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Temp File FINAL Allergen A4 Web1 PDF
Temp File FINAL Allergen A4 Web1 PDF
January 2013
Index
Foreword .................................................................................... p. 03
Introduction .............................................................................. p. 04
2. Risk Management Processes ........................................................ p. 06
2.1. Overview ............................................................................... p. 06
2.2. People ................................................................................. p. 08
2.3. Supplier Management ............................................................. p. 10
2.4. Raw Materials Handling ........................................................... p. 11
2.5. Equipment and Factory Design ................................................... p. 12
2.6. Production Process and Manufacturing Controls ............................. p. 13
2.7. Consumer Information ............................................................. p. 15
2.8. Product Development and Change .............................................. p. 16
2.9. Documentation and Record-Keeping ........................................... p. 17
3. Cleaning and Cleaning Validation .................................................. p. 18
3.1. General ................................................................................. p. 18
3.2. Cleaning Methods ................................................................... p. 20
4. Analytical Methods and their Application ......................................... p. 22
5. Key Principles of Allergen Risk Management .................................... p. 24
6. Glossary ..................................................................................... p. 26
p // 2
Foreword
Allergenic foods possess some unique effect levels and use them in food
characteristics as a food safety hazard, safety risk assessment, agreement
which need to be considered in assessing between stakeholders has not yet
and managing the risk: been reached on how to interpret this
information in public health terms.
p // 3
Introduction
This Guidance sets out general principles that can be Additionally, the following documents were considered
used to manage specific foodstuffs causing allergy or in the drafting of this Guidance:
certain intolerances in different situations. The focus
of this Guidance is the production of prepacked foods FoodDrinkEurope Guidance document on the
intended for sale to the general population. However, practical application of the Directive 2003/89/EC on
the general principles also apply to non-prepacked ingredient and allergen labe lling (Version 08/2005).
p // 4
Scope
Objectives
This Guidance has been drafted for the management -
in any food manufacturing environment - of allergenic This document aims to:
foods and substances (allergens) identified in EU
legislation. provide general guiding principles to all
food operators regarding food allergen
Food companies have a responsibility to establish a
risk management, which can be readily
food safety management system to comply with legal
adapted to different product process and
requirements. Allergen Management should be an
production facility designs.
integrated part of food safety assurance strategies
and should consider the risk from food allergens
provide information about food allergy
together with other food safety risks. It should be
built into operational standards for a companys own and food allergens to indicate their
manufacturing, for third party manufacturing performed importance as food safety hazards.
on behalf of the company and be incorporated into all
raw material supply standards.
p // 5
Risk Management
Processes
2.1 Overview
The need to manage potential risks from allergenic foods in a food production environment is universally
accepted by all stakeholders in the food supply chain. This responsibility may be met in several different
ways, for instance, via a Prerequisite Programme and then via integration in a business HACCP Programme.
Allergen management in food businesses should This evaluation should be carried out by personnel
be seen as an integral part of existing food safety appropriately trained in allergen management.
management rather than a completely new system.
An effective allergen management system must Documented procedures for the control and prevention
consider all operations from sourcing of raw materials of contamination must be in place and visible or
through manufacturing and packaging to the finished readily available to all employees in the work area. The
product, including new product development. procedures should contain information about:
Food businesses should operate in line with Good Product development guidelines in terms of allergens.
Manufacturing Practice (GMP) principles. This requires Good hygiene, for example, rules regarding clothing,
a commitment to ensuring that products meet food hand-washing and hand contact with foods.
safety, quality and legal requirements, using appropriate
manufacturing operations controls, including effective Cleaning of premises, equipment and tools.
food safety and quality assurance systems. Adherence
Handling of rework materials, for example, the
to existing GMP controls will be essential for allergen
conditions under which such products may be used.
management, for example, avoiding cross-contact
by segregation using cleaning, separate utensils, line Waste management, for example, how waste should
dedication, equipment and storage dedication, etc. be labelled and kept separate from rework.
Risk management starts with risk assessment, which, Situations where potential cross-contamination can
for allergens, requires consideration of, at a minimum, occur between raw materials, products, production
the likelihood that they are present, their physical form lines or equipment, and each employees responsibility
(powder, liquid, pieces, etc), as well as the amount of any for preventing this.
allergen present. Risk management must encompass
Production scheduling.
every component of the supply chain, from raw materials
supply specifications to the sale of the finished product Labelling of raw materials, semi-finished goods and
and including product design and development. finished products.
p // 6
Changes to any process within a food production will therefore require a re-assessment of the original
facility, or introduction of a new raw material or risk for all potentially affected products and, if required,
product, can affect allergen cross-contact risks for application of new risk management measures. Any
other products manufactured at the same site. Moving new relevant risk identified, which cannot be reduced
production of a product to another site may also alter further, will need to be communicated to consumers, for
the allergenic risk associated with it. Any such changes instance through advisory labelling.
Figure 1 below illustrates the critical elements that must be considered in assessing allergen risks in a food
manufacturing environment (numbers refer to sections in the document).
p // 7
2.2 People
2.2.1 Training
General allergen awareness including the
All involved in the commercialisation, production and nature and possible consequences of their
distribution of foods should understand the implications unintended or undeclared presence in products
of the presence of food allergens and the need to
and specifics from a consumer perspective.
manage the ensuing risk. Thus, individuals (e.g. top
management, marketing, internal auditors, product Awareness of allergen presence in raw
developers, design engineers, plant personnel materials and ingredients.
and contractors, employees handling consumer
Awareness of the hazards and allergen
complaints) should receive training specific to their job
responsibilities in this area. They should become aware risks identified at each stage of the food supply
of measures needed to minimize the risk of allergen chain, including production, storage, transport
cross-contact. All appropriate personnel should be and/or distribution process and the corrective
encouraged to take immediate action, if any risk of measures, the preventive measures and
contamination is suspected. documentation procedures applicable in the
individuals business.
Allergen training should be provided to all new employees
during orientation and should be repeated on a regular Hygienic design of facilities and equipment in
basis (annual refresher courses are recommended). relation to allergens.
Any visitors to site should receive appropriate induction
Procedures for storage of raw materials
according to site GMP rules.
and products, verified and validated cleaning
Training and awareness programes should regimes, re-work, label controls and waste
include as appropriate: management.
p // 8
2.2.2 Personal Hygiene
p // 9
2.3 Supplier Management
A food operator at any point in the supply chain can Understand the allergen risk analysis from each
only perform his own risk assessment effectively if supplier in order to apply the analysis appropriately and
he is in possession of correct information about the consistently to their products.
complete allergen status of the raw materials and
ingredients used. This requires knowledge of each Ensure that information from suppliers is correctly
suppliers understanding and application of allergen recorded, including complete allergen status i.e.
management. When it comes to allergens and other intentionally present allergenic derivatives as well as
risks, a good relationship between raw material suppliers potential cross-contact.
and manufacturers promotes good product safety.
Lay down procedures on how information received
In practice, a food operator will need to: from the supplier is handled/processed/acted upon.
Ascertain that the allergen status is fully described Make sure a change notification process is in place
in raw material, packaging, labelling and specifications with the supplier, so that newly identified allergen risks
declarations. For instance, generic terms such as for ingredients that are already being supplied, are
flavouring, spices are not appropriate where these properly notified and can be acted upon.
substances originate from allergenic sources according
to European legislation. Where several alternative ingredients can be substituted
Assess each supplier and the application of in a product, e.g. alternative seasonings and raising
allergen management practices in their operations agents with carriers or a particular ingredient may
and document that assessment. For instance, this can need to be purchased from different suppliers, the food
be achieved by means of a questionnaire and, where operator needs to ascertain the impact on the allergen
appropriate, an audit. status of the resulting product(s).
p // 10
2.4 Raw Materials Handling
2.4.1 Incoming Raw Materials Handling 2.4.2 Handling of Raw Materials and
Intermediate Semi-Finished Products
The focus at this step should be the clear identification of
incoming raw materials and ingredients and minimising The main risks that arise from raw material storage
the possibility of cross-contact. Thus: are cross-contamination of other raw materials and
inadvertent selection for a recipe of an allergenic
Allergenic raw materials, semi-finished products,
material not present in the product. Thus, the key
etc., should be identified upon receipt and, if possible,
principles that should be applied are clear identification
kept in sealed packaging or separate from each other
and segregation of each allergenic material from other
and from other foods. Clear labelling reduces the risk of
materials and each other.
mix-ups and cross-contact.
As appropriate:
All deliveries should be checked before unloading
commences. For all deliveries (including allergenic Assure/check that allergenic materials are
materials) consideration should be given to the need for delivered clearly labelled, and securely packed to
a special allergen spillage procedure, analogous to prevent accidental misuse, cross-contact or damage
glass breakage procedures. prior to receipt.
Store allergenic raw materials in clearly identified
Where allergenic materials are sampled on delivery,
areas, for example, using colour-coded boxes and/or
measures should be in place to make sure that the
demarcation of storage areas using painted lines on
sample and the sampling tools do not create a cross-
the floor.
contact risk, for example, by using colour-coded and/
or disposable sampling equipment. Bulk delivery All allergenic materials should be stored in clearly
points should be locked when not in use to prevent marked packaging until required.
unauthorised off-loading prior to the completion of Where allergenic raw materials are de-bagged or
necessary checks. de-boxed, they should be placed in dedicated closed
and clearly labelled containers. Such containers must
only be used for storage of other raw materials after
appropriate cleaning using validated procedures.
Ingredients, in dry powder form, can present a
particular danger of cross-contamination during
handling. Special care should be taken with these
types of ingredients.
Ascertain segregation and management of allergenic
materials at all stages of the manufacturing process,
including picking and transfer. In cases where
allergenic materials are stored in non-segregated areas,
appropriate means of preventing cross contact should
be used, for example utilisation of bottom-level racking.
Ensure information on the identity of raw materials is
readily accessible and available.
