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

Viewpoint

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 practices in allergen management have increased the safety of food products to allergic consumers, the standards applied by different manufacturers remain divergent in the absence of agreed approaches to risk assessment. This has been reected in a considerable expansion of precautionary labelling and a concomitant 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 responsibility of all the stakeholders involved. Action levels, by permitting a consistent use of precautionary labelling and clear communication of the allergen status of a food, will play a crucial role in ensuring that risks from allergenic foods are reduced as far as possible.

Background The concept of managing food allergens as a food safety risk emerged in the last decade of the 20th century and has matured considerably over the last 10e15 years. Allergen management has evolved in line with the growing knowledge and understanding of the issue. Initially, little was known about the key determinants of risk; namely how sensitivity and reactivity to allergens varied across the susceptible population, and in response to the dose consumed. Knowledge of the numbers of consumers affected was also almost non-existent, even for the best-studied allergenic foods, such as peanuts. Industrys approach to date has been based around existing Good Manufacturing Practices (GMPs) assuring segregation of allergenic ingredients and systematic declaration of allergens on labels where mandated. However, more needs to be done to minimise risk and to provide allergic consumers with consistent risk communication and a wide choice of products. Application of allergen management principles is still inconsistent. Individual manufacturers are currently interpreting risk in the supply chain differently, as there are no agreed approaches to perform risk assessment to a common standard. In the absence of knowledge about the levels of allergens required to provoke adverse reactions, many manufacturers have adopted a purportedly fail-safe approach using precautionary labelling. Initially welcomed as helpful by allergic consumers, the increasing and inconsistent use of this type of warning across product types and sectors has considerably lessened its impact as a risk reduction tool (Sampson, Munoz-Furlong, & Sicherer, 2006). This has led to consumers being increasingly frustrated with precautionary labelling and taking risks. To improve this situation for consumers, the food industry and the enforcement authorities, a risk management approach based on quantitative assessment of allergen risk has been proposed by the FDF Allergens Steering Group. FDF Allergens Steering Group The Food and Drink Federation (FDF) represents the interests of the UKs food and non-alcoholic drinks industry, which is the countrys largest manufacturing sector. Its membership comprises approximately a third of UK food manufacturers of all sizesemaking products as diverse as

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

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breakfast cereals, organic yogurt and many others e as well as trade associations and groups dealing with specic sectors of the industry. The FDF set up an Allergens Steering Group of industry experts to deal with issues relating to allergen control and labelling. The Group works to review the status of allergen management in food manufacturing, disseminate best practice and propose steps to further develop risk management capability. This paper summarises the Groups work and proposes a vision for best practice based on evolution from the current hazard-based approach to a risk-based approach, which is made possible by recent developments in scientic and clinical knowledge about food allergy. A fundamental premise underlying this vision is that dealing with food allergy is a shared responsibility between the food industry, regulators, health professionals and, last but by no means least, allergic patients themselves. This vision is framed by several elements discussed below. Current allergen management The UK food and drink industry expects manufacturers to produce safe, high quality products, which are clearly labelled with allergens in ingredient declarations. Provision of accurate and unambiguous information on product packs is essential to allow sensitive consumers to make informed decisions as to whether they can safely consume the product. Food manufacturers declare the presence of common allergenic ingredients (as dened in Directive 2007/68/EC, the most recent amendment of Annex IIIa of the Food Labelling Directive 2000/13/EC) in pre-packaged foods sold to the public in accordance with regulatory requirements. Industrys current approach to allergen management encompasses existing Good Manufacturing Practices, within a classic Hazard Analysis Critical Control Points (HACCP) approach (Codex Alimentarius Commision, 1997), including traceability through the supply chain, segregation of allergenic ingredients and application of allergen cleans, to assure production of accurately labelled safe food. A visually and physically clean standard for processing/ manufacturing operations control of allergen cross-contamination, based on thorough visual inspection of the production line (following cleaning) and of the nal product, has been shown to provide a practical and effective risk management approach (Jackson et al., 2008), and negates the need for allergen on-line detection methods. Despite these stringent measures the industry recognises that it still needs to do more. Allergen controls in practice While accurate labelling may seem a straightforward issue, incorrect labels actually account for a large proportion of product recalls in the UK, as well as in other countries. Data for the UK over the last two years show that the two main causes of recalls are the omission of an allergen on an

