Food Allergy and Intolerance

Online Training
Module 3 Transcript

Managing allergens in the factory

Module 3 Transcript

Contents

Lesson 1: Introduction 4
Module objectives 4
Lesson 2: Staff training 4
Potential allergen cross-contamination situations 4
Handwashing 5
Clothing and uniform requirements 5
Rework 5
Waste control 5
Cleaning procedures 5
Dedicated equipment 6
Lesson 3: Allergens found in ingredients 6
Allergens found in ingredients 6
Ordering from suppliers 6
Labelling of prepacked food 7
Lesson 4: Packaging 7
Design of packaging 7
Bar code scanners 7
Multipack products 8
Lesson 5: Cleaning 8
General cleaning 8
Swab testing 8
Compressed air cleaning 8
On the spot cleaning for spillages 9
Dismantling equipment 9
Lesson 6: Storage 9
Storage area 9
Storage containers 9
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Lesson 7: Monitoring and review 9

Allergen management systems 9
Health check 10
More information 11
Lesson 8: Cross-contamination 12
Dedicated equipment 13
Air supply 13
Manufacturing schedules 13
Rework 14
Lesson 9: What to do if things go wrong? 14
Root cause analysis 14
Withdrawals and recalls 15
Lesson 10: Unassessed quiz 15
Quiz question 1 15
Quiz question 2 16
Quiz question 3 16
Quiz question 4 16
Lesson 11: Summary 16
Module 3 Assessment 17

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Module 3 Transcript

There are a lot of issues that need to be taken into consideration in the factory when
it comes to managing allergens.

Lesson 1: Introduction
This module looks at the critical points in a food manufacturing environment and how
to minimise the risk of food allergen incidents.

Module objectives
After working through this module, you will be able to:

• understand what allergen management procedures to follow when handling,

storing and producing food
• understand hygiene, cleaning and safety standards to minimise the risk of
cross-contamination of allergens
• understand how to monitor and review appropriate allergen control systems

Lesson 2: Staff training

All staff (including temporary staff and contractors) involved in handling ingredients,
equipment, utensils, packaging and final products should be aware of allergens. They
should also be made aware that consuming allergens for someone who has a food
allergy can have serious consequences.
Appropriate procedures on the control of allergens should be available and/or visible
in the reception and production areas, so that staff and visitors are aware of them.
Such procedures should include information on:

Potential allergen cross-contamination situations

All staff must be trained in ways to prevent allergen cross-contamination of food, if
the factory handles one or more of the main 14 allergens on site.
Cross-contamination occurs when an allergen is unintentionally incorporated into
another food that is not intended to contain that allergen.
For example, a factory is producing peanut butter bars from 8am to 10am each day.
At 10 am, the same machinery used to produce the peanut bars is used to produce
chocolate bars. The machinery is not thoroughly cleaned before the production of the
chocolate bars. There is a high risk that these will be cross-contaminated by peanut,
even though peanuts have not been used as an ingredient in the chocolate bars.

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Handwashing
To avoid allergen cross-contamination staff should wash their hands frequently and
effectively.
Posters encouraging staff to wash their hands after working with allergenic
ingredients and / or products should be placed in areas where allergenic products are
manufactured. Text could include:
'Always wash your hands thoroughly after coming into contact with allergenic
products to avoid cross-contamination'.

Clothing and uniform requirements

To ensure that allergen cross-contamination from clothing and uniforms does not
occur, staff working in an area manufacturing products containing allergens should
wear designated clothing or uniform. This should be determined following a risk
assessment carried out by the Food Business Operator (FBO).

Rework
Rework refers to a product that has been recovered or rejected from normal
production and has been subject to reprocessing. The term is often used when ‘out-
of-specification products’ are subject to further processing to ensure the specification
requirements are met.
For example, a cake factory realises that they have used the wrong food colourant
for the topping of their ‘chocolate and almond cake’. As a result, the cakes do not
look like the picture used on the packaging. For more information, see lesson 8 of
this module – ‘cross-contamination’.