Considerations for raw material storage also apply to
semi-finished products.
p // 11
2.5 Equipment and Factory Design
Production includes ingredient dispensing, recipe Movement Control:
make-up, mixing the raw materials and ingredients, Limit movement between physically separated areas
processing them and then packaging the finished or dedicated equipment, to avoid allergen cross-
product. Critical allergen risks related to equipment contact between these and other operations. Manage
and factory design include incorrect equipment the movement of equipment, personnel, vehicles and
selection, cross-contact between materials as well as maintenance tools.
between products produced on the same line. Good
Manufacturing Practices (GMP) form the basis for Cleaning:
minimising these risks. Where there is a significant risk of cross-contact from
shared equipment then the equipment must be capable
Specific considerations to minimise allergen risks of being cleaned effectively. Appropriate protocols must
include: be in place to verify and validate the cleaning regime.
p // 12
2.6 Production Process and Manufacturing Controls
2.6.1 Recipe Verification 2.6.3 Internal Labelling for Handling
and Production
The first requirement to avoid allergen risks is to
ensure the correct materials are used in the recipe. There must be control procedures to ensure proper
Systems therefore need to be designed to avoid recipe labelling of raw materials, semi-finished goods and
mistakes. These systems will depend on the actual products. When finished packing materials are of the
production facility, and can include not only verification same or similar appearance, (e.g. for different flavour
of the recipe at the time of addition of materials, but variants), it is especially important to ensure that the
also software and engineering design features to avoid correct packaging is used. In this context, a checklist to
use of the wrong ingredient(s). An example would be be signed by the person responsible is recommended.
a system which checks barcodes in the recipe against
those of the raw materials or ingredients when these are Co-products, misshapes and broken products, which for
weighed out for a pre-mix and prevents the operator quality reasons are not acceptable as finished products
from continuing if they do not match. Rework represents but could still be consumed by employees or sold
a special case of an ingredient which these systems through factory shops, must be subject to the normal
also need to consider. risk assessment and risk communication controls.
p // 13
It is important that, following recipe changes or the 2.6.5 Rework Internally Recycled Product
introduction of a new allergen cross-contact risk etc,
the old packaging is not only withdrawn from use but is Defined procedures for the handling of rework in
physically destroyed, so that it cannot be used in error. production must be in place. Ideally, the principle should
It is also essential to ensure that the product is packed be identical into identical i.e. rework should go into
in the correct packaging. If packaging variants are of another batch or run of the same product. Where this
similar appearance, such as different flavour variants, is not practicable, allergen containing rework should
additional controls are recommended, for example, by only be used in product where that specific allergen
installing an inline scanner. is already present (for example, reworking chocolate
that contains hazelnuts or hazelnut fillings into other
There should be systems to ensure packaging is hazelnut-containing chocolate products). Oils used for
removed at the end of a run, including any packaging cooking allergenic foods (for example, shellfish, fish
that may be within the wrapping machine. This will help and breaded or battered products) should not be used
to avoid packaging mix-ups when the product to be subsequently for cooking products not containing that
packed is changed. allergen without undergoing a validated filtration step.
Finished products containing allergens should be The use of re-work material containing allergens must
securely packaged so that they cannot contaminate be properly managed and documented. Storage,
other products. It is important to ensure that the correct processing, identification and labelling procedures
outer packaging is used for multi-pack products. must all be the same as those for the original allergens.
Responsibility for the management of rework must be
clearly defined.
p // 14
2.7 Consumer Information
2.7.1 Ingredient Labelling 2.7.2 Non-commercial Samples
(e.g. for taste sessions, exhibitions)
Labelling is a very important risk management and risk
communication tool. Food information legislation in the Complete allergen information for those allergens
EU lists foods known to cause allergic hypersensitivity in identified in EU labelling legislation should be available
a significant proportion of the European population, and to European consumers prior to consumption for non-
several foods known to provoke intolerance reactions commercial samples (i.e. products not for resale
in sensitive individuals such as sulphites, lactose and presented at taste sessions, sent to customers or
gluten. Substances or products causing allergies or presented at exhibitions). Alternatively consumers
intolerances, as well as ingredients and processing could be pre-screened and rejected from taking part in
aids originating from a substance or product causing consuming such commercial samples should they have
allergies or intolerances are required to be declared for any food allergies or intolerances.
pre-packed and for non-pre-packed foods, unless the
derivatives are specifically exempted by the legislation.
p // 15
2.8 Product Development and Change
The starting point for all food production is ensuring Ensure information on the presence, or
that complete product specifications are available. potential presence, of allergens is made
In product development, the ingredients and available to those involved in factory trials
manufacturing procedures should be looked at from and in taste testing.
an allergy perspective. The people responsible for
development of products and recipes must have sound Ensure information is clearly conveyed
knowledge of the risks to people with food allergies with products presented for wider test and
and other food intolerance. By definition, most food marketing purposes.
allergens are common and valuable components of the
diet and it is neither practicable nor even desirable to
exclude them from new products. However, in order not
to add complexity to existing allergen risk management
practices, new product development technologists
p // 16
2.9 Documentation and Record-Keeping
Efficient and accurate record keeping is critical to the A record of the risk management programme should be
application of allergen management within a food safety retained with the risk assessment to demonstrate due
programme. A simple record-keeping system can be diligence. This may be shared, as appropriate, with
effective and easily communicated to employees. It enforcement agencies and customers to demonstrate
should be integrated into existing operations using how risks have been managed and reduced. This should
existing paperwork, such as delivery invoices and include details of how the programme is validated,
checklists to record allergen status. and ongoing verification. Internal compliance with
instructions and procedures for control of allergen risks
should be verified regularly by trained internal auditors.
p // 17
Cleaning and
Cleaning Validation
3.1 General
Effective cleaning is one of the most important aspects of any allergen problems and any relevant industry
management strategy. A visually and physically clean Standard is not just guidance, where this has been
a casual visual inspection of the production line or area, it also requires that developed, should be followed.
all of the trouble spots are identified and inspected (key inspection points Adequate procedures should be in
should be highlighted on cleaning schedules). place for cleaning both production
and packaging machinery.
Cleaning considerations should be the whole production line may be
Where adequate cleaning cannot
built into the design of equipment. visually assessed and complies
be assured (e.g. because of
For instance, dismantling should with the visibly clean Standard (no
inaccessibility), the residual risk
be made easy so that hidden product residue visible).
from allergen cross-contact should
areas of the equipment can be
be assessed and advisory labelling
adequately accessed and cleaned Documented and validated
used, if deemed appropriate.
as failure to clean properly can cleaning procedures using proper
lead to a build-up of raw material cleaning equipment are essential
The actual cleaning procedure
or product residue inside the to ensure that effective cleaning is
must not contaminate other areas
equipment. Avoiding the crossover performed. Adequate time must be
(for example, by use of compressed
of production lines and allowing allocated for cleaning.
adequate space for effective air), or an area which has already
cleaning will also help minimise the Cleaning practices that are been cleaned (for example,
risk of allergen cross-contact. satisfactory for microbiological clean dry mix areas from the top
safety may not be adequate for down). Any spillage that occurs
Line cleaning must be evaluated removing some allergens and during production, storage and
for its ability to control the hazard; their validity for such a purpose transportation should be cleaned
i.e. issues with heterogeneously should be assessed. Equipment up immediately to ensure that there
distributed common allergen may need to be dismantled and is no subsequent allergen cross-
traces due to cross-contact and manually cleaned to ensure contact. Where known allergen
effectiveness of (controlled) wet or hard to clean areas are free from cross-contact has occurred, the
dry cleaning need to be assessed. allergen residues. Particular food contaminated material should be
Line cleaning of heterogeneously materials (for example, powders, labelled and physically moved
distributed allergenic material will seeds, pastes and particulates) away from the non-contaminated
be considered as effective only if may present significant cleaning ingredients and work-in-progress.
p // 18
Consideration should be given to maintenance activities,
such as the use of dedicated tools or adequate cleaning
procedures where tools are not dedicated. Where
adherence to a cleaning regime is part of a separation
system, it should be validated as fit for purpose and
compliance should be monitored.
p // 19
3.2 Cleaning Methods
3.2.1 Wet Cleaning material addition points, internal hoppers and packing
machinery. It is unlikely to be sufficient to flush only the
Wet cleaning systems can be very effective and are primary process (main mixer, etc.).
the best cleaning option, where practicable and usable
without introducing microbial risk. They are particularly Consideration should be given to the quantity and
effective where allergens are in a form that may be nature of the flushing material. Flushing agents
difficult to remove using dry cleaning only. The cleaning should be inert non-allergenic materials such as salt.
stage and cleaning chemicals must be capable of Where the chosen flushing agent is not a significant
removing all contaminants and the rinsing stage must ingredient in the next production batch, an additional
be sufficient to flush the system. clean may be appropriate.
In dry food manufacturing environments, a separate Used flushing materials should be identified, handled
risk assessment should be undertaken to ensure that and stored using the same controls as for the original
no microbiological hazards are introduced as a result of allergen which the flush now potentially contains.
any wet cleaning procedures. Subject to an individual companys risk assessment, it
may be appropriate for used flush material to be used
3.2.2 Dry Cleaning as an ingredient in a production batch containing a
similar allergen profile (e.g. salt used for flushing after
Where dry cleaning is undertaken, the use of brushes, the production of an egg-containing batter could be
dustpans etc. is acceptable, but suitably filtered/ used as an ingredient for subsequent production of
protected vacuum systems are often preferred. The the same or a similar egg batter). Otherwise, the flush
use of compressed air is strongly discouraged, as the material should be carefully disposed of in a manner
airstream could re-contaminate adjacent equipment or which will not lead to cross-contact.
carry allergens into clean areas. Cleaning equipment
should be well maintained. The most effective and cost efficient methods for
prevention of allergen cross-contact may be based
It is essential that cleaning equipment is itself cleaned on a combination approach, for example scheduling,
to prevent the transfer of allergens. Dedicated cleaning cleaning and flushing. The nature and extent of any
equipment which is identified by colour can be used to cleaning programme will be determined by the risk
minimize cross-contamination. assessment.
The use of flushing materials as a mechanism for In addition to routine cleaning verification (the process
removing and/or reducing levels of allergenic materials line is inspected and signed back into normal use
can be beneficial and can be more effective when used after cleaning to confirm that all detailed measures,
in combination with other cleaning methods. Flushes cleans, flushes, etc. Have been completed), it is
should pass through all parts of the plant with which necessary to regularly demonstrate that allergen
the allergen may have been in contact, including raw protocols remain effective.
p // 20
It is recommended that the validation be carried by A validation study requires the physical validation of
a multi-skilled team. In addition to production staff, the cleaning (post cleaning and/or pre-operational
the team could include (as appropriate) engineers, inspection process) combined with quantitative
quality specialists, hygiene specialists, and people analytical evidence by using validated analytical
with knowledge of allergens. It is important to include methods. When no test for the analytical validation is
people with detailed knowledge of the process, the available, allergen line validations should follow the
equipment and the relevant cleaning procedure. It is physical validation protocol only and then comply
also important that the related cleaning procedures are with the visibly clean Standard (no product residue) or
developed and thoroughly documented in advance of test for a marker allergen (a labelled allergen with the
any validation activity. highest percentage by formula).
p // 21
Analytical
Methods and their
Application
Allergen management depends on a number of factors outlined in this Guidance document. Analysis
can help and support understanding of allergen management capability and control but should never be
regarded as the sole tool sufficient for allergen management.
