking instructions

Where the final product has on-pack cooking instructions for the consumer that are equivalent to a full cook, this
may be justification for the product to be considered for production in a low-risk area.

In these situations the site is expected to have a full validation of the cooking instructions to ensure that products
cooked according to the instructions will consistently produce a safe product, fit for consumption. Where cooking
instructions are used, the auditor will include these within the audit, and the site will be required to demonstrate
that the instructions are appropriate and correct, that the product will achieve the correct temperature within the
correct time, and therefore that a safe product is consistently produced.

Where cooking instructions are not demonstrably correct or the validation is insufficient, this may result in a non-
conformity; for example, against clause 5.2.4.

Good practice when developing cooking instructions is to consider whether there is any known consumer use which
may result in consumption of the product without adequate cooking. In this situation it may be necessary to amend
production processes or customer instructions to ensure safe use of the product.

2.3 Handling high-risk and high-care products in the same production risk zone
Good segregation is a vital control in preventing products being re-contaminated with pathogens after the
microbiological kill or reduction step. The Standard therefore expects that high-risk and high-care areas will be
segregated from low-risk areas (see sections 3.2 and 4.2 below).

The Global Standards Technical Advisory Committee has also specifically considered whether high-risk and high-
care areas need to be segregated from each other or whether products manufactured in these areas could be
handled in the same area for part or all of the post-cooking processes (e.g. the use of shared slicing lines for cooked
and cured/fermented meat products and/or shared packing lines).

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The committee concluded that the risk that the high-risk area is designed to control is that of the introduction of
pathogens (specifically Listeria and other psychotrophs) into the area and cross-contamination of the fully cooked
products.

Products which, through their process and/or inherent chemical characteristics are unsuitable for the growth of
Listeria, may nonetheless be contaminated and could be a source of cross-contamination of other vulnerable
products.

Therefore, the Standard requires:

• all products handled in the high-risk area to have undergone a process equivalent to a 6 log reduction of Listeria
before entering the area
• if the processes used (e.g. curing/fermenting of particular products which the site wishes to slice or pack in the
high-risk area) have been validated as effective in achieving a 6 log reduction there is no problem in these
products being sliced in the same high-risk area as fully cooked products, providing:
• validation of the processes is in accordance with guidance in Codex CAC/GL 69 Guidelines for the Validation of
Food Safety Control Measures. It must not be based on final product testing alone
• this validation is product- and facility-specific (due to the variability in methods of processing and products
produced).

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3 High-risk areas – specific

requirements
High-risk areas require the highest levels of hygiene, controlled working practices, and high standards of design and
fabrication of facilities and equipment to prevent product contamination with regard to microbiological hazards.

High-risk areas contain only components or foods that have undergone a cook or similar process, typically
to achieve a 6 log reduction for Listeria (see Appendix 3 of the Standard for an example of time/temperature
combinations achieving this). Where a single area needs to include some components that have not received a full
cook as well as fully cooked components (e.g. sandwiches; ready meals topped with an uncooked ingredient such
as fresh herbs; or baked cheesecake topped with an uncooked ingredient such as fresh fruit) this will be classed as
high-care.

This section contains the interpretation for the specific requirements that are highlighted for high-risk areas.

3.1 Designation of production risk zones (clauses 4.3.1)

All sites need to ensure that the production facilities are suitable for the types of products they are manufacturing,
processing or packing. This includes an assessment of the production risk zones needed for the prevention of
microbiological contamination.

Full details on the definitions of the production risk zones recognised by the Standard are given in appendix 2 of the
Standard.

3.2 Identification of production risk zones on a map (clauses 4.3.2 and 8.1.1)
The objective of identifying the production risk zones on a map or factory plan is to ensure that the standards of
environmental hygiene, particularly those concerning equipment, buildings, cleaning and personnel hygiene, are
appropriate for the work being undertaken in that specific area. It also allows product and personnel flows to be
reviewed to ensure they do not compromise product safety.

The Standard is based on six recognised zones that occur within factories:
• high-risk areas
• high-care areas
• ambient high-care areas
• low-risk areas
• enclosed product areas
• non-product areas.

Appendix 2 of the Standard provides a more detailed explanatory guidelines to help assess the appropriate risk
zones for products produced at the site.

Note that high-risk, high-care and ambient high-care areas usually apply only to part of the factory’s processes,
typically following a microbiological kill step, until the products are enclosed in packaging. Therefore a site is likely
to have a number of different production zones.

3.3 Physical segregation (clause 8.1.2)

The Standard requires that ‘where high-risk areas are part of the manufacturing site, there shall be physical
segregation between these areas and other parts of the site’.

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The purpose of physical segregation is to provide a self-contained area where uncovered (i.e. unprotected) high-risk
products are handled after the microbiological kill step (e.g. cooking) until they are fully protected, usually by means
of final packaging. The segregating barrier must prevent the risk of microbiological cross-contamination from:
• pathogens that may be present in a low-risk area or on products or ingredients that have not received a full cook
• all people moving between the high-risk area and other areas, except through designated changing areas and using
defined changing procedures (see section 3.8 below)
• the movement of all equipment, chemicals, utensils or materials into the high-risk area, except through designated
ports with sanitising controls in place (see sections 3.6 and 3.7 below)
• water or other liquids on the floor washing into the high-risk area
• airborne contaminants (e.g. dust particles or water droplets).

The ideal barrier is a full-height wall separating the high-risk area from other areas. To ascertain the suitability of
the segregating barrier a risk assessment should be carried out and documented. (It is expected that newly built
factories will employ full wall separation where high-risk facilities are required.)

Time segregation is not an acceptable alternative for high-risk areas, except for the transfer points explained below.

3.3.1 Transfer points (clause 8.1.2)

The location and operation of all transfer points must not compromise the segregation of high-risk and low-risk
areas. For example, where raw materials or staff move into a high-risk area, consideration must be given to whether
this introduces a contamination hazard and therefore requires procedures such as:
• the use of disinfection
• removal of outer packaging
• double-door ovens, blast chillers or freezers (i.e. those with separate entrance and exit; see below on the use of
single-door ovens or smokehouses)
• controlled airflow (see section 3.4 below)
• consideration of the design of entrances and exits (e.g. rolling doors may represent a risk when raised because
they will have been in contact with the floor and are difficult to clean effectively).

Where transfer of product is through a controlled gap in the segregating barrier good practice is to consider the size
of the gap. It should be as small as possible and only large enough to complete the appropriate transfer of product
or ingredients. For example, where there is a cook step in the production of high-risk products, best practice is for
the cooker to become the transfer point into the high-risk area via a double-door system (i.e. the cooker is loaded in
the low-risk area and unloaded directly into the high-risk area).

Although new cooker installations and newly built sites are expected to incorporate double-door cooking systems,
many existing plants are equipped with single-door cookers and have established risk-based procedures for the
loading and unloading of the cookers to prevent cross-contamination of cooked products.

The Standard therefore accepts the use of single-door cooking systems (including smokehouses) where a thorough
risk assessment has been completed as an interim measure before eventual upgrading. Operating practices must be
consistently achievable, effective and prevent the cross-contamination of cooked products. The risk assessment
must have considered and controlled the potential risks from:
• cross-over between cooked and raw products in the cooker loading and unloading areas
• operators and their clothing (e.g. people handling cooked products who have previously worked with raw products)
• hand contamination resulting from people touching surfaces such as common equipment, cooker control panels
and cooker door handles
• equipment used for transferring product into and out of cookers
• airborne contamination from low-risk processes (e.g. the loading and unloading area should be separate from the
main low-risk processing area)
• the floor (e.g. contamination of the wheels of trolleys transferring cooked products to the high-risk area).

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When cooked products have been unloaded from the cooker they must be moved immediately to a designated
high-risk area meeting the requirements of the Standard.

The procedures in operation where single-door cookers are in use will be assessed by the auditor to ensure they are
adequate, effective and understood by operators. The audit report must describe the procedures in place to protect
the cooked products from contamination.

3.4 Drainage (clause 8.2.1)

The flow of drains must not present a risk of contamination to the high-risk area; they should flow from high-risk to
low-risk areas.

