EFFECTIVE ALLERGEN

MANAGEMENT

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MANAGEMENT

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© 2022 BRCGS
ISBN: 978-1-78490-446-3

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Contents
Part 1: Introduction 03
How this guideline is organised 03
Legislative considerations 04
Customer considerations 05

Part 2: Raw Material Control 06

Specifications and supplier questionnaires 06
Supplier audits 09
Assessment of raw materials 10
Managing changes 10

Part 3: List of Allergenic Materials 11

Part 4: Risk Assessment for Allergen Cross-contact 14

Understanding the allergens on site 15
Identifying the hazard 15
Identifying where allergen cross-contact can occur 16
Evaluating the risks and implement controls 18
Reviewing the assessment 19

Part 5: Allergen Cross-contact and Control Procedures 21

Segregation 21
Changes of protective clothing 22
Dedicated and identified equipment and utensils 22
Scheduling 22
Airflow 26
Recipe changes and new product development 26
Waste handling and spillage control 27
Personal hygiene 27
Staff movement 27
Permitting foods on site 28

Part 6: Rework 29
Part 7: Allergen Claims 30
Part 8: Allergen Cleaning Regimes 31
Cleaning methodology and instructions 31
Cleaning schedules 32
Cleaning validation, verification and monitoring 32
Cleaning tools, equipment and chemicals 36

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Part 9: Allergen Training 38

Staff training 38
Engineering, contractors and temporary staff 38

Part 10: Packaging Controls 39

On-pack warning labels 39
Label creation and maintenance 39
Start-up and changeover controls 40

Part 11: Allergens in Packaging Material 42

Cleaning process 43
Segregation procedures 43
Product labelling 43

Part 12: Consumer Products 44

Appendices 45
Appendix 1: Examples of legislative allergen lists 45
Appendix 2: Allergen analysis 47
Appendix 3: Further information 49

Acknowledgements
BRCGS would like to acknowledge the invaluable input and assistance from Campden BRI who have contributed to
the writing of this guideline.

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Part I
Introduction
Managing allergens provides a significant challenge for suppliers across the food, packaging and consumer goods supply
chains.

An allergic reaction occurs when the immune system of a susceptible individual adversely reacts to a food or substance
(usually a protein) that is harmless for most individuals. Food allergies represent a significant health hazard for an
increasing percentage of the world’s population. Therefore, the correct management of allergenic materials throughout
the food supply chain is a paramount aspect of food safety.

In addition to allergies, there are a number of conditions (that are considered to be food hypersensitivities) producing
adverse symptoms in susceptible individuals. This includes food intolerance such as lactose intolerance and auto-
immune conditions such as coeliac disease. While the main focus of this guidance is food the tools and techniques
discussed can be applied to the manufacture of any food or non-food product and packaging.

Incorrect allergen management has resulted in a considerable number of product withdrawals and is the most common
cause of recall. A root cause analysis of these recalls has suggested that the main causes can be summarised as:

• Unintentional presence of an allergen. This could be due to allergen cross-contact2 of a raw material or product
during production, or the accidental addition of an allergen by using the wrong recipe.
• Mis-packing – where the wrong packaging is used, e.g. due to insufficient changeover controls or a lack of training of
packing line staff.
• Wrongly labelled packaging. This could be due to specification errors, a failure to transfer all information during
packaging development, ineffective change management (such as when a recipe changes) or printing controls
and sign-off of new packaging.

An allergen management plan is a documented system that serves to identify, control, educate and communicate
the risk and presence of allergens on the site, from raw materials through to finished products. This includes a
risk assessment of allergen cross-contact and the implementation of controls to minimise or eliminate the risk of
contamination to and/or from the final product.

How this publication is organised

This guidance has been designed to provide further explanation of the allergen management requirements of several
BRCGS Standards (referred to as ‘the Standard’) and to aid individuals and companies in the development of robust
allergen management systems and procedures that adequately meet requirements. While the guidance concentrates
on food safety, allergen management features in requirements in our global standards on storage and distribution,
packaging materials, gluten-free and consumer products.

Allergen management affects all aspects of the Standard. Even if allergens are not specifically mentioned in the wording
of the requirement a failure to meet the requirement could lead to an allergen issue in the production cycle.

This guideline will concentrate on five themes:

• Materials and allergens – understanding the raw materials that arrive on site.
• Risk assessment – the significance of any process, activity or ingredient should be evaluated by accurate cross-contact
risk assessments to determine the control or action required.
• Control procedures – the segregation of allergens and activities to reduce the risk of allergen cross-contact.

2
The terms cross-contact and cross-contamination are used interchangeably in guidance about allergen management. Within this document the terms are used to mean
the transfer of any material from one surface or food to another surface, food or product.

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• Cleaning regimes – cleaning controls and on-going monitoring to remove or reduce the risks of allergen
cross-contact.
• Packaging and labelling – understanding raw materials used in packaging, packaging controls in production and
keeping the consumer informed.

The guidance will look at these themes in detail and consider their part in a comprehensive allergen management
system (see Figure 1). The guidance should be read in conjunction with those parts of a Standard that specifically
reference allergen management.

G
GIN R
MA AW
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PA AND IAL
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ELI
LAB
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LIS RGE
LE
NI

T O NS
AI

F
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EFFECTIVE
ASSES K

ALLERGEN
ING

MANAGEMENT
RIS
CLEAN

SMEN
T

PR
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M I DU
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REWORK

Figure 1 Core elements of an allergen management system

Whether systems implemented comply with the Standard will be a decision made by the auditor during a BRCGS audit.
The auditor will refer to evidence collected and observations made during the audit.

Legislative considerations
There are an estimated 180-200 foods that can cause adverse reactions. Legislation in many countries identifies the
foods or ingredients that are most likely to cause a reaction in that geographic region and which must therefore be
managed in the supply chain. Some of these ingredients must be declared on packaging where it is present in a product
because customers must be informed before they make a purchase. Examples of such legislation include European
Union Regulation (EU) No. 1169/2011, as amended, on the provision of food information to consumers and the US Food
Allergen Labeling and Consumer Protection Act 2004.

Companies must ensure they understand the full legislative definitions of the allergens they are handling, as this may
vary from country to country or region to region. For example, ‘tree nuts’ in some regions include products that are not
botanically defined as tree nuts, such as coconuts, pine nuts or almonds.
National legislation in place in the country of sale as well as in the country of production must be used to identify

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those substances that must be managed as allergens. Where products are both produced and sold in countries where
there are no legal requirements for the labelling of allergens, refer to the list of allergens as defined in the Codex
Alimentarius General Standard for Labelling of Pre-packaged Foods. This list should be used as the basis for assessing
compliance to the Global Standard Food Safety.

Good practice and legislative requirements change routinely as new research is published. It is important that sites have
a mechanism to remain up to date, so that they consistently meet requirements.

Some examples of the different legislative allergen lists are given in Appendix 1.

Customer considerations
Some customers, such as brand owners or large retailers, have very detailed allergen requirements. Manufacturing
sites need to ensure they are aware of these requirements when developing and reviewing their allergen management
systems.

Reviewing the allergen management plan

The allergen management system needs to be reviewed based on risk, including when there:
• is a change in raw materials or suppliers
• is a change to the manufacturing process
• will be an introduction of new machinery or equipment
• is a change to cleaning practices and procedures

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Part 2
Raw Material Control
Raw materials are a potential source of allergens and of allergen cross-contact. Therefore, supplier approval and raw
material assessment procedures represent a key aspect of the allergen management system.

Start by understanding the certification status of the raw material supplier. For example, ask if the supplier’s site is
BRCGS certificated. The certification status of all BRCGS certificated sites can be confirmed on the BRCGS Directory
(directory.brcgs.com). Certificated sites can provide a copy of their last audit report which will explain their approach to
allergen management.

When completing supplier and raw material assessments it is important to ensure all raw materials are considered,
including additives, processing aids and any materials that may be in contact with products. For example, with composite
ingredients (one with several components) this will need to include all of the materials used in the manufacture of the
composite ingredient.

Particular care is needed if the presence of an allergen is not immediately apparent, for example where:
• carriers are used in additives and flavourings
• imports are from geographic areas using different legislation, as this can result in differences in understanding.
• allergens (including sulphur dioxide) are applied earlier in the supply chain, as it is easy to forget these or omit them
from raw material specifications
• generic terms such as ‘vegetable oil’ are used (generic terms are unacceptable in raw material assessments as the
botanical origin is unclear).

The assessment of raw materials generally comprises a number of steps:

1. Checking third-party certification status.
2. A supplier approval process – all suppliers should have allergen control and management processes and these should
be assessed as part of the supplier approval process.
3. Completion of a raw material specification.
4. Additional information obtained via the completion of an allergen questionnaire.
5. Where necessary, a supplier audit or visit.
6. Risk assessment of the ingredient.

Supplier and raw material records should be regularly reviewed to ensure the most up-to-date information is available.

Specifications and supplier questionnaires

Raw material specifications should be the first source of information regarding the allergen status of each raw material.
The specification should indicate both the allergen content (i.e. the deliberate addition of an allergen) and the risk of
the material having cross-contact with an allergen that is not a deliberate ingredient.

Specification data from suppliers

It is important for the site to ensure that fully completed specifications are in place for all raw materials, including
additives, carriers and processing aids, and no ingredient should be used before the specification has been received
from the relevant supplier(s). Particular care should be taken with generic terms, compound ingredients or products that
may contain ‘hidden ingredients’, to ensure the specification provides full clarity on all of the constituent materials.

As the specification is used as a primary source of communication between the site and the supplier it is rarely
satisfactory to simply include a list of yes/no tick boxes, especially in relation to allergen cross-contact, as this does
not provide a clear indication of the level of risk (i.e. the likelihood of contamination occurring or the level that may be

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present). The raw material supplier should therefore be given the opportunity to explain each of the conclusions that
have been reached.

However, wherever possible the documents should be straightforward and self-explanatory as this can help avoid
confusion. Table 1 gives an example of the allergen section of a specification.

Allergen Information
Please complete the table below, clearly indicating which allergens are present in the product supplied. The table
must include all allergens and any ingredient or derivative* made from one of the listed allergens. It must include
both deliberately added materials and any risk of allergen cross-contact. Where an allergen is present full details
must be provided.

Present in Product Yes (present) Ingredients or Details including: format

No (absent) derivatives of allergen - solid, liquid,
made from listed powder, risk of allergen
allergens cross-contact
Cereals containing gluten/
derivatives
Crustaceans/derivatives
Molluscs/derivatives
Eggs/derivatives
Fish/derivatives
Peanuts/derivatives
Nuts/derivatives
Soybean/soya/derivatives
Milk/derivatives
Celery/derivatives
Mustard/derivatives
Sesame seeds/derivatives
Sulphur dioxide and sulphites
(at any concentration)
Lupin/derivatives

*The term ‘derivative’ refers to any material or foodstuff manufactured from the allergen; for example, butter and
cheese are both derivatives of milk. Some processed ingredients (e.g. oils or vinegars) can be made from a range of
raw materials and it is obviously important that those manufactured from allergens are clearly identified.