Analytical testing is inappropriate for quality control ATP (adenosine tri-phosphate) and protein assays are
purposes but supports upstream quality assurance, also on site assays but not specific for allergens. These
validating cross-contamination control capability. detect general contamination with biological material
/proteins which are not necessarily the allergens of
The typical applications of analytical testing are: concern, but can indicate level of cleaning capability.
Provision of quantitative data for the purposes of risk Analytical results can be misleading unless critical
assessment; considerations are built in along with competent
technical advice. These considerations include:
Confirmation of raw materials composition;
p // 22
Analytical results are very useful when the effectiveness
of cleaning procedures (cleaning validation) needs
to be assessed. Here, quantitative values give an
insight whether the procedure is appropriate to remove
allergens from the production line. On site swabbing
test and dipstick tests can indicate that the tested
part of the production line remains free from allergens
(to its limit of detection). However, a single test result
does not provide sufficient information about the
allergen presence/absence. A single test as part of a
holistic allergen management review to verify absence
of allergens is very good supporting evidence of the
success of the risk management control measure.
p // 23
Key Principles
of Allergen Risk
Management
In summary, the allergen status of all raw materials (including intentionally present flavourings, additives,
carriers, rework and processing aids and assessment of probable cross-contact), should be known. Food
operators must be able to demonstrate their responsibilities as follows:
People
p // 24
Manufacturing Communication
p // 25
Glossary of Terms
p // 26
Food additive carrying out any of the activities lactose intolerance is caused
related to any stage of production, by a deficiency of the digestive
Any substance not normally
processing and distribution of food. enzyme, lactase.
consumed as a food in itself
and not normally used as a
Food Business Operator (FBO) Food safety hazard analysis
characteristic ingredient of food,
whether or not it has nutritive value, The natural or legal persons A food safety hazard analysis is
the intentional addition of which to responsible for ensuring that the done in order to determine which
food for a technological purpose requirements of food law are met potential hazards need to be
in the manufacture, processing, within the food business under controlled, how much control is
preparation, treatment, packaging, their control. needed, and which combination of
transport or storage of such food control measures should be used in
results, or may be reasonably Food Hygiene order to make sure that food is safe.
expected to result, in it or its by-
The measures and conditions
products becoming directly or Food Safety Management
necessary to control hazards
indirectly a component of such System (FSMS)
and to ensure fitness for human
foods.
consumption of a foodstuff taking A network of interrelated elements
into account its intended use. that combine to ensure that food does
Food allergy
not cause adverse human health
An IgE-mediated hypersensitivity effects. These elements include
Food information
reaction. programmes, plans, policies,
Information concerning a food
procedures, practices, processes,
Food allergy occurs when the and made available to the final
goals, objectives, methods, controls,
immune system becomes sensitised consumer by means of a label,
roles, responsibilities, relationships,
to specific food antigens, usually other accompanying material,
documents, records and resources.
proteins. Subsequent exposure to or any other means including
A FSMS is often one part of a larger
the specific allergenic protein when modern technology tools or verbal
management system.
ingested can produce adverse communication.
reactions in the sensitised person,
which can include potentially fatal Food intolerance
anaphylaxis. A hypersensitive reaction which is
non-allergic, where immunological
Food business mechanisms have not been
Any undertaking, whether for profit proven or are not responsible
or not and whether public or private, for the reaction. For example,
p // 27
Good Manufacturing Practice Hazard is capable of binding to that
(GMP) specific antigen (also known as an
A biological, chemical or physical
antibody).
A production and testing practice agent in, or condition of, food with
that helps to ensure a quality the potential to cause an adverse
Inflammation
product. Basic preventive health effect.
guidelines for plant and facility General term for the reaction
operations. Guidelines aimed at Hypersensitivity of tissues to injury, infection or
food processors aim to include all a localised immune (allergic)
A state in which objectively
HACCP methods and procedures response; characterised by the
reproducible symptoms or signs
and typically address (1) plant infiltration of inflammatory cells and
can be initiated by exposure
design and construction material, clinically by heat, redness, swelling
to a defined stimulus at a dose
(2) water supply, (3) plumbing and and pain.
tolerated by normal subjects.
toilet facilities, (4) equipment and Hypersensitivity causes objectively
utensils, (4) raw food handling Ingredient specifications
reproducible symptoms or signs,
and testing practices, (5) personal initiated by exposure to a defined Technical document used to define
hygiene, (6) pest control, and (7) stimulus that is tolerated by normal the critical parameters of raw
waste disposal. subjects. Food allergy is an IgE- materials, processes and finished
mediated hypersensitivity reaction products which are necessary
HACCP (Hazard Analysis to allergenic foods and their to manufacture the quality,
Critical Control Point) derivatives in sensitised individuals. composition and characteristics
intended, including allergen
HACCP is a methodology and a
IgA, IgD, IgE, IgG, IgMIgE presence.
management system. It is used
to identify, prevent, and control Classes of immunoglobulin.
food safety hazards. HACCP
Ingredient
Immunoglobulin E is a type of
management systems use the antibody which may cause an Any substance or product, including
following methodology: allergic reactions found in the flavourings, food additives and
immune system. We produce food enzymes, and any constituent
1. Conduct a hazard analysis.
IgE molecules to fight infections of a compound ingredient, used in
2. Identify critical control points
caused by parasites, like worms; the manufacture or preparation of a
(CCPs).
or those that cause malaria. We food and still present in the finished
3. Establish critical limits for each
do not understand why, but the product, even if in an altered form;
critical control point.
immune system of some people residues shall not be considered as
4. Develop procedures to monitor
mistakenly produces IgE to ingredients.
critical control points.
harmless things like pollen or dust
5. Design corrective actions to
mites, giving rise to hay fever and
Label
handle critical limit violations.
asthma, and to some foods, giving Any tag, brand, mark, pictorial or
6. Create a food safety record
rise to food allergies. other descriptive matter, written,
keeping system.
printed, stencilled, marked,
7. Validate and verify your safety
Immunoglobulin embossed or impressed on, or
system.
attached to the packaging or
HACCP was developed by the A protein molecule produced
container of food.
Codex Alimentarius Commission. and secreted by B lymphocytes
in response to an antigen, which
p // 28
Labelling Management reviews are also used Packaging
to identify and assess opportunities
Any words, particulars, trademarks, The placing of one or more
to change an organisations quality
brand name, pictorial matter foodstuffs in primary wrapping, in
policy and quality objectives, to
or symbol relating to a food a secondary container, and any
address resource needs, and to
and placed on any packaging, subsequent containers.
look for opportunities to improve its
document, notice, label, ring or
products.
collar accompanying or referring to Pre-packed food
such food.
Manufacturing process Any single item for presentation
as such to the final consumer and
Lactose intolerance Manufacturing processes are the
to mass caterers, consisting of a
steps through which raw materials
A state in which an individual is food and the packaging into which
are transformed into a final product.
unable to digest significant amounts it was put before being offered
of lactose, the predominant sugar for sale, whether such packaging
in cows milk. This results from a Microbiological safety encloses the food completely or
deficiency of the enzyme lactase, only partially, but in any event
A microbiological criterion
normally produced by the mucosal in such a way that the contents
means a criterion defining the
cells of the small intestine. cannot be altered without opening
acceptability of a product, a batch
or changing the packaging; pre-
of foodstuffs or a process, based
Management packed food does not cover foods
on the absence, presence or
packed on the sales premises at
All the activities that are used to number of micro-organisms, and/
the consumers request or pre-
coordinate, direct, and control an or on the quantity of their toxins/
packed for direct sale.
organization. The term management metabolites, per unit(s) of mass,
does not refer to people. It refers to volume, area or batch (Regulation
Prerequisite Programme (PRP)
activities. (See top management (EC) No. 2073/2005).
below for reference to people). The conditions that must be
Operating procedure established throughout the food
Management Review chain and the activities and
A document which describes the practices that must be performed
The purpose of a management regularly recurring operations in order to establish and maintain
review is to evaluate the overall relevant to the quality of the a hygienic environment. PRPs
performance of an organisations investigation. The purpose of an must be suitable and be capable
food safety management system operating procedure is to carry out of producing safe end products
and to identify improvement the operations correctly and always and providing food that is safe for
opportunities. These reviews are in the same manner. An operating human consumption. PRPs support
carried out by the organisations top procedure should be available at HACCP plans.
managers and are done on a regular the place where the work is done.
basis. The overall purpose of a Processing
management review is to evaluate Operational standards
Any action that substantially
the suitability, adequacy, and
Qualitative or quantitative technical alters the initial product, including
effectiveness of an organisations
requirements which must be met heating, smoking, curing, maturing,
quality management system, and to
to achieve intended targets and drying, marinating, extraction,
look for improvement opportunities.
characteristics of a process, part- extrusion or a combination of those
product or finished product. processes.
p // 29
Processing aid Risk Senior / Top management
Any substance which (i) is not A function of the probability of an A person or a group of people
consumed as a food by itself; adverse health effect occurring at the highest level within an
(ii) is intentionally used in the upon exposure to an identified organisation. It refers to the people
processing of raw materials, foods hazard. who coordinate, direct and control
or their ingredients, to fulfil a certain organisations.
technological purpose during Risk analysis
treatment or processing; and (iii) A process consisting of three Small and Medium-sized
may result in the unintentional but interconnected components: risk Enterprise (SME)
technically unavoidable presence assessment, risk management and The category of micro, small and
in the final product of residues of risk communication. medium-sized enterprises (SMEs)
the substance or its derivatives is made up of enterprises which
provided they do not present any Risk assessment employ fewer than 250 persons
health risk and do not have any A scientifically based process and which have an annual turnover
technological effect on the final consisting of four steps (i) not exceeding EUR 50 million, and/
product. hazard identification (ii) hazard or an annual balance sheet total not
characterisation, exposure exceeding EUR 43 million.