There must be a plan of the drains for these areas showing the direction of flow and location of any equipment
fitted to prevent the back-up of waste water. This could include, for example, the use of totally separate drains for
these areas, non-return or anti-syphon valves, one-way traps or having a sufficient drop.

Good practice is for sites to have documented procedures detailing the action to be taken in the event of a failure of
the drain traps or water backing up into the high-risk area. This should be more proactive than just mopping up and
continuing production, as clause 8.2.1 requires that drains are prevented from becoming a source of contamination.
For example, a full clean with assessment of the cleaning performance (clause 8.5.2) may be required to reinstate
and confirm the high-risk status of the area.

The Standard (section 4.11.8) requires all manufacturing sites undertake environmental monitoring of the factory
environment. It is good practice to include the drains in the high-risk area within this testing programme.

3.5 Air flow and ventilation in high-risk areas (clause 8.2.2)

Properly designed air handling systems should be a fundamental component in the control of risks from airborne
contaminants (including potential pathogens and spoilage micro-organisms). Good practice is to consider:
• temperature and/or humidity of air entering the area (as this may influence growth of micro-organisms)
• prevention of ingress of airborne micro-organisms from other factory areas (e.g. by ensuring positive pressure
compared to other areas of the factory)
• filtration to prevent contaminants from the air source entering the production area
• equipment design, cleaning and maintenance (to ensure equipment does not become a source of contamination)
• direction of airflow (from high-risk to low-risk to prevent potential contamination of products in high-risk).

Therefore, high-risk areas must be supplied with sufficient changes of filtered air and a risk assessment must be
completed which considers:
• legislative requirements – some countries have legislative requirements for ventilation in food facilities (including,
for example, the number of air changes and filters)
• source of air – the air inlet needs to be located to minimise the intake of contaminated air (e.g. as a minimum,
upwind of potential contaminants such as dust and chemical vapours)
• frequency of air changes
• specification of filter used – although there is no absolute standard for the filters, the grade required will depend
on the source of the air and the length of exposure of high-risk products or ingredients
• frequency of replacement of filters
• the need to maintain positive pressure compared with adjacent areas, particularly where there is an interface with
low-risk areas.

There is a wide range of industry guidelines relating to the correct design and parameters (e.g. number of air changes
and filter size) of ventilation systems, including:
• EHEDG Doc. 47 Guidelines on Air Handling Systems in the Food Industry – Air Quality Control for Building
Ventilation

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• ISO 16890-1:2016 – Air filters for general ventilation – Part 1: Technical specifications, requirements and
classification system based upon particulate matter efficiency (ePM).

The effectiveness of the filter and system employed should be checked by the use of periodic sampling of air close
to the outlet of the air ducts for microbiological quality.

3.6 Removable walls (clause 8.2.3)

Production risk zones may have removeable walls or removable wall panels, to allow the movement of large items
or specialist equipment between areas. Where removable walls are used, they must be properly constructed and
installed, free of any cracks or gaps. Good practice is to ensure they are also easy to clean, non-absorbent, wear-
resistant, resistant to corrosion, can withstand getting cleaned by high-pressure hose reels (from the low-risk side, as
this method of cleaning is not generally used in high-risk areas), hot water and chemical cleaners.

Where a site uses removable walls, they must develop a documented procedure to ensure its use is proactively
controlled. The procedure should contain a log of sequential activities and actions to be completed. This procedure
may be developed by the HACCP team, as part of the development of the food safety plan, or be verified and sign
off by the HACCP or food safety team (refer to section 2.12 of the Standard especially clause 2.12.1 and 2.12.3).

There are a number of clauses within the Standard that will apply to the design and use of removeable walls. For
example:
• Removeable walls must be included within the assessments and design of the high risk area (see clauses 8.1.2
and 8.1.3). For example, taking into account the source of potential contamination i.e. air, water, flow of people,
type of equipment being moved, water, chemicals, etc to ensure the environment and activities cannot pose
any additional risk to the products handled in the area. Additionally any legal requirements in the country or
region shall be taken into consideration.
• The location of the removable wall must be identified on the site map (ref clause 4.3.2).
• Clause 2.4.1 requires the site to consider the intended use of the product and consideration should be given to
whether the use of a removable wall increases the risk to intended users, for example those from vulnerable
groups.
• The site will need to develop the cleaning and reconditioning procedures required to return the area to its high
risk/high care status after the removable wall is replaced. The methods employed must be validated to
demonstrate that the controls are effective in preventing cross-contamination risk as well as the specific
pathogens that present a risk to the product or environment (see clause 8.5.2).
• As part of the cleaning process the site will need to establish appropriate control measures and critical limits and
the actions to be taken in event of a failure (see clause 8.5.2).
• The area must be signed off by an authorised manager before high risk production recommences (see
clause 4.7.4).
• Staff who can authorise the removal of the wall must be identified (clause 1.2.1, 1.2.2 and 8.2.3), and all staff
involved in the process suitably trained.

Developing an effective removable walls procedure

In order for the use of removable wall to be effective, it is important that the procedure is designed for the specific
area at a site.
• Step 1: Assess additional risks. Clause 2.7.1 requires the site to identify the potential hazards at each step of the
production process. The site will therefore need to assess any hazards that may be associated with the use of
a removeable wall, for example, location of the removable wall, potential new sources of product contamination
(the movement of water or air through the wall if it wasn’t tight fitting), affects of corrosion, ease of cleaning and
resistance to cleaning procedures and chemicals, unauthorised use of the removable wall or poorly timed used of
the removable wall.
• Step 2: Develop draft procedures. Develop a sequential log of activities/actions to be completed, including:
• who is authorised to remove the wall
• timing for removal (e.g. only when there is no production)

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• removal process
• re-installation process
• post-re-installation cleaning
• sign-off of the high risk area as suitable for production.
• Step 3: Validate the draft procedures. Validation is used to ensure there is no risk of contamination of product
from the conditions created by the use of the removable wall (see clauses 2.12.1 and 2.12.3 for more information).
• Step 4: Finalise procedures and associated documentation (e.g. records and sign-off). This procedure must be
signed off by the HACCP or food safety team (see clause 4.7.4). Records should be kept that show each step was
completed, when it was completed, who did the process and who checked and signed off the area as acceptable.
• Step 5: Train relevant staff. Key staff must be trained in this procedure, including authorised operators, cleaning
team, engineers and technical. Where cleaning is completed by an external hygiene service provider they must be
trained in this procedure as well.
• Step 6: Complete ongoing monitoring and verification. Validation is completed before introducing the new
procedure, and verification on an ongoing basis. Verification is the application of checks or tests, at regular
intervals, to ensure that the procedure is still working and continues to deliver the required output. Verification
activities may include internal audits, record reviews, swabs or tests of the cleaned wall and the assessment
of staff to ensure they have a clear understanding of the removable wall procedure. This may be completed as
an independent activity or incorporated into other site procedures, for example, inclusion in the environmental
monitoring programme (section 4.11.8) or the internal audit programme (section 3.4).
• Step 7: Review. This procedures should be reviewed whenever there are changes to the area, equipment or
processes (see section 2.12).

3.7 Maintenance (clause 8.3.1)

Maintenance activities must respect the segregation requirements of the high-risk areas.

Engineers’ tools for routine maintenance, minor breakdowns and tools that are frequently required (e.g. spanners)
should be kept captive within the high-risk area. Cleaning of these tools should be included in the cleaning
schedule.

Where specialist tools or equipment need to be brought into the area for a specific task, mechanisms should be in
place to ensure this does not result in contamination. These could include cleaning all equipment before entry into
the high-risk area and thorough cleaning of the high-risk area post-maintenance.

3.8 Acceptance of equipment into high-risk areas (clause 8.3.2)

Clause 8.3.1 highlights that good practice is for tools and equipment to be dedicated to the high-risk area to ensure
that the movement between areas does not create a potential route for microbiological contamination. However,
many sites will have:
• specialist equipment or tools that cannot practically be retained in the area
• occasions when specialist hygiene, maintenance or repair of high-risk equipment is required which necessitates
removal of the item(s) from the area.

When this occurs, it is important that a pre-defined procedure is in place (as stated in clause 8.3.2), so that the
cleanliness and removal of potential contaminants can be assessed prior to returning the item to the area.