Table 1 Example of the allergen section of a specification completed by a supplier

NB this is not an exhaustive list of allergens. An allergen list is liable to be different for each country.

The example in Table 1, if completed correctly by the supplier should provide the company with a list of the allergenic
materials of interest. This avoids potential confusion, particularly when importing ingredients from countries with
differing legislation. By clarifying any allergens present at the start of the process a manufacturer can check the list

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against any legislation. This will prevent confusion and delays when a supplier suddenly highlights that they were not
aware of the need to declare X.

There is also value in ensuring that, where the allergen includes multiple foodstuffs, these are explained either in
the table or adjacent to the table. For example, terms such as cereals, crustaceans, shellfish or nuts may appear self-
explanatory, but as shown in Appendix 1 can refer to different foods in different countries.

The table also asks the supplier to identify any derivatives manufactured from the allergens. Again this helps to
avoid confusion and, although some legislation (such as the EU) exempts certain derivatives, it is preferable for the
specification to collect all the information, to allow subsequent decisions to be based on full information.

The specification must include information regarding both the deliberate addition of allergenic ingredients and
potential allergen cross-contact. There are a number of ways to collect both sets of information:

• A single table - titled to make it clear that information on both deliberate ingredients and allergen cross-contact must
be included.
• Two separate tables - one for deliberate ingredients and one to record potential allergen cross-contact. This has the
advantage of separating both sets of information in an unambiguous format.

Supplier questionnaires
Where the raw material specification is insufficient to complete an assessment of the ingredient, additional information
must be obtained. The most common mechanism for collating this information is the use of an allergen questionnaire.
The aim of the questionnaire is to obtain clarity on:

• the risk of allergen cross-contact that exists both at the supplier’s site and in the supply chain (including during
transportation or bulk shipment where knowledge of the previously transported products may be relevant)
• the likelihood or probability that allergen cross-contact will occur (e.g. shared equipment or shared processing areas)
• the raw material supplier’s understanding of the risks within the supply chain (e.g. a processed ingredient may have
several stages and be handled by a number of different companies or outsourced to co-packers or
specialist operations)
• management or control procedures that are in place to prevent the contamination occurring (e.g. segregation or
validated cleaning of shared lines)
• monitoring or verification procedures that are in operation
• relevant analysis or testing that is completed.

Table 2 shows an example of a supplier allergen questionnaire.

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Please complete the following table. It must confirm which allergenic foods (or derivatives of allergens) are
currently present or handled in your manufacturing site and in the manufacturing sites of each ingredient or
material supplied. Where there are several manufacturing sites for a material please complete a separate line per
site. In all cases full details should be provided.
Cereals containing

Sulphur dioxide
Soybeans/soya

Sesame seeds

and sulphites
Crustaceans

Molluscs

Mustard
Peanuts

Celery
gluten

Lupin
Product Supplier
Nuts
Eggs

Milk
Fish

description code Details

Table 2 Example of a supplier allergen questionnaire

Where an ingredient is purchased from a third party such as an agent or broker this can cause additional complications
in the timely receipt of detailed technical information. However, the same basic principles apply, and the company
should not use any ingredient for which a full specification and complete set of allergen information are not available.

Supplier audits
Supplier audits and visits are a particularly useful tool for assessing the supplier’s understanding and their allergen
management controls.

All audits should be risk-based, and should, for example, consider:

• whether the raw material supplier’s site is certificated to a relevant third-party scheme such as BRCGS
• any known allergens on site
• the allergen profile of raw materials
• allergens in product formulation and any changes
• any complaints involving allergens
• recent incidents (e.g. recalls/withdrawals).

The audit should aim to:

• assess the effectiveness of the allergen management plan
• check the validation and verification of the allergen cleaning programmes
• assess allergen procedures and allergen cross-contact controls
• assess the allergen profile of foods produced
• compare the list of known allergens handled on site with those actually in use during the visit
• assess the supplier’s raw material controls
• check the allergen training procedures and records
• assess the use of protective clothing, dedicated equipment and utensils
• review production scheduling, waste handling and rework
• check any food restrictions brought onto site
• ensure labelling claims are accurate.

The audit should be documented and the details included in the assessment of the raw materials. To maximise the value
of audits they should be conducted by staff with appropriate training and experience.

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Assessment of raw materials

There should be a documented procedure detailing the process for assessing raw materials based on the information
obtained from the supplier (plus any relevant information from the supplier approval process). The company needs to:
• Assess each supplier – understand the risk from each supplier.
• Assess each ingredient – so that they can be correctly managed.
• Clearly identify any ingredient which is an allergen (or contains an allergen).

An allergen management plan is required to prevent allergen cross-contact with other products and it is important to
understand the risk of allergen cross-contact in the supply chain. Start with the question ‘is there a genuine risk that the
raw material will be contaminated with an allergen that is not a deliberate ingredient at some stage in the supply chain?’.

Hazard Analysis Critical Control Point (HACCP) Principle 6 highlights that an important part of the assessment process
is to consider the need for verification steps, for example how can the company remain confident that the risk is low
and remains low? Verification requires objective evidence that the initial assessment continues to be met. Examples of
possible verification include:
• analysis of samples of raw material
• periodic review of specifications/questionnaires with relevant suppliers
• audits.

The level of verification required will be dependent on the risk associated with a particular supplier or raw material.

Managing changes
It is vital that companies have mechanisms to ensure any changes in a raw material’s allergen status are communicated
in advance of the changes being made. It is recommended that this communication is made a contractual requirement
and that no changes are permitted without due consultation, in advance of the change.

When information about forthcoming changes is received the manufacturer will need to assess the significance of the
changes, the timescales involved and the appropriate next steps. For example, necessary action may include:
• Label changes – including both the ingredients list and allergen information. Since a consumer may purchase the
product without reading the ingredients list some companies add a voluntary ‘new recipe’ or ‘new allergen
information’ label to the front of the pack to alert consumers to the change.
• Communication with customers – including consumer support groups such as the Anaphylaxis Campaign.
• Changes to production scheduling.
• Reviewing alternative sources of the raw material.

The manufacturer will need to ensure rigorous version control procedures, so that only the correct up-to-date version
is used in subsequent activity. For example, only the most recent version of the raw material specification can be used
when designing new product labels.

Following any change in supplier, businesses should have procedures or polices to ensure that these changes are
accompanied by a review of the product(s) being supplied regarding the supplier’s allergen control program.

In addition to the communication of planned changes, the system should include incident management control
whereby any incident at the raw material manufacturer’s site or in the supply chain is communicated in a timely and
effective manner. This could affect the allergen status of an ingredient that has already been dispatched.

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Part 3
List of allergenic materials
The next step in allergen management aims to ensure the manufacturer knows comprehensively exactly what allergens
are everywhere on site.

All materials that contain allergenic substances (including ingredients, blends, processing aids, operation aids,
intermediates and finished products) must be listed in a single reference document. Particular care should be applied to
‘hidden allergens’ such as carriers used in additives. This is to ensure that the company has up-to-date knowledge of the
allergens handled and the processes and products in which they are used.

The information regarding raw materials should be available from the assessments described in Part 2. A single list
collates all the raw material data and adds the details for the allergens in all intermediates and final products. This is
a fundamental step in the risk assessment process used by the site to manage potential allergen cross-contact. The
accuracy of the list will have wide-ranging implications for procedures including, product labelling, manufacturing
schedules, cleaning regimes and communication to customers.

There is no set format for the list but obvious examples include listing the ingredients ‘by allergen’ (as shown in Table 3)
or listing all the allergens per material (as shown in Table 4).

Allergen Material
White flour
Wholemeal flour
Wheat
All biscuit products
Biscuit mix rework
Skimmed milk powder
Milk Liquid milk
All biscuit products
Biscuit mix rework
Liquid egg
Egg
Egg glaze
Vanilla biscuit

Table 3 Example of a list of allergen-containing materials (by allergen)

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Material Wheat Nuts Peanut Egg Milk Fish Sesame Mustard Celery
White flour
Wholemeal flour
Biscuit mix
rework
Liquid egg
Egg glaze
Skimmed milk
powder
Liquid milk
Walnut biscuit
Fruit biscuit
Vanilla biscuit

Table 4 Example of a list of allergen-containing materials (by material)

The design of the table would need to be adjusted to ensure the incorporation of all raw materials, aids, intermediates
and finished products and for the complete list of allergens that need to be managed (including the allergens defined in
legislation). Products must comply with the legislation in the country/jurisdiction where they are sold).

Where a company uses a large number of ingredients, a number of similar ingredients or the same one from several
suppliers, then it is necessary to include sufficient information in the list to distinguish between them. Similarly, where
different recipes are used for different brand owners these should be distinguished. Table 5 shows an example.

Material Wheat Nuts Peanut Egg Milk Fish Sesame Mustard Celery
English flour 123
grade X
English
wholemeal flour
456 grade X
Derby flour 123
grade X
Brand A – walnut
biscuit
Brand B – walnut
biscuit
Brand C – walnut
biscuit

Table 5 List of allergen-containing materials (different recipes for different brand owners)

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To ensure information is accurate companies should restrict who has the authority to purchase new materials and make
sure there is a clear communication process between the purchaser and the manager of the allergen list.

It is important that all areas of the company responsible for introducing new materials onto the site, including
new product development (NPD) and engineering are aware of the purchasing route. The most common error
associated with maintenance of an accurate list is for a department to introduce a new allergen without appropriate
communication. If a company has no nuts listed on their allergen list there should be no nuts anywhere on site. This
includes departments that use new or different ingredients such as NPD or the canteen. See sections on recipe changes
and new product development on page 26 on permitting foods on site on page 28.

The company will also need a mechanism to record the ingredients that are at genuine risk of allergen cross-contact.
When the list of allergen-containing materials is confirmed as complete, proceed with the raw material risk
assessment process.

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Part 4
Risk assessment for allergen
cross-contact
It is important to understand the aim of an allergen cross-contact risk assessment before one is carried out as the term
tends to be interpreted differently across the industry. A risk assessment aims to identify all of the events, situations
or processes where cross-contact can occur. A site can then introduce procedures or policies to manage the risk, for
example protecting ingredients and products which do not contain the allergen from being contaminated by those
which do contain it. Where it is not possible to remove the risk of allergen cross-contact entirely controls should be
implemented to reduce the risk as far as practicable and allow accurate communication to manufacturers, retailers and
ultimately consumers.

There are risk assessment tools that can be used during allergen cross-contact assessments, but the overall process can
be summarised as shown in Figure 2.

UNDERSTANDING THE ALLERGENS ON SITE

IDENTIFY THE HAZARD

IDENTIFY WHERE CROSS-CONTACT CAN OCCUR

EVALUATE THE RISK AND IMPLEMENT CONTROLS

REVIEW THE ASSESSMENT

Figure 2 The allergen cross-contact assessment process

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Understanding the allergens on site

The first step in the cross-contact risk assessment process is to identify the allergens that are on site. Reference should
be made to a number of sources of information including:
• the list of allergenic raw materials. It is important that the list includes all raw materials, aids, intermediates and
finished products
• a raw material risk assessment
• new product development. The NPD processes must be documented and clearly defined in procedures. For example,
if a pre-production trial is to be conducted on a production line, then consider how this will be carried out. Consider
allergens used and how it will affect other production activities, including subsequent production on the same line.
• engineering – for example, if aids (e.g. lubricants) are used these should be suitable for a food environment.
• catering, contractors and vending machines.