Raw material assessment (iii) and (iv) risk
Material before being processed or characterisation. Validation
manufactured into final form. A process that is used to ensure
Risk management that food safety control measures
Retail The process, distinct from risk are capable of being effective.
assessment, of weighing policy The validation process uses
The handling and/or processing
alternatives in consultation with evidence to determine whether
of food and its storage at the
interested parties, considering risk control measures are capable of
point of sale or delivery to the final
assessment and other legitimate controlling or managing identified
consumer, and includes distribution
factors, and, if need be, selecting food safety hazards and ensuring
terminals, catering operations,
appropriate prevention and control that end-products are safe.
factory canteens, institutional
options.
catering, restaurants and other
Verification
similar food service operations,
Risk communication Act or process of establishing
shops, supermarket distribution
The interactive exchange of (confirming) the accuracy or
centres and wholesale outlets.
information and opinions throughout existence of something; in
the risk analysis process as regards the quality field, verification is
Rework
hazards and risks, risk-related a systematic, objective, and
Taking by-products from a specific documented process of confirming
factors and risk perceptions,
food manufacturing process and that a product or service conforms
among risk assessors, risk
either re-processing to ensure a to various requirements (customer,
managers, consumers, feed and
product meets specification, or regulatory, etc.). A process that
food businesses, the academic
recycling by-products back into the uses objective evidence to confirm
community and other interested
process for efficiency purposes. that specified requirements have
parties, including the explanation
of risk assessment findings and the been met.
basis of risk management decisions.
p // 30
p // 31
Annex 1
Background on Food
Allergies and Intolerances
p // 32
Introduction What is a food allergy?
Food allergies affect around 2 to 4% of the population (1, Food allergy refers to an inappropriate immune response
2) in Europe and an estimated 5-8% of children. Allergic to a food constituent (almost always a protein), causing
reactions to foods also account for a high proportion of the food to provoke an allergic reaction when it is eaten
admissions to hospitals for acute allergic reactions (3). again. Foods can produce many different types of
This means that in the 500 million population of the 27 allergic responses, but from a public health and food
EU Member States, an estimated 10-20 million people safety perspective, those with the greatest impact
suffer from a food allergies. However, the number who are those in which the immune system produces IgE
believe they have a food allergy is considerably higher antibodies to proteins in the food and those reactions are
at around 20% of the population (4). Many children the primary concern of this guidance. Care needs to be
outgrow their allergies, such as those to milk and eggs taken to differentiate food allergy from food intolerance,
by the age of 5-7 years. Other allergies, such as to fish such as lactose intolerance, which does not involve the
and peanuts, tend to persist. For practical purposes, no immune system (see below).
cure exists for food allergy and allergic consumers must
avoid foods which contain the ingredient(s) to which
they are allergic.
Classification of Food Allergy and Food Intolerance by European Academy of Allergy and Clinical Immunology (EAACI), 2004.
p // 33
Allergic reactions to food can vary from very slight to
severe and occasionally fatal, depending on the dose,
These symptoms can include one
the individual and other factors. Food allergy affects
or more of the following.
a greater proportion of children than adults (5) and
reactivity to some allergenic foods, such as milk and Skin problems (hives, itching,
egg, tends to be largely outgrown, while allergy to
dermatitis, eczema, conjunctivitis,
others, such as peanuts, generally persists.
swelling of the lips, mouth).
During an IgE-mediated reaction to a food, rapid release Respiratory problems (rhinitis,
of chemicals in the body (e.g. histamine) occurs,
asthma, breathing difficulties,
resulting in symptoms sometimes within minutes but
swelling of the throat).
occasionally up to 2 or more hours after ingestion of the
offending food. Gastrointestinal problems
(nausea, stomach pain, vomiting,
diarrhoea).
p // 34
How Much is Too Much?
The range of minimum doses required to provoke a doses in the allergic population for some allergens
reaction in allergic people (thresholds) spans a very (6), making it possible to assess allergen risks
wide range, from micrograms to grams. Recent work quantitatively (7).
has helped to characterise the distribution of these
Distribution of minimun eliciting doses (thresholds) in peanut-allergic patients from allergy clinics
(from reference 6). The distribution shows that 10% of the tested population would react to about
17mg of peanut.
p // 35
Other Adverse Reactions Food Processing and
to Foods Involving the Allergenicity
Immune System
Because allergic reactions start with the recognition
Coeliac disease manifests itself as an immunologically of the allergen (protein), any process that modifies the
mediated, non-IgE reaction to gliadin, a prolamin (gluten structure of a protein will have the potential to affect
protein) found in wheat, and similar proteins found in allergenicity. Food processing induces several physical,
the crops of the tribe Tritiaceae (which includes other chemical and biochemical changes that are known to
cultivars such as barley and rye). It is an autoimmune potentially impact the allergenic potential of proteins.
disorder of the small intestine that occurs in genetically Certain methods of food processing may enhance,
predisposed people of all ages from middle infancy reduce, or eliminate the allergenic potential of a food (9).
onward. Symptoms include chronic diarrhoea, failure
to thrive (in children), and fatigue, but these may be Removal of the protein fraction of the food can
absent, and symptoms in other organ systems have reduce exposure to allergens sufficiently to prevent
been described. Over the longer-term, osteoporosis allergic reactions (e.g. highly refined seed oils). This
and other severe health effects have been reported. is recognised by the exemptions granted in the
labelling legislation. However, there are no general
rules regarding how different allergenic foods respond
to physical (i.e., thermal, mechanical), chemical, or
What is food Intolerance? biochemical processing methods. Consequently,
unless sound evidence exists that a specific processing
Food intolerance refers to adverse reactions to foods,
method reduces allergenicity, it should be assumed that
which do not involve the immune system and are
the allergenic potential of a processed food is identical
not usually the result of inherent toxicity, but of some
to that of the food in its unprocessed form.
characteristic of the food (pharmacological activity),
the affected individual (enzyme deficiency) or where
the cause is unknown. Although not usually immediately
life-threatening, such reactions can make the sufferer To find out more:
feel extremely unwell and can have a major impact on
Jackson WF (2003) food allergy. ILSI Concise
working and social life.
Monograph Series. ILSI Press, Brussels.
p // 36
References
6. Taylor, S.L., Crevel, R.W.R., Sheffield, D., Kabourek,
1. Kanny, G; Moneret-Vautrin, DA; Flabbee, J;
J., Baumert, J.(2009) Threshold Dose for Peanut: Risk
Beaudouin, E; Morisset, M; Thevenin, F (2001).
Characterization Based Upon Published Results from
Population study of food allergy in France. J Allergy Clin
Challenges of Peanut-Allergic Individuals,Food and
Immunol. 2001 Jul; 108(1): 133-140.
Chemical Toxicology 47, 1198-1204.
p // 37
Annex 2
Allergen Risk Analysis
and Management
p // 38
Allergen Risk Analysis and Management
Effective risk management of food allergens requires appropriately trained experts, such as members of
careful consideration of allergen presence, both HACCP teams, as an integral part of the manufacturers
intentional from the recipe, and unintended through quality and food safety system.
cross-contamination across all stages of food production
from farm to fork. The allergenic foodstuffs and their derivatives which
should be considered are those which have been
Allergen HACCP risk assessments will help to identify identified as of public health importance and require
where allergen hazards occur and whether the mandatory labelling, as outlined in EU legislation. The
existing systems can manage the potential risk under same approach could be utilised generically for other
normal operating conditions and good manufacturing allergenic foodstuffs.
practice. Such risk analysis should be undertaken by
Characterisation of potential risk from the presence Where practical and feasible, manufacturing processes
of allergens in the finished manufactured product should be modified to minimise the probability and extent
is a fundamental activity within any food operation of cross-contamination. Approaches for application of
HACCP and should be done for each individual food advisory labelling need to be developed.
handling site.
These stages of characterisation require information
There are several recommended steps for allergen risk as to allergen presence in the recipe and in potential
characterisation to ensure the necessary information is cross-contamination scenarios for all the allergens of
available, and the necessary assessment considerations concern to a significant level of detail. They also require
have been covered. Completion of these stages will allow a thorough understanding of the likelihood of cross-
a food operator to determine whether allergen labelling contamination, and demand evidence of the capability
is required for the finished product, identify the specific of manufacturing controls to remove/avoid cross-
allergen-derived foodstuffs which need to be declared, contaminating allergen presence.
and whether, despite good manufacturing practices
and allergen risk management controls, any additional The assessment described can also be used for
advisory warning might be required to provide further internal audits of allergen controls as a formal validation
risk communication to allergic consumers. form to support site specific HACCP programmes, for
evaluations of current manufacturing practices and
Advisory labelling for the unintentional presence of changes to them, for risk assessments when new
allergens should only be used when following a thorough allergen containing products are being introduced,
risk assessment, there is a significant probability of and for evaluation of the impact of changes to existing
allergen cross-contamination occurring at a level which products (e.g. changes in the allergen list) and changes
poses an unacceptable risk to allergic consumers. to processes.
p // 39
2. Stages of an Allergen HACCP Risk Analysis
2.1. Identify all allergens 2.1.2. Identify potential 2.2.1. List all the concerned
present on site opportunities for cross-contact products / processes / lines and
within suppliers operations their respective allergen profiles,
Aim: To identify allergen hazards (growing, harvesting, processing, all potential carry-overs, cross-
that may be introduced by food storage, transportation) contamination allergens and
or non-food materials, or by Does your supplier risk rework added to the processes /
food contact, and to determine assessment show likelihood lines.
the control mechanisms for the of cross-contact and can it be
Assess and reference all
identified hazards. quantified?
relevant raw materials, semi-
Can your suppliers procedures finished product and finished
2.1.1. Identify allergen presence
manage out this risk (cleaning, product specifications.
from materials intentionally
scheduling, dedication)?
added to the finished product A separate assessment is
recipe (either ingredients, required for each allergen to ensure
2.1.3. Repeat the above for any
additives, processing aids, cross-contact between different
allergenic derivatives that may be
rework and holdover, etc.). Fully allergenic ingredients is also
introduced via non-food/packaging
describe the name or type of addressed, not only that between
materials (either packaging
material, for example, flour is allergenic and non-allergenic
materials for raw materials, rework,
wheat flour. List carriers for foodstuffs.
holdover, finished product, or other
flavours, for example: lactose.
materials which become contact
materials during production or 2.2.2. Identify the areas where
Do the allergenic derivatives
during consumer use). potential cross-contact may
contain allergenic protein?
occur.
Are the allergenic derivatives 2.1.4. Do this for every food
Shared storage, handling, mixing,
particulates / pieces, or difficult to and non-food material present on
transportation.
manage, e.g. sticky, oily? site, including raw materials and
semi-finished ingredients. Cross-over / spillage points.
If so, assess whether procedures
are capable of managing the risk of Shared cleaning equipment.
2.2. Identify potential
cross-contact.
opportunities for cross-
Shared production / packaging
Do the identified allergens / contact within own operations
equipment and lines.
allergenic derivatives require (handling, storage, production
labelling on pack? processes, packing). Airborne cross-contamination.
p // 40
2.2.3. Construct an allergen Likely: likely under normal upon consumption of very low
cross-contact map for site. operating conditions. amounts, and to which a significant
number of consumers in Europe
Relevant HACCP documents or Unlikely: unlikely to arise but still are allergic; have been identified
forms may be used to assist. possible. by the European Food Safety
Authority (EFSA) and the European
When constructing a map all 2.4. Determine the allergen Commission as requiring risk
ingredients, materials, rework, work hazard rating of any identified management through mandatory
in progress, processes and flow allergen cross-contact on-pack declarations. These are
of people through manufacturing presence. listed in EU labelling legislation and
which may present a risk of
present a recognised risk of severe
allergen cross-contact should be Aim: To evaluate the severity of the allergic reactions to European
considered. risk identified. Taken together the consumers which requires risk
amount of hazardous allergenic management.