This procedure is likely to include cleaning requirements, visual inspection and/or other microbiological
assessment.

3.9 Portable equipment (clause 8.3.3)

Systems are required to ensure that the transportation of small portable items (e.g. pens, clipboards or handheld
electronic devices) does not become a potential route of product contamination.

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Good practice is for these items to be dedicated to the high-risk area. Where this is not practical specific procedures
must be in place to prevent contamination; for example, a cleaning procedure for these items.

3.10 High-risk changing facilities (clause 8.4.1)

Where facilities manufacture high-risk products, personnel must enter and exit the high-risk area via a specific,
designated changing facility (i.e. a facility that is separate from other lower-risk changing areas) and must follow
documented instructions to:
• change into specific, dedicated protective clothing (i.e. clothing that is not worn in other areas of the factory)
• use visually distinct protective clothing (e.g. in a different colour or style) including clean overalls and headwear
• change or clean footwear prior to entry to the area (see below)
• apply clothing in a given order, for example:
• apply hair covering
• remove shoes or low risk footwear
• step over the barrier (see below)
• put on clean dedicated footwear
• wash and sanitise hands (to prevent the contamination of the clean protective clothing)
• put on coat or overalls
• wash and sanitise hands after the changing procedure.

When personnel leave the high-risk area, there must be clear instructions for the order in which they should change
out of their protective clothing (e.g. to ensure that they remove overalls before handling shoes or hair coverings).
This is particularly important where the clothing is to be reused (e.g. when someone temporarily leaves the high-risk
area for lunch or a break, and needs to put the protective clothing back on later).

Anyone who enters a high-risk area while production is in progress or when open products are present, such as
visitors, must follow the same clothing rules as production staff.

Footwear worn in high-risk areas must be dedicated to the factory (i.e. factory-issued and not worn outside the
factory). The use of clean footwear that is worn only in the high-risk area, together with effective measures for
changing into such footwear, is the preferred option to meet the requirements of the Standard. The site must have
procedures to ensure that the footwear is captive to the high-risk area (i.e. worn only in that area) and that the
changing area is laid out with an effective system to differentiate areas for wearing high-risk footwear from other
areas (e.g. by use of a barrier or bench system).

By exception, boot-wash facilities at the entrance to high-risk areas may be used instead of changing into captive
footwear dedicated to the high-risk area, where this is managed and validated to effectively prevent the introduction
of pathogens. The site must have undertaken a risk assessment to identify the suitability of the boot-wash
facilities and controls to manage the effective sanitising of footwear. The controls must have been validated by
microbiological swabbing of footwear, floors and the drains in the high-risk area, to demonstrate the absence of
pathogens (e.g. Listeria species).

For such controls to be effective they should include the following:

• The footwear must be company-issued and of a design that is easily cleaned (i.e. upper surfaces must be smooth,
and cleats on soles must be sufficiently spaced so as not to trap dirt that may not easily be removed by boot-wash
equipment).
• The potential for cross-contamination of boots prior to boot-washing must be considered. Permitted areas where
footwear can be worn before entry to a high-risk area must be clearly defined (e.g. the same footwear must not be
worn outside the facility or in low-risk processing areas prior to entering the high-risk area).
• The boot-wash equipment must be suitably designed, well maintained and demonstrably effective in cleaning and
sanitising the footwear.
• The minimum cleaning time and concentrations of detergent and sanitiser used must be determined, monitored,
documented and controlled to ensure the effective cleaning of footwear.

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• A cleaning schedule (i.e. cleaning of the boot-wash facility and equipment) should be in place to ensure that the
boot-wash does not become a source or vector of microbiological contamination.
• The environmental monitoring programme must ensure ongoing verification of the continued effectiveness of the
footwear controls (e.g. by swabbing footwear, floors and drains within high-risk areas).

Consideration must be given to the location of the boot-wash facilities (i.e. they must be at the entrance to the
high-risk area but at a suitable distance from production).

Records must be maintained of detergent and sanitiser checks, and the effectiveness of cleaning of the boot-wash
facilities.

All visitors and contractors entering the area will need to be provided with company-issued footwear and follow the
company rules. Shoe covers are not satisfactory for high-risk areas as they rarely cover the whole shoe and often tear
or fragment during use, resulting in a lack of protection and the potential to become a foreign-body risk.

On entry to high-risk areas, all staff, visitors and contractors must wash and disinfect their hands.

3.11 Cleaning procedures (clause 8.5.1)

Cleaning procedures for high-risk areas (including the building fabric, all processing equipment and food contact
surfaces) must be documented and include information on:
• staff responsible for cleaning
• equipment, building and plant to be cleaned
• frequency of cleaning
• methods to be used
• materials to be used (e.g. required chemicals and concentrations – good practice is to follow the cleaning chemical
manufacturer’s instructions relating to concentration, temperature and contact time)
• cleaning equipment to be used, such as hoses or brushes
• instructions on the correct and safe dismantling of equipment where this is required for cleaning purposes
• records to be kept
• responsibility for verification
• methods of verification (e.g. visual inspection, adenosine triphosphate (ATP) monitoring or microbiological swabs).

3.12 Acceptable limits for cleaning (clause 8.5.2)

The limits of acceptable and unacceptable cleaning performance must be defined for environmental cleaning in
high-risk areas.

The limits must be based on the risk, and may include visual inspection, ATP monitoring or specific microbiological
analysis.

When monitoring the cleanliness of the equipment, and particularly the more general high-risk environment, it is
important to look at trends as well as individual results and to use the results to review the effectiveness of the
cleaning and environmental controls.

3.13 Cleaning equipment (clause 8.5.3)

Equipment used for cleaning high-risk areas must be visually distinctive (e.g. colour-coded) and dedicated for use in
that area; i.e. it should not be removed for cleaning or any other purpose.

Consideration should also be given to the cleaning equipment used in the high-risk area to ensure it is fit for
purpose; for example, high-pressure hoses are not normally used due to the potential to create aerosols and move
debris.

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3.14 Waste disposal (clause 8.6.1)

Waste disposal systems must ensure that the risk of contamination to products is minimised through the control of
cross-contamination and of pests.

Risk assessment must consider the movement and flow of waste. For example, bins must be dedicated to either
high- or low-risk areas and must not be moved between the two. High-risk waste should be transferred to other
containers at the high-risk transfer point.

3.15 Laundry services (clauses 8.7.1–8.7.2)

The company will need to assess and monitor the laundry (e.g. by visual inspection, regular audits and a complaints
procedure) to ensure that the process is maintained and under control. This will include audits of the laundry
completed either directly by the site or by a suitable third party. The frequency of the audit should be based on risk.

The laundry company must be able to demonstrate that it has processes to ensure that:
• a suitable level of cleanliness is maintained (e.g. microbiological validation and verification tests have been
completed)
• clothes are commercially sterile (this means that any vegetative forms of micro-organisms associated with food
poisoning and/or spoilage have been removed by, for example, processing the clothes at a temperature no lower
than 65°C for a minimum of 10 minutes or no lower than 71°C for a minimum of 3 minutes)
• adequate segregation of dirty and cleaned clothes
• cleaned clothes are protected from contamination until they have been delivered to the site (e.g. by the use of
covers or bags).

Home laundering is not acceptable for protective clothing worn in high-risk areas.

3.16 Changes of protective clothing (clause 8.7.3)

Protective clothing must be changed at least daily, and spare clothing must be available on demand should it
become soiled.

3.17 Documented facility inspections (clause 3.4.4)

The Standard requires a programme of documented inspections to ensure that the factory environment and
processing equipment are maintained in a suitable condition (as identified in clause 3.4.4). These hygiene- and
fabrication-based inspections assess the standards of cleaning, equipment, building fabrication and personal
hygiene to ensure that high standards are maintained and that the production environment is safe and hygienic.

The frequency of the inspections should be based on risk. For open product areas inspections need to be at least
monthly. Inspections in high-care and high-risk areas should be more frequent; for example, daily or weekly.

3.18 Environmental monitoring (clause 4.11.8)

The aim of the environmental monitoring programme is to provide ongoing verification that procedures such as
cleaning and sanitisation are functioning correctly and as intended.