The activities discussed earlier, such as those on raw material risk assessment, can also be reused in this step. For
example, if the specifications, questionnaires, and audits discussed in Part 2 give full understanding of the risks
associated with raw materials then it is possible to make confident decisions at this stage of the process.

Identifying the hazard

It is important that the site understands the hazard it is managing. In this case the hazard is the inadvertent
consumption of an allergen by an individual with food allergy.

The aim of the risk assessment process is to identify the products that do not deliberately contain the specific
allergen(s) and manage the likelihood of contamination of these products by implementing suitable controls to
eliminate (where possible) or reduce the risk of allergen cross-contact. For example, in a list of allergenic materials
developed by a biscuit manufacturer it is relatively straightforward to identify which ingredients or products will, in
principle, need to be protected from allergen cross-contact (see Table 6).

In Table 6 the tick symbol indicates the deliberate presence of the specific allergen, while the yellow shading highlights
those ingredients or products that do not contain the allergen and will therefore need to be protected from cross-
contact. Rework and final products have been highlighted in bold text to distinguish them from raw materials. In this
example none of the ingredients or products need to be protected against allergen cross-contact with wheat or milk
because all of the final products deliberately contain both of these allergens. However, cross- contact controls are
needed for both egg and walnuts as not all of the final products contain these allergens as deliberate ingredients.

Material Wheat Nuts Peanut Egg Milk Fish Sesame Mustard Celery
White flour
Wholemeal flour
Biscuit mix rework
Liquid egg
Egg glaze
Skimmed milk powder
Liquid milk
Walnuts
Vanilla extract
Sultanas
Walnut biscuit
Fruit biscuit
Vanilla biscuit
Table 6 Example of a list of ingredients and products for allergen cross-contact assessment
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Material Wheat Nuts Peanut Egg Milk Fish Sesame Mustard Celery
White flour
Wholemeal flour
Biscuit mix rework
Liquid egg
Egg glaze
Skimmed milk powder
Liquid milk
Walnuts
Puffed rice
Vanilla extract
Sultanas
Walnut biscuit
Fruit biscuit
Vanilla biscuit
Puffed rice cakes

Table 7 Example as in Table 6, with the addition of rice cake and its ingredients

At this stage it is also useful to consider hazard characterisation (i.e. the relevance of the form in which the allergen(s)
are present). This includes:
• The physical nature of the potential contaminant. For example, liquids might be easily distributed through a batch of
product compared to a piece of nut, where an amount of allergen could be present at a single point.
• The amount of allergenic protein likely to be present (e.g. a fully refined nut oil may contain little protein compared
to the whole nut).

Identifying where allergen cross-contact can occur

An important step of the risk assessment processes is to understand the likelihood of allergen cross- contact occurring.
Having identified the products that are potentially at risk it is necessary to consider whether that allergen cross-contact
can actually occur and, if so, where in the manufacturing process this can happen.

It is essential to consider all locations and processes in the site, from goods receipt to delivery when considering where
cross-contact could occur.

Creating an allergen map

A useful way to identify where allergen cross-contact can occur is to use the site plan and the process flow diagrams to
create an allergen map. Mark the locations of the allergen-containing materials and plot the routes they take through
the factory on the plan. By knowing exactly where the allergens are and where they go, it is then possible to identify the
locations, processes or situations where allergen cross-contact could occur. This is particularly useful where materials
that do not contain the allergen are also handled in the same area or on the same equipment. It is important to use up-
to-date process flow diagrams to ensure that no step in the manufacture of any product is omitted from the assessment.

Where the site handles a large number of products or ingredients it may be possible to group products with the same
allergens and similar processes into a single consideration (see Table 8).

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Product Description Allergens Present

Wheat Soya Mustard
Basic beef 12×
Basic beef (catering pack)
Beef 12x
Beef (Retailer A)
Beef (Retailer B)
Beef (Retailer C)
Beef and pickle
Beef
Peppered beef and chicken
Beef and chicken
Ham and beef
Ham and beef
Ham and beef (Retailer A)
Ham and beef (Retailer B)

NB: For the purposes of this example the raw materials have been omitted from the table; they would, however,
need to be included in an on-site assessment of allergens.

Table 8 Grouping products by allergens present

In Table 8 rather than assessing 13 individual products the products can be grouped into four categories:
• soya and mustard containing
• soya and wheat containing
• soya, wheat and mustard containing
• soya containing.

This grouping process can only be used where the allergens and the processes are the same. Where the processes are
different it is necessary to consider the individual products to establish the significance of the differences.

When considering the points at which allergen cross-contact can occur, the probability or likelihood of allergen cross-
contact actually occurring should also be considered. For example, the use of open, uncovered vessels of material
transferred via scoops is more likely to have cross-contact with similar materials than an enclosed system involving
sealed drums dispensing material via enclosed pipework and a pump. If the pump is shared between a number of
materials then the likelihood of allergen cross-contact increases considerably and the controls would need to be
more rigorous.

As part of the assessment process pay attention to any areas of plant design that are known to be of high risk for
allergen cross-contact. This could include, for example, deadlegs in pipework where allergen-containing material could
accumulate, whether the site uses shared or dedicated production lines, and the ease with which equipment can be
cleaned and inspected.

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Evaluating the risks and implementing controls

Once the risk assessment has identified the source(s) of allergen cross-contact identify control mechanisms. Preference
should be given to those controls that eliminate or totally remove the risk, followed by those that manage, reduce or
minimise the risk. This hierarchy is shown in Figure 3.

ELIMINATION
(e.g. removal from site)

SEGREGATION AND
ISOLATION

SCHEDULING AND CLEANING

Figure 3 Hierarchy of controls for allergen cross-contact

At each point of the production process where a risk of allergen cross-contact has been identified consider:
• Can the risk of allergen cross-contact at this point of the process be removed?
• What allergen management controls are already in place? Do the current controls eliminate the risk?
• Are there additional allergen management controls which should be put in place?
• Where removal of the risk is not possible, how can the risks be managed so that the potential for allergen cross-
contact is minimised?

Part 5 of this guideline explains some of the common controls used to minimise the risk of allergen cross-contact.

The effectiveness of any system or policy to manage allergen cross-contact must be validated as far as reasonably
practicable to ensure that it consistently delivers the expected level of control. An example validation process for
cleaning is outlined in Part 8.

Once a validated mechanism has been established:

• document the procedure or policy
• implement the procedure into standard operating procedure
• train relevant staff in the new requirements
• communicate to all relevant parties. A raw material control might need to be communicated to suppliers and the
exclusion of a specific allergen from the site would need to be communicated to all staff, contractors and visitors)
• introduce verification and monitoring procedures to ensure that the control continuously delivers within expected
parameters.

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Reviewing the assessment

It is important to establish whether the newly introduced controls remove or reduce the risk (i.e. does a significant
risk remain?). Where the risk cannot be effectively removed, assess the need to communicate to customers and/or
consumers, for example by using precautionary allergen labelling. This will depend on the level of remaining risk despite
suitably implemented allergen controls, legislation in country of sale, etc.

Precautionary allergen labelling should not be seen as a reason to omit other factory-based controls and should only be
used where a genuine risk remains after the introduction of best practice.

Reviews will also be needed when significant changes are planned, such as new products are to be introduced, new
ingredients will be used, new equipment is being installed, there is a change to scheduling or cleaning regimes, etc.

Tables 9, 10 and 11, where the grouping together of the bulleted points show how a risk analysis process might work, the
different stages of the processes and their consequences.

• Oven chips contain refined sunflower oil as a deliberate ingredient

• The oven chips do not contain deliberately added peanut ingredients that
require labelling.
• Raw material specification for sunflower oil declares risk of cross-contamination
with peanut oil.
• Further information from the supplier confirms there is a probable risk of cross-
contamination, under normal operating conditions, between refined sunflower
oil and refined peanut oil as they are made using shared equipment.
• The potentially cross-contaminating material is a highly refined oil with little or
no protein present.
• Analysis confirms batches of peanut oil consistently do not contain peanut
protein.
• The risk is associated with a raw material, and additional on-site controls by the
oven chip manufacturer will not mitigate this risk.
• There is no need for a precautionary allergen label for peanut because the only
probable risk of peanut exposure is highly refined peanut oil with little or no
protein present.

Table 9 Example: production of oven chips with sunflower oil that was refined in premises also refining peanut oil

• Pasta ‘A’ does not contain any egg ingredients that require labelling.
• Both pasta products are made on the same line.
• There is probable risk of allergen cross-contact under normal operating
conditions.
• Egg is added to the pasta mix (for pasta ‘B’) pre-extrusion, as a powder which is
evenly distributed.
• Extruded pasta shapes can be lodged in various locations post-extrusion.
• Production of pasta ‘B’ is scheduled after pasta ‘A’ to minimise carry-over of egg-
containing material.
• Due to the nature of the product, daily changeover wet cleaning throughout the
process is not possible except at the weekend shutdown when the line is able
to dry out.

Table 10 Example: production of two pasta products (only one of which contains egg) on the same line

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• The line is rigorously visually inspected following daily changeover dry cleaning
routines to minimise product retention.
• No further measures can be taken to reduce:
- egg residues from the pre-extruded product flow
- probable risk of particulate product cross-contamination (as noted above –
whole pieces of pasta shapes can be lodged on the line)
• There is a need for a precautionary allergen label for egg or pasta ‘A’.

• Salted potato crisps do not contain any cheese or dairy ingredients.

• Salted potato crisps are made on the same line as cheese-flavoured crisps
• There is probable risk of cross-contamination under normal operating
conditions.
• The cheese flavouring is a fine powder, which is evenly distributed.
• The cheese flavouring includes milk-based ingredients.
• Rigorous good manufacturing practice (GMP) measures are in place.
• Use of shared equipment is minimised.
• Shared equipment is accessible for cleaning.
• Physical segregation measures are in place for all areas other than the shared
equipment.
• Salted potato crisp production is scheduled first, followed by the cheese-
flavoured product.
• Salted potato crisp production can only start following a thorough clean,
inspection and sign-off.
• There is no need for a precautionary allergen label for cheese (milk) because
the measures effectively control the cross-contact.

Table 11 Example: production of cheese-flavoured potato crisps on the same line as salted potato crisps

A number of organisations have published possible approaches to allergen risk assessment including the Allergen
Bureau, BSI, Codex Alimentarius, Campden BRI, the Food Standards Agency and Health Canada. Details can be found in
Appendix 3.

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Part 5
Allergen cross-contact and control
procedures
The risk assessment process should be used to identify and develop the controls and procedures required to manage
allergens throughout the site. These procedures must be documented and training given to the appropriate staff.