ingredient label and placing the wrong product in the wrong pack (Food Standard Agency, 2009). Since 2005, there has been a rise in the number of allergen incidents reported to the Food Standards Agency (FSA). This rise is believed to have been an effect of the implementation of food labelling regulations and general food law (Regulation (EC) 178/2002) with its obligation on industry to report suspected food law breaches to their competent authority and the specic provision relating to vulnerable groups such as allergic consumers. In 2008, the number of allergen incidents levelled off; 86 allergen incidents were reported in 2007 and 84 in 2008, although few resulted from a reaction in a consumer. The breakdown of allergen incidents by allergen type is shown in Fig. 1 for both 2007 and 2008. While milk is the major type of allergen incident in both years, 2008 has seen a 32% decline in the number of incidents in this category compared to 2007. This is believed to be the result of the FSAs campaign to address cross-contamination of dark chocolate with milk. In order both to manage allergens effectively and provide the necessary information to consumers, it is important to adopt an integrated approach to ensure that allergen information is transmitted accurately across the supply chain (Crevel, 2009, chap. 5, Alldrick, 2009, chap. 6). Controlling allergens and minimising the risk to consumers remains a priority for food companies. However, consumers are confused by and often distrustful of allergen labelling (particularly precautionary labelling) (Food Standard Agency, 2002). The requirements for allergenic ingredient labelling are clearly dened in legislation, but no such clarity exists around precautionary labelling (e.g. may contain, made on the same line as), which attempts to alert consumers to the risk of inadvertent allergen presence. Good allergen management practice dictates that precautionary labelling should be applied following a risk assessment, which establishes that there is an unacceptable risk of provoking reactions in allergic individuals, i.e. a real likelihood that a signicant but unavoidable amount of allergen cross-contamination would occur. However, the concept of assessing the risk from allergens is still relatively new compared to risk assessment for chemical contaminants. Also, such a risk assessment is challenging because the information on which it is based is limited and its interpretation is difcult

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

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because of the lack of an agreed approach. Consequently, a given phrase does not currently imply the same level of risk if the product is from different manufacturers. Many manufacturers have adopted extremely conservative practices, leading to the proliferation of precautionary labelling. This proliferation has led to a reduction in the effectiveness of this measure in limiting risk as allergic individuals take risks in the face of reduced food choices (Sampson et al., 2006), i.e. precautionary labelling is ignored and therefore the risk to consumers actually increases. Consumers are confused by the wide variety of phrases used, which appear to imply a different level of risk, but in practice do not do so. Current industry guidance is to keep precautionary labelling as simple as possible. FSA guidelines currently promote use of may contain (Food Standard Agency, 2006). Provision of clear, unambiguous and consistent consumer information is a common goal. Precautionary may contain labelling, if used correctly is a very important risk reduction and communication tool. However, experience indicates that it must be focussed and reect a real risk. How do we move forward? The FDF Allergens Steering Group sees the key being to move from a hazard based approach for allergen management to one based on risk. Current allergen management focuses largely on the hazard. This has driven conservative industry standards around control of unintentional allergen cross-contact during food manufacture, where allergen management and cleaning approaches can sometimes chase molecules around the supply chain. It is not realistic or practicable to expect to eliminate allergens from the majority of food plants or to dedicate plants (and lines) to specic allergens (Crevel, 2009, chap. 5, Alldrick, 2009, chap. 6). The result of such conservative approaches has been widespread (over) use of precautionary statements. An unintended consequence of this has been less choice as well as more risk for allergic consumers as they are confused and frustrated about the labels and therefore take risks (Food Standard Agency, 2002; Hee et al., 2007; Sheth et al., 2010). The ultimate conclusion is that all industrially manufactured food will eventually carry a precautionary label, unless agreement can be reached on a consistent approach to decision making for the use of precautionary warning statements, such as quantitative management action levels. A risk-based approach addresses these issues as it shares responsibility across the supply chain. Quantitative action levels based on good science would allow industry to consistently manage cross contact within clear, quantiable boundaries accepted by regulators and well-tolerated by consumers. Such an approach provides transparent guidance on labelling decisions and management actions as well as promoting better management of personal food allergy. Risk can be dened as the probability that a hazard will become manifest, and is often expressed as a function of the