The Standard is not prescriptive on the specific details within the programme, such as the micro-organisms to test,
frequency of environmental monitoring or the locations within the facility that are tested, as this will be dependent
on site and product specifics. However, since high-risk areas are specifically designed to prevent pathogen
contamination it is likely that an effective programme will include a significant consideration of the high-risk area.

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4 High-care areas – specific

requirements
High-care areas require high levels of hygiene, controlled working practices, and suitable design and fabrication of
facilities and equipment to minimise product contamination by microbiological hazards.

Before entering the high-care area, vulnerable products and ingredients must have undergone a process to reduce
any contamination by pathogenic bacteria (e.g. by means of a chlorine wash of salad materials), or a heat treatment/
cooking step that is not a full pathogen kill step (e.g. pasteurisation).

This section contains the interpretation for the specific requirements that are highlighted for high-care areas.

4.1 Designation of production risk zones (clauses 4.3.1)

All sites need to ensure that the production facilities are suitable for the types of products they are manufacturing,
processing or packing. This includes an assessment of the production risk zones needed for the prevention of
microbiological contamination.

Full details on the definitions of the production risk zones recognised by the Standard are given in Appendix 2 of
the Standard.

4.2 Identification of production risk zones on a map (clauses 4.3.2 and 8.1.1)
The objective of identifying on a map (or factory plan) the production risk zones is to ensure that the standards of
environmental hygiene, particularly those concerning equipment, buildings, cleaning and personnel hygiene, are
appropriate for the work being undertaken. It also allows product and personnel flows to be reviewed to ensure they
do not compromise product safety.

The Standard is based on six recognised zones that occur within factories:
• high-risk areas
• high-care areas
• ambient high-care areas
• low-risk areas
• enclosed product areas
• non-product areas.

Appendix 2 of the Standard provides a detailed explanatory guidance to help assess the appropriate risk zones for
products produced at the site.

Note that high-risk, high-care and ambient high-care areas usually apply only to part of the factory’s processes,
typically following a microbiological kill step, until the products are enclosed in packaging. Therefore a site is likely
to have a number of different production zones.

In recent years there have been some well-publicised food poisoning incidents associated with a wide range of
products that had not previously been considered a concern. This emphasises the fact that processors need to
understand their products thoroughly and configure their food safety systems accordingly.

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4.3 Physical segregation (clause 8.1.3)

It is important that the high-care area is effectively protected from re-contamination from the low-risk zones. This
is most effectively achieved by full physical segregation by means of walls separating the high-care area from other
factory areas. Access to the area should be restricted and the segregation should take into account all possible
routes of contamination (e.g. airborne or by personnel, tools, equipment and footwear).

The segregating barrier must be capable of preventing the risk of cross-contamination from:
• pathogens that may be present in a low-risk environment or on products or ingredients that have not undergone a
process to reduce or remove any contamination by pathogenic bacteria
• all people moving between the high-care area and other areas except through designated changing areas
• the movement of all equipment, utensils or materials into the high-care area except through designated ports with
sanitising controls in place
• water or other liquids on the floor washing into the high-care area
• airborne contaminants (e.g. dust particles or water droplets).

Where full wall segregation is employed, ideally transfer of product is through a controlled gap in the segregating
barrier, good practice is to consider the size of the gap, as this should be as small as possible and only large enough
to complete the appropriate transfer of product or ingredients (i.e. for the product or ingredient to pass through),
thereby minimising the potential for contaminants (e.g. airborne or water droplets).

Where a separate, fully walled-off area is not available for high-care, alternative procedures must be in place
to segregate the high-care area and prevent access to unauthorised people, transfer of materials or equipment
(except via a controlled route) and microbiological contamination from airborne particles or water droplets. This
may include time or space separation, control of movement or other restrictions. In assessing the suitability of the
segregating barrier, a risk assessment must be carried out and documented. The method employed must be validated
to demonstrate that controls are effective in preventing cross-contamination and must be documented.

The auditor will critically examine the arrangements to ensure that potential risks for contamination have been
addressed and that the alternative controls are consistently workable before the solution is considered acceptable
(this will be recorded in the audit report).

Where the solution is time segregation, the changeover between standard and high-care operations should be
as infrequent as possible, as it is unlikely that a sufficient standard of cleaning could be reached if changes occur
frequently during a day. Fully validated procedures to change the area from low-risk to high-care are required. These
activities need to be taken into account when scheduling production to ensure effective transformation of the area,
including personnel.

If the same personnel are responsible for the area during low-risk and high-care operations, they must undergo a
complete change of protective clothing.

Where product characteristics meet the description of high-care but the systems are fully enclosed (e.g. dairies
filling cartons with milk) the production area is considered to be an enclosed product area. However, additional
precautions are required when breaking into the lines or filler (e.g. for maintenance, to free product jams or cleaning).
Wherever equipment integrity is compromised, the necessary hygiene requirements must be completed before
packing can recommence.

4.4 Drainage (clause 8.2.1)

The flow of drains must not present a risk of contamination to the high-care area. Drains should flow from high-care
to low-risk areas.

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There must be a plan of the drains for these areas showing the direction of flow and location of any equipment
fitted to prevent the back-up of waste water. This could include, for example, the use of totally separate drains for
these areas, non-return or anti-syphon valves, one-way traps or having a sufficient drop.

Good practice is for sites to have documented procedures detailing the action to be taken in the event of a failure
of the drain traps or water backing up into a high-risk area. This should be more proactive than just mopping up and
continuing production, as clause 8.2.1 requires that drains are prevented from becoming a source of contamination.
For example, a full clean with assessment of the cleaning performance (clause 8.5.2) may be required to reinstate
and confirm the high-care status of an area.

4.5 Ventilation
There is no specific requirement in the Standard for an air overpressure in high-care areas. Where there are no
legislative requirements, it is still good practice for the ventilation system to balance such that there is no large
movement of air from low-risk into high-care areas.

4.6 Removable walls (clause 8.2.3)

Production risk zones may have removeable walls or removable wall panels, to allow the movement of large items
or specialist equipment between areas. Where removable walls are used, they must be properly constructed and
installed, free of any cracks or gaps. Good practice is to ensure they are also easy to clean, non-absorbent, wear-
resistant, resistant to corrosion, can withstand getting cleaned by high-pressure hose reels (from the low-risk side, as
this method of cleaning is not generally used in high-care areas), hot water and chemical cleaners.

Where a site uses removable walls, they must develop a documented procedure to ensure its use is proactively
controlled. The procedure should contain a log of sequential activities and actions to be completed. This procedure
may be developed by the HACCP team, as part of the development of the food safety plan, or be verified and sign
off by the HACCP or food safety team (refer to section 2.12 of the Standard especially clause 2.12.1 and 2.12.3).

There are a number of clauses within the Standard that will apply to the design and use of removeable walls and
include the following examples:
• Removeable walls must be included within the assessments and design of the high care area (see clauses 8.1.2
and 8.1.3). For example, taking into account the source of potential contamination such as air, water, flow of
people, type of equipment being moved, water, chemicals, etc to ensure the environment and activities
cannot pose any additional risk to the products handled in the area. Additionally any legal requirements in the
country or region shall be taken into consideration.
• The location of the removable wall must be identified on the site map (ref clause 4.3.2).
• Clause 2.4.1 requires the site to consider the intended use of the product and consideration should be given to
whether the use of a removable wall increases the risk to intended users, such as those from vulnerable groups.
• The site will need to develop the cleaning and reconditioning procedures required to return the area to its high
risk/high care status after the removable wall is replaced. The methods employed must be validated to
demonstrate that the controls are effective in preventing cross-contamination risk as well as the specific
pathogens that present a risk to the product or environment (see clause 8.5.2).
• As part of the cleaning process the site will need to establish appropriate control measures and critical limits and
the actions to be taken in event of a failure (see clause 8.5.2).
• The area must be signed off by an authorised manager before high care production recommences (see clause
4.7.4).
• Staff who can authorise the removal of the wall must be identified (clause 1.2.1, 1.2.2 and 8.2.3), and all staff
involved in the process suitably trained.