Waste control
Care should be taken when disposing of allergenic ingredients and products.
Allergens should be sealed in labelled containers and removed from the
manufacturing area to avoid being mixed with non-allergenic ingredients and
products.

Cleaning procedures
Even very small amounts of allergens can cause serious reactions, including
potentially fatal anaphylactic shock. For more information, see lesson 5 of this
module – ‘cleaning’.

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Dedicated equipment
Some manufacturers might choose to dedicate a production line or equipment to
products that are free from specific allergens (for example, nut or wheat free). These
production lines can still be used to make other products as long as they do not
contain that particular allergen and/or have not been cross-contaminated with this
allergen.
Dedicated equipment could include balances, sieves, packing machines or storage
bins.

Lesson 3: Allergens found in ingredients

Allergens found in ingredients

Manufacturers need to be aware of the presence of the 14 major allergens found in
Annex II of Regulation (EU) No. 1169/2011 in all ingredients.
Allergens might be present in ingredients because they were intentionally added as
an ingredient or processing aid, but also because allergen cross-contamination has
unintentionally occurred. Cross-contamination can happen during the manufacturing
and handling of ingredients, as well as earlier in the food chain, for example during
harvesting and transport.
Ingredients suppliers (and their agents) must be aware of the hazards arising from
cross-contamination by allergens so their products conform to the manufacturer’s
product specification. Ingredients should be fully described in product specifications.

Ordering from suppliers

FBOs should have procedures in place to assess the presence of allergens in the
ingredients they use. They should do the same for ingredients used by their
suppliers.
Manufacturers should check the specification sheets of ingredients and products
when they are ordering from suppliers and when the products are delivered. This is
to ensure products meet the specification required. They should also ask their
suppliers appropriate questions. For example:

• What procedures do the suppliers have in place to prevent cross-

contamination?
• What is the likelihood of cross-contamination for their products?
• What other products are produced on the same lines?

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Labelling of prepacked food

When listing ingredients on prepacked food, FBOs must emphasise the name of the
allergens in the ingredients list. For example, tahini contains sesame seeds which
are one of the 14 main allergens. The ingredient label for the tahini must emphasise
the presence of sesame seeds – using bold letters is one option.
The use of an allergen statement to signpost and explain how allergen information is
emphasised within the ingredients list is permitted. For example: Allergy advice: For
allergens including cereals containing gluten, see ingredients in bold.
For more information on how to label allergens on prepacked food, see Module 4 –
‘providing accurate allergen information for prepacked and non-prepacked food’.

Lesson 4: Packaging
Incorrect packaging and/or labelling is a significant cause of allergen-related product
recalls and can represent a significant cost to industry (for example, in terms of
returning or reprocessing products). Where possible, dedicated packing lines to
reduce the risk of mislabelling should be considered.
FBOs should have procedures in place to review and approve all proposed product
labels for all food. For example, if a retailer contracts a separate company to pack
products for them and provides labelling, the supplier of the labels should ensure the
ingredients are correctly declared.
This is to ensure the ingredients, including the main 14 allergens, are declared
accurately and that they are updated with any change in the formulation of the
product. To avoid allergen labelling errors, there should be a procedure for
destroying old packaging and labels (and to maintain electronic document control of
old labels) when recipes/formulations have been changed.

Design of packaging
When designing packaging, FBOs must consider the food information requirements
for mandatory food allergen labelling (see module 4 - ‘Providing accurate allergen
information for prepacked and non-prepacked food’), such as the minimum font size,
the legibility, visibility, contrast of text and accuracy (for example, the needs of
consumers with visual impairments such as colour blindness).

Bar code scanners

If it is not possible to have dedicated packaging lines for allergenic products, then
procedures for checking that the correct labels are applied to products should be
implemented and audited regularly. This is to ensure that accurate information is

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provided to allergic consumers. Checks should be in place between processing and

packing to ensure the correct packaging is used, for example by using bar code
scanners to trace the product through the production process.

Multipack products
Where products are sold in multipacks, allergen information must be displayed on the
outer packaging. If allergen information is also provided on the packaging of
individual products, it must be consistent with the outer packaging.