2.3. Assess each potential food potentially present, and the
issue identified in 2.2 against probability that they are present Other countries outside the EU have
critical elements per the table in the final product describe the different patterns of food allergy
in section 3 of this appendix overall level of risk requiring control. and therefore other / additional food
for compliance with the best
allergens should be considered for
practice considerations and When assessing risk associated those markets.
evaluate the probability for with allergens there are several key
cross-contact as likely or parameters which will influence 2.4.2. Allergen Protein
unlikely. judgment regarding the severity: Presence
amount of allergen (in practice
Aim: To determine the probability amount of allergenic protein) The protein component of the
that allergen cross-contact will allergen potency and prevalence, allergenic food is responsible
occur and ensure the control and physical form of allergenic for causing the reaction. Lower
measures used for the minimisation ingredients. protein content = lower allergenic
of the potential for cross-contact
potential. Materials with levels of
are practical and sufficiently robust 2.4.1. Allergen potency and protein below analytical detection
to be effective. The rationale for the prevalence would therefore generally present
evaluation should be documented.
low or very low risk potential.
Potency refers to the amount of
2.3.1. Are best practice allergenic food needed to provoke Some allergenic derivatives have
considerations in place? Are a reaction. been exempted from mandatory
there opportunities to improve
allergen labelling on-pack on the
risk management practices? Prevalence relates to the number basis of dossiers demonstrating the
of individuals in the population lack of allergic reactions upon food
2.3.2. What is the probability of who react to a specific allergen. challenge with these derivatives.
cross-contact occurring under Allergens which are known to These are listed in EU labelling
normal operating conditions? provoke severe adverse reactions legislation.
p // 41
Examples include highly refined Determination of the possibility It should be recognised that
oils derived from allergens such of particulate contamination ongoing verification of control
as refined soya bean oil, or highly should not automatically lead to a measures will still need to
processed allergen derivatives precautionary label. Assessment be undertaken, after allergen
such as wheat maltodextrin. These of the probability of such risk assessment has been
all have extremely low protein contamination, combined with completed and the requirements
concentrations, and therefore the factors described in earlier implemented, using a variety of
have low allergenic potential as sections, should be used to identify methods to ensure it is working
demonstrated in clinical studies. risk from the final product. effectively in practice. This may
include audit, data analysis and
2.4.3. Physical Form of 2.5. Determine whether review, or additional sampling and
Allergenic Ingredients appropriate control measures testing.
are currently in place or can
Particulates and fragments (nuts, be implemented to minimize 2.5.1. Identify control measures
seeds, chunks, solid agglomerates the risk of allergen cross- in place to manage allergen
etc.) will usually remain intact contact. cross-contamination using
and could potentially appear critical elements in Table 2 as a
as non-homogeneous (hot This is referred to as risk best practice guide.
-spot) contamination. This will management and determined
potentially deliver higher doses of through a process of monitoring, 2.5.2. Confirm effectiveness of
contaminating allergenic material to validation and verification. control measures assigned
the consumer. Readily dispersible for minimising risk of cross
contamination includes powders or Validation work should be carried contamination through robust
liquids in homogeneous form e.g. out and documented for each scientific validation.
milk powder, soya flour. These are control measure/combination of
likely to appear evenly distributed control measures. Cleaning is a 2.5.3. Confirm ongoing verification
throughout a product. Therefore commonly applied control measure procedures in place to assure
consideration needs to be given to as it usually provides the break allergen risk management
the form of the cross-contaminating between allergen-containing and practices are carried out and
material and the form of the non-allergen-containing products. remain effective.
product e.g. powder into powder, If the control measure has been
powder into liquid or particulates implemented previously, the results
into powder. from this historical work can be
used as an input into the validation
Therefore, the following risk potential study. Guidance on undertaking a
ranking for the cross-contaminating cleaning validation study is set out
material is suggested: in appendix 6.
Viscous Pastes
Liquid /
Particulates / Gels /
Powder
Agglomerates
p // 42
2.6. Determine risk 2.6.1. What should be
communication requirements mandatorily labelled in the
to identify any intentionally ingredients declaration on
present and unintentionally finished product pack?
present allergens for the
consumer. 2.6.2. Are any additional
advisory warnings of unintended
Aim: To provide the necessary presence needed? If so, for
information to consumers to allow which allergens?
avoidance of products containing
allergens. For further details on labelling
requirements see Annex 3 and 6.
p // 43
Table 2A Critical elements for HACCP Risk Analysis and Risk Management
p // 44
p // 45
p // 46
p // 47
p // 48
p // 49
4. Considerations for Risk Prevention
Following an analysis of food allergy incidents, the The checklists below in Table 2B are provided to act as
most common causes of allergen risk management a guide for food operators to verify that the likely causes
failure are considered to be (i) intended product in of these failures are considered and controlled within
intended pack that is wrongly labelled (ii) mismatch of their allergen risk management programme. They can
product to packaging, and (iii) unintentional presence also be used to support root cause analysis in the event
of allergen in product. of a food allergy incident.
p // 50
p // 51
p // 52
p // 53
p // 54
p // 55
Annex 3
Allergen Labelling
p // 56
Regulation (EU) 1169/20111 on the provision of food information to consumers considerably changes
existing legislation on food labelling, including information and requirements on allergens. The new rules
will apply from 13 December 2014.
The Regulation outlines requirements relating to allergens such as mandatory particulars, the labelling of
certain substances or products causing allergies and intolerances, additional voluntary information and
allergen labelling of non-pre-packed foods.
Summary
Substances or products causing allergies must be The following articles are relevant for aller-
indicated, also for non-prepacked foods; gen labelling 2:
Each ingredient or processing aid originating from a
Article 9.1(c): Mandatory particulars
substance or product causing allergies or intolerances
must be: Article 21: Labelling of certain substances
or products causing allergies or intolerances
- Indicated in the list of ingredients with reference Article 36.3(a): Additional voluntary allergen
to the name of the substance or product as labelling (may contain)
listed in Annex II;
Article 44.1(a) and 44.2: Allergen labelling
Emphasised through a typeset that distinguishes it of non pre-packed foods
from the rest of the list of ingredients; Annex II: List of substances or products
If no list of ingredients is provided, the substance or causing allergies or intolerances
product causing allergies or intolerances must be
indicated by means of contains + [substance(s)/
product(s)].
1 Regulation (EU) No 1169/2011 of the European Parliament
When the name of the food clearly refers to the and of the Council of 25 October 2011 on the provision of food
substance or product causing allergies or intolerances, information to consumers, amending Regulations (EC) No
it is not necessary to label the concerned substance 1924/2006 and (EC) No 1925/2006 of the European Parliament
or product. and of the Council, and repealing Commission Directive
The European Commission must systematically 87/250/EEC, Council Directive 90/496/EEC, Commission
re-examine and, where necessary, update the list Directive 1999/10/EC, Directive 2000/13/EC of the European
of substances or products causing allergies or Parliament and of the Council, Commission Directives
p // 57
Article 9.1(c): Mandatory particulars 21.1: PRESENTATION OF THE LABELLING OF
CERTAIN SUBSTANCES OR PRODUCTS CAUSING
In accordance with Articles 10 to 35 and subject to the ALLERGIES OR INTOLERANCES
exceptions contained in this Chapter, indication of the
following particulars shall be mandatory: Without prejudice to the rules adopted under Article
[] 44(2), the particulars referred to in point (c) of Article 9(1)
shall meet the following requirements:
(c) any ingredient or processing aid listed in Annex II or
derived from a substance or product listed in Annex II Food business operators must indicate the substances
causing allergies or intolerances used in the manufacture or products causing allergies or intolerances in the way
or preparation of a food and still present in the finished specified in the following sub-paragraphs.
product, even if in an altered form;
[] Where specific national measures have been introduced
by individual Member States on non-pre-packed foods
Food business operators must label any ingredient or with regard to the form of expression and presentation of
processing aid: the allergens that have to be provided on a mandatory
listed in Annex II; or basis (Art. 44.2), these precede over the requirements
derived from a substance or product listed in Annex II of Article 21.
The list of Annex II is outlined in Annex 3 to this (a) they shall be indicated in the list of ingredients in
Guidance. Labelling of these ingredients, processing accordance with the rules laid down in Article 18(1),
aids, substances or products causing allergies or with a clear reference to the name of the substance or
intolerances is obligatory when they are used in the product as listed in Annex II; and
manufacture or preparation of a food and are still present
in the finished product, even if in an altered form. The ingredients that according to the Annex II of
the Regulation are substances or products causing
Further rules on how to label are specified in Article 21. allergies or intolerances must be indicated in the list
of ingredients with a clear reference to the name of the
Article 21: Labelling of certain substance or product as listed in Annex II. Hence, there
are no changes in this respect compared to the current
substances or products causing
allergen labelling situation in Directive 2000/13/EC.
allergies or intolerances
(b) the name of the substance or product as listed
Article 21 is the main article covering allergen labelling.
in Annex II shall be emphasised through a typeset
It is structured as follows: that clearly distinguishes it from the rest of the list of
ingredients, for example by means of the font, style or
21.1: Presentation of the labelling of certain
background colour.
substances or products causing allergies or
intolerances
The name must be emphasised through a typeset
21.2: Systematic re-examination and possible different than that from the rest of the list of
update of the list of substances or products causing ingredients, for example by means of the font, style
allergies or intolerances or background colour.
p // 58
Emphasis may best be achieved by indicating the
ingredients concerned in bold in the list of ingredients.
Examples:
However, food business operators may use other ways
of emphasis, amongst others, for reasons of technical Strawberry-flavoured soy drink, where soy
feasibility, be it those mentioned in the provision (font, lecithin is used in the flavour;
style, background colour) or others.
