Trends in Food Science & Technology 21 (2010) 619e625

Viewpoint

* Corresponding author.

0924-2244/$ - see front matter � 2010 Elsevier Ltd. All rights reserved.doi:10.1016/j.tifs.2010.09.004

A vision for allergen

management best

practice in the food

industry

R. Ward, R. Crevel, I. Bell,

N. Khandke, C. Ramsay and

S. Paine*

Food and Drink Federation Allergens Steering Group,

6 Catherine Street, London, WC2B 5JJ, UK

(Tel.: D44 207 420 7138; fax: D44 20 7379 8538;

e-mail: selina.paine@fdf.org.uk)

Allergenic foods have become recognised as a food safety

hazard over the last two decades. Over the same period,

knowledge about the biology and clinical characteristics of

food allergy has grown, together with information that can

be used to assess the risk more accurately. While current prac-

tices in allergen management have increased the safety of food

products to allergic consumers, the standards applied by differ-

ent manufacturers remain divergent in the absence of agreed

approaches to risk assessment. This has been reflected in a con-

siderable expansion of precautionary labelling and a concom-

itant reduction in consumers’ trust, resulting in risk-taking. To

address these issues, this paper advocates a risk management

approach based on a common agreed set of principles, leading

to consistent and well-understood management action levels

across the food industry. The approach also recognises that

minimising the risk from allergenic foods is a shared responsi-

bility of all the stakeholders involved. Action levels, by permit-

ting a consistent use of precautionary labelling and clear

communication of the allergen status of a food, will play a cru-

cial role in ensuring that risks from allergenic foods are re-

duced as far as possible.

BackgroundThe concept of managing food allergens as a food safety

risk emerged in the last decade of the 20th century and hasmatured considerably over the last 10e15 years. Allergenmanagement has evolved in line with the growing knowledgeand understanding of the issue. Initially, little was knownabout the key determinants of risk; namely how sensitivityand reactivity to allergens varied across the susceptible pop-ulation, and in response to the dose consumed. Knowledgeof the numbers of consumers affected was also almostnon-existent, even for the best-studied allergenic foods,such as peanuts.

Industry’s approach to date has been based around exist-ing Good Manufacturing Practices (GMPs) assuring segrega-tion of allergenic ingredients and systematic declaration ofallergens on labels where mandated. However, more needsto be done to minimise risk and to provide allergic con-sumers with consistent risk communication and a widechoice of products. Application of allergen managementprinciples is still inconsistent. Individual manufacturers arecurrently interpreting risk in the supply chain differently,as there are no agreed approaches to perform risk assessmentto a common standard.

In the absence of knowledge about the levels of aller-gens required to provoke adverse reactions, many manufac-turers have adopted a purportedly “fail-safe” approachusing precautionary labelling. Initially welcomed as helpfulby allergic consumers, the increasing and inconsistent useof this type of warning across product types and sectorshas considerably lessened its impact as a risk reductiontool (Sampson, Munoz-Furlong, & Sicherer, 2006). Thishas led to consumers being increasingly frustrated with pre-cautionary labelling and taking risks.

To improve this situation for consumers, the food in-dustry and the enforcement authorities, a risk manage-ment approach based on quantitative assessment ofallergen risk has been proposed by the FDF AllergensSteering Group.

FDF Allergens Steering GroupThe Food and Drink Federation (FDF) represents the in-

terests of the UK’s food and non-alcoholic drinks industry,which is the country’s largest manufacturing sector. Itsmembership comprises approximately a third of UK foodmanufacturers of all sizesemaking products as diverse as

620 R. Ward et al. / Trends in Food Science & Technology 21 (2010) 619e625

breakfast cereals, organic yogurt and many others e as wellas trade associations and groups dealing with specific sec-tors of the industry.

The FDF set up an Allergens Steering Group of industryexperts to deal with issues relating to allergen control andlabelling. The Group works to review the status of allergenmanagement in food manufacturing, disseminate best prac-tice and propose steps to further develop risk managementcapability.

This paper summarises the Group’s work and proposesa vision for best practice based on evolution from the currenthazard-based approach to a risk-based approach, which ismade possible by recent developments in scientific and clin-ical knowledge about food allergy. A fundamental premiseunderlying this vision is that dealing with food allergy isa shared responsibility between the food industry, regulators,health professionals and, last but by no means least, allergicpatients themselves. This vision is framed by several ele-ments discussed below.

