Checklist for allergen control in food production

Consumers expect and demand all food handlers to have the knowledge and
insight required to supply safe food of high quality. As a
food producer you should read and understand relevant
national guidelines on food allergy . You need to gain
insight on what you can do to supply safe food to allergic
consumers.

The purpose of this checklist is to help you as a food

producer to evaluate your procedures for allergen
control and to improve them. The checklist was translated
and slightly adapted in June 2008 from an appendix in the
Swedish version of "Swedish Food Sector Guidelines for:
Management and labelling of food products with reference
to Allergy and Intolerance", April 2005.

The list below shows the major allergenic foods and

products thereof which require labelling in EU (as of July
2008). Hazard Analysis and Critical Control Point (HACCP) programmes must cover
these foods.

Cereals containing gluten (wheat, rye, Crustaceans

barley, oats, spelt, kamut or their
hybridized strains)
Eggs Fish
Peanuts Soybeans
Milk (including lactose) Nuts (cashews, hazelnuts, macadamia
nuts, Brazil nuts, pecan nuts, walnuts,
almonds, pistachio nuts, Queensland nuts)
Celery Mustard
Sesame seeds Sulphur dioxide and sulphites at
concentrations of more than 10 mg/kg or
10 mg/litre expressed as SO2
Lupin Molluscs

If you change the allergens in a product or the production process, you need to
re-examine the procedures in the checklist in order to ensure that no mistakes
occur.
 Risk assessment
The purpose of an allergen risk assessment is to determine the risks due to
unintentional presence of allergens. Based on the result of the risk assessment you
can decide whether or not allergen advisory labelling is appropriate.

Important factors to cover in the risk assessment are:

 Which allergenic foods or ingredients that

unintentionally could get into contact with your food
products
 The amount of the allergenic food generally needed to
provoke a reaction in allergic people
 How common adverse reactions are to a particular
food
 Whether subgroups of the population have an
increased risk
 The relative allergenicity of your ingredient and whether processing changes
the allergenicity. In general there is no effective way to process out
allergens. But clearly if no or very little protein is present as could be the
case for e.g. refined nut oils, the risk of an allergic reaction is very low.
 The physical form of the ingredient e.g. whether air-borne cross-contact is a
possibility
 How cross-contact could happen and how likely it is to happen

In practice it is difficult to assess the risk with our current knowledge. Recent
research has concluded that there exist lower limits under which food allergens
will not cause any symptoms (called a threshold). Researchers use data from the
diagnostic method double blind placebo controlled food challenge (DBPCFC) to
obtain knowledge on thresholds for individuals. However, current available data
do not permit estimation of population thresholds with adequate certainty. The
amount of food allergen that may trigger allergic reactions visible for others range
from a tenth of milligram in rare cases up to grams, and sometimes tens of grams,
with considerable variability between individuals as well as between allergens.
The data also indicate that, at the level of the allergic population, the lower the
dose of food, the less severe symptoms, and the lower the proportion of allergic
people with symptoms. However, in diagnostic challenges with milk, egg, peanut,
soy and wheat patients who experienced more severe reactions tended to react to
a lower dose than those experiencing milder reactions. A review of diagnostic
DBPCFCs conducted since the 1970s found that the majority of food-allergic
individuals tested needed to eat more than 500 mg of the offending food to
provoke allergic reactions, but a significant minority responded to lower doses.
To date, the most reliable data on individual threshold levels come from studies
performed in peanut allergic patients. Sufficient DBPCFC data do likely exist for
cows’ milk, eggs and peanuts to be able to make a statistical evaluation to predict
a dose of those foods that it will be safe for the majority of allergic individuals to
eat. However, it is only recently that scientists and regulatory authorities have
started discussions on what is the best way to make statistical evaluations of the
individual data. So it still remains a matter of debate how to use the individual
threshold data to predict the amount of food safe to eat for most allergic
patients. The Australian Food and Grocery Council is to our knowledge the first
organisation to develop and recommend the use of an allergen risk assessment tool
to harmonise the application of allergen precautionary labelling.

Even though the risk is difficult to assess you can decrease it if you decrease how
likely it is for allergen cross-contact to happen on your premises. That is one of
the major objectives of allergen risk management.