Wheat flour;
In the absence of a list of ingredients, the indication of All dairy products, e.g. cheese, yoghurt,
the particulars referred to in point (c) of Article 9(1) shall cream, butter, as it is clear that they are
comprise the word contains followed by the name of the derived from milk (see Annex XII and XIII of
substance or product as listed in Annex II. Reg. 1234/2007 for further explanation on the
definition and designation of dairy products);
When no list of ingredients is given (e.g. for glass Tuna pat.
bottles intended for reuse which are indelibly marked
and which therefore bear no label, ring or collar), the
word contains followed by the name of the substance Furthermore, in those cases where the name of the
or product causing allergies or intolerances must be ingredient clearly refers to the substance or product
indicated. causing allergies or intolerances, it is also not required to
label the concerned substances or products. The name
Where several ingredients or processing aids of a food of the food is the legal name of the food as determined
originate from a single substance or product listed in Article 9.1(a) and Article 17. For example, when the
in Annex II, the labelling shall make it clear for each name of the food contains words such as yoghurt,
ingredient or processing aid concerned. cream, butter, cheese etc., it is clear for the consumer
that these products contain milk.
Where the food contains several ingredients or
processing aids that originate from one substance or 21.2: SYSTEMATIC RE-EXAMINATION AND
product causing allergies or intolerances, the operator POSSIBLE UPDATE OF THE LIST OF SUBSTANCES
must either repeat the reference to the substance or OR PRODUCTS CAUSING ALLERGIES OR
product as many times as it is present or choose any INTOLERANCES
other presentation which makes clear that different
ingredients or processing aids originate from one single In order to ensure better information for consumers
allergen. and to take account of the most recent scientific
progress and technical knowledge, the Commission
The indication of the particulars referred to in point shall systematically re-examine and, where necessary,
(c) of Article 9(1) shall not be required in cases where update the list in Annex II by means of delegated acts,
the name of the food clearly refers to the substance or in accordance with Article 51.
product concerned.
p // 59
The European Commission must systematically Food information provided on a voluntary basis
re-examine and, where necessary, update the list shall meet the following requirements:
of substances or products causing allergies or
(a) it shall not mislead the consumer, as referred to
intolerances.
in Article 7;
Here, it needs to take into account:
(b) it shall not be ambiguous or confusing for the
the objective of ensuring better information for consumer; and
consumers; and
(c) it shall, where appropriate, be based on the
the most recent scientific progress and technical relevant scientific data.
knowledge, supported by an EFSA Opinion.
Article 36.3(a): Additional voluntary According to Article 36.3(a), the European Commission
allergen labelling (may contain must adopt implementing measures detailing the
information on the possible and application of the requirements related to voluntary
unintentional presence of substances information on may contain labelling (i.e. the possible
or products causing allergies or and unintentional presence in food of substances
intolerances) or products causing allergies or intolerances).
FoodDrinkEurope supports the development of
Article 36 covers the applicable requirements for European guidance related to may contain labelling.
voluntary food information and the implementing
measures that the European Commission needs to take
on the application of the requirements.
p // 60
Article 44.1(a) and 44.2: allergen Of particular relevance for allergen labelling is Article
44.1(a), which specifies that information concerning
labelling of non pre-packed foods
allergens must be available for non-prepacked foods.
p // 61
Annex II of Regulation (EU) 1169/2011: substances or products causing allergies or intolerances
is obligatory when they are used in the manufacture or
List of Allergens and Exemptions
preparation of a food and are still present in the finished
product, even if in an altered form.
It is important that information on the presence of foods
proven to produce an adverse allergenic or intolerance
Note: This list will be systematically re-examined and,
reaction should be available for sensitive consumers,
where necessary, updated taking into account the
to make informed choices which are safe for them. The
objective of better information for consumers and
list of allergenic foods and foods causing intolerance
the most recent scientific progress and technical
which require mandatory declaration in the EU is found
knowledge.
in Annex II of Regulation (EU) No 1169/2011, see
below. Labelling of these ingredients, processing aids,
1 Cereals containing gluten, namely: wheat, 7 Milk and products thereof (including
rye, barley, oats, spelt, kamut or their lactose), except:
hybridised strains, and products thereof,
(a) whey used for making alcoholic distillates
except:
including ethyl alcohol of agricultural origin;
(a) wheat based glucose syrups including
(b) lactitol.
dextrose1;
8 Nuts, namely: almonds (Amygdalus
(b) wheat based maltodextrins1;
communis L.), hazelnuts (Corylus avellana),
(c) glucose syrups based on barley; walnuts (Juglans regia), cashews (Anacardium
(d) cereals used for making alcoholic distillates occidentale), pecan nuts (Carya illinoinensis
including ethyl alcohol of agricultural origin. (Wangenh.) K. Koch), Brazil nuts (Bertholletia
2 excelsa), pistachio nuts (Pistacia vera),
Crustaceans and products thereof;
macadamia or Queensland nuts (Macadamia
3 Eggs and products thereof; ternifolia), and products thereof, except for
nuts used for making alcoholic distillates
4 Fish and products thereof, except: including ethyl alcohol of agricultural origin;
(a) fish gelatine used as carrier for vitamin or
9 Celery and products thereof;
carotenoid preparations;
(b) fish gelatine or Isinglass used as fining 10 Mustard and products thereof;
agent in beer and wine.
11 Sesame seeds and products thereof;
5 Peanuts and products thereof;
12 Sulphur dioxide and sulphites at
6 Soybeans and products thereof, except: concentrations of more than 10 mg/kg or 10
(a) fully refined soybean oil and fat1; mg/litre in terms of the total SO 2 which are to
be calculated for products as proposed ready
(b) natural mixed tocopherols (E306),
for consumption or as reconstituted according
natural D-alpha tocopherol, natural D-alpha
to the instructions of the manufacturers;
tocopherol acetate, and natural D-alpha
tocopherol succinate from soybean sources; 13 Lupin and products thereof;
(c) vegetable oils derived phytosterols and 14 Molluscs and products thereof.
phytosterol esters from soybean sources;
1 And the products thereof, in so far as the process
(d) plant stanol ester produced from vegetable
oil sterols from soybean sources. that they have undergone is not likely to increase the
level of allergenicity assessed by the Authority for the
relevant product from which they originated.
p // 62
p // 63
Annex 4
Allergen Change Over
(Cleaning/Flushing)
Validation
p // 64
Purpose Definitions
This annex provides guidance on how to validate Validation: Confirmation by examination and through
change-over practices (cleaning, flushing) where provision of objective evidence that the allergen
on common food manufacturing equipment and to Verification: Confirmation by examination and through
determine quantitatively the level of carryover in order the provision of objective evidence that the requirements
to assess and, if necessary, mitigate the resulting risk. of the allergen change-over are applied at all times.
p // 65
The validation should be considered part of the plants Validation of all individual lines might not be necessary,
HACCP programme and repeated on a regular basis (for if they are essentially of the same design. Different lines
example, every two years), and if changes in formulation, might need to be assessed individually depending on
process, equipment or change-over procedure occur. the nature of the differences in the design and how
The documentation should be maintained at each these will affect cleaning and carryover effectiveness.
manufacturing location.
CHANGE-OVER No Update
(CLEANING/FLUSHING) Flow diagram accurate? the flow
diagram
VALIDATION Yes
No
No
Samples meet
acceptable criteria?
Yes
No
Samples meet
acceptable criteria?
Yes
Validation completed
p // 66
I Guideline for Physical Validation
1. A flow diagram showing all areas may be used for training 6. Once the physical validation
equipment associated with the purposes and placement in the is complete, the cleaning protocol
process used to manufacture cleaning procedure as appropriate. and pre-operation checklist
product on a production line should be used for each allergen
should be developed. Equipment 3. Existing documentation, like changeover.
that comes in direct contact cleaning procedures (including
with allergens as an ingredient specific instructions for 7. If validated commercial
or finished product should be disassembly), pre-operation check allergen test kits are available for
highlighted. Components through sheets, HACCP check sheets, post the allergen(s) (marker protein),
which product or ingredients do cleaning check sheets, should be the analytical validation step as
not flow, but where material can updated by utilising the information described in Section II should
accumulate must be included gathered above. follow.
(e.g. vacuum filters in pneumatic
transport systems). Highlighted 4. The updated detailed pre-
areas should receive a detailed operation inspection sheet should
allergen cleaning and a visual be validated by a physical walk
inspection or a cleaning combined through of the line, with trained
with flushing where areas exist, employees who are knowledgeable
which cannot be accessed for about manufacturing, quality and
cleaning and inspection. By the allergen change over process.
utilising the flow diagram, a Corrections should be made as
walkthrough of the production needed in the pre-operation form
line during the cleaning process to account for any learning.
(with cleaning procedure) with
employees knowledgeable about 5. Relevant cleaning parameters
the cleaning and manufacturing should be documented in the
process should be undertaken to cleaning procedure to assure
ensure completeness. removal of allergens and this
should be considered as part of
2. Equipment that will need the cleaning protocol needed for
disassembly, special attention, an effective allergen clean (e.g.
or access to be cleaned and caustic wash at 2 % v/v, 75C, for
where sampling for the analytical 10 minutes). When the equipment
validation shall be done should cannot be inspected after cleaning,
be identified and made note of. adherence to these parameters
Specific steps or actions needed should be verified after each
to effectively clean the line must cleaning, for example, for complex
be included in the change-over CIP (clean in place) installations.
procedure. Photographs of the
identified difficult to clean or access
p // 67
II Guideline for Analytical Validation
1. The validation sampling should be cleaned for the allergen sanitising of the swabbed surfaces
meet acceptable criteria for changeover (after sampling is required.
three (3) consecutive runs. In the production will be resumed with a
c) If an external lab is used,
absence of operational actions similar allergen profile). If this is
swabs should be kept cool during
limits (e.g. VITAL) for the specific not possible, the samples should
shipping and tested within 24
allergen all test results should be be analysed as soon as possible,
hours. Shipping information should
less than the limit of quantification and either the test results awaited
be obtained from the lab before
(LOQ) of the specific validated, before resuming production or
sampling.
quantitative test method. the product placed on hold until
the results are available. Another d) NOTE: Though delivering
2. If contamination is deemed to alternative would be to clean the quantitative results, surface
be non-homogeneous the number line a second time and re-check it. swabbing is a comparative method
of samples per validation should and should not be done in isolation
be increased to maximise to 5. When the allergen validation is from product or rinsate testing. It
probability of detecting residual performed the product containing might be that swabs will be positive,
contamination. This may include the allergen should be tested for the while the first product through
a combination of swabbing and presence of the allergen. Therefore the line will meet acceptable
product/flushing mass testing. If a pre-cleaning sample should be criteria. In risk assessment terms,
the physical constitution of the taken as a positive control. This will the important consideration is
contaminant will not allow for serve to ensure that the test kit is the extent to which any residue
representative samples (large effective in detecting the specified transfers to the product.
pieces, chunks), analytical testing allergen.