Lesson 5: Cleaning

General cleaning
Very small amounts of allergens can cause adverse reactions, including potentially
fatal anaphylactic shock. Therefore, thorough cleaning that is effective in reducing
the risks of allergen cross-contamination should be carried out where required. To
identify where allergens are a cross-contamination risk, the FBO should carry out a
risk assessment.
Some ingredients (for example, powders) present significant cleaning problems as
they can become airborne and contaminate areas of a factory. Relevant industry
guidance, where this has been developed, should be followed. Adequate procedures
must be in place for cleaning both production and packaging machinery.
For example, an extraction ventilation system could be placed over the production
lines to reduce the risk of airborne particulates circulating in the air and
contaminating other parts of the factory.

Swab testing
Cleaning practices that are satisfactory for hygiene purposes may not be adequate
for removing allergens. To check that cleaning practices are effective at removing
allergens, allergen residue/environmental swab testing can be used in conjunction
with other allergen testing to validate the cleaning method. Efficacy of cleaning
should be monitored regularly and re-validated if there are any changes.

Compressed air cleaning

Care is needed to ensure that the cleaning of one manufacturing line does not
contaminate another (using compressed air cleaning, for example), or an area that
has already been cleaned (by cleaning dry mix areas from the top down).

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On the spot cleaning for spillages

Any spillages that occur during production, storage and transportation should be
cleaned up immediately to ensure that there is no subsequent allergen cross-
contamination. Where known allergen contamination has occurred, the contaminated
material should be labelled and physically moved away from the non-contaminated
ingredients and work in progress.

Dismantling equipment
Equipment might need to be dismantled and manually cleaned to ensure ‘hard to
reach’ areas are free from allergen residues. At this point, consideration should be
given to maintenance activities, such as the use of dedicated cleaning equipment or
adequate cleaning procedures where equipment is not dedicated.

Lesson 6: Storage

Storage area
To avoid cross-contamination, steps should be taken to ensure that allergens do not
come into contact with other ingredients, including other allergens, during handling
and storage.
Allergenic ingredients should be stored in clearly identified areas (for example, using
colour-coded boxes or the demarcation of storage areas using painted lines on the
floor).

Storage containers
Where allergenic ingredients are removed from their original packaging, they should,
if possible, be placed in dedicated lidded and labelled containers and made easily
identifiable. Such containers should not be used for storage of any other ingredients.
If an allergenic ingredient is in a form that can easily become airborne e.g. powder, it
is advised to not remove it from its packaging until ready to use. For example, a bag
of powdered nuts, spices, or cereal flour.

Lesson 7: Monitoring and review

Allergen management systems

Allergen management needs to be considered as part of the FBO’s food safety
management system (which can include the FBO HACCP plan). This is everything

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from managing supplier information to managing the information provided to

customers.
Allergen management systems should be validated, monitored and reviewed to
provide assurance that they are working correctly. This is done most effectively by an
audit or 'health check' of the system. In addition to routine checks on manufacturing
operations, a periodic 'health check' can find any weaknesses in the system so that
corrective action can be taken. A key benefit of auditing the system is to provide
evidence of due diligence in managing allergens.

Health check
The 'health check' should, as a minimum, include:

Review and verification of the allergen analysis and allergen

management system

Validation and verification procedures should be implemented to confirm that the

allergen management system is working correctly. This might include auditing of
control procedures and any tests, random sampling and analysis. The hazard control
system should be reviewed regularly and particularly after any changes in the
manufacturing process or premises, to confirm that all critical control points are under
control. Following completion of this risk assessment, manufacturers should then
determine whether allergen advisory statements are appropriate.