Current allergen managementThe UK food and drink industry expects manufacturers to

produce safe, high quality products, which are clearly la-belled with allergens in ingredient declarations. Provisionof accurate and unambiguous information on product packsis essential to allow sensitive consumers to make informeddecisions as to whether they can safely consume the product.Food manufacturers declare the presence of common aller-genic ingredients (as defined in Directive 2007/68/EC, themost recent amendment of Annex IIIa of the Food LabellingDirective 2000/13/EC) in pre-packaged foods sold to thepublic in accordance with regulatory requirements.

Industry’s current approach to allergen management en-compasses existing Good Manufacturing Practices, withina classic Hazard Analysis Critical Control Points (HACCP)approach (Codex Alimentarius Commision, 1997), includ-ing traceability through the supply chain, segregation of al-lergenic ingredients and application of “allergen cleans”, toassure production of accurately labelled safe food. A “visu-ally and physically clean” standard for processing/manufacturing operations control of allergen cross-contam-ination, based on thorough visual inspection of the produc-tion line (following cleaning) and of the final product, hasbeen shown to provide a practical and effective risk man-agement approach (Jackson et al., 2008), and negates theneed for allergen on-line detection methods. Despite thesestringent measures the industry recognises that it still needsto do more.

Fig. 1. Number of allergen incidents reported to the FSA in 2007 vs2008. Source: FSA Annual Report of Incidents 2008 (FSA, 2009).

Allergen controls in practiceWhile accurate labelling may seem a straightforward is-

sue, incorrect labels actually account for a large proportionof product recalls in the UK, as well as in other countries.Data for the UK over the last two years show that the twomain causes of recalls are the omission of an allergen on an

ingredient label and placing the wrong product in the wrongpack (Food Standard Agency, 2009).

Since 2005, there has been a rise in the number of aller-gen incidents reported to the Food Standards Agency(FSA). This rise is believed to have been an effect of theimplementation of food labelling regulations and generalfood law (Regulation (EC) 178/2002) with its obligationon industry to report suspected food law breaches to theircompetent authority and the specific provision relating tovulnerable groups such as allergic consumers.

In 2008, the number of allergen incidents levelled off; 86allergen incidents were reported in 2007 and 84 in 2008, al-though few resulted from a reaction in a consumer. Thebreakdown of allergen incidents by allergen type is shownin Fig. 1 for both 2007 and 2008. While milk is the majortype of allergen incident in both years, 2008 has seen a 32%decline in the number of incidents in this category com-pared to 2007. This is believed to be the result of theFSA’s campaign to address cross-contamination of darkchocolate with milk.

In order both to manage allergens effectively and pro-vide the necessary information to consumers, it is importantto adopt an integrated approach to ensure that allergen in-formation is transmitted accurately across the supply chain(Crevel, 2009, chap. 5, Alldrick, 2009, chap. 6).

Controlling allergens andminimising the risk to consumersremains a priority for food companies. However, consumersare confused by and often distrustful of allergen labelling (par-ticularly precautionary labelling) (Food Standard Agency,2002). The requirements for allergenic ingredient labellingare clearly defined in legislation, but no such clarity existsaround precautionary labelling (e.g. “may contain”, “madeon the same line as”), which attempts to alert consumers tothe risk of inadvertent allergen presence.

Good allergen management practice dictates that precau-tionary labelling should be applied following a risk assess-ment, which establishes that there is an unacceptable risk ofprovoking reactions in allergic individuals, i.e. a real likeli-hood that a significant but unavoidable amount of allergencross-contaminationwould occur. However, the concept of as-sessing the risk from allergens is still relatively new comparedto risk assessment for chemical contaminants. Also, sucha risk assessment is challenging because the information onwhich it is based is limited and its interpretation is difficult

621R. Ward et al. / Trends in Food Science & Technology 21 (2010) 619e625

because of the lack of an agreed approach. Consequently,a given phrase does not currently imply the same level ofrisk if the product is from different manufacturers.

Many manufacturers have adopted extremely conserva-tive practices, leading to the proliferation of precautionarylabelling. This proliferation has led to a reduction in the ef-fectiveness of this measure in limiting risk as allergic indi-viduals take risks in the face of reduced food choices(Sampson et al., 2006), i.e. precautionary labelling is ignoredand therefore the risk to consumers actually increases.

Consumers are confused by the wide variety of phrasesused, which appear to imply a different level of risk, butin practice do not do so. Current industry guidance is tokeep precautionary labelling as simple as possible. FSAguidelines currently promote use of “may contain” (FoodStandard Agency, 2006).

Provision of clear, unambiguous and consistent consumerinformation is a common goal. Precautionary “may contain”labelling, if used correctly is a very important risk reductionand communication tool. However, experience indicates thatit must be focussed and reflect a real risk.