is not recommended. Instead a 1.2. Rinsate (e.g. CIP, crate
quantitative risk assessment should 6. Options for sampling and testing washing machines, manual foam
be done by evaluating the amount are: cleaning regimes)
of pieces or chunks, their size and
their distribution in a sample along 1.1. Swabs (surfaces) a) Two representative (e.g. covering
with an estimate of the occurrence. all CIP loops) rinsate samples from
a) For product contact surface
the final rinse should be collected
swab samples (10 cm X 10 cm) are
3. Disinfection agents may interfere to be taken after the line has been
and tested.
with analytical tests and should be
cleaned. b) For testing purposes, the pH is
rinsed off before sampling. Labs or
required to be between 6.0 and 8.0.
kit suppliers should be consulted to b) Take swab from representative
If the pH is outside these limits, it
confirm. product contact locations. Target
is required continue to rinse the
surfaces on a worst case scenario
system until the pH of the final rinse
4. To minimise potential product basis (difficult to clean, rough or
is 6.0 8.0. If the final rinse does
hold in case of results not meeting pitted surfaces/welds, bends or
not fall in that range, the final rinse
acceptable criteria, there is the anywhere where the product could
time needs to be revised.
option to simulate a changeover by hang up). If swabbing buffers
cleaning as the line would normally contain additives, a re-clean or
p // 68
c) Testing should be done within b) If samples are taken at various c) The validation is passed, if at
24 hours. If samples need to be times, the validation is passed if minimum the last two samples (with
shipped to an external laboratory, at minimum, the last two samples the examples above: after 5 and 10
they should be collected, stored (with the examples above: after 5 minutes) meet acceptable criteria.
and shipped to avoid degradation, and 10 minutes) meet acceptable
d) Time and amount of material
for instance by using a refrigerated criteria based on agreed reference
utilised for the flushing should be
courier. values. All products tested before
recorded and documented and the
those two samples shall not be
allergen change over procedure for
1.3. Final Product used as finished product for the
future production runs should be
product of concern.
An appropriate sampling plan changed accordingly.
should be developed and applied,
1.4. Flushing with inert material
and its performance and limitations
(e.g. product, salt, sugar)
clearly understood.
a) Perform a cleaning first to remove
a) Samples of the finished product
as much residue from product
from first product coming off the
contact surfaces and adjacent
line should be taken. Depending
areas as possible.
upon product type and situations
(e.g. held-up areas down the line) b) Once the line starts, collect
the number of samples and times first flushing material samples at
when samples are taken may vary. reasonable intervals after start up,
As an example: samples taken at as an example after 1.5 and 10
0,1, 5 and 10 minutes, minimum 3 minutes.
samples per time-period (for a total
of about 1 kg/time period).
p // 69
Annex 5
Allergen Analysis
p // 70
Introduction The Analytical Laboratory
This annex is intended to give an overview of the Laboratories conducting analysis of allergens should be
analytical techniques and protocols that can aid appropriately equipped, have the facilities to perform
decision-making in the management of allergenic/ this type of analysis and have staff trained accordingly.
foodstuffs or those causing intolerances. However, due Any laboratory performing such analysis should be
to the complex nature of food products and the broad accredited according to ISO 17025, and additionally,
range of food business operators, the annex will not specifically accredited for the methods it performs.
cover specific analytical questions. It should also be able to demonstrate regular and
successful participation in proficiency tests for these
Analytical techniques used for detecting the presence methods.
or absence of residual or cross-contaminating
allergenic or intolerance substances vary. A visually The laboratory should handle all tasks according to
and physically clean standard forms the basic starting Good Laboratory Practice or equivalent guidelines.
point for allergen management and can provide a good
basis for safe operation once it has been validated and Additional laboratory requirements specific to the
periodically verified, using one (or more) of the methods methodologies used will be described in the appropriate
described. Absence of an allergen above a specified section of this annex.
detection limit on visually clean equipment can be used
as the basis for a limited quantitative risk assessment if It is good practice before a laboratory is tasked with
the sampling is representative. analysis to obtain confirmation on its ISO 17025
accreditation for allergen analytical methods as well
The methods and techniques mentioned can also as several results from proficiency test programmes for
aid in the confirmation of material composition, batch allergens (e.g. FAPAS1) should be requested.
qualification and to contribute to the due diligence of
any product claims. Analytical techniques for allergen
analysis continue to be developed and it is advisable for
all users to keep up-to-date with Regional and National
initiatives on methods, matrixes and analytic validation.
p // 71
it has not previously analysed. Ideally, manufacturers
Food Matrices should provide a control sample of the matrix in which
cross-contact allergen is to be measured, which is know
Food matrices can have a significant impact on the
not to contain the allergen under investigation. This
analytical result. Also, the choice of methods and
sample serves to check for the presence of the allergen
sampling procedures often depend on the information
in the raw materials and to demonstrate spiking with
regarding the food matrix.
and recovery of the allergen.
p // 72
Samples should be taken using clean equipment, If the allergen containing product is likely to spread
preferably single use spoons or spatulas. Samples beyond the immediate production equipment (e.g.
should be placed in clean, also preferably single powder or spray), the risk areas should be swabbed to
use, containers to avoid false positive results through identify any possible contamination.
contaminated sample equipment and storage
containers. Samples should be sent to the laboratory For dry manufacturing processes, it may be more
in conditions that prevent deterioration of samples. Dry appropriate to monitor levels of allergen contamination
samples tend to be less susceptible to deterioration using settle plate or air monitoring samples.
compared to liquid or moist samples. While the
former can be sent without chilling, the latter should, To confirm the effectiveness of cleaning, quantitative
depending on the expected transport time, preferably analysis is required, showing the reduction of allergen
be sent chilled. after cleaning. Care has to be taken as some cleaning
agents can negatively influence the ELISA and PCR
leading to false negative results. Before cleaning
Type of Samples: validation, the laboratory should be consulted to advise
on possible adverse effects of cleaning agents.
The type of sample taken for analysis will ultimately
depend on the specific activity being monitored and b) Cleaning validation samples: Heterogeneous
the manufacturing environment. This can be broadly Cross-Contamination Assessment.
categorised as follows:
Environmental Swabs monitoring residual allergens In the event that the risk of allergen contamination
on food contact surfaces. is deemed to be heterogeneous (particulates, nuts,
seeds etc.), the approach outlined in section (a) also
Purge Materials/ Flushing Mass monitoring system needs to include a detailed visual inspection and
where wet cleaning is not appropriate. physical strip down of equipment. This will highlight
Air Samples/ Settle Plates used to monitor dusting. those points in the process where more rigorous
sampling is required. For further guidance refer to the
CIP Rinsate used to monitor effectiveness of annex on cleaning validation.
clean-in-place systems.
p // 73
Technology According to Technologies in Detail -
Purpose Advantages and
Generally, protein or peptide detecting methods are
Disadvantages
to be preferred over DNA detection methodologies
Protein Based Methods
(usually polymerase chain reaction, PCR) since the
presence of DNA may not indicate the presence of
Since all food allergens listed in annex IIIa of 2007/68/
allergenic protein, and a negative PCR result may not
EC are, with the exception of sulphur dioxide and
indicate the absence of protein3.
sulphites, proteins, protein is the primary analyte that
should be targeted. Protein based methods can be
divided into two groups: immunological methods and
Technologies Recommended protein separation methods. Immunological methods
for Typical Purposes are antibody-based, i.e. an antibody, similar to the one
causing the allergic reaction in humans, detects the
proteins. Typical methods are ELISA (Enzyme Linked
For validation of cleaning processes, or for ingredient
Immuno Sorbent Assay) and LFD (Lateral Flow Device;
or finished product testing enzyme linked immune-
commonly known as dipstick/ rapid lateral flow devices).
sorbent assays (ELISA) should be used as the technique
Immunological methods are long established in many
is generally quantitative.
routine laboratories and are the method of choice for
For routine cleaning verification checks, LFDs can industry and regulatory bodies because of the specificity
be used on site but should be supported by regular and sensitivity of the antibodies. They are used in
confirmation by ELISA. food industry laboratories and by official food-control
bodies to detect and quantify allergens present in food.
In case of ambiguous results by a protein-based
Protein separation methods like mass spectrometry
method, PCR results can serve as a secondary
(MS) are based on the separation of proteins or their
confirmatory check. However, this typically only makes
fragments (peptides) due to their variable size and
sense, due to PCR sensitivity for certain allergens, when
charge. They are mostly used as an alternative method
ELISA results are higher than 10-20 mg/ kg (ppm).
of analysis when an ambiguous result is recorded by
PCR should only be used where no other protein other methodology. Recent developments in LC MS-MS
detection technology is available (e.g. celery detection methodology have shown encouraging results, and in
or tree-nuts other than almond, hazelnut, walnut). the future, it is likely that it will serve as a confirmatory
method for the analysis of formal samples.
Mass spectrometric methodology, as it is not a routine
technology yet, should be used where secondary
confirmatory checks are required where results differ
3
using conventional methodology. NOTE: The European Directive 2007/68/EC for the
labelling of food allergens does not differentiate between
LFD should be used on site for routine cleaning proteins and other compounds (e.g. metabolites or
validation checks and can also be used for release DNA). Any derivative requires labelling if part of the
testing of finished products. ingredient list
p // 74
ELISA Lateral Flow Devices (LFD)
ELISAs have been much favoured in allergen analysis. LFDs (also called dipsticks) are a rapid immune-
The specificity and sensitivity of ELISA technology, chromatographic technique, available as a single-
with limits of detection or quantification at low mg/ use format device that allows qualitative detection
kg level, make it a simple tool for allergen detection of the allergen. The typical LFD is a colorimetric test
and quantification, allowing relatively fast and high that contains a control line (ensuring the validity of the
throughput analysis. It is widely used in food industry assay) and a test line, which determines the presence/
laboratories and by official food-control bodies to detect absence of the target allergen. These assays are
and quantify allergens present in allergenic food or typically used on site for rapid analysis (typically
commodities. So far, ELISA test kits validated for defined absence of allergen). While the costs of LFDs are lower
matrices include peanut (in cereals, cookies, ice cream than ELISA, they provide only a yes/ no answer. In some
and chocolate; under the auspices of AOAC and EC instances, results may vary depending on the LFD lot
JRC, Park et al 2005, Poms et al 2005) and hazelnut (in used. Therefore a regular comparison of LFD with ELISA
cereals, ice cream and chocolate; under the auspices of results is recommended.
the German Federal Office for Consumer Protection and
Food Safety, BVL). However, many others are routinely LFDs should be used when quick on-site presence/
used by food laboratories. absence checks for individual allergens need to be
performed as part of the continuing risk assessment.
It is important to realise that ELISAs have some
drawbacks: these include that only one target allergen
can be detected/quantified per test, i.e. a composite
food containing potentially 5 allergens require 5 different
ELISA assays which may provide a resource challenge.