Product and ingredient specifications

Manufacturers need to be aware if allergens are present in any of their ingredients

and check regularly so that they are aware of any changes.
Allergen information can be obtained through auditing suppliers or through
information provided by the suppliers. Auditing can be done on a regular basis.
For more information, see our sections ‘ordering from suppliers’ and ‘allergens found
in ingredients’.
Manufacturers should ensure that materials/ingredients are ordered against a clear
specification and that they ask appropriate questions of their suppliers. Food
businesses can request copies of suppliers’ risk assessments to understand why
they use voluntary allergen statements on their products such as “may contain x”.
Voluntary allergen statements on products should only be used following an
assessment of the risk of cross-contamination. FBOs should include the voluntary
allergen statements provided by their suppliers on their products unless they can
justify not doing so by virtue of their own risk assessments and controls.

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For more information on voluntary allergen statements, please see Module 6 – ‘The
use of voluntary labelling’.

Cleaning procedures

Investment in developing and following appropriate cleaning regimes will help to

minimise cross-contamination and can reduce the need for product recalls. For more
information, see lesson 5 ‘Cleaning’.

Training records

Manufacturers should ensure that their employees receive relevant and structured
ongoing training, so they remain aware of food allergens and their consequences
(see lesson 1 – ‘staff training’). Such training should explain the facts as well as
highlight the company's good manufacturing practice principles and effective food
safety management system. Manufacturers should keep certificates of registration,
qualifications and documents to record training completed by their employees.

Analysis of customer complaints

If manufacturers discover a safety issue which affects a product that they have
placed on the market they must get in touch with the competent authority. (See
lesson 9 – ‘what to do if things go wrong?’)
Customer complaints should be investigated. Changes to allergen management and
labelling procedures should be made where necessary. Manufacturers should keep a
record of these customer complaints and show what action was taken as a result.

Good manufacturing practices

Most food producers already employ good manufacturing practices (GMP) to ensure
that they are able to produce food safely. GMP require appropriate manufacturing
operations, effective food safety management systems (using HACCP-based
principles), and quality assurance systems, as well as a commitment and discipline to
ensure products meet food safety, quality and legal requirements.
Food safety management procedures should be based on hazard analysis and
critical control point (HACCP) principles.

More information
You can find more information on food allergen management in the Food and Drink
Europe (FDE) guidance on food allergen management for food
manufacturers.

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You can find a detailed explanation of the allergen labelling and information
requirements in our Technical guidance.

Lesson 8: Cross-contamination
FBOs' allergen management systems need to include ways of preventing or
minimising the potential for allergen cross-contamination. To do so, they need to
ensure that information identifying the allergens present in the food is clear and
correct. Retail and food service establishments must be able to communicate the
allergens present in the food they prepare. Controls should be risk-based.
Information that may be helpful in assessing the likelihood of allergen cross-
contamination resulting in a risk to the consumer with a food allergy includes:

• allergens present in the factory

• allergens that share the same processing line
• the nature of the allergen (for instance, whether the food itself is an allergen,
derived from an allergen, or the allergen is a component in an ingredient)
• whether allergens are, or may be, present, as notified by the supplier
• whether the allergenic food is a particulate, powder, liquid or paste form
• the processing steps and equipment where the allergen is used
• ease of preventing allergen cross-contact between processing lines
• ease of cleaning the equipment used to process foods with different allergen
profiles
• the amount of an allergen due to allergen cross-contamination likely to be
present in the final product
• the level of training and understanding of the staff in the factory

FBOs producing food at more than one site should consider whether it is feasible to
consolidate production, processing and storage of products containing specific
allergens at one location. Although this may not always be possible, particularly for
small businesses, it could be used to limit allergen cross-contamination.
Where it is not possible to have dedicated production facilities, there are a number of
ways of separating the production of allergen-containing products from those that do
not contain the allergen.
These can include:

• using different areas of the factory

• using physical barriers between the production lines
• using dedicated equipment
• minimising unnecessary movement of materials

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• appropriate scheduling of production runs, including appropriate cleaning of

equipment between production runs
• controlling rework, ensuring that residual material containing an allergen is not
reworked into a product not containing that allergen
• separating the air supply, where this is practical
• effective cleaning procedures are also important in managing allergen cross-
contamination