How do we move forward?The FDFAllergens Steering Group sees the key being to

move from a hazard based approach for allergen manage-ment to one based on risk.

Current allergen management focuses largely on the haz-ard. This has driven conservative industry standards aroundcontrol of unintentional allergen cross-contact during foodmanufacture, where allergen management and cleaning ap-proaches can sometimes “chase molecules around the supplychain”. It is not realistic or practicable to expect to eliminateallergens from the majority of food plants or to dedicateplants (and lines) to specific allergens (Crevel, 2009, chap.5, Alldrick, 2009, chap. 6).

The result of such conservative approaches has beenwidespread (over) use of precautionary statements. An un-intended consequence of this has been less choice as well asmore risk for allergic consumers as they are confused andfrustrated about the labels and therefore take risks (FoodStandard Agency, 2002; Hefle et al., 2007; Sheth et al.,2010). The ultimate conclusion is that all industrially man-ufactured food will eventually carry a precautionary label,unless agreement can be reached on a consistent approachto decision making for the use of precautionary warningstatements, such as quantitative management action levels.

A risk-based approach addresses these issues as it sharesresponsibility across the supply chain. Quantitative actionlevels based on good science would allow industry to consis-tently manage cross contact within clear, quantifiable bound-aries accepted by regulators and well-tolerated byconsumers. Such an approach provides transparent guidanceon labelling decisions and management actions as well aspromoting better management of personal food allergy.

Risk can be defined as the probability that a hazard willbecome manifest, and is often expressed as a function of the

intrinsic hazard and the exposure to that hazard. Thisdefinition is sometimes expanded to include severity of the re-sulting adverse effect. Thus, risk is defined in ISO/IEC Guide51 as the combination of the probability of occurrence of harmand the severity of that harm (ISO 22000, 2005). The key con-cept is therefore that of probability.

In linewith that concept, riskmanagement does not seek toeliminate the risk, which is generally regarded as impossibleunless there is no exposure, but to reduce the probability ofharm to a level considered tolerable. What is tolerable gener-ally reflects the balance of different stakeholder interests.

Although sufficient data are currently available only fora few allergenic foods (e.g.Taylor, Nordlee, Niemann, &Lambrecht, 2009), the knowledge to apply a risk-based ap-proach has become available in recent years (Kruizingaet al., 2008; Rimbaud, Heraud, La Vieille, Leblanc, &Crepet, 2010), a key component of which is establishing ac-tion levels for allergens.

Action levels for allergen managementThe Action Level for an allergen [allergenic food] de-

notes the amount per portion, which when unavoidablypresent in a product despite allergen management controlefforts, would not elicit severe reactions in the vast majorityof sensitive individuals.

Commonly accepted tolerable levels have yet to be es-tablished for food hypersensitivity (with the exception ofgluten) and Directive 2003/89/EC gives no threshold orguidance as to what constitutes a tolerable or safe level.The current UK qualitative approach is detailed in theFSA Guidance on Allergen Management and ConsumerInformation (Food Standard Agency, 2006). This continuesto be an active document and the FSA has future plans toproduce revised quantitative guidance with allergen man-agement levels and validated analytical methods.

There have been attempts to establish management/reg-ulatory threshold values in other countries, for example bythe Swiss Authorities and the Australian Food and GroceryCouncil Voluntary Incidental Trace Allergen Labelling(VITAL) system. International activities towards establish-ing action levels include the FSA/EuroPrevall Workshopsin Madrid in May 2007: Approaches to Risk Assessmentin Food Allergy (Madsen et al., 2009) and Vienna in May2009: What is a tolerable level of risk?

Allergen risk management approachApplication of a hazard-based approach decreases the

food choices of the allergic population through prolifera-tion and inconsistent usage of precautionary labellingwhich increases the possibility that they will suffer nutri-tional deficiencies. It will certainly reduce quality of life(Avery, King, Knight, & Hourihane, 2003). Consumers’failure to react to products carrying precautionary warningsmay be wholly misinterpreted leading to wrong and danger-ous conclusions that they are no longer allergic. Maximis-ing favourable public health outcomes (minimising risk to

622 R. Ward et al. / Trends in Food Science & Technology 21 (2010) 619e625

allergic consumers) thus ineluctably leads to a risk-basedapproach to allergen management in preference to a haz-ard-based one.

According to our vision, foods for normal use, not bearingprecautionary labelling, will be well-tolerated by the vast ma-jority of allergic consumers (See Fig. 2). It must be appreci-ated that the absence of a “may contain” label is notsynonymous with the product being “free-from”. The clearimplication is therefore that there are a small number of highlysensitive and reactive allergic people who should only con-sume specially prepared “free-from” foods.