Risk management
Risk management is about eliminating or reducing the
risk of unintentional presence of allergens including
cross-contact and of wrong labelling. Allergens need to
be managed from the very beginning with product
design all way through the production process to the
finished product. The following are important areas to
consider in risk management of food allergens:

o Employee training and supervision

o Product design and formulation
o Supply chain of raw materials
o Manufacturing premises, equipment and processes
o Cleaning
o Packaging and labelling

The checklist may help you as a food producer to evalutate your procedures for
allergen control and to improve them.

Employee training and supervision

Training and supervision of all staff is essential to avoid unintentional presence of
allergens in products and incorrect labelling. All staff need to be aware of how
important their role is in protecting allergic consumers.
 The “Think on ….. Allergy and allergens” is a freely
available training program for employees in food
manufacturing plants developed by Nestlé. The training
program consist of an introductory page, a short guide
how to use the material, 3 training sessions each with
5-6 problems, and feedback-sheets. A training session
takes 30-60 minutes and can be done without a trained
moderator and without preparation. The idea is to
perform the training on site. When a group has worked
with a session their supervisor gives feedback using the
corresponding feedback-sheets.

The Food Standards Agency (UK) has developed online

training material for enforcement officers but food
manufacturers may also be interested in using the
material to train employees.

FARRP (Food Allergy Research and resource Program) have together with Silliker
Inc. created commercial training material for employees in food production
facilities. This material consists of a video, and different written material.

Training Programme for Factory Employees:

"THINK ON... Allergy and Allergens"
The programme is designed for factory employees, working in food manufacturing
and/or other technical assistance functions. The idea is to offer an easy-to-
perform basic training programme on control of food allergens and food allergy.

The programme is intended at the same

time to raise Quality and Food Safety
Awareness and to draw the attention of
our people to gaps and to means for
improvement in a very basic and
interactive manner.

A training session takes 30 – 60 minutes

and can be done without a trained
facilitator and without preparation. The
material is available as pdf-files and can
be printed out on every PC (or can just be
copied).
We recommend groups are formed with about 8 people from the same production
unit. One of them acts as the facilitator. The group works on given questions,
which are first answered individually, then discussed in the group and finally, the
answers are fixed on a board close to either the production line, the group's rest
room, or any other convenient place.
At a convenient time after the training, the training supervisor gives the group
feedback on their answers using the corresponding feedback sheet. It must be
completed taking into account the factory and line specific issues. We recommend
using the evaluation to motivate people by giving positive feedback to the groups. 
The material remains on the board until the next training session. In the meantime
it is used as a discussion platform – i.e., if people do not understand some issues
completely, they can ask their training supervisor next time they see him/her and
time allows for discussion.

The advantages of such training are obvious. It is interactive and not in a classical
class-room model. It is highly flexible and can even be done during production
interruptions, planned or unplanned. On the other hand, it is an instrument to find
out which issues are understood and accepted by our collaborators and which ones
need further attention.

This project called "Denkpause" was initiated by the German operational company
of Nestlé.

The German package on food allergens and allergy has been slightly adapted
and translated into English by Nestlé Quality Management to be available for a
broader audience. EuroPrevall has made minor changes to the version provided by
Nestlé. The 3 training sessions, each with 5 or 6 tasks, the feedback-sheets and a
short instruction how to perform the training sessions are attached as pdf-files.

Links to training material:

Short instruction
First training session
Feedback from first training session
Second training session
Feedback from second training session
Third training session
Feedback from third training session
Problems on gluten

Product design and formulation

Whenever possible it is good practice not to include an allergenic ingredient in a
product unless it is necessary. Some questions that a manufacturer or food
formulations expert needs to consider are:
  Is a specific allergen essential to the functionality of your new or
reformulated product? Could an alternative ingredient be used?
 Is the allergen already handled at the facility where you plan to
manufacture the new product? Could you manufacture your new product at
a facility where the allergen is already handled? 
 Are people who you target your new product towards likely to be
particularly sensitive to a specific allergen (e.g. geographical differences or
differences between children and adults)?
 What is the risk of allergen cross-contact to other products if you introduce
a new product on an existing or a new production line?