Particular attention should be given to:

• segregation
• changes of protective clothing
• dedicated and identified equipment and utensils
• scheduling
• airflow
• recipe changes and new product development (NPD)
• waste handling and spillage control
• personal hygiene
• staff movement
• foods permitted on site, including in vending machines, catering facilities for staff and food brought to site by staff.

These topics are considered in more detail in the following sections.

Segregation
Wherever practical, allergens and allergen-containing materials should be segregated and kept separate from materials
that do not contain the allergen/s. This requires the use of dedicated areas, equipment and production lines.

Where a site handles multiple allergens, it is not sufficient to have one storage area for allergens and one for non-
allergens. Each allergen must be prevented from contaminating other products or ingredients, including other allergens
- for example milk cross-contact with nuts is just as much of a problem as maize flour cross-contact with nuts.

The segregation of allergens should start as soon as ingredients arrive on site at goods receipt. Checks should
include making sure the materials are correctly labelled (including allergen information) and that there are no spills or
breakages, which could represent a risk to the integrity of the materials.

Store the raw materials to ensure that cross-contamination cannot occur. This could include:
• storage in separate dedicated areas
• clear labelling of allergenic materials
• allergens not stored above non-allergens
• all containers and packs of product sealed or closed. Where part-used packs of an ingredient are returned to the
storage area these must be in sealed containers/packaging to minimise the potential for spillage.

Where practicable, production lines should be dedicated to a specific allergen or group of allergens. This includes
weighing equipment and any equipment used within the mixing areas such as sieves.

Where dedicated production lines are not possible, consideration must be given to the design of the line and any
additional controls that may be required to ensure that allergen cross-contact does not occur.

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Check:
• areas that are known to create airborne dust are suitably isolated or shrouded
• open production lines containing allergens are not located above those which do not contain them
• movement of staff handling different allergens is restricted
• particular attention is paid to shared areas that may present specific challenges, such as fryers, ovens or chillers.

Changes of protective clothing

Protective clothing must not be a source of allergen cross-contamination. Consideration using separate clothing or
overalls when handling specific allergens or where there is a high risk of allergen cross-contact, e.g. during manual
operations involving fine powders or sticky materials which may adhere to clothing.

Where a change of clothing is required, the management of the clothing and how it will be distinguished from other
workwear must be addressed. Colour-coding could be used to visibly distinguish workwear for different products, or
the site could issue clean workwear prior to the production of specific products. This could be collected and laundered
once the production is complete. Alternatively, use disposable overalls worn in addition to normal workwear.

Best practice is for staff to remove protective clothing before using the canteen or consuming food. This ensures that
the clothing is not inadvertently contaminated with an allergen that could subsequently contaminate a product.

Dedicated and identified equipment and utensils

The use of dedicated tools, containers and utensils (both for production and for allied activities such as maintenance) is
recommended to avoid potential contamination from equipment into products.

All dedicated equipment should be clearly labelled or colour-coded to allow easy identification.

Where different colours are used for different allergens, products or purposes then the meaning of each colour must be
clear to staff. Provide training in the company policy to staff and signs in the production area.

Consider whether there are other resources, besides equipment and utensils, that should be dedicated to specific
allergens. For example, the reuse of cooking oil or water could potentially transfer an allergenic material into a non-
allergenic product produced later using the same oil or water.

Scheduling
Scheduling is a useful tool in allergen management where complete segregation is not possible and therefore all or part
of the production line is shared with different allergens or products that do not contain the allergen.

Best-practice for scheduling is to:

• produce allergen-containing products after those which do not contain the allergen(s)
• complete a deep clean of the shared equipment following production of allergen-containing products (e.g. at the end
of the day or when a production shift finishes)
• wherever possible minimise the frequency of product changeovers between allergen-containing production runs (a
smaller number of long production runs is preferable to a large number of short runs, as this will minimise the amount
of allergen deep cleaning required and reduce the potential for allergen cross-contact).

When planning production schedules, consider all stages of the production process, including activities such as mixing,
weigh up and packing, which may operate at different times to the main production lines. The aim is to ensure that
these activities do not represent a potential source of contamination. For example, the weighing out of flour is likely to
create airborne dust that could cause allergen cross-contact of products which do not contain allergens.

The movement of staff, raw materials or open products into areas that are handling different allergens should be limited.

When planning a production schedule for allergen control, start with the list of allergen-containing products. Table 12
shows the list for a company that produces a range of meat products and handles three allergens (wheat, soya
and mustard).

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Product Description Allergens Present

Wheat Soya Mustard
Basic Beef 12x
Basic Beef (catering pack)
Classic beef 12x
Classic beef (retailer A)
Beef 12x
Beef (retailer A)
Beef (Retailer B)
Beef (Retailer C)
Beef (Retailer D)
Beef and pickle
Beef
Peppered beef and chicken
Beef and chicken
Ham and beef
Ham and beef (Retailer A)
Ham and beef (Retailer B)
Ham and beef (Retailer C)
British classic beef and
tomato
Ham and beef
Beef and ham (Retailer A)
Beef and ham (Retailer D)

Table 12 Example of a list of products manufactured in a site handling three allergens

The site can schedule production of products containing allergens by choosing those with the fewest allergens and
then working through the product list in increasing number of allergens. For example, on a particular production day the
manufacture of Beef (Retailer A) could follow the production of Beef 12 x as the allergens are identical. These products
could be followed by production of peppered beef and chicken as this contains more allergens with all the initial
allergens still present. The reverse schedule would not be permitted.

Many companies will have additional scheduling concerns, such as quality or taint that must be managed as part of the
scheduling process. For example, in the above table it is clear that there are three species of meat whose integrity must
be maintained during the manufacturing process. Therefore, scheduling will need to consider this additional concern, as
shown in Table 13.

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Product Description Species Allergens

Chicken Beef Pork Wheat Soya Mustard
Basic Beef 12x
Basic Beef (catering pack)
Classic beef 12x
Classic beef (retailer A)
Beef 12x
Beef (retailer A)
Beef (Retailer B)
Beef (Retailer C)
Beef (Retailer D)
Beef and pickle
Beef
Peppered beef and chicken
Beef and chicken
Ham and beef
Ham and beef (Retailer A)
Ham and beef (Retailer B)
Ham and beef (Retailer C)
British classic beef and
tomato
Ham and beef
Beef and ham (Retailer A)
Beef and ham (Retailer D)

Table 13 Example of scheduling with the additional concern of different species of meat

The site will need to apply two scheduling rules:

• identical or increasing allergens only (subsequent production must include ALL previous allergens) AND
• identical or increasing species only (subsequent production must include ALL previous species).

Production can only be scheduled in an order that meets both requirements, for example:
Beef 12 x followed by Beef (Retailer A) OR Basic beef 12 x followed by Classic beef 12 x followed by Beef and ham
(Retailer A).

Scheduling assessment rating

Some companies summarise the scheduling information into a single column, ‘the scheduling assessment rating’, which
combines both of the site’s scheduling concerns. Any product that contains the same allergens and the same species
are given the same rating, as shown in Table 14.

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Product Description Species Allergens Scheduling

Assessment
Chicken Beef Pork Wheat Soya Mustard Rating
Basic Beef 12x A
Basic Beef (catering pack) A
Classic beef 12x B
Classic beef (retailer A) B
Beef 12x C
Beef (retailer A) C
Beef (Retailer B) C
Beef (Retailer C) C
Beef (Retailer D) C
Beef and pickle C*
Beef C
Peppered beef and chicken D
Beef and chicken D
Ham and beef E
Ham and beef (Retailer A) E
Ham and beef (Retailer B) E
Ham and beef (Retailer C) E
British classic beef and
F*
tomato
Ham and beef F
Beef and ham (Retailer A) G
Beef and ham (Retailer D) G
*Occasionally, specific products will need additional controls and these can either be added as additional columns
or added to the summary. For example, the shading indicates that the product has a strong flavour or colour and
should be run last before a full clean.

Table 14 Rating products containing the same allergens and species

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This rating allows the permitted schedules to be constructed in advance, which is simpler for staff. Rather than having
to consider whether a specific combination is acceptable, they can simply refer to a pre-prepared table. An example is
shown in Table 15.

Permitted Schedules
1 2 3 4 5 6 7
A B C E C C A
B D D F F G D
G G G G G

Table 15 Example of a pre-prepared table of permitted schedules

In other words, schedule 1 in Table 15 allows any product rated ‘A’ to be followed by any product rated ‘B’, which in turn
can be followed by any product rated ‘G’ and therefore it is relatively easy to confirm that Basic beef 12 x followed by
Classic beef 12 x followed by Beef and ham (Retailer A) is permitted.

In addition to the production schedule, another important aspect is the scheduling of non-production activity and in
particular cleaning and changeover activities. There is a temptation to minimise the time spent on these activities in
order to maximise time available for production. However, it is important to assign sufficient time to changeover activity
including:
• cleaning
• packaging checks
• line sign-off.

All sites must ensure that the staff responsible for production schedules are sufficiently trained in the site’s allergen
management plan and the importance of correct scheduling of activities.

Airflow
Air conditioning and such as cooling fans should be considered in relation to allergen management. The way air flows
can disperse the allergen, thus causing a cross-contact risk. For example some allergens (e.g. cereals, milk or lupin) can
be present in the form of a fine powder that can easily be dispersed. High airflows, such as those generated by cooling
fans, could blow these powders or particulate materials around the production area.

The use of high-pressure air (or water) lines is not recommended for cleaning in areas where allergens are handled due
to the possibility of distributing the allergen over a wide area. The speed of the production line can influence the risk of
airborne contamination (e.g. the rate of deposition of an allergenic powder).

Where the movement of airborne allergenic materials cannot be entirely prevented consideration should be given to
the use of suitable barriers such as enclosed areas, full-length screens, lids or shrouds.

Recipe changes and new product development

New product development (NPD) and recipe changes must be aligned with the company policies on allergen control.
For example, a site choosing to be nut free must be nut free throughout, including NPD areas.

Any changes or development must be formally approved by the HACCP team or an authorised HACCP committee
member before the products or ingredients are introduced into the factory. The aim is to ensure that new risks, for
example a new allergen, are only introduced once the consequences are well understood and correctly controlled.

Consideration should be given to the validity or need for an allergen to be added to a product that would not otherwise
contain the allergen. If the allergen provides a specific function or flavour then its inclusion is valid and should be

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maintained. However, where this is not the case consider using a non-allergenic alternative (e.g. the use of unrefined nut
oil as a salad dressing might be avoided by using an alternative oil).

Although allergic consumers should always read the full ingredients list when deciding on the suitability of a particular
product, where a recipe change affects the allergens present in a product, consideration should be given to how this
will be communicated. A site may choose to notify allergy support groups who can communicate the changes to
their members or to communicate directly to consumers using on-pack ‘new allergen information’ labels or through
marketing and advertising.

Waste handling and spillage control

Waste handling systems need to ensure that the risk of allergen cross-contact of products is minimised and that waste
disposal from open product areas is managed to ensure it does not compromise product safety.