intrinsic hazard and the exposure to that hazard. This denition is sometimes expanded to include severity of the resulting adverse effect. Thus, risk is dened in ISO/IEC Guide 51 as the combination of the probability of occurrence of harm and the severity of that harm (ISO 22000, 2005). The key concept is therefore that of probability. In line with that concept, risk management does not seek to eliminate the risk, which is generally regarded as impossible unless there is no exposure, but to reduce the probability of harm to a level considered tolerable. What is tolerable generally reects the balance of different stakeholder interests. Although sufcient data are currently available only for a few allergenic foods (e.g.Taylor, Nordlee, Niemann, & Lambrecht, 2009), the knowledge to apply a risk-based approach has become available in recent years (Kruizinga et al., 2008; Rimbaud, Heraud, La Vieille, Leblanc, & Crepet, 2010), a key component of which is establishing action levels for allergens. Action levels for allergen management The Action Level for an allergen [allergenic food] denotes the amount per portion, which when unavoidably present in a product despite allergen management control efforts, would not elicit severe reactions in the vast majority of sensitive individuals. Commonly accepted tolerable levels have yet to be established for food hypersensitivity (with the exception of gluten) and Directive 2003/89/EC gives no threshold or guidance as to what constitutes a tolerable or safe level. The current UK qualitative approach is detailed in the FSA Guidance on Allergen Management and Consumer Information (Food Standard Agency, 2006). This continues to be an active document and the FSA has future plans to produce revised quantitative guidance with allergen management levels and validated analytical methods. There have been attempts to establish management/regulatory threshold values in other countries, for example by the Swiss Authorities and the Australian Food and Grocery Council Voluntary Incidental Trace Allergen Labelling (VITAL) system. International activities towards establishing action levels include the FSA/EuroPrevall Workshops in Madrid in May 2007: Approaches to Risk Assessment in Food Allergy (Madsen et al., 2009) and Vienna in May 2009: What is a tolerable level of risk? Allergen risk management approach Application of a hazard-based approach decreases the food choices of the allergic population through proliferation and inconsistent usage of precautionary labelling which increases the possibility that they will suffer nutritional deciencies. It will certainly reduce quality of life (Avery, King, Knight, & Hourihane, 2003). Consumers failure to react to products carrying precautionary warnings may be wholly misinterpreted leading to wrong and dangerous conclusions that they are no longer allergic. Maximising favourable public health outcomes (minimising risk to

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allergic consumers) thus ineluctably leads to a risk-based approach to allergen management in preference to a hazard-based one. According to our vision, foods for normal use, not bearing precautionary labelling, will be well-tolerated by the vast majority of allergic consumers (See Fig. 2). It must be appreciated that the absence of a may contain label is not synonymous with the product being free-from. The clear implication is therefore that there are a small number of highly sensitive and reactive allergic people who should only consume specially prepared free-from foods. In order to provide consistency of advice to allergic consumers, three classications for foodstuffs can be described (See Fig. 3): 1. FREE FROM For such foods there would be no mild reactions in the vast majority of highly sensitive allergic individuals. The named allergen of concern is analytically absent to a high degree of condence, with GMPs to ensure absence of specic allergen. 2. SUITABLE FOR These foods would not provoke adverse reactions in the vast majority of allergic individuals. Allergen management cross-contact control is well-managed. The allergen is analytically detectable but the amount is below the action level. No specic labelling relating to allergens is applied, except that which is mandatory. 3. NOT SUITABLE FOR (carries MAY CONTAIN label) There are capable allergen management controls in place to ensure that these foods generate no severe reactions in

the vast majority of allergic individuals. However, unavoidable traces/very small amounts of allergenic materials are present in a signicant proportion of product units despite risk management efforts and these are above the action level. The rst step in the process is to carry out a calibrated risk assessment across the supply chain from farm to fork for pre-packed foodseagainst agreed (quantitative) action levels, including best practices for risk management of allergens in manufacturing processes (See Table 1). A vital component of this approach is a clear and consistent risk communication of product/ingredient status across the supply chain. This will result in optimal consumer recognition and understanding of distinct categories of pre-packed products enabling at-risk consumers to make safe choices easily and ensure that those choices are maximised. Harmonised manufacturing standards, based on action levels derived from scientic knowledge of the prole of reactivity of the allergic population, will improve the clarity and consistency of food allergen labelling. It will therefore provide greater assurance of safety for allergic consumers. Cross-industry standards, integrated into allergen control/ management and overall food safety management, which are then communicated to allergic consumers and health professionals, can help reduce risk by linking possible exposure to what each allergic consumer nds tolerable. This consistency in risk communication would operate in a similar way to the way that the Codex gluten standard protects people with coeliac disease and enables them to maximise their choices and minimise the risk of reactions. A major barrier to further evolution of allergen management is the uncertainty around the application of the