More information
National Guidelines

 National guidelines on management and labelling of food allergens

Supply chain of raw materials

You need to establish appropriate procedures to assess
the allergen status of food ingredients for use on your
premises. You may do that through supplier audits or
questionnaires to your suppliers. Some questions that
you may consider to ask your suppliers are:

 Whether an ingredient contains any food

allergens either as a major component, a minor
component or due to cross contact.
  How your suppliers manage food allergens.
 To notify you of any changes in the allergen status of the ingredients they
supply.

More information
National guidelines

 National guidelines on management and labelling of food allergens

Example questionnaire:

 Australian Allergen Bureau questionnaire of ingredient supplier.

Manufacturing premises, equipment and processes

The ideal approach to avoid cross contact
with allergens is to dedicate production
facilities to specific allergenic products.
This is however not always an option
particularly in small businesses. The key to
manage cross contact with allergens in such
a situation is to find ways to separate the
production of allergen-containing products
from those that do not contain the
allergen. Some questions that you may
consider are:

 Is it possible to store ingredients with different allergens in clearly

identified areas?
 Is it possible to have dedicated production lines or areas?
 Is it possible to erect physical barriers and/or separate the air supply
between production lines or areas?
 Is it possible to minimise the movement of material and personnel between
production lines or areas?
 Is it possible to dedicate utensils and equipment?
 Is it possible to design equipment to minimise cross contact?
 Is it possible to schedule production runs to minimise possible cross contact
(allergen after non-allergen)?
 Is it possible to clean between production runs with allergens and non-
allergens?
 Is it possible to manage re-work that contains an allergen to ensure that it
is only re-worked into a product that already contains the allergen?
  Is it possible to label held-over products and unused packaging material in a
suitable way? 

If it is not possible to separate products with and without allergens adequately you
need to assess the risk of allergen cross contact and if appropriate use advisory
labelling.

More information
National guidelines

 National guidelines on management and labelling of food allergens

Cleaning
Documented and validated cleaning procedures are critical to avoid allergen cross
contamination. You need to seek out and inspect all the trouble spots. Cleaning
practices that are satisfactory for hygiene purposes may not be adequate to
remove all allergens. Equipment may for example need to be dismantled to
remove allergen residues. A tool you can use to validate your cleaning is to test
for allergen residues. 

Many test methods are

commercially available for food
allergen analysis. Most of the
analyses are immunochemical
methods such as ELISA but DNA-
based detection based on PCR is
growing in popularity. However,
the development of analytical
methods to detect levels of
allergens is still at an early stage.
EU has not yet agreed
independently validated methods
for all the allergens for which
ingredient labelling is required.
The kits that are currently
available may vary in how sensitive
and specific they are. They may
also vary in how effective they are
to analyse different food materials.
At the moment you can therefore choose to validate your cleaning procedure by
looking thoroughly at the production line after cleaning.

If it is not possible to clean your production line adequately you need to assess the
risk of allergen cross contamination and if appropriate use advisory labelling.

More information
National guidelines

 National guidelines on management and labelling of food allergens

Analytical Methods:

 Jackson LS, Al-Taher FM, Moorman M, DeVries JW, Tippett R, Swanson KMJ,
Fu T-J, Salter R, Dunaif G, Estes S, Albillos S, Gendel SM (2008). Cleaning
and other control and validation strategies to prevent allergen cross-contact
in food-processing operations. J Food Prot 71, 445-458.

 Allergen tests certified by AOAC International

 More detailed information on food allergen analysis: S Kerbach, AJ Alldrick,

RWR Crevel, L Dömötör, A DunnGalvin, ENC Mills, S Pfaff, RE Poms, B
Popping, S Tömösközi (2009). Managing food allergens in the food supply
chain – viewed from different stakeholder perspectives. Quality Assurance
and Safety of Crops & Foods, 1(1), 50-60.

Packaging and labelling

Incorrect packaging and/or labelling cause the
majority of the allergen-related product recalls.
In order to ensure accurate information to your
allergic consumers you need to implement
procedures to check that your products end up
with correct labels. Some areas where you may
minimise the risk of applying incorrect labels
are:

 Checks should be in place between processing and packaging.

 Check labels during product run.
 Destroy old packaging when you need to use new packaging following a
recipe change or new allergen cross contact risk.
 Be sure to remove all packaging at the end of a run.
  Be sure to use the correct outer packaging for multi-pack products.