In addition, several companies offer antibody kits for the
same allergen, all with somewhat different specificities
and sensitivities. This can generate divergent results
if the same sample is tested using two different kits.
Frequently found differences are between ELISA kits for
the detection of gluten. Here, alternative methods like
MS could be used for confirmation.
p // 75
Mass Spectrometry (MS) DNA Based Methods
In the near future, MS methods will likely play an important The most popular DNA-based techniques are PCR
role, providing a viable alternative confirmatory method and real-time PCR. Both are used qualitatively for
since MS has the potential to directly detect proteins/ the detection of food allergenic compounds. These
peptides (and therefore, the hazard itself) at low levels techniques typically amplify a part of the species-
similar to those achieved by ELISA and PCR. The high- specific- or allergen-encoding DNA sequence.
test potential of mass spectrometry lies in its capability
to analyse multiple targets (multiple allergens) in The detection of food allergens by DNA-based
a single analysis (the so-called screening). This techniques is controversial because they do not detect
distinguishes mass spectrometry from ELISA, and as the target protein but the marker DNA that may or may
a direct detection tool, from PCR. Another advantage not correlate with the amount of the allergen in the
is that, unlike antibody based technologies, processing food product. Examples are those food components
has a lesser impact since MS detects the weight, not that are formulated with protein-rich ingredients,
the structure which is often changed during processing. e.g. egg- or milk powder. The quantity of DNA in the
The accurate detection of the allergen relies on the sample, the presence of interfering compounds in
identification of peptide fragments which are cleaved the DNA preparation as well as its quality determines
by the enzyme trypsin during sample extraction. the success of the assay. An advantage of PCR over
Studies on highly processed foods where the peptides ELISA is that all the assay components are available
become highly modified, can impede the cleavage of commercially and it is easy to develop. PCR is the only
the peptides and hence detectability of the allergen. As alternative for those regulated allergens for which ELISA
with other methods matrix validation must be conducted is not available (e.g. celery). One of the drawbacks of
to provide confidence in the analytical results. PCR detection is that DNA is highly unstable in acidic
environments (e.g. tomato sauce). Here, protein or
MS also has the potential to be semi- or fully automated peptide based assays should be used if at all possible.
potentially allowing high throughput of samples. As with Also, issues can arise in laboratories from cross
any new methodology, its future application on analysis contamination when small amounts of target DNA from
of food allergens is still somewhat restricted due to high previous assays contaminate the PCR mix and generate
equipment costs and the need for specialist expertise false positive results. Other issues are found with animal
in method development. However, easy-to-use toolkits products which trigger allergic responses while others
are already in the pipeline by several major equipment from the same animal, do not. As an example, PCR
manufacturers, essentially simplifying the use of the analysis cannot distinguish between DNA originating
methodology for the non-expert user. from non-allergenic beef meat and allergenic milk,
or non-allergenic chicken meat and allergenic egg4.
Laboratories operating PCR equipment should have
at least four separate areas, ideally separate rooms for
sample preparation, PCR mix preparation, PCR and post
PCR handling (e.g. gel electrophoresis)5. Therefore,
PCR analysis should only be requested where needed
and the laboratory conducting the analysis should have
geographically separated areas to minimise the risk of
cross-contamination with amplified DNA.
p // 76
DNA methods should be used if no alternative protein
methods are available or as supporting information to
confirm ELISA/ LFD results when contamination levels
of 10mg/ kg (ppm) or higher are expected.
p // 77
Analytical Technologies at a Glance
All techniques can be prone to interferences (false positive/
negative), which is why rigorous validation is required.
p // 78
p // 79
Annex 6
Gluten-Free Foods
p // 80
This annex provides an overview of the rules governing the use of claims to indicate the suitability of
foods for people intolerant to gluten and the compositional requirements that must be met in order to use
such claims.
It must be noted that the legislative framework covering the rules on the composition and labelling of
foodstuffs suitable for people intolerant to gluten is currently being reviewed by the European Commission.
The location of the gluten provisions will be affected by this review. Further information is provided in
section 3 below.
a) Background b) Purpose
Prior to this Regulation there were no legally defined This Regulation aligns EC legislation with the new
compositional standards for gluten- free foods, Codex Standard. Harmonisation at an EU level of the
however manufacturers were encouraged to work to conditions under which the terms gluten free and
the international standard set by Codex Alimentarius. very low gluten can be used will ensure a high level
This standard was recently revised to take account of of protection for people intolerant to gluten. In addition,
the latest scientific advice. The new standard2, adopted consistent labelling will help consumers with different
in July 2008, sets a maximum level of 20mg/kg of sensitivities to gluten to make informed choices about
gluten in order for food to be labelled as gluten free, the foods that are most suitable for them.
and 100mg/kg of gluten for foods labelled as very low
gluten- restricted to foods processed to remove gluten. c) Scope
Use of the term gluten- free is permitted by Regulation The Commission Regulation applies to all foods
(EC) No 41/2009 which applies to food for people (including alcohol, food supplements, etc.), pre-packed
intolerant to gluten. Coeliac disease is a permanent and non pre-packed, except infant formulae and follow-
food intolerance, where scientific evidence has shown on formulae. However, the PARNUTS Framework
that very low amounts of gluten up to 20 mg/kg are safe Directive states that PARNUTS3 shall only be sold pre-
to these consumers. Gluten-free foods may, therefore, packed, unless Member States provide exemption from
contain levels of gluten, which are above the limit of this rule.
detection of the analytical tests used, but less than the
new Codex Standard for gluten- free foods of 20mg/kg.
1 EC Regulation 41/2009/EC concerning the composition and labelling of foodstuffs for people intolerant to gluten:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:016:0003:0005:EN:PDF
2 CODEX STAN 118-1979: http://www.codexalimentarius.net/download/standards/291/cxs_118e.pdf
3 Parnuts are foodstuffs which are intended for particular nutritional uses, which owing to their special composition or manufacturing
process are intended to satisfy the particular nutritional requirements of specific groups of the population.
p // 81
The Commission Regulation applies to the labelling, the final consumer. The term very low gluten can only
presentation and advertising of foods. Therefore, the be used for PARNUTS foods, prepared specifically for
provisions related to the use of the claims very low those intolerant to gluten, and with a level of between
gluten and gluten free do not apply solely to the 20mg/kg and 100mg/kg in the food as sold to the final
labelling of foods but also to any form of advertising consumer. A flow chart to help you to determine the
and presentation, which includes, for example, most appropriate claim for your product is enclosed as
off-pack labelling, such as websites, leaflets, product Figure 1.
lists, customer care lines and shelf labels.
The term suitable for coeliacs (or logos which
are intended to indicate this) can only be used in
When the claim gluten- free is used, this must not
conjunction with the claims permitted by the Regulation
mislead the consumer by suggesting that the particular
(i.e. alongside gluten free or very low gluten).
food is special in having that property, when all other
foods of that type are also gluten free. These new rules came into effect on 9 February 2009.
Manufacturers had until 1 January 2012 to comply with
the new requirements, but were allowed to use the new
d) Requirements
terms from February 2009, provided that the products
Under this Regulation, the term gluten-free may only comply with the compositional criteria. Products that
be used for PARNUTS foods or normal foods4 with a did not comply by 1 January 2012 should have been
level of gluten below 20mg/kg in the food as sold to removed from the market.
www.eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:124:0021:0029:EN:PDF
Foods specially prepared for people intolerant to gluten making either gluten-free or very low gluten claims must be
notified to the relevant authority when placed on the market for the first time. This is because of an EC obligation to
monitor the market. It is therefore the responsibility of the manufacturer, or in the case of imported foods, the importer,
to notify the relevant authority whenever products are marketed in one or more Member States. Notification is required
in each country in which the product is marketed.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:304:0018:0063:EN:PDF
The allergen labelling rules continue to apply alongside rules for gluten free claims. These rules require products
containing gluten-containing cereals to make this clear on the label. This may be in the ingredients listing or, in the
absence of a list of ingredients, in a statement prefixed by the word contains.
p // 82
Figure 1: How to label your product if you would like to make a claim
about its suitability for people intolerant to gluten
STEP 1
Is your product a
Parnuts food, which has
been specially prepared
to meet the dietary
needs of people
intolerant to gluten and
marketed a such?
STEP 2
Does your product STEP 2B
contain 20mg/kg or Does your product
less either through YES NO contain 20mg/kg
substitution of a or less gluten?
gluten-containing
ingredient and/or use
of a gluten-reduced
ingredient?
STEP 3
YES NO Does your product
contain 100mg/kg You may label your YES NO
You should label your Your product cannot be
or less gluten and product gluten free labelled gluten free
product gluten free contain a No claim can be made
gluten-reduced about its suitability for
ingredient? people with coeliac
disease
4 Normal Foods or foods for normal consumption have not been processed, manufactured or prepared in a way to meet the
specific needs of people with a particular nutritional requirement, e.g. malt vinegar, a cereal bar that is traditionally made with
puffed rice.
p // 83
3. Review European PARNUTS Legislation
a) General b) Rules Covering Gluten-Free Labelling
The European institutions, on the basis of a proposal The initial Commission proposal suggested that the
submitted by the Commission as part of its on-going existing gluten-free foods governed by Regulation
programme of simplification and reducing legislative (EC) 41/2009 move under the general food law with no
burden, are reviewing the current Framework Directive special provisions.
on PARNUT foods (Directive 2009/39/EC).
Following intensive discussions around this issue,
This proposal for a Regulation5 on food intended for the European institutions ultimately decided to move
infants and young children and on food for special the provisions of Regulation 41/2009 into the revised
medical purposes repeals the provisions of Directive Food Information to Consumers Regulation, taking into
2009/39/EC (the majority of the provisions laid down account that coeliacs are vulnerable consumers who
date back to 1977) and intends to address the difficulty require more specific provisions.
experienced by consumers in making an informed
choice between dietetic foods, fortified foods, foods A specific recital has been included in the last
bearing claims and foods for normal consumption. The compromise text ensuring the future labelling
proposal abolishes the concept of dietetic foods for the differentiation between specially formulated gluten free
benefit of the expression specialised nutrition. products and those for general consumption, via the
adoption of delegated and implementing acts.
The adoption and entry into force of updated European
legislations as, inter alia, Regulation 1924/2006 on
nutrition and health claims made on foods, Regulation
1925/2006 on the addition of vitamins and minerals and
other substances to food and Regulation 1169/2011
on the provision of food information to consumers, is a
additional factor making necessary the thorough review
of Directive 2009/39/EC.
5 European Commission Proposal for a Regulation on Food Intended for Infants and Young Children and on Food for Special
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