Dedicated equipment
Consideration should be given to the dedication of equipment in production facilities.
For example, weighing equipment, scoops and utensils should be dedicated and the
weighed product should be placed in dedicated, lidded and labelled containers.
Consideration should also be given to colour coding equipment. However, this may
not be practical where:

• a number of allergens are being handled

• colour coding is used already for the identification of types of food such as
cooked or raw ingredients or vegetarian products

Air supply
Where possible, FBOs should consider the problems or issues that can be caused by
using a common air supply. For example, milk powder used elsewhere in a factory
may enter the air supply and then be deposited on the surface of dairy-free desserts.
Where allergenic ingredients and products may easily become airborne (for example,
cereal flours, powdered materials), dedicated air conditioning/extraction fan systems
could be used to contain the dust. Positive pressure could also be used in rooms free
from an allergen to prevent traces of this allergen entering the room in the air.

Manufacturing schedules
Scheduling the manufacture of allergenic products should be carefully done.
Consider if it is possible for products which do not contain the allergenic ingredients
to be manufactured first, and for products containing the allergenic ingredients to be
made at the end of a production run, to keep them separate.
Additionally, long manufacturing runs of allergenic products should be undertaken
wherever possible. This will minimise changeovers and should be followed by a
major clean down.

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Lesson 7: Monitoring and review 9

Allergen management systems 9
Health check 10
More information 11
Lesson 8: Cross-contamination 12
Dedicated equipment 13
Air supply 13
Manufacturing schedules 13
Rework 14
Lesson 9: What to do if things go wrong? 14
Root cause analysis 14
Withdrawals and recalls 15
Lesson 10: Unassessed quiz 15
Quiz question 1 15
Quiz question 2 16
Quiz question 3 16
Quiz question 4 16
Lesson 11: Summary 16
Module 3 Assessment 17

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RCA is a method that can be used to determine how and why the food incident
occurred and to help identify actions to prevent future incidents. The results of the
RCA can be used to review how the food business manages food safety and
hygiene, including the traceability, withdrawal and recall of unsafe food.
Food businesses are required to review their HACCP when something goes wrong.
RCA is an effective tool to achieve this.

To learn more about root cause analysis, take our RCA course.

Withdrawals and recalls

A withdrawal is when unsafe food is removed from the supply chain before it has
reached consumers.
A recall is when unsafe food which may have reached the final consumer is removed
from the supply chain and consumers are advised of the reason for the recall and to
take appropriate action, for example to return or dispose of the unsafe food.
You can find more information on recalls and withdrawals in our Food incidents,
product recalls and withdrawals guidance.
To receive information on allergy related recalls, you can sign up to allergy alerts on
the FSA website.

Lesson 10: Unassessed quiz

You can complete the assessment when you are ready. If you wish, you can test
your knowledge by completing this short unassessed quiz first.
If you have any difficulties in completing this, it is recommended that you review the
module again.

Quiz question 1
A recall is when unsafe food is removed from the supply chain before it has reached
consumers.
Is this statement true or false?
Take a moment to think about it.
The correct answer is: False

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Quiz question 2
A withdrawal is when unsafe food is removed from the supply chain before it has
reached consumers.
Is this statement true or false?
Take a moment to think about it.
The correct answer is: True

Quiz question 3
Thoroughly cleaning equipment will reduce the risk of cross-contamination of
allergens.
Is this statement true or false?
Take a moment to think about it.
The correct answer is: True

Quiz question 4
Rework is an area of allergen risk.
Is this statement true or false?
Take a moment to think about it.
The correct answer is: True

Lesson 11: Summary

This module explained the importance of adopting robust allergen management
procedures in a food manufacturing environment.
You should now be able to:

• understand what allergen management procedures to follow when handling,

storing and producing food
• understand hygiene, cleaning and safety standards to minimise the risk of
cross-contamination of allergens
• understand how to monitor and review appropriate allergen management
systems
If you are unsure about any of these areas, go back and reread the relevant
section(s) of this module.

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Module 3 Assessment
Now that you have finished this module you can complete the assessment for
Module 3 when you are ready by returning to the main course menu.

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