More information
National guidelines

 National guidelines on management and labelling of food allergens

 Checklist for allergen control in food production
 Consumers expect and demand all food handlers to have the knowledge
and insight required to supply safe food of high
quality. As a food producer you shoul read
andunderstand relevant nationalguidelines on food
allergy . You need to gain insight on what you can
do to supply safe food to allergic consumers.
 The purpose of this checklist is to help you as a
food producer to evaluate your procedures for
allergen control and to improve them. The
checklist was translated and slightly adapted in June
2008 from an appendix in the Swedish version of
"Swedish Food Sector Guidelines for: Management
and labelling of food products with reference to
Allergy and Intolerance", April 2005.
 The list below shows the major allergenic foods and
products thereof which require labelling in EU (as of July 2008). Hazard
Analysis and Critical Control Point (HACCP) programmes must cover these
foods.

Cereals containing gluten (wheat, rye, Crustaceans

barley, oats, spelt, kamut or their
hybridized strains)
Eggs Fish
Peanuts Soybeans
Milk (including lactose) Nuts (cashews, hazelnuts, macadamia
nuts, Brazil nuts, pecan nuts, walnuts,
almonds, pistachio nuts, Queensland nuts)
Celery Mustard
Sesame seeds Sulphur dioxide and sulphites at
concentrations of more than 10 mg/kg or
10 mg/litre expressed as SO2
Lupin Molluscs
   
 If you change the allergens in a product or the production proces, you
need to re-examine the procedures in the checklist in order to ensure
that no mistakes occur.

Risk communication
After you have assessed the risk of cross
contact with allergens, and where
possible eliminated or reduced the risk,
you need to decide whether or not
precautionary labelling is appropriate.
You should only use precautionary
labelling where there is a demonstrable
and significant risk of allergen cross-
contact. You should never use
precautionary labelling as a substitute
for Good Manufacturing Practice.

Several of the national guidelines provide detailed advice on how you can
communicate the allergen risk to you consumers via the product label. Allergic
consumers need ingredient information, which is easy to find, read and understand
and where any allergen cross contact, which has proved impossible to control, is
made clear. Most of the guidelines recommend to use simple phrases such as “May
contain X” or “May be present: X” for precautionary labelling.

In addition to communicating with your consumers via the label you may choose to
provide additional information via a consumer careline.  You are welcome to print
out and use the pdf file: Food allergy guidance notes for consumer careline staff .

More information
National guidelines

 National guidelines on management and labelling of food allergens

 National guidelines on management and
labelling of allergens
 The below guidelines are voluntary
recommendations. The British and
Australian guidelines are good examples
as they are the most comprehensive.
Australia is to our knowledge the first
 country to develop and recommend the use of an allergen risk assessment
tool to harmonise the application of allergen precautionary labelling.
 We do not endorse any of the guidelines but they may help a company in
dealing with cross contact allergens.