In order to provide consistency of advice to allergic con-sumers, three classifications for foodstuffs can be described(See Fig. 3):

1. FREE FROMFor such foods there would be no mild reactions in thevast majority of highly sensitive allergic individuals. Thenamed allergen of concern is analytically absent toa high degree of confidence, with GMPs to ensureabsence of specific allergen.

2. SUITABLE FORThese foods would not provoke adverse reactions in thevast majority of allergic individuals. Allergen manage-ment cross-contact control is well-managed. The aller-gen is analytically detectable but the amount is belowthe action level. No specific labelling relating to aller-gens is applied, except that which is mandatory.

3. NOT SUITABLE FOR (carries MAY CONTAIN label)There are capable allergen management controls in placeto ensure that these foods generate no severe reactions in

“FREE

FROM”

“SU

No mild reactions in

the vast majority of

highly sensitive

No rea

vast mPUBLIC

HEALTH

OUTCOME

allerg

allergic Individuals

Manufacturing

Lower limit of

analytical

detection

MANAGEMENT

PARAMETER

A

manag

cont

well

Allergen analytically

absent to a high

degree of confidence,

GMPs to ensure

absence of specific

allergen

Lower AMOUNT O

ALLERGEN

STATUS

Fig. 2. Allergen risk man

the vast majority of allergic individuals. However, un-avoidable traces/very small amounts of allergenic mate-rials are present in a significant proportion of productunits despite risk management efforts and these are abovethe action level.

The first step in the process is to carry out a calibratedrisk assessment across the supply chain from farm to forkfor pre-packed foodseagainst agreed (quantitative) actionlevels, including best practices for risk management of aller-gens in manufacturing processes (See Table 1). A vital com-ponent of this approach is a clear and consistent riskcommunication of product/ingredient status across the sup-ply chain. This will result in optimal consumer recognitionand understanding of distinct categories of pre-packed prod-ucts enabling at-risk consumers to make safe choices easilyand ensure that those choices are maximised.

Harmonised manufacturing standards, based on actionlevels derived from scientific knowledge of the profile of reac-tivity of the allergic population, will improve the clarity andconsistency of food allergen labelling. It will therefore pro-vide greater assurance of safety for allergic consumers.Cross-industry standards, integrated into allergen control/management and overall food safety management, whichare then communicated to allergic consumers and health pro-fessionals, can help reduce risk by linking possible exposureto what each allergic consumer finds tolerable. This consis-tency in risk communication would operate in a similar wayto the way that the Codex gluten standard protects peoplewith coeliac disease and enables them to maximise theirchoices and minimise the risk of reactions.

A major barrier to further evolution of allergen manage-ment is the uncertainty around the application of the

“MAY CONTAIN” ITABLE

FOR” “NOT SUITABLE FOR”

ctions in the

ajority of

No severe reactions in

the vast majority of

allergic individualsic Individuals

facility “IN CONTROL”

Action

level

llergen

ement cross-

act control

-managed

Allergen management

controls managed, with

unavoidable traces

present despite efforts

F ALLERGENIC PROTEIN Higher

agement approach.

“FREE FROM”

“MAY CONTAIN”

“NOT SUITABLE FOR”

Lower limit of

analytical

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level

Manufacturing facility “IN CONTROL

“SUITABLE FOR”

AMOUNT OF AL ERGENIC PROTEINlower higher

XE

AM

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OR

PE

CU

DT

IR

TSI

DU

BI

TN

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Fig. 3. Typical profiles of unintentional allergen content according to allergen status.

623R. Ward et al. / Trends in Food Science & Technology 21 (2010) 619e625

scientific and clinical data currently being generated; an is-sue which is being addressing proactively with key stake-holders (Madsen et al., 2010, 2009).

In Europe/UK and elsewhere, many individual food man-ufacturers have validated action levels for use in their individ-ual operations which represent consistent capable allergenrisk management. Consistent figures are not yet used acrossthe food industry. There is also no regulatory agreement asto which quantitative figures represent capable control to tol-erable levels of cross-contamination of allergens in food.