Consider:
• Scheduling of waste removal.
• The movement and flow of waste – defined routes should be identified that allow the transport of waste materials
away from open product areas to the designated waste storage with minimal opportunity for allergen cross-contact
to occur.
• Containers used for waste should be dedicated for that purpose. Those used for raw material storage, rework or
finished product should not be used for waste, which should instead be collected in appropriate, designated and
easily identifiable (e.g. labelled or colour-coded) containers.
• Containers used for waste materials should be suitably covered (e.g. with a properly fitting lid).

The site should operate a ‘clean as you go’ procedure so that any spill is cleaned up immediately. Where the spill is an
allergen or suspected of being of an allergenic material then the site will need to implement a specific documented
procedure detailing how the spill of the allergenic material will be managed.

These procedures should include:

• Who to notify (e.g. line or production manager with authority to take action).
• Isolation and management of potentially contaminated products i.e. those that are in the area of the spill, are not fully
enclosed and do not already contain the allergen. This includes raw materials, work-in-progress, intermediates or final
products.
• Location (preferably close proximity) and availability of the equipment to clean a spill.
• How to clear up the spill – including the method and the equipment to use.
• Requirements for inspection, validation of clean-up and the authorisation to recommence production.
• Inspection of footwear and protective clothing.
• Records to be kept.

The action taken should be risk-based and therefore may be dependent on the location of the spill. A spillage in a
production area with open product is likely to be of higher risk than in a closed product area such as a storeroom.

Personal hygiene
The Standard requires handwashing to be conducted at a frequency appropriate to the level of risk to the product.
When considering allergen control this may include between products, when moving between lines or when handling
different ingredients and when returning from non- production areas such as a storeroom or the canteen.

Staff movement
Where allergens are handled on specific lines or in specific areas of the site, staff movement between these areas and
those not handling the allergen/s should be minimised to reduce the potential for cross-contamination.

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Permitting foods on site

Staff facilities (e.g. canteens, vending machines and staff lunches) must be considered as potential sources of allergens;
this is particularly important where a company chooses to manage an allergen by defining the site as ‘free from the
allergen’ (e.g. a nut-free site).

To be effective the site policy must be communicated to, and understood by, staff and relevant contractors. For example,
catering staff or vending machine owners must be aware of any requirements to restrict or label the allergens that are
present.

Where allergens that are not used in all the products manufactured are permitted in catering areas, this should be
detailed in policy documents and suitable controls must be in place, creating an effective barrier, such that these
allergens are kept within the permitted zone. Controls could include staff training on the risks and the procedures in
operation to minimise this risk of contamination, for example the need to remove protective clothing before using the
canteen or consuming food.

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Part 6
Rework
Rework is a potential source of contamination that can affect both safety (e.g. allergen contamination) and quality (e.g.
taint or colour contamination). Specific documented procedures are therefore required to prevent rework containing
allergens from being used in products or processes that would not otherwise contain those allergens. Therefore best
practice is that rework is only used on a like-for-like basis (i.e. it is only used in batches of exactly the same product as it
was originally produced for).

Rework must be stored in an appropriate manner (e.g. in covered or sealed containers that are labelled with full
traceability information including references to both the ingredient/product, batch codes and date codes).

The use of rework should always be documented within the production records.

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Part 7
Allergen Claims
Claims such as ‘[allergen]- free’ and ‘free from [allergen]’ are definitive statements advising the consumer that the
specified allergen(s) and their derivatives are not present in the product and that they have been manufactured in such
a way as to prevent cross-contamination with these allergens. Reference must be made in policy documents to any
legislative requirements or limits within the country of sale to ensure these are consistently met.

Whenever a company makes an allergen claim it will attract the most susceptible individuals (i.e. those who suffer from
the allergy and who will consequently rely on the continuous accuracy of the claim). Therefore, the risk assessment
associated with the production of these products and the resultant controls must be proportionate to the increased
hazard.

All the requirements discussed in this document are relevant to products with claims but products that claim to be
definitively free will require additional controls, time and management to ensure the claim is consistently correct.

Consider:
• Additional raw material approval controls. Raw material suppliers must understand the nature of the claim that will be
made on the final product and be committed to maintaining the controls to deliver the claim. This will usually include
additional control and monitoring of their:
- raw materials and supply chain including sourcing and supplier approval
- production processes to prevent cross-contamination
- validation, verification and monitoring regimes.
• Raw material supplier audits – these ingredients are of higher risk due to the nature of the claim and should
therefore be high priority for supplier audits.
• Raw material testing and release procedures – incoming raw materials will be tested on a risk-assessed basis for cross-
contamination with the allergen of interest.
• Design of storage and production areas – wherever possible these ingredients and products should be manufactured
in a dedicated site (i.e. where the allergen is not present). Where this is not possible the use of dedicated areas and
dedicated equipment that remains segregated from any materials containing the allergen is recommended. It is
unlikely that sites could reliably produce a product with an allergen-free claim on shared equipment.
• Production controls.
• Final product testing – to a risk-assessed frequency to ensure that the claim is consistently complied with and that no
unexpected cross-contamination has occurred.

Production processes for products must be fully validated to ensure they consistently meet the claim and the
effectiveness of the process must be routinely verified. Documented records should be kept as evidence.

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Part 8
Allergen Cleaning Regimes
Cleaning regimes are commonly used as an allergen control to reduce the risk of allergen cross-contact. It is therefore
important that all cleaning activity is appropriately designed, validated, completed and verified.

Cleaning methodology and instructions

Cleaning methodology should be designed to consistently achieve the desired level of cleaning.

The removal of allergenic materials from production areas introduces some specific challenges and therefore sites
should not assume that standard cleaning methodology (i.e. methods used for microbiological cleanliness) will be
sufficient for effective allergen removal.

When considering the cleaning methods required the site must:

• identify what should be cleaned and when
• design and trial cleaning procedures and validate their effectiveness
• consider all aspects of the cleaning process including the cleaning chemicals to be used, temperatures, water quality,
flow rates (where running water is required), water hardness or other factors that could affect the efficiency of the
cleaning chemical, time and resource required
• establish sign-off processes
• incorporate verification and monitoring procedures into site operations
• pay attention to situations where there are difficult-to-clean food matrices (e.g. sticky or fatty materials or
heterogeneous particulates) or in situations, such as dry factories, where water cannot be used, as a greater degree
of cleaning is likely to be needed to reliably remove the allergen/s to or below an acceptable level. In these situations
specialist advice should be sought, for example on the type of detergent best suited to remove the debris or residue.

All cleaning methods should be documented to ensure a consistent approach to the cleaning. As a minimum these
documented cleaning methods should include:
• the name of the equipment, factory plant or area that the method relates to
• any equipment reference number
• identification of who is responsible for the cleaning
• whether sign-off is required and by whom
• the chemicals required (including concentrations and instructions for safe handling)
• the personal protective equipment that must be worn during the cleaning activity
• the cleaning equipment/tools to be used – if specific tools are to be used (e.g. colour-coded equipment) then this
must be included
• the cleaning schedule or frequency, including appropriate information/references if more than one type of cleaning is
required (e.g. a daily clean and a monthly deep clean)
• instructions on how to complete the cleaning activity
• key inspection points (e.g. reference to any difficult-to-clean areas or checks the cleaning staff should complete)
• any special requirements or other important information (e.g. if an engineer is required to disassemble equipment, or
power should be disconnected before cleaning).

All new equipment should be assessed prior to purchase for ease of cleaning (including the ease of access, potential
deadlegs or difficult-to-clean areas). Where essential pieces of equipment cannot achieve this ease of cleaning, the site
will need to introduce specific management strategies into the cleaning instructions to ensure potential allergen cross-
contact is correctly addressed.

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Cleaning schedules
Documented cleaning schedules must be available for all items of equipment, plant and factory areas. The schedule
typically takes the form of a tabulated overview; however, best practice is to ensure that the relevant information also
appears on the individual cleaning methods/instructions.

The aim of the schedule is to ensure equipment is cleaned according to the site’s risk assessment and/or HACCP and to
ensure responsible staff know when the activities need to be completed.

Table 16 shows an example of a cleaning schedule identifying when specific cleaning will take place.

Ref Equipment/area name Changeover Daily Weekly Monthly Annual Comments

A1 Conveyor 1
A2 Bowl mixer 1
A2 Bowl mixer 2
A3 Spiral chiller
E1 Tray wash Monthly first day
of each month
B1 Walls above 2m Monthly first day
of each month
Annually: during
July shutdown

Where an activity is completed infrequently, as in the last two rows of this table, it is good practice to set
actual dates.

Table 16 Example of a cleaning schedule

An important aspect of scheduling is to ensure that sufficient resources (time and staff) are available to complete
the clean effectively. This is particularly true of cleaning during a product changeover as many sites have designed
changeover controls that are as concise and compact as possible to avoid undue delays in production. While this is
logical from a production point of view, where allergen control is required it is vital that sufficient time is scheduled
for rigorous cleaning and sign-off procedures. When allowing time for changeover cleaning, senior management must
always bear in mind that the management of allergens is a food safety issue.

Sites should ensure that production schedules are used to minimise the need for changeovers requiring an allergen
clean. Cleaning schedules should also consider the potential to contaminate adjacent production lines or other areas of
the factory during the cleaning (e.g. the use of air lines/water jets could distribute powdered allergenic materials).

Wherever there is a deviation from the normal or planned production schedule (e.g. due to promotional activity or line
breakdown) the allergen profile of the products should be examined to ensure that the risk of allergen cross-contact
has not changed. This is particularly important where a product is manufactured on a different line from the line on
which it is normally produced.

Cleaning validation, verification and monitoring

There are several requirements within allergen management that require validation, verification and monitoring
activities, most notably to ensure the effectiveness of allergen cleaning methods.

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Validation and verification

Validation is described as the process of obtaining evidence that a control measure (or combination of control
measures), if properly implemented, will be capable of controlling a hazard to a specified outcome. For example, the
validation of the allergen cleaning regime should demonstrate that the system has been designed and checked to
ensure that it delivers the correct level of control (i.e. that the allergen(s) of concern are removed or reduced to or
below the acceptable level).

Validation
Validation needs to be completed whenever a product, process, procedure or system is initially being designed or
when there is a significant change (i.e. before it is actually introduced or used). Examples include when a new product
is introduced, cleaning regimes or cleaning chemicals are changed or parts of the production line are changed. It is also
good practice to review the validation routinely (e.g. using an annual recheck).