Country/ Title of guideline

Organisation
Australian Food “Food Industry Guide to Allergen Management and labelling”,
and Grocery 2007 revised edition.
Council.
The VITAL risk assessment tool
A comprehensive but at the same time relatively short guide (18 pages). The guide
contains chapters on food allergy, allergen management, testing and analysis of
allergens, and allergen labelling. The recommended approach to control the
possibility of allergen contamination is through a HACCP (Hazard Analysis and
Critical Control Point) program. The guide goes through the key areas that food
companies need to consider to control allergen risk. These include employee
training and supervision, raw material sourcing and storage, production
scheduling, equipment and premises design, manufacturing (e.g. cleaning
procedures, control of rework), labelling, and post-manufacturing controls. The
guide introduces Voluntary Incidental Trace Allergen Labelling (VITAL). VITAL is a
risk-based methodology that food producers can use to apply appropriate allergen
precautionary labelling. 
Swedish Food “Swedish Food Sector Guidelines for: Management and
Retailers labelling of food products with reference to Allergy and
Federation and Intolerance”, English version, August 2005.
Swedish Food
Federation.
A comprehensive 18 page guide with 6 pages of appendices based on the first
Australian guide from 2002. Some chapters in this guide contain more detailed
guidance compared to the Australian guide. One of the appendices contains a
helpful list with examples of foods and food ingredients that may contain
allergens.  
Finnish Food and “Labelling warnings of allergen in foodstuff due to cross
Drink Industries. contamination”, December 2005. For availability (in Finnish)
contact Finnish Food and Drink Industries: www.etl.fi.  
In Finnish. This 2-page guide mainly deals with advisory statements and includes a
flowchart similar to the one in the Swedish guideline. 
UK/Food Standards “Guidance on allergen management and consumer
Agency information”, July 2006.
The most comprehensive national guideline for food producers and retailers (43-
pages including appendices). It provides voluntary best practice advice on how to
assess the risks of cross-contamination of a food product with an allergenic food
or food ingredient and then to determine whether advisory labelling is
appropriate. Chapters on background and purpose, new product development and
reformulation, manufacturing and communication of allergen information are
included. The guide also contains a useful appendix with information on the
prevalence, severity, and reaction level of the allergens that have to be labelled
in the EU.  It also contains information on the main derivatives of these allergenic
foods. Another appendix suggests a step-by-step approach to access the hazard of
possible allergen cross-contamination and provide a flowchart similar to the ones
in the other national guidelines to determine if advisory labelling is appropriate. 
This appendix also contains a description of currently available allergen testing
methods without going into specific commercial test-kits.
Federatie “Guidelines on Additional Labelling Regarding the Potential
Nederlandse Presence of Allergens Due to Cross-contamination”, 2005. For
Levensmiddelen availability contact FNLI
Industrie (FNLI)
In Dutch. This 7-page guideline covers the EU labelling legislation, points to
consider in a HACCP analysis, and advisory statements in relation to allergens.
FR/Association “Guide des bonnes pratiques pour la reduction des presences
Nationale des fortuites d´allergenes majeurs”, February 2005. For
Industries availability contact ANIA
Alimentaires (ANIA)
In French. This 22-page guideline deals with allergen management in the food
industry.
Italian food “Etichettaturea degli allergeni, linee guida di
industry federalimentare”, March 2005.
association
(Federalimentare)
In Italian. Allergen labelling guide.
U.S. Food and Drug The U.S. labelling legislation, guidelines and reports.
Administration
(USFDA)
The USFDA has a webpage with information for the food industry and food
allergen inspectors.

 “Guidance for Industry: Questions and Answers Regarding Food Allergens…” is

guidance for the industry to the food allergen labelling law.

“Approaches to Establish Thresholds for Major Food Allergens and for Gluten in
Food” is a 108-page report which gives an overview of food allergy and celiac
disease with a focus on approaches that could be used to establish thresholds for
food allergens.

"Guide to Inspections of Firms Producing Products Susceptible to Contamination

with Allergenic Ingredients" is guidance for food allergen inspectors. It goes
through potential problems in relation to allergens in product development,
receiving, equipment, processing, final product testing, and labelling.
Canadian Food Allergen check list for food suppliers and manufacturers.
Inspection Agency
The Canadian Food Inspection Agency has a webpage with information for the
industry as well as consumers. “Tool for managing allergen risk in food products”
is an allergen check list that food suppliers and manufacturers can use to manage
allergen risk. 
Canadian Food “Food Retail and Food Services Code”, September 2004.
Inspection System
Implementation
group
This 89-page paper provides practical, user-friendly interpretations and guidance
for compliance with Canadian legislation for food retail and food service
premises. Chapter 3.5.2 contains one paragraph about food allergens and a
reference to appendix C. Appendix C  (3 pages) mainly deals with strategies for
manufacturers to deal with food allergies.
Food Safety “Guide to Food Safety Training”, 2003, 2009.
Authority of
Ireland
The “Guide to Food Safety Training” is available at three levels. It covers food
safety skills that staff at different levels and managers should know. Level 2 and 3
have included knowledge about food allergens. Each of the guides contains a
checklist that can be used to record the training.

Top 10 Links
Throughout the website you can find links to
more information related to the specific area
you are reading about. In this section we have
made a collection and description of the 10
most important links where you can find
additional information.