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Developing an effective removable walls procedure

In order for the use of removable wall to be effective, it is important that the procedure is designed for the specific
area at a site.
• Step 1: Assess additional risks. Clause 2.7.1 requires the site to identify the potential hazards at each step of the
production process. The site will therefore need to assess any hazards that may be associated with the use of
a removeable wall, for example, location of the removable wall, potential new sources of product contamination,
(the movement of water or air through the wall if it wasn’t tight fitting), affects of corrosion, ease of cleaning and
resistance to cleaning procedures and chemicals, unauthorised use of the removable wall or poorly timed used of
the removable wall.
• Step 2: Develop draft procedures. Develop a sequential log of activities/actions to be completed, including:
• who is authorised to remove the wall
• timing for removal (e.g. only when there is no production)
• removal process
• re-installation process
• post-re-installation cleaning
• sign-off of the high care area as suitable for production.
• Step 3: Validate the draft procedures. Validation is used to ensure there is no risk of contamination of product
from the conditions created by the use of the removable wall (see clauses 2.12.1 and 2.12.3 for more information).
• Step 4: Finalise procedures and associated documentation (e.g. records and sign-off). This procedure must be
signed off by the HACCP or food safety team (see clause 4.7.4). Records should be kept that show each step was
completed, when it was completed, who did the process and who checked and signed off the area as acceptable.
• Step 5: Train relevant staff. Key staff must be trained in this procedure, including authorised operators, cleaning
team, engineers and technical. Where cleaning is completed by an external hygiene service provider they must be
trained in this procedure as well.
• Step 6: Complete ongoing monitoring and verification. Validation is completed before introducing the new
procedure, and verification on an ongoing basis. Verification is the application of checks or tests, at regular
intervals, to ensure that the procedure is still working and continues to deliver the required output. Verification
activities may include internal audits, record reviews, swabs or tests of the cleaned wall and the assessment
of staff to ensure they have a clear understanding of the removable wall procedure. This may be completed as
an independent activity or incorporated into other site procedures, for example, inclusion in the environmental
monitoring programme (section 4.11.8) or the internal audit programme (section 3.4).
• Step 7: Review. This procedures should be reviewed whenever there are changes to the area, equipment or
processes (see section 2.12).

4.7 Maintenance (clause 8.3.1)

Maintenance activities must respect the segregation requirements of the high-care areas.

Engineers’ tools for routine maintenance or minor breakdowns and tools that are frequently required (e.g. spanners)
should be kept captive within the high-care area. Cleaning of these tools should be included in the cleaning
schedule.

Where specialist tools or equipment need to be brought into the area for a specific task, mechanisms should be
in place to ensure this does not result in contamination. These could include, for example, cleaning all equipment
before entry into the high-care area and thorough cleaning of the high-care area post-maintenance.

4.8 Acceptance of equipment into high-care areas (clause 8.3.2)

Clause 8.3.1 highlights that good practice is for tools and equipment to be dedicated to the high-care area to ensure
that the movement between areas does not create a potential route for microbiological contamination.

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However, many sites will have:

• specialist equipment or tools that cannot practically be retained in the area
• occasions when specialist hygiene, maintenance or repair of high-care equipment is required, necessitating
removal of the item(s) from the area.

When this occurs, it is important that a pre-defined procedure is in place (as stated in clause 8.3.2), so that the
cleanliness and removal of potential contaminants can be assessed prior to returning the item to the area.

4.9 Portable equipment (clause 8.3.3)

Systems are required to ensure that the transportation of small portable items (e.g. pens, clipboards or handheld
electronic devices) does not become a potential route of product contamination.

Good practice is for these items to be dedicated to the high-care area. Where this is not practical, specific
procedures must be in place to prevent contamination (e.g. a cleaning procedure for these items).

4.10 High-care changing facilities (clause 8.4.1)

The objective of the clause is to ensure that protective clothing, once applied, is not contaminated before entry into
the high-care area. Therefore, where facilities operate a high-care area, personnel must enter and exit the high-care
area via a specific, designated changing facility. Documented instructions must be available for staff explaining
how to:
• change into specific, dedicated protective clothing (i.e. clothing that is not worn in other areas of the factory)
• use visually distinct protective clothing (e.g. in a different colour or style) including clean overalls, headwear and
footwear
• change footwear prior to entry to the area (see below); shoe coverings are not acceptable for use in high-care
areas
• apply clothing in a given order, for example:
• apply hair covering
• remove shoes
• step over the barrier
• put on dedicated footwear
• wash hands (to prevent the contamination of the clean protective clothing)
• put on coat or overalls
• wash and sanitise hands after the changing procedure.

When personnel leave the high-care area, there must be clear instructions for the order in which they should
change out of their protective clothing (e.g. to ensure that they remove overalls before handling shoes or hair
coverings). This is particularly important where the clothing is to be reused (e.g. when someone temporarily leaves
the high-care area for lunch or a break, and needs to put the protective clothing back on later).

Normally these changing facilities are physically segregated from other changing areas. However, in exceptional
circumstances it may be possible for a site to use time segregation. This means changing facilities are shared with
low-risk staff, but with different shift patterns to ensure that low-risk and high-care staff are not using the facility
at the same time. It may be necessary for changing facilities to be cleaned between different groups of workers
depending on the risk.

The auditor must be satisfied that the potential risks have been assessed and that procedures are capable of being
consistently operated without abuse.

Footwear worn in high-care areas must be dedicated to the factory (i.e. factory-issued and not worn outside the
factory). However, they may either be captive to the high-care area or cleaned on entry to the area using boot-
wash facilities. ‘Captive to the area’ means that it is worn only in that area and that an effective system is in place to
differentiate areas for wearing high-care footwear from other areas (e.g. by using a barrier or bench system).

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Where boot-wash facilities are used they must be managed and controlled to ensure their effectiveness and prevent
them from becoming a source of contamination. It is expected that the site will apply similar controls to the boot-
wash controls described in section 3.8.

There must be an ongoing programme of environmental monitoring (e.g. of footwear, floors and drains) to
demonstrate the continued effectiveness of the footwear control.

All visitors and contractors entering the area will need company-issued footwear and follow company rules
regarding changes procedures; shoe covers are not satisfactory for high-care areas as they rarely cover the whole
shoe and often tear or fragment during use, resulting in a lack of protection and the potential to become a foreign-
body risk.

4.11 Cleaning procedures (clause 8.5.1)

Cleaning procedures for high-care areas (including the building fabric, processing equipment and food contact
surfaces) must be documented and include information on:
• staff responsible for cleaning
• equipment, building and plant to be cleaned
• frequency of cleaning
• methods to be used
• materials to be used (e.g. required chemicals and concentrations; good practice is to follow the cleaning chemical
manufacturer’s instructions relating to concentration, temperature and contact time)
• cleaning equipment to be used, such as hoses or brushes
• instructions on the correct and safe dismantling of equipment where this is required for cleaning purposes
• records to be kept
• responsibility for verification
• methods of verification (e.g. visual inspection, ATP monitoring or microbiological swabs).

4.12 Acceptable limits for cleaning (clause 8.5.2)

The limits of acceptable and unacceptable cleaning performance must be defined for environmental cleaning in
high-care areas.

The limits must be based on the risk, and may include visual inspection, ATP monitoring or specific microbiological
analysis.

When monitoring the cleanliness of the equipment, and particularly the more general high-care environment, it
is important to look at trends as well as individual results and to use the results to review the effectiveness of the
cleaning and environmental controls.

4.13 Cleaning equipment (clause 8.5.3)

Equipment used for cleaning high-care areas must be visually distinctive (e.g. colour-coded) and dedicated for use in
that area (i.e. it should not be removed for cleaning or any other purpose).

Where it is not possible to clean equipment in the high-care area effectively, a suitable transfer process should be in
operation; for example, by heating or disinfecting the equipment before returning it to the high-care area.
Consideration should be given to the cleaning equipment used in the high-care area to ensure it is fit for purpose;
for example, high-pressure hoses are not normally used in high-care areas due to the potential to create aerosols
and move debris.

4.14 Waste disposal (clause 8.6.1)

Waste disposal systems must ensure that the risk of contamination to products is minimised through the control of
cross-contamination and of pests.