Before commencing a cleaning validation activity it is important to do the following:

• Define the acceptable level or criteria (i.e. what does the cleaning need to achieve).
• Define exactly what needs to be measured (e.g. which allergen(s) need to be considered).
• If there are multiple allergens then the site will need to consider whether they can all be treated by the same risk
assessment or are likely to need different controls (e.g. peanuts, milk and sesame seeds are physically very different
and will react to management strategies such as cleaning in different ways).
• Identify suitable test methods – this is usually best achieved by discussion with a laboratory (refer to Appendix 2
for further information relating to allergen analysis). Consideration must be given to the type of sample that will
be tested (e.g. raw materials, final products, environmental swabs, etc.), the allergen to be tested and the inherent
strengths, limitations and sensitivity (i.e. limits of detection or limits of quantification) of the available methods.
Care must be exercised in the choice of testing technology to ensure that inaccurate results are not obtained because
of the choice of an inappropriate test. The contract laboratory should be able to advise on the choice of tests.
• There are a range of activities that can be incorporated into a validation study. Examples include:
- reviewing documents and data – such as historical data from the site technical publications or data/
recommendations from consultants/contractors (e.g. the cleaning contractor or cleaning chemical supplier)
- experimental trials (e.g. using proposed new equipment or pilot plants to trial proposals)
- challenge testing
- product testing
- mathematical modelling
- benchmarking (e.g. using information relating to similar products or processes), though care should always be taken
when benchmarking to ensure any nuances or variations are assessed
- pre-production trials
- obtaining information from external specialists such as equipment manufacturers about the equipment they supply.

However, for cleaning validation where there is an allergen cross-contact risk, the most common process is to trial the
proposed cleaning process in a worse-case scenario (i.e. where effective cleaning is likely to be most difficult) and test
resultant samples. Figure 4 outlines the process.

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The process flow diagram and site map, supported by historical test data, indicates that there is a genuine risk
of product allergen cross-contact.

Discussion with the cleaning contractor, equipment manufacturer and the cleaning chemical provider suggests
that it should be possible to improve management of this allergen cross-contact.

Cleaning regime/methods designed – considering what will be cleaned, the standard of cleaning required, time
constraints, detergents to be used (and their correct handling), personnel involved and any necessary training, etc.

A validation test is designed where the proposed cleaning regime will be trialled using the worst-case production/
cleaning schedule (for example, using the manufacture of products with the highest level of allergen, the most at-risk
product and/or difficult-to-clean matrices). Manufacture the allergen-containing product and retain a sample for
testing (often required as a positive control, if the products haven’t been tested before).

Conduct the proposed clean.

Collect any environmental samples that are required, for example swabs of food contact surfaces (consider targeting
difficult-to-clean areas), flush material or rinse waters.

Manufacture a non-allergen product that is susceptible to allergen cross-contact.

Collect suitable samples such as the first pack manufactured and at appropriate intervals throughout the
production run.

Good practice is to repeat the validation to ensure representative results are obtained (e.g. three replicates).

Collate all the data from the replicate exercises and document. Assess against the aims of the validation and
the defined acceptance criteria.

Figure 4 Validation of a proposed cleaning process

Sometimes the validation exercise will establish that the results are not satisfactory and the required acceptable level
has not been reached. In these situations make design changes and retest. For example, with the cleaning validation
consider:
• How the cleaning procedure can be amended – this could include frequency or scheduling of cleaning or the
cleaning processes.
• Whether it is possible to identify and therefore address the cause of the problem. For example, are there difficult-to-
clean parts of the equipment, a difficult-to-remove food matrix, or biofilm that needs to be managed?
• Review the results in the context of the original risk assessment and HACCP – has anything changed or been overlooked?

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• Confirm that any laboratory tests are correct and have been checked to prevent interferences or matrix/cleaning
chemical effects.
• Have checks been performed on the raw materials to ensure they are not a source of additional, unexpected allergen
cross-contact?
• Looking for techniques other than cleaning to reduce potential allergen cross-contact (e.g. segregation, dedicated
equipment or improved scheduling).
• Where allergen controls have been sufficiently implemented and allergen cross-contact cannot be avoided, will be
necessary to consider the need for on-pack advisory precautionary allergen labelling?

Verification
Verification is defined as the application of methods, procedures, tests or evaluations, in addition to monitoring,
to determine whether a control measure is operating as intended. Verification is an ongoing series of checks to a
predefined schedule. Therefore, verification of the allergen cleaning regime will be seeking to demonstrate that it
continues to be effective and delivers the desired level of cleaning.

There are a range of activities that can be incorporated into verification activities. These include:
• audits – both internal and external or third-party (where these specifically include cleaning activities)
• record review – visual inspection and cleaning sign-off
• observation of activity (e.g. if the deep clean only takes place during the night shift should the technical or quality
assurance manager observe the activity?)
• routine testing – including product testing, environmental swabs and lateral flow devices
• trending of relevant data (e.g. monitoring results or product test results)
• a planned schedule for the completion of each verification activity.

The use of adenosine triphosphate (ATP) bioluminescence techniques, while effective as a general hygiene evaluation
tool, are not representative of the level of allergenic protein removed during a cleaning process and care should be
exercised if using this technique following an allergen cleaning exercise (see Appendix 2 for further information).

If the use of lateral flow devices testing is incorporated into verification activities, their validity needs to be confirmed as
part of the cleaning validation.

Where verification indicates that the process is no longer delivering the required standard of cleaning it is vital that
the significance of the difference is assessed immediately such that any potential food safety issue can be managed
efficiently and effectively.

The outcome of verification activities should be documented along with any corrective actions taken and the timescales
for their completion.

Monitoring
Monitoring is defined as conducting planned observations or measurements to assess whether a control measure was
applied at the specific time or to a specific batch of product and whether it was within acceptable limits. There are many
processes within factory operations that require monitoring and records of each must be maintained. This includes
records of when the cleaning activity was completed, by whom and who signed off the cleaning as satisfactory prior to
production. Figure 5 shows an example of a cleaning record.

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MyCompany Foods
Site Area: Production Week Comencing:

MON TUE WED THU FRI SAT SUN

METHOD EQUIPMENT/ FREQUENCY Clean Clean Clean Clean Clean Clean Clean Clean Clean Clean Clean Clean Clean Clean
AREA
Sign Sign Sign Sign Sign Sign Sign Sign Sign Sign Sign Sign Sign Sign

A1 Conveyor 1 Daily

A2 Bowlmixer 1 Daily
A2 Bowlmixer 2 Daily
A3 Spiral chiller Daily

DOCUMENT REFERENCE ISSUE DATE/VERSION NUMBER ISSUE/AUTHORISED BY

Figure 5 Example of a cleaning record

The records should be specific and show what was actually checked. For example, in the checklist in Figure 5 the
specific items of equipment are listed, and there is not just a single tick box that everything is complete.

Cleaning tools, equipment and chemicals

Cleaning equipment must be identifiable and specific for the use. It may be dedicated to a specific allergen, a single use
or designed to be effectively cleaned. It could include:

• dedicated equipment that is clearly identifiable for the purpose (e.g. colour-coded)
• equipment that is designed to be easily cleaned. Methods and schedules for cleaning this equipment must be
documented, implemented and verified.

Any automated cleaning systems such as tray washes or cleaning in place (CIP) systems that are used to clean
equipment that has been in contact with/used to handle allergenic materials should be designed accordingly and their
effectiveness assessed. In some systems cleaning solutions are reused or recycled (sometimes with the addition of fresh
reagents) and the potential exists for this recycling to recycle allergenic materials and thus re-contaminate the line. A
thorough validation study will reveal if this issue is indeed a concern and adjustment of the operating parameters (e.g.
an increase in the pre-rinse time) may assist in delivering the desired results. Ongoing verification through first-off-the-
line testing or filter swabbing will be needed to ensure the continued efficacy of the cleaning process.

Chemical choice is a matter of site preference but the objective in an allergen-related cleaning activity is to remove and
not denature or materially affect the allergen. Thus the detergent will be selected to best remove the adherent soiling
(e.g. an alkaline detergent for a meat-based residue).

When planning changeover cleaning additional considerations must be borne in mind (production schedules, health
and safety of operators, etc.). The use of neutral-based detergents may be considered, as some research shows that in
the short contact time usually available during this type of clean the emulsification of any fat or oil-based soiling, and
its subsequent suspension in the liquid matrix, is more effective at lifting the allergenic protein from the surface of food
contact equipment than saponification of fats through the use of an alkaline detergent.

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When considering the ‘deep cleans’ that are generally undertaken by the hygiene team, the detergent will normally
match the soil constituents and the cleaning process usually involves additional removal stages (e.g. a pre- and post-
detergent rinse along with manual agitation).

Research on the removal of allergenic proteins during cleaning is continually developing and it is therefore important
that the choice of detergent or any change to the detergent or cleaning regime must be fully validated to ensure its
effectiveness at removing the specific food matrices and allergenic materials used on the site.

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Part 9
Allergen Training
Staff awareness and training are important in the management of allergens. All personnel (including temporary staff,
contractors and visitors) must receive training to raise awareness of food allergens and the specific allergen controls
used by the company.

Staff training
The level of training should be proportionate to the on-site hazard (e.g. a site which does not handle any allergens will
have a different level of risk to one with several allergens present) and appropriate to the individual’s role. For example,
junior staff will require a general understanding of the importance of allergens, plus any specific procedures in which
they are involved, whereas the technical team will require a greater level of detail.

Allergen training must be provided for new staff and normally takes place during the induction period. Updated training
must be provided if there are significant changes in the company, and refresher training is also recommended
(e.g. annually). Typical training could include:
• What are allergens?
• Why allergens are important (e.g. the potential consequences of an error).
• Company-wide policies on allergens (e.g. if the site restricts the presence of certain allergens).
• Products or ingredients that are handled on site that contain allergens.
• Allergen procedures in operation in the area where the staff are working (e.g. procedures for prevention of allergen
cross-contact, and procedures for storage, labelling, segregation, hygiene, etc.).
• Specific allergen management activities for which the individual(s) will be responsible. For example, the goods receipt
team will need to understand risks associated with specific raw materials, spillages during transit or after receipt,
correct handling and storage of allergenic materials, etc.
• Action to take if any risk of allergen cross-contact is suspected (e.g. due to a spillage or other event).

The format of the training should be designed to maximise its usefulness; for example, the language in which the
training is completed and the use of pictures or exercises. Allergen awareness is also important for individuals who
are only on site for a short period. Consider how these individuals are trained or informed of the site procedures and
policies.

Engineering, contractors and temporary staff

The following colleagues should be included in the allergen training programme to ensure they understand the
relevance of allergen control and the potential consequences of mis-management:
• On-site engineers
• Off-site engineers
• Temporary staff
• Agency workers and seasonal employees

The site must ensure that the safety and integrity of products are not jeopardised during maintenance and engineering
operations. The working practices, including the actual maintenance and post-maintenance sanitisation procedures,
should be assessed to ensure they do not introduce an allergen cross-contact risk (e.g. all materials and lubricants
should be free from allergens).

A procedure must be in place to ensure that, following maintenance work, equipment is cleaned and any debris
removed before the equipment is returned to production. Best practice is for an authorised individual (e.g. the
production manager) to formally accept equipment back into operation following an inspection, to confirm that
maintenance and associated cleaning have been completed satisfactorily. A record of all maintenance and subsequent
checks should be completed.
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Part 10
Packaging Controls
Documented procedures must be in place to ensure that the correct packaging and labels are in use. There are two main
aspects of this:
• label creation and maintenance
• packaging controls to prevent mis-packs.

On-pack warning labels

Where controls cannot prevent allergen cross-contact and there is a significant and genuine risk of a product containing
allergens that are not deliberately added and are therefore not mentioned in the ingredients list, the use of on-pack
advisory precautionary allergen labelling should be considered.