Organisation Title of material and availability

Institute of The InformAll Database. Available at:foodallergens.ifr.ac.uk
Food Research
(IFR), UK
The InformAll Database (which is being developed with funding from the
European Union) at the moment contains information about 84 foods that have
been reported to cause allergy. The database has summaries about each food
suitable for a wide readership. In addition it contains a more technical part with
a section on the clinical characteristics of the allergy (such as symptoms, and
diagnosis) and a section on biochemical information about the allergens (e.g.
allergen stability towards different processes).
Food Safety Allergen Bureau. Webpages available
Centre at: www.allergenbureau.net
Allergen
Bureau,
Australia
The Allergen Bureau represents a centralized collection of information about
food allergens relevant for the food industry in Australia and New Zealand.
Food Allergy and intolerance. Webpages available
Standards at:www.food.gov.uk/safereating/allergyintol
Agency (FSA),
UK
This website gives information on the Food Standards Agency's work on food
allergy and intolerance, including research, labelling, advice to caterers and
guidance notes.
U.S. Food and The U.S. labelling legislation, guidelines and reports. Available
Drug at:www.fda.gov/Food/LabelingNutrition...
Administration
(USFDA)
The USFDA has a webpage with information for the food industry and food
allergen inspectors.
“Guidance for Industry: Questions and Answers Regarding Food Allergens…” is
guidance for the industry to the food allergen labelling law.
“Approaches to Establish Thresholds for Major Food Allergens and for Gluten in
Food” is a 80-page report which gives an overview of food allergy and celiac
disease with a focus on approaches that could be used to establish thresholds for
food allergens.
 
Canadian Food Allergen check list for food suppliers and manufacturers.
Inspection Available at: 
Agency www.inspection.gc.ca/english/...
The Canadian Food Inspection Agency has a webpage with information for the
industry as well as consumers. “Tool for managing allergen risk in food products”
is an allergen check list that food suppliers and manufacturers can use to manage
allergen risk. 
European “Opinion of the Scientific Panel on Dietetic Products, Nutrition
Food safety and Allergies on a request from the Commission relating to the
Authority evaluation of allergenic foods for labelling purposes”, February
(EFSA) 2004. Available at:www.efsa.europa.eu/EFSA/...
This comprehensive 197-page report contains general chapters on clinical
symptoms, epidemiology, influence of various factors in the distribution of food
allergies, considerations on the structure of food allergens, analytical methods
for allergen detection, possible effects of processing on allergenicity of foods,
and threshold doses. For each of the foods or food ingredients that have to be
labelled according to the EU legislation (cereals containing gluten, crustaceans,
fish, eggs, peanuts, soy, milk, nuts, celery, mustard, sesame, and sulphites) the
report describes background, frequency, clinical features, identified allergens,
detection of allergens, cross-reactivities, possible effects of food processing on
allergenicity and derived products, and threshold doses.
Institute of “Food Allergy”. Written (web pages), February 2009. Download
Food Science PDF at:www.ifst.org/document.aspx?id=119
& Technology
(IFST)
This 21-page paper gives a comprehensive overview over the nature and cause of
food allergies including information about the major food allergens. It outlines
recent changes in legislation (with a focus on Europe) and emphasises the
measures that manufacturers should take to minimise the problems including
carrying out a HACCP-style analysis to prevent allergen contamination, and
training of all personal. The paper also contains a chapter on precautionary
labelling, a chapter on measuring allergens in food (including information about
thresholds, and a chapter on allergenic potential of novel foods.
Ontario “The HACCP Advantage – Program Manual”, 2005. Available
Ministry of at:www.omafra.gov.on.ca/... 
Agriculture, Guidebook (176 pages) available at: /www.omafra.gov.on.ca/...
Food and
Rural Affairs
(OMAFRA),
Canada
This 124-page manual (and the accompanying guidebook) was designed by
OMAFRA to be a practical, cost-effective and preventative food safety system for
all non-federally registered food processing facilities, regardless of size,
commodity or volume processed. Allergens (especially contamination with
allergens) are mentioned throughout the manual. One of the program standards
(02.6) deals specifically with allergen control.
The Food Webpages available at: www.farrp.org/
Allergy
Research &
Resource
Program
(FARRP)
FARRP - headquartered at the University of Nebraska - is an organisation that
develops assays to detect allergenic food residues and offers allergen residue
analysis. FARRP also designs and coordinates clinical studies to determine
threshold doses for allergenic foods and assesses the allergenicity of food
ingredients. FARRP offers consultation and training to help the food industry
reduce allergen risk.
European Food Safety in Europe. Available
Commission at:ec.europa.eu/food/food/index_en.htm
The Food Safety in Europe website contain links to European food safety
regulations including the general food law and the labelling regulation.