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Risk assessment must consider the movement and flow of waste. For example, bins must be dedicated to either
high-care or low-risk areas and must not be moved between the two. High-care waste should be transferred to other
containers at the high-care transfer point.

4.15 Laundry services (clauses 8.7.1–8.7.2)

The company will need to assess and monitor the laundry (e.g. by visual inspection, regular audits and a complaints
procedure) to ensure that the process is maintained and under control. This will include audits of the laundry
completed either directly by the site or by a suitable third party. The frequency of the audit should be based on risk.

The laundry company must be able to demonstrate that it has processes to ensure that:
• a suitable level of cleanliness is maintained (e.g. that microbiological validation and verification tests have been
completed)
• clothes are commercially sterile. This means that any vegetative forms of micro-organisms associated with food
poisoning and/or spoilage have been removed (e.g. by processing the clothes at a temperature no lower than 65°C
for a minimum of 10 minutes or no lower than 71°C for a minimum of 3 minutes)
• adequate segregation of dirty and cleaned clothes
• cleaned clothes are protected from contamination until they have been delivered to the site (e.g. by the use of
covers or bags).

Home laundering is not acceptable for protective clothing worn in high-care areas.

4.16 Changes of protective clothing (clause 8.7.3)

Protective clothing must be changed at least daily, and spare clothing must be available on demand should it
become soiled.

4.17 Documented facility inspections (clause 3.4.4)

The Standard requires a programme of documented inspections to ensure that the factory environment and
processing equipment are maintained in a suitable condition (as identified in clause 3.4.4). (These hygiene- and
fabrication-based inspections assess the standards of cleaning, equipment, building fabrication and personal
hygiene to ensure that high standards are maintained and that the production environment is safe and hygienic.

The frequency of the inspections should be based on risk. For open product areas, inspections need to be at least
monthly. Inspections in high-care and high-risk areas should be more frequent; for example, daily or weekly.

4.18 Environmental monitoring

The aim of the environmental monitoring programme is to provide ongoing verification that procedures (such as
cleaning and sanitisation) are functioning correctly and as intended.

The Standard is not prescriptive on the specific details within the programme, such as the micro-organisms to test,
frequency of environmental monitoring or the locations within the facility that are tested, as this will be dependent
on site and product specifics. However, since, high-care areas are specifically designed to reduce potential pathogen
contamination it is likely that an effective programme will include a significant consideration of the high-care area.

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5 Ambient high-care areas –

specific requirements
Ambient high-care areas require high levels of hygiene, carefully controlled working practices, suitable design of
facilities and good process flow to minimise product contamination by microbiological hazards.

Ambient high-care areas are required where open, ready-to-eat or ready-to-reheat foods are processed and packed,
and contamination of the food by vegetative forms of pathogens could result in food poisoning. Specifically, this
is required where the site handles a raw material that introduces a risk of pathogens, and undertakes a process to
remove those pathogens; it would typically be a cooking process.

It should be noted that the Standard includes only two clauses relating to specific requirements for ambient
high-care (clauses 8.1.1 and 8.1.4). Clauses that refer to either high-risk or high-care (without specific reference to
ambient products) are not applicable to ambient high-care. This section contains the interpretation of the specific
requirements for ambient high-care areas.

5.1 Designation of production risk zones (clauses 4.3.1)

All sites need to ensure that the production facilities are suitable for the types of products they are manufacturing,
processing or packing. This includes an assessment of the production risk zones needed for the prevention of
microbiological contamination.

Full details on the definitions of the production risk zones recognised by the Standard are given in appendix 2 of
the Standard.

5.2 Identification of production risk zones on a map (clauses 4.3.2 and 8.1.1)
The objective of identifying the production risk zones on a map (or factory plan) is to ensure that the standards of
environmental hygiene, particularly those concerning equipment, buildings, cleaning and personnel hygiene, are
appropriate for the work being undertaken. It also allows product and personnel flows to be reviewed, to ensure they
do not compromise product safety.

The Standard is based on six recognised zones that occur within factories:
• high-risk areas
• high-care areas
• ambient high-care areas
• low-risk areas
• enclosed product areas
• non-product areas.

Appendix 2 of the Standard provides a detailed explanatory guidance to help assess the appropriate risk zones for
products produced at the site.

A site is likely to have a number of production zones and high-risk, high-care and ambient high-care areas usually
apply only to part of the factory’s processes; typically following a microbiological kill step, until the products are
enclosed in packaging.

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In recent years, there have been food poisoning incidents associated with a wide range of products which had
not previously been considered a concern. This emphasises that processors need to understand their products
thoroughly and configure their food safety systems accordingly.

5.3 Documented risk assessment and microbiological control in ambient high-care

areas (clause 8.1.4)
Where finished products meet the definition of ambient high-care, the site will need to conduct a risk assessment
to identify the potential risks of cross-contamination (e.g. locations where cross-contamination could occur) and
introduce procedures and processes to manage these potential risks. The procedures required will be dependent on
the level of risk, but they could include, for example:
• Segregation Normally this would be physical separation; however, time segregation would be permitted where
the site can demonstrate that processes effectively prevent the risk of contamination.
• Management of the process flow Ensuring a logical (and usually linear) process so that implicated raw materials
are not in the same area as the final product (or intermediates that have been through the process to remove or
reduce micro-organisms).

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Appendix 1
Production zone decision trees
and definitions
The Standard identifies a number of different production risk zones within the processing and storage facilities
which require corresponding levels of hygiene and segregation to reduce the potential for product contamination
with pathogenic micro-organisms. Identifying production areas in this way helps to ensure that the appropriate food
safety controls are in place and to consider whether the movement of personnel and materials between these areas
needs to be restricted. On pages 29 and 30 are examples of decision trees that may help with this decision making
process. They must be used in conjunction with the definitions of production risk zones provided in Appendix 2 of
the Standard.

In addition to the definitions a site must take into consideration any evidence of reasonable use/misuse (refer to
clause 2.4.1) in conjunction with the decision tree.

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Step Refer to production zone

Are the final products stored ambient, chilled or frozen? Ambient
1 decision tree 2 (figure 2).

Chilled or frozen

Enclosed product areas –for

Are products or ingredients within the area open to the
Step example, warehouses, piped
environment i.e. neither packaged nor fully enclosed in No
2 liquids (e.g. milk, fruit juice,
tanks or pipes etc.
wine).

Yes

Enclosed product areas:

Step Will products undergo a full cook step** in the for example, high pressure
Yes
3 final pack? processing (HPP) fruit
juices, irradiated foods.

No

Does the product support the growth of pathogens, or Low risk area – for example,
survival of pathogens that could subsequently grow fresh fruit and vegetables,
during the normal storage or use of the product unless foods stored chilled or frozen
Step No solely to extend shelf life (e.g.
stored chilled or frozen? (N.B: Listeria
4 frozen fruit and vegetables)
monocytogenes can whilst frozen and
grow at chilled temperatures). that can only be consumed
after cooking, hard cheese.

Yes

Does the area contain products which on the basis of Low risk area – for example,
cooking instructions and known customer use*, raw meat, vegetables (e.g.
Step undergo full cooking** prior to consumption Yes potatoes), prepared meals
5 (i.e are the products ready to eat or eaten following a containing raw protein,
full customer cook)? frozen pizza, unbaked
frozen pies.

No High care area – for example,

fresh prepared salads,
sandwiches, cured meats,
Step Have all vulnerable products received, prior to entry into cold smoked salmon,
No
6 the area, a heat treatment equivalent to 70oC for 2 minutes? dairy desserts with uncooked
components, prepared meals
Yes with garnishes***, chilled
pizzas.
High risk area - for example, cooked meats, pate,
houmous, prepared meals without garnishes, dairy
desserts with cooked components.

Figure 1 Production zone decision tree 1 – chilled and frozen products.

* If the product is ready to eat or to heat or on the basis of known customer use, it likely to be eaten without adequate cooking, then proceed to step 6.
** Thermal treatment equivalent to 70OC for 2 minutes.
*** Raw or not pH/aw stabilised so will support the growth of Listeria monocytogenes.