The use of such a warning label should be justifiable on the basis of the risk assessment and must not be a substitute for
good allergen control practices.

The company will need to reference the national legislation and guidance in the country of sale, as legislative
requirements vary both in terms of what is permitted and the wording that may be used. Where a precautionary allergen
labelling is required and permitted, reference to regulatory guidelines or industry codes of practice should be used to
ensure best practice is followed. It is particularly important that the source and reliability of these guidelines is known,
as it is particularly easy to misinterpret labelling legislation in some parts of the world.

Consider:
• The location of the warning. Most consumers would expect to find any such warning in close proximity to the
ingredients list.
• The visibility of the statement. Distinct colour, location and font size can all aid consumers but may be stipulated
in law.
• The choice of warning phrase used. To ensure that the meaning and risk is clearly communicated to the consumers
who consume the product.

Where a product is manufactured for another brand owner (e.g. a retailer) refer to the brand owner’s policy on allergen
labelling as this may contain specific requirements such as the wording to be used.

Where a product is manufactured or co-packed in multiple locations with different levels of allergen cross-contact risk,
this will need to be managed. One solution would be to label all products with the worse-case scenario.

Some manufacturers choose to apply an action level or allergen threshold as part of their risk assessment process for
precautionary allergen labelling, where this is permitted by the regulatory authorities/legislation in the country of sale.

Label creation and maintenance

One of the common causes of allergen-related withdrawals and recalls is packaging and labelling that does not reflect
the actual allergen content of the product. Procedures must be in place to ensure that accurate information is recorded
on all packaging and labels.

Packaging should be considered as a raw material and should be subject to all the requirements for raw materials
detailed in the Global Standard Food Safety including full supplier approval, raw material risk assessment and goods
receipt checks.

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Companies should ensure the following:

• There is comprehensive communication between all relevant parties. For example,:
- raw material suppliers
- specification managers
- label/packaging designers
- packaging suppliers and printers
- brand owners (where the site manufactures for another brand owner).
• All raw material suppliers have provided full up-to-date information on the ingredients supplied.
• The new label design process is a planned, structured process that includes a specific assessment of the allergen
information that should appear on pack. Any changes to product or packaging specifications during the design or
manufacturing processes must result in an assessment by an appropriately qualified technical representative to ensure
that the packaging remains an accurate representation of the product and that any changes in allergen labelling are
captured and incorporated.
• The individual(s) responsible for compiling the label has:
- a good understanding of allergens and the legislative requirements for allergen labelling in the country in which the
product will be sold
- access to up-to-date information regarding the product (this should include product specification, raw material
specification and raw material allergen questionnaires)
- access to an up-to-date allergen cross-contamination risk assessment for the production process
- an understanding of any brand-owner-specific policies on allergen labelling.
• All packaging and label suppliers are risk assessed to ensure that they have adequate controls in place, at all
points of the production process (e.g. to prevent mixed packs of cartons, mixed spliced spools or use of redundant
printing templates). The use of packaging suppliers certificated to the Global Standard Packaging Materials should be
considered as this helps establish the level of the controls in the operation.
• A label approval process is in place that includes a check and sign-off of the on-pack allergen labelling. It is important
that this process includes a rigorous check of the proposed label against the product specification and that all parts of
the label are checked for consistency (e.g. the ingredients list with any voluntary allergy advice). It is
recommended that this process should be completed when the final artwork is available, preferably when the proof or
pack copy is available and before the full print run is authorised.
• Every batch of packaging and labels is checked on receipt against the specification or proof label to ensure accuracy.
Where practical, checks should be made in several places within the batch. It is vital that this check is completed for
every batch of packaging and labels to ensure only fully compliant packaging materials and labels are accepted onto
site.
• Consideration is given to the process for checking multilingual packaging.
• Recipe changes and new product development are managed, such that the correct version of packaging is available
and it is clear to production staff when it should be used.
• Stocks of old packaging are isolated and disposed of in a timely manner to prevent accidental use. Where old labels
or packaging cannot immediately be removed from site (e.g. for financial accounting purposes), then consideration
must be given to a mechanism to prevent accidental use (e.g. use of a separate storage area or by defacing the
old labels or rendering them unusable).

Records of the checks should be maintained and it is often useful to include samples of the packaging at each step,
which can be used as a reference.

Start-up and changeover controls

The packing of products into the wrong packaging is also a significant cause of withdrawals and recalls and therefore
controls must be in place to ensure that all products are packed into the correct packaging.

Make sure that:

• Start-up checks are carried out by trained, authorised individuals to ensure that all previous production run
packaging has been removed from the line and from the production area. This would involve disposal of or returning
to the packaging storeroom.

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• Checks are in place to ensure that the recipe used in production matches the packaging selected. This is particularly
important when there is a prolonged period between manufacture and packing (e.g. where there is a prolonged post-
cooking cooling step or where products are stored in bulk until required).
• New batches, rolls or packs of labels and packaging are verified as correct before packing commences.
• Packaging storage areas are designed and maintained in a way that facilitates easy identification of the correct
packaging material.
• The changeover checks ensure that changes in the product being manufactured are matched by appropriate changes
in the packaging.
• Where packaging is multi-component (e.g. a container with a separate lid), controls are in place to ensure that all parts
of the packaging are correct and correctly match with each other.
• There are checks to ensure primary and secondary packaging (e.g. a multi-pack of several products or flavours sold
together) match and both are correct for the products being sold.
• Part-used batches of packaging are returned to the storeroom and not left in the packing area.

Monitoring
Rigorous monitoring is recommended to ensure the correct label/packaging is applied throughout the run. Run label
checks during production. Some sites have found the use of automated technology, such as an online bar code scanner,
provides an additional layer of control.

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Part 11
Allergens in Packaging Materials
There are a number of raw materials used in packaging which are derived from allergens. It includes some types of
paperboard and plastic packaging that may contain soy-derived glues or resins, wheat-derived starches or casein-
derived coatings and additives. Although the risk is quite low, latex is used in many types of food packaging materials,
including rubber bands, meat netting, stickers found on some fruit and vegetables and the adhesive used for cold
sealing of confectionary.

In food and non-food applications certain packaging materials may be encapsulated with fragrances (scents) for masking
or marketing purposes. Fragrances delivered in plastic parts are used in stores to create a mood and/or bring products
to the consumers’ attention and are included in food and beverage packaging. Fragrances are used to mask unpleasant
odours in applications such as dustbin bags or household chemical containers and in PVC to cover the smell of sulphur-
based stabilisers. Some fragrances may contain allergenic or sensitising ingredients.

Depending on the function the scent is being used for it may be considered an active material according to legislation
in the EU and there could be labelling implications requiring the fragrance to be added to the list of ingredients. EU
legislation on active and intelligent materials states that “Active materials and articles shall not bring about changes
in the composition or organoleptic characteristics of food, for instance by masking the spoilage of food, which could
mislead consumers”. Before using a fragrance in cosmetics it is worth checking Regulation (EC) No 1223/2009.

Legislation relating to packaging materials in different countries/jurisdictions may refer specifically to allergens, but
often there are overriding principles laid down in law relating to food contact materials that will apply. For example
Regulation (EU) No. 1935/2004 on materials and articles intended to come into contact with food, states that materials
and articles, “shall be manufactured in compliance with good manufacturing practice so that, under normal or
foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:
a) Endanger human health
b) Bring about an unacceptable change in the composition of the food
c) Bring about a deterioration in the organoleptic characteristics thereof.”

It is the responsibility of the packaging manufacturer to ensure that they comply with this legislation, and in accordance
with it they must provide a written declaration that they comply. General legislation around the provision of safe food
should also be considered.

Manufacturers of packaging materials should consider the control of allergens through the establishment,
implementation, and maintenance of an effective allergen management plan.

An allergen management plan used for packaging materials should take the same approach as that used for food
manufacturing sites. For example the plan serves to identify, control, educate and communicate the risk and presence of
allergens on the site, from raw materials through to finished products. The site must be aware of allergen legislation in
the country of manufacture and in the country or region where the packaging will be sold.

The plan should define the policies and procedures for managing allergens which should include at a minimum a:
• hazard analysis and risk assessment (HARA) for allergens
• cleaning process specifically for allergens
• segregation procedure to control allergens
• list of product allergen labels used on the packaging materials.

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The hazard analysis and risk assessment

This shall include a risk assessment of allergen cross-contact and the implementation of controls to minimise or
eliminate the risk of contamination to the packaging material. Where allergens have been identified as part of the hazard
analysis and risk assessment the routes for allergen cross-contact from incoming materials to storage and dispatch of
finished products need to be identified. Documented policies and procedures for the control and handling of allergenic
materials should be established to avoid allergen cross-contact.

The cleaning process

Any areas or equipment that may be in cross-contact with allergens may require specific cleaning procedures as
covered by the Global Standard Packaging Materials, section 4.8. As for routine cleaning procedures, the specific
cleaning procedures shall be validated, verified and records of checks documented to ensure the risk of allergen cross-
contact is mitigated.

Segregation procedures
Any materials identified as containing allergens should be stored and handled in such a way as to minimise any risk of
contamination. Measures to consider include:
• physical segregation
• the use of separate protective clothing and equipment when handing allergenic material
• waste handling and spillage controls.

Packaging material product labelling

The presence of allergens needs to be communicated to customers and may be subject to legislative requirements in
the country of sale. The accuracy of labels and communication is paramount. Additionally, where a site is responsible
for the manufacture of printed materials such as labels, it will require processes to ensure the accuracy and legality of
the material.

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Part 12
Consumer Products
The group of consumer products is very diverse. Items from cosmetics to domestic cleaning materials use different
materials and finishes vary. It is important that allergens and sensitising materials are reviewed to prevent any
susceptible individuals having reactions.

The management of allergens in the non-food industry and the manufacture of consumer products should apply similar
practices to those used for food and packaging. Companies that manufacture consumer products should determine
whether allergenic or sensitising materials are used and should establish a documented system that defines the policies
and procedures for the control of the used allergens or sensitising materials.

The allergen management system for consumer products should consider:

• the legislative or regulatory requirements on allergens or sensitising materials in the country or region where the
company is based
• the legislative or regulatory requirements considering allergens or sensitising materials in the country or region where
the company is intending to sell the product
• the raw materials, aids and products that are being used, and any potential allergen or sensitising content
• the methods and design of control practices to prevent allergen contamination. This includes segregation, scheduling,
cleaning regimes, production, use of identified and dedicated equipment
• that the labelling of all final products is accurate and legal.

In some jurisdictions there are legal requirements for the naming of allergens and sensitising ingredients on the
product label (e.g. using the Latin names of ingredients such as prunus amygdalus dulcis oil instead of sweet
almond oil).

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Appendix 1
Examples of Legislative Allergen Lists
Table 17 highlights the list of foodstuffs treated as allergenic by Codex Alimentarius and legislation in the EU, USA,
Canada, Australia and Japan. Please note the information in this appendix was correct at the time of going to press but
legislation is always subject to change and reference should be made to relevant current legislation in the country of
manufacture and of sale.