In contrast, in Australia and New Zealand, food operatorshave developed the VITAL system (http://www.allergenbureau.net/vital/) to provide a standardised allergenrisk assessment procedure across the whole food industry.VITAL was developed by a committee consisting of foodindustry representatives, regulators, legal counsel, a foodallergic consumer advocate and a scientific consultant andwas launched as a freely available tool for the food industryin June 2007. Adoption of VITAL is voluntary and not

Table 1. The Key: supply chain consistency in risk assessmentapproaches

Risk assessment e are allergens in food and/or in handlingenvironment?� Intentional presence is identified and declared� Likelihood and extent of unintentional (cross-contact) presenceare assessed

Risk management e how to control and assure finished productstatus?� Segregation e for storage, handling, packing e through cleaning,scheduling and planning

Risk communication e how to identify product status?� Product identification and traceability� Clear declarations of allergen presence

a legal requirement, however, food retailers areincreasingly expecting manufacturers to utilise VITAL forrisk assessment of cross-contact allergens on their pre-packaged, private label branded products. This is a modelwhich could potentially be used in other parts of the world.

Stakeholders’ mutual responsibilitiesDealing with food allergy is a shared responsibility be-

tween the food industry, regulators, health professionalsand, last but by no means least, allergic patients themselves.All stakeholders have responsibilities in allergen riskmanage-ment encompassing consistent risk assessment, capable cross-contact control management programmes, accurate allergencommunication down the supply chain and accurate on packrisk communication to show product status. In turn, allergicindividuals must play their role by avoiding allergens of con-cern and paying attention to risk advice on pack.

There are many opportunities for stakeholders to helpfulfil this vision and it will require all parties to activelyengage to deliver consistent application of risk manage-ment. Suggested stakeholder deliverables would includethe following:

� Industry e Relevant expert advice, applicable bestpractices.

� Regulators e Transparent risk assessment, clear regula-tion and guidance.

� Enforcement e Consistent reinforcement of standards,informed advice on improvements/corrective actions.

� Healthcare professionals e Informed patient guidanceon avoidance. (The provision of allergy services in theUK requires significant improvement, as highlightedby the House of Lords Science and TechnologyCommittee Report on Allergy (2007), if this is to beachieved.)

624 R. Ward et al. / Trends in Food Science & Technology 21 (2010) 619e625

Industry supply chain improvementIndustry must resolve inconsistencies that exist in its ap-

proaches to allergen risk management; align supply chainrisk interpretation using the agreed action levels to provideclear and consistent business-to-business communication.

All stakeholders need to promote best practice acrossmanufacturing using existing best practice tools such asFDF guides, FSA guidance, and Campden BRI guides.

Consumer risk interpretationAs discussed already, allergic consumers can have difficul-

ties in interpreting product ingredient labels, and in particularthey have become confused about the meaning of precaution-ary labelling. Significant proportions of consumers are ignor-ing on pack advice, putting themselves at risk. Developmentof training for consumers explaining the risk from declared al-lergenic ingredients and possible unintended allergen pres-ence will help them understand the relevance of on packallergen information. Improved consistency across industryover the application and wording of precautionary labellingwill also greatly assist consumer understanding.

At the most basic level of public health protection, aller-gic consumers need to read the ingredient list to ensure thata product does not contain “their” allergen. Beyond that,those who are very reactive also need to understand, withthe help of health professionals, that absence of a precaution-ary label does not equate to “free-from”, although the prod-uct would be well-tolerated by most people with that allergy.

The proposed approach would recognise that these veryreactive people exist as a distinct group, who would benefitfrom specially designed (“free-from”) foods, in the sameway as those who suffer from coeliac disease or diabetesmellitus. Such recognition would foster the provision ofsuch foods, which could be made to standards defined aspart of the overall vision presented in this paper.

All allergic individual also needs to understand, in thecontext of new, harmonised action levels, that the presenceof a precautionary label indicates a significant probabilitythat a non-ingredient allergen is present in an amount thatwould present a risk and that they should not eat that product.

ConclusionThe FDF Vision has been drawn up with the aim of min-

imising the risk to our allergic consumers whilst maximis-ing their choices. We firmly believe that industry riskmanagement practices are sufficiently capable to deliverthis vision to the highest standards.

The risk-based approach serves both consumers and in-dustry better than a hazard-based approach and together wecan leverage the full power of industry capability to manageallergens and allow consumers to make the right choices.

To establish this vision we must ensure consistent riskassessment across the supply chain with consistent deci-sion-making for consumer risk communication. Stake-holder reinforcement of principles is important and asa matter of some urgency we need agreement on action

levels for allergen risk management. Availability of datafor risk assessment as well as analytical methods to validateprocesses and verify that quantitative limits have beenachieved are critical. Sufficient data are still currentlyonly available for relatively few allergenic foods (Tayloret al., 2010), but this number will rapidly increase as recentresearch projects bear fruit (Mills et al., 2007). Similarly,analytical methodologies are developing rapidly to a pointwhere they can be reliably used in operational settings(Taylor et al., 2009; Van Hengel, 2007).

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