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Step Chilled / Refer to production zone

Are the final products stored ambient, chilled or frozen?
1 frozen decision tree 1 (figure 1).

Ambient

Enclosed product areas –

Are products or ingredients within the area open to the
Step for example, warehouses,
environment i.e. neither packaged nor fully enclosed in No
2 piped liquids, such as milk,
tanks or pipes etc.
fruit juice, wine.

Yes

Low risk area – for example,

Does the area contain products which on the basis of
Step vegetables (e.g. potatoes),
cooking instructions and known customer use*, Yes
3 dried foods (e.g. cereals, rice,
undergo full cooking** prior to consumption?
raw pulses).

No

Will vegetative pathogens (e.g. Salmonella) survive with

Low risk area – for example,
the potential to cause food poisoning during normal
canned products, dried soup,
Step use and consumption of the product due to subsequent
No bakery products, biscuits,
4 growth of the pathogen or protection and survival of the
crisps, breakfast cereals, flour,
pathogen by the food matrix (e.g. high fat) resulting in a
dried herbs, sugar, tea, coffee.
low effective dose?

Yes

Low risk area – for example,

Is the raw material(s) susceptible to contamination muesli, use of pre-made
with vegetative pathogens which could subsequently chocolate in confectionery
Step cross-contaminate finished product and does the site’s No (i.e. no raw cocoa on site),
5 manufacturing process include a process step which use of roasted peanuts in
removes the pathogen (i.e. a pathogen kill step)? further processed products
(i.e. no raw peanuts on site).

Yes

Ambient high care – for example, manufacture of

chocolate from raw cocoa beans, manufacture of peanut
butter from raw peanuts.

Figure 2 Production zone decision tree 2 – ambient products.

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Definitions
Ambient high care
An ambient area designed to a high standard where practices relating to personnel, ingredients, equipment, packaging
and environment aim to minimise potential product contamination by pathogenic micro-organisms.
Products handled in these areas are vulnerable, as pathogens are known to survive on the product.

Cook
A thermal process designed to heat a food item to a minimum of 70°C for 2 minutes or equivalent. Alternative cooking
processes may be accepted or required where these meet recognised national guidelines and are validated by scientific data.
Note that other processes achieving a 6 log reduction (e.g. irradiation, high-pressure processes) should be considered in
the same way as conventional ‘cook’ processes.
Enclosed product area
An area of the factory where all products are fully enclosed and therefore not vulnerable to environmental
contamination.
High-care area
An area designed to a high standard where practices relating to personnel, ingredients, equipment, packaging and
environment aim to minimise product contamination by pathogenic micro-organisms.
High-care product
A product that requires chilling or freezing during storage, is vulnerable to the growth of pathogens, has received a
process to reduce microbiological contamination to safe levels (typically 1–2 log reduction) and is ready to eat
or heat.
High-risk area
A physically segregated area, designed to a high standard of hygiene, where practices relating to personnel, ingredients,
equipment, packaging and environment aim to prevent product contamination by pathogenic
micro-organisms.
High-risk product
A chilled or frozen ready-to-eat/ready-to-heat product or food where there is a high risk of growth of pathogenic micro-
organisms.
Low-risk area
An area with emphasis on hygiene and prevention of foreign body and allergen contamination but where the pathogen
risk is reduced based on the product, cook step or other controls.
Low risk product
A product that does not support the growth or survival of pathogens which could subsequently grow during normal
storage or use or is designed to undergo a later kill step.
Non-product area
Parts of the site where products are never taken, such as canteens, offices and laundries.
Ready-to-eat food
Food intended by the manufacturer for direct human consumption without the need for a full cook.
Ready-to-heat food
Food designed by the manufacturer to be suitable for direct human consumption without the need for cooking.
The heating of the product is intended to make the product more palatable and is not a microbiological kill step.
Full definitions can be found within Appendix 2 of the Standard.

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Appendix 2
Example products and typical
production zones
The following table gives examples of products from the 18 food groups and typical production zones applicable
to the post-process handling stages. This provides a guide only, because within a particular food group there may
be a number of different specific product types with different characteristics or filling methods which may result in
a different risk zone categorisation. For example, yogurts will have variable pH values which may or may not make
them susceptible to Listeria and therefore manufacture may require a high-care or low-risk area as applicable. It is
essential that sites understand the characteristics and safety rationale for their products. If there is any concern,
they should ensure that adequate validation or support is available for their decision. For unique products and
formulations, sites will need to revert to best practice and risk assessment, rather than try to ‘fit’ the product into the
current categories or examples. Sites should discuss this with their certification body in advance of the audit.

Category Notes Example products Zone Comments

1. Raw red meat High-risk, high-care Side of beef Low risk
and ambient high-
care production
zones are not
applicable for
products in this
category as products
are expected to be
cooked before eating

2. Raw poultry High-risk, high-care Whole chicken Low risk

and ambient high-
care production
zones are not
applicable for
products in this
category as products
are expected to be
cooked before eating

3. Raw prepared High-risk, high-care Sausages Low risk

products (meat and and ambient high-
vegetarian) care production Beef burger Low risk
zones are not
Uncooked pie Low risk
applicable for
products in this
category as products
are expected to be
cooked before eating

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Category Notes Example products Zone Comments

Pizza – cooked from Low risk If there is known
frozen consumer use that
these are likely to
be eaten without
adequate cooking,
then additional
controls may be
required

Pizza – chilled Low risk/high care If there is known

consumer use that
these are likely to
be eaten without
adequate cooking,
then additional
controls may be
required

Fish fingers Low risk

Ready-to-cook Low risk Meals within this

prepared meals category require a
full customer cook
4. Raw fish products High-risk, high-care Fish fillets Low risk
and preparations and ambient high-
care production
zones are not
applicable for
products in this
category as products
are expected to be
cooked before eating
5. Fruit, vegetables High-risk, high-care Potatoes Low risk
and nuts and ambient high-
care production Apples Low risk
zones are not Bananas Low risk
applicable for
products in this Nuts in shell Low risk Note: Prepared
category. Production nuts (including
processes either do pasteurised nuts)
not include a kill step are in category 17
or require cooking

6. Prepared fruit and Prepared fruit pieces High care Low-pH fruit mixes
vegetables may also require
high care to protect
them from spoilage

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Category Notes Example products Zone Comments

Washed, ready-to- High care
eat salads

Coleslaw – High care Low pH coleslaw

mayonnaise-based may be low-risk but
requires protection
from spoilage
organisms
Frozen fruit/ Low risk/high care Consideration
vegetables should be given to:
• the production
processes; for
example, is the
product blanched
(equivalent to a
microbiological
reduction process
making it high
care)?
• cooking
instructions;for
example, are
instructions
provided which
require a full
consumer cook?
• known product
uses;for example,
are consumers
eating the product
without a full cook
(even if the
manufacturer’s
intention is for
a full cook)?
These must be
considered as
part of the HACCP
process to define
the specific
controls needed
(see clause 2.4.1)

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Category Notes Example products Zone Comments

7. Dairy, liquid egg The dairy category Fresh pasteurised High care Note: Where the
and pasteurised fruit includes many milk line and filler are
juice products which, fully enclosed, this
depending is considered an
upon product enclosed area
characteristics,
may be either low Yogurt High care Yogurts with a low
risk or high care. pH may be low-
Often even the risk but require
products classified protection from
as low-risk require spoilage organisms
an environment
with high hygiene Hard cheese (e.g. Low risk Based on low aw,
standards to protect cheddar, parmesan) pH and salt content,
them from spoilage although high
organisms (e.g. yeasts hygiene standards
and moulds). Some are required to
dairy processes prevent mould
are fully enclosed contamination
from pasteurisation
Soft cheeses (e.g. High care
to filling. In such
mozzarella, brie)
circumstances
these are classed as Hard cheese from Low risk Unpasteurised milk
requiring enclosed unpasteurised milk does not have a
product zones, pathogen reduction
although the high- step (i.e. it is not high
care precautions care) but relies on
must be applied low aw, pH and salt
when opening fillers content to control
or lines microbiological
hazards.