Allergen EU USA Canada Australia Japan Codex

Cereals
contain gluten Wheat Wheat Wheat Wheat Wheat Wheat
Oats Triticale Oats Oats
Barley Barley Barley
Rye Rye Rye
Khorasan Spelt Spelt
Spelt
Crustaceans*
Eggs
Fish
Peanuts
Soybeans
Milk
Nuts*
Almonds Almonds Almonds Walnuts
Brazil Beech Brazil
Cashew Brazil Cashew
Hazelnut Butternut Hazelnut
Macadamia Cashew Macadamia
Pecan Chestnut Pecan
Pistachio Chinquapin Pine nut
Walnut Coconut Pistachio
Hazelnut Walnut
Ginkgo nut
Hickory
Lichee
Macadamia
Pecan
Pine nut
Pili nut
Pistachio
Shea nut
Walnut
Celery
Lupin
Molluscs
Mustard
Sesame seeds
(From Jan 2023)
Sulphur dioxide
and sulphites
Buckwheat

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* Particular care needs to be taken where there are differences from country to country in the legislative definition
(e.g. of nuts or crustaceans).

** Legislative requirements in Japan are split into two sections:

• Those for which identification is mandatory (shown in the table above).
• Those where identification is advised. This list includes abalone, almond, bananas, squid, salmon roe, oranges,
cashews, kiwi fruit, beef, sesame, tree nuts, salmon, mackerel, soybeans, chicken (poultry), pork, matsutake
mushrooms, peaches, Japanese yams, apples and gelatine.

Table 17 Foodstuffs treated as allergenic by Codex Alimentarius and legislation in the EU, USA, Canada, Australia
and Japan

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Appendix 2
Allergen Analysis
There are a number of occasions when the use of analysis may be considered as part of allergen management. These
include:
• when introducing processes, scheduling or equipment
• the introduction of a new allergen-containing ingredient
• a change in the contamination risk of an existing ingredient
• when completing validation or verification activities
• to support allergen-based claims.

Whenever analysis is undertaken it is important to select the correct sample, test and laboratory to ensure that the
results deliver the required level of information and confidence.

It should always be remembered that testing is a useful tool for verifying the status of allergen controls within a product
or manufacturing site; it is not a replacement for good allergen management.

The following is a brief summary of the main considerations associated with allergen analysis. Sites should always
seek expert advice (e.g. from a contract laboratory) prior to commencing analysis and at all stages of the process from
sampling to the interpretation of results.

Purpose of testing
Before testing establish why it is being carried out and, as a consequence:
• what will be tested (i.e. ingredients, final products, the environment)
• the identification of suitable samples. For example if the company is seeking to establish whether a cross-
contamination risk exists at a specific point, then the risk may be highest at the beginning of the production run or at
changeover and these would therefore be targeted for sampling
• the most suitable test methods – including decisions about laboratory use, the availability of rapid tests and the limits
of detection required
• the action that will be taken based on the results.

Sampling
The importance of sampling should never be overlooked – test results are only as reliable as the samples submitted.
All sampling should be risk-based and should aim to maximise the probably of detecting the adverse contaminant (if it
is present). Therefore consider:
• which samples to take and when to take them
• how to obtain a sample that is appropriate for the material or process. A few grams from the first packet opened might
not be representative of the whole consignment of a raw material, especially if this is a bulk commodity.
• the number of samples required. One sample may not be representative and for validation studies it is recommended
that at least three replicate trials are made to ensure a consistent, reliable result
• whether the allergen is likely to be heterogeneous or homogeneous. Some allergens exist as powders or liquids and
are therefore likely to be spread evenly throughout a product or raw material (homogeneous), whereas particulate
allergens such as seeds or nuts are likely to be unevenly distributed (heterogeneous).
• the expected concentration of allergen. For example, the likelihood of allergen cross-contamination will partially
depend on how much allergen was present in the previous products run on the same line.
• the degree of processing that the allergen has undergone as this may affect some test methods.

Interaction with contract laboratories

The BRCGS Standards covered in the scope of this document require that, whenever analysis is undertaken, which is
critical to product safety or legality, the laboratory shall have gained recognised accreditation or operate in accordance

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with ISO 17025. It is important to remember that, while the laboratory itself must have accreditation, the laboratory
must also be accredited to conduct the actual test methods. This requirement is likely to affect the testing associated
with allergen management. Any method of analysis used that does not have some method of accreditation should have
clear justification as to why it was used.

It is important to discuss the analysis and samples with the chosen laboratory prior to sending the samples. This is in
order to:
• Ensure the suitability of the tests for the sample type. Many allergen tests are based on specific antibodies and
therefore the test can vary depending on the actual allergenic ingredient (e.g. whole milk compared to whey powder,
egg white compared to egg yolk, or roasted peanuts compared to raw or boiled peanuts). The laboratory should be
able to advise on the most suitable tests.
• Confirm that the food or sample matrix has been trialled with the relevant test so that a reliable test can be expected.
Some food matrices and cleaning chemicals can interfere with the test to produce false positive or false negative
results, which obviously need to be avoided.
• Make sure samples arrive at the laboratory in good condition. This is particularly relevant to perishable foods but also
to swabs and other matrices.
• Check the appropriateness of the limit of detection. For example what is the lowest level of allergen that can be
detected in the test.
• Check the lower limit of quantification – for example the lowest level of allergen that can be quantified in the test.
• Facilitate interpretation of the result.

It is important to understand the limits of the testing and confirm it is suitable for the planned use as this will be key in
the interpretation of results, particularly those relating to presence/absence tests.

Ensure that the laboratory understands whether a quantitative (numerical amount) or qualitative (presence/absence)
result is required.

Rapid test kits

Rapid test kits include dipsticks or lateral flow devices that are designed to be used in food factories to provide a
quick indication of whether the allergen is present. They are not the same as the tests performed in fully equipped
laboratories.

Rapid screening techniques for the detection of allergens enable the testing of a greater number of products,
equipment or environmental samples and have the advantage of being quick tests that can be completed on site.
However, they are generally qualitative, are not accredited and are more limited than laboratory-based analysis.
Therefore, they should only be used as part of an allergen analysis programme and not as the sole method of testing.

Rapid screening techniques are not suitable for validation studies (e.g. cleaning validation) but may be incorporated into
verification or monitoring activities. Where testing is required, validation studies should use accredited laboratory test
methods.

As with all allergen analysis, rapid test kits should be checked prior to initial use to ensure that there are no unexpected
matrix effects (e.g. by trialling the test with known positive and negative samples to ensure the correct results are
obtained).

While ATP tests are widely used to assess cleaning standards, they are of limited use within allergen management
programmes because:
• the limit of detection of these tests is often too high for allergen management. The ATP test may give an acceptable
or negative result although sufficient allergenic protein is present to cause an issue or incident
• they are not a good marker for allergenic protein due to the inherent lack of specificity.

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Appendix 3
Further Information
Anaphylaxis Campaign
Charity group supporting people at risk of severe allergies with information, support and education as well as working
with food industry, education, healthcare and other key audiences. www.anaphylaxis.org.uk

AXIO Proficiency Testing

AXIO provides proficiency testing schemes with localised support across a global network to over 13,000 laboratories in
more than 160 countries www.lgcstandards.com/GB/en/Proficiency-Testing/cat/280731

BRCGS
A series of globally recognised standards for food manufacturers, storage and distribution companies, agents and
brokers, and packaging manufacturers.
www.brcgs.com

Global Standard Consumer Products

Global Standard Food Safety
Global Standard Gluten-Free
Global Standard Packaging Materials
Global Standard Storage and Distribution

Safefood 360
Safefood 360° RISK is an entry-level, line-of-sight risk data tool that uses big data sources to provide a clear measure
of risk in the supply chain, scan for potential risk trends, and provide valuable input into the development of local
HACCP plans.
www.safefood360.com

Allergen guidance for food businesses. Online guidance for food businesses, providing allergen information and best
practice for handling allergens. Food Standards Agency, www.food.gov.uk

Allergens: Assessing risk and mapping your facility, BSI, www.bsigroup.com

Allergens in Cosmetics – online guidance on allergens in cosmetic products. Food and Drug Administration,
www.fda.gov

Cleaning and Disinfection of Food Factories: a practical guide (Guideline 55), Campden BRI, 2020,
www.campdenbri.co.uk

Code of Practice on Food Allergen Management for Food Business Operators (CXC 80-2020) – guideline on the
controls, practices, risks and requirements of allergens throughout the food supply chain, Codex Alimentarius, 2020,
www.fao.org/fao-who-codexalimentarius

Components of an Effective Allergen Control Plan. Explains allergen control for food processors, Food Allergy Research
and Resource Program, https://farrp.unl.edu/

Food Allergens: Practical Risk Analysis, Testing and Action Levels (Guideline 71), Campden BRI, 2013,
www.campdenbri.co.uk

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Food allergen labelling and information: Technical guidance online guidance for businesses on allergen labelling. Food
Standards Agency

Food Allergies – online guidance on food allergens. Food and Drug Administration, www.fda.gov

Food Industry Guide to Allergen Management and Labelling for Australia and New Zealand, Allergen Bureau, 2021,
https://allergenbureau.net/

General Standard for the Labelling of Pre-packaged Foods (Codex Stan 1-1985 as revised) – guidelines on food labelling
which in section 4 includes the list of foods ‘known to cause hypersensitivity and shall always be declared’, Codex
Alimentarius, www.fao.org/fao-who-codexalimentarius

General Principles of Food Hygiene (CXC 1-1969 as revised) - guidelines on the general food hygiene practices food the
whole food supply chain, considering those for allergens, www.fao.org/fao-who-codexalimentarius

Guidelines for the Validation of Food Safety Control Measures (CAG/GL 69-2008) – guidelines on the concept of
validation, the tasks required, the validation process and the need for re-validation, Codex Alimentarius, 2008,
www.fao.org/fao-who-codexalimentarius

Guidance on Food Allergen Management for Food Manufacturers. This guidance sets out the general principles to
manage allergens in pre-packed foods, Food Drink Europe, www.fooddrinkeurope.eu

HACCP: a practical guide (Guideline 42), Campden BRI, 2015, www.campdenbri.co.uk

Introduction to food allergen risk assessment, e-seminar published on GOV.uk.

Regulation (EU) No 1169/2011, on food information to consumers, as amended, European Union,

https://eur-lex.europa.eu

Regulation (EC) No 1935/2004, on materials and articles intended to come into contact with food, as amended,
European Union, https://eur-lex.europa.eu

Requirements for the Safe Food for Canadians Regulations, online guidance on preventive controls for allergens,
www.canada.ca

Risk Assessment and Management of Raw Materials (Guideline 65), Campden BRI, 2019, www.campdenbri.co.uk

Validation of Cleaning to Remove Food Allergens (Guideline 59), Campden BRI, 2009, www.campdenbri.co.uk

Voluntary Incidental Trace Allergen Labelling (VITAL), a risk assessment tool for food manufacturers which employs
action levels. Allergen Bureau, www.allergenbureau.net

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