However, where the

cheese aging process
can be demonstrated
to achieve a similar
microbiological
reduction as a
cooking process
(a regulatory
requirement in some
countries), then the
cheese should be
treated as high care.
In either situation
high standards of
hygiene may be
required depending
on the type of
cheese.

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Category Notes Example products Zone Comments

Raw milk cheeses
should be handled
separately from
other high-care
products

Soft cheese from Low risk Unpasteurised

unpasteurised milk milk does not
have a pathogen
reduction step (i.e.
it is not high care)
and unpasteurised
cheeses usually
do not meet the
definitions in the
Standard for high risk
or high care.

However, where the

cheese aging process
can be demonstrated
as achieving a similar
microbiological
reduction as a
cooking process
(a regulatory
requirement in some
countries), then the
cheese should be
treated as high care.
In either situation
high standards of
hygiene may be
required depending
on the type of
cheese.

Raw milk cheeses

should be handled
separately from other
high-care products

Fromage frais High care

Butter (salted) Low risk

Butter (unsalted) High care

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Category Notes Example products Zone Comments

Ice cream High care Listeria
monocytogenes can
survive in frozen
products

UHT milk Enclosed/high care These products are

either sterilised in
pack or enclosed
for sterile fill – an
open product would
be considered high
care

Dried milk powder Ambient high care Note: Packing areas

usually operate
to near high-risk
requirements
because of
Salmonella risks

Freshly squeezed Low risk Where low pH

(unpasteurised) fruit or other natural/
juice added inhibitors
are present, high
standards are still
required to reduce
spoilage

Pasteurised juice Low risk/high care Where low pH

and fruit/vegetable or other natural/
smoothies added inhibitors
are present, high
standards are still
required to reduce
spoilage

8. Cooked meat/fish All products in this Ham High risk

products group are cooked
and unless additional Cooked chicken High care
preservatives are
added to extend Meat pâté High risk
shelf-life and
prevent the growth Long-shelf-life High care
of pathogens they cooked meat with
would require preservatives
handling in a high-
Hot smoked fish High risk
risk area after
cooking

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Category Notes Example products Zone Comments

9. Raw cured and/ This group of Dry-cured meats High care
or fermented meat products relies (e.g. parma ham)
and fish upon a combination
of chemical Cold-smoked fish High care
characteristics in the (e.g. salmon)
final product rather
Fermented dried High care
than cooking to
meat (e.g. salami)
change an otherwise
raw product into
a ready-to-eat
product; e.g. salt, low
pH, preservatives and
smoking. Preparation
and packing of
finished products
require high-care
production zones

10. Ready meals and All products in Sandwiches High care

sandwiches, ready- this category will
to-eat desserts require either a Ready-to-heat High risk Unless uncooked
high-risk or high- meals garnishes are added
care environment for
Soup chilled to heat High risk Unless the product
the preparation and
is fully enclosed,
packing of finished
through to and
products
including filling

Quiche High risk

Cream cakes High care Including products

(short-life) containing fruit

Egg custard High risk When sold chilled

Dairy desserts High risk

Baked cheesecake High risk

with no additional
toppings

Baked cheesecake Dependent on Where risk

with topping topping assessment shows
the topping has
been processed
to an equivalent
microbiological kill
step, then the product
should be treated as
high risk (e.g. a fruit
puree which has
received a full cook).

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Category Notes Example products Zone Comments

Where the product
introduces
an additional
microbiological risk
(e.g. the addition
of unprocessed
fruit which has
not received a
microbiological
kill step), then the
product should be
treated as high care

Hot-eating pies – High risk With filling fully

for heating only enclosed (e.g. by
pastry or pie case)

11. Low/high acid High-risk and high- Canned fish Low risk
products in cans/ care production
glass zones are not Pickled vegetables Low risk
applicable for
products in this Jam Low risk
category because
most products are Honey Low risk
processed within
a sealed container Peanut butters Ambient high care The Standard
or hot-filled. The requires ambient
category also high-care areas
contains a range of where the roasting
hot- and cold-filled of peanuts occurs at
products in jars the site.
which are preserved
by virtue of pH, aw Where sites
or a combination of are purchasing
factors peanuts roasted
elsewhere (e.g. at
a supplier’s site),
the Standard does
not prescribe an
ambient high-care
area; however, it is
still important that
the site has suitable
controls to prevent
contamination of
susceptible raw
materials and final
products

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Category Notes Example products Zone Comments

12. Beverages High-risk, high-care Soft drinks Low risk
and ambient high-
care production Water Low risk
zones are not
applicable for
products in this
category

13. Alcoholic drinks High-risk, high-care Wine Low risk

and ambient high-
care production Beer Low risk
zones are not
applicable for
products in this
category. Most
products have an
alcohol content
sufficient to prevent
growth of pathogens
and are enclosed to
the point of filling

14. Bakery High-risk, high-care Bread Low risk

and ambient high-
care production Madeira cake Low risk
zones are not
applicable for Decorated cakes – Low risk Cakes decorated
products in this ambient with butter
category. Note: creams, jam fillings,
Chilled bakery chocolate, icing etc.
products such
as cream cakes, Biscuits/cookies Low risk
egg custards and
Jam tart Low risk
cheesecakes are in
category 10

15. Dried food Products in this Flour – without heat Low risk
ingredients category will either treatment
be low risk or
Flour – heat-treated Ambient high care
ambient high care
Instant coffee Low risk

Dried herbs Low risk/ambient

high care

16. Confectionery Products in this Chocolate – on site Ambient high care The Standard requires
category will either manufacture from ambient high-care
be low risk or raw beans areas where on-site
ambient high care manufacture is from
raw beans

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Category Notes Example products Zone Comments

Chocolate – use of Low risk Although the
pre-made chocolate Standard does
that is manufactured not prescribe an
at another site or ambient high-care
by a raw material area when the site
supplier is purchasing pre-
made chocolate
manufactured at
another site or
by a raw material
supplier, it is still
important that the
site has suitable
controls to prevent
contamination of
susceptible raw
materials and final
products

Boiled sweets Low risk

Jellies Low risk

17. Breakfast cereals Products in this Crisps/snacks Low risk

and snacks category will be
either low risk or Cornflakes Low risk
ambient high care
Roasted nuts Ambient high care The Standard
requires ambient
high-care areas where
the roasting of nuts
occurs at the site.

Where sites are

purchasing nuts
roasted elsewhere
(e.g. at a supplier’s
site), the Standard
does not prescribe
an ambient high-care
area; however, it is
still important that
the site has suitable
controls to prevent
contamination of
susceptible raw
materials and final
products

Muesli Low risk

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Category Notes Example products Zone Comments

18. Oils and fats High-risk, high-care Olive oil Low risk
and ambient high-
care production Salad dressing Low risk
zones are not
applicable for Mayonnaise Low risk
products in this
category Lard Low risk

Table 2 Examples of products by category and the typical risk zones required following the microbiological
reduction or kill step.

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UNDERSTANDING PRODUCTION
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Further reading
BRCGS Standards are a series of globally recognised standards for food and packaging manufacturers, agents,
brokers storage and distribution companies.

BRCGS publishes a series of best-practice guidelines on topics including complaint handling, pest control, internal
auditing, product recall, traceability and foreign-body detection. We also provide over 65 interactive courses
developed and delivered by experts across the world and aimed at auditors, certification bodies and food safety
professionals.

Details of BRCGS publications, training, courses and events can be found are www.brcgs.com. Certificated sites can
find copies of BRCGS publications on BRCGS Participate. Specific titles you might find of use include:

Global Standard Food Safety (Issue 9)

Global Standard Food Safety (Issue 9), Interpretation Guideline
Effective Allergen Management
Effective Environmental Monitoring
Understanding Air Quality in Food Production

Food Standards Agency (FSA)

Food and Drug Administration (FDA)
Guidelines for the Validation of Food Safety Control Measures, CAC/GL69, Codex (2008)
Guidelines of Air Handling Systems in the Food Industry – Air Quality Control for Building Ventilation,
EDEDG Doc 47: Guidelines on Air Handling Systems in the Food Industry – Air Quality Control for
Building Ventilation
ISO 168901-11:2016 Air Filters for General Ventilation: Part 1, ISO

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Safety

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