ALLERGEN STATUS

FREE FROM

SUITABLE FOR

MAY CONTAIN NOT SUITABLE FOR

PUBLIC HEALTH OUTCOME

No mild reactions in the vast majority of highly sensitive allergic Individuals

No reactions in the vast majority of allergic Individuals

No severe reactions in the vast majority of allergic individuals

Manufacturing facility IN CONTROL

MANAGEMENT PARAMETER

Lower limit of analytical detection

Action level

Allergen analytically absent to a high degree of confidence, GMPs to ensure absence of specific allergen

Allergen management crosscontact control well-managed

Allergen management controls managed, with unavoidable traces present despite efforts

Lower

AMOUNT OF ALLERGENIC PROTEIN

Higher

Fig. 2. Allergen risk management approach.

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FREE FROM SUITABLE FOR

MAY CONTAIN NOT SUITABLE FOR

Manufacturing facility IN CONTROL Lower limit of analytical detection Action level

EXAMPLE PRODUCT DISTRIBUTIONS

lower

AMOUNT OF ALLERGENIC PROTEIN

higher

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

scientic and clinical data currently being generated; an issue which is being addressing proactively with key stakeholders (Madsen et al., 2010, 2009). In Europe/UK and elsewhere, many individual food manufacturers have validated action levels for use in their individual operations which represent consistent capable allergen risk management. Consistent gures are not yet used across the food industry. There is also no regulatory agreement as to which quantitative gures represent capable control to tolerable levels of cross-contamination of allergens in food. In contrast, in Australia and New Zealand, food operators have developed the VITAL system (http://www. allergenbureau.net/vital/) to provide a standardised allergen risk assessment procedure across the whole food industry. VITAL was developed by a committee consisting of food industry representatives, regulators, legal counsel, a food allergic consumer advocate and a scientic consultant and was launched as a freely available tool for the food industry in June 2007. Adoption of VITAL is voluntary and not

a legal requirement, however, food retailers are increasingly expecting manufacturers to utilise VITAL for risk assessment of cross-contact allergens on their prepackaged, private label branded products. This is a model which could potentially be used in other parts of the world. Stakeholders mutual responsibilities Dealing with food allergy is a shared responsibility between the food industry, regulators, health professionals and, last but by no means least, allergic patients themselves. All stakeholders have responsibilities in allergen risk management encompassing consistent risk assessment, capable crosscontact control management programmes, accurate allergen communication down the supply chain and accurate on pack risk communication to show product status. In turn, allergic individuals must play their role by avoiding allergens of concern and paying attention to risk advice on pack. There are many opportunities for stakeholders to help full this vision and it will require all parties to actively engage to deliver consistent application of risk management. Suggested stakeholder deliverables would include the following:  Industry e Relevant expert advice, applicable best practices.  Regulators e Transparent risk assessment, clear regulation and guidance.  Enforcement e Consistent reinforcement of standards, informed advice on improvements/corrective actions.  Healthcare professionals e Informed patient guidance on avoidance. (The provision of allergy services in the UK requires signicant improvement, as highlighted by the House of Lords Science and Technology Committee Report on Allergy (2007), if this is to be achieved.)

Table 1. The Key: supply chain consistency in risk assessment approaches Risk assessment e are allergens in food and/or in handling environment?  Intentional presence is identied and declared  Likelihood and extent of unintentional (cross-contact) presence are assessed Risk management e how to control and assure nished product status?  Segregation e for storage, handling, packing e through cleaning, scheduling and planning Risk communication e how to identify product status?  Product identication and traceability  Clear declarations of allergen presence

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Industry supply chain improvement Industry must resolve inconsistencies that exist in its approaches to allergen risk management; align supply chain risk interpretation using the agreed action levels to provide clear and consistent business-to-business communication. All stakeholders need to promote best practice across manufacturing using existing best practice tools such as FDF guides, FSA guidance, and Campden BRI guides. Consumer risk interpretation As discussed already, allergic consumers can have difculties in interpreting product ingredient labels, and in particular they have become confused about the meaning of precautionary labelling. Signicant proportions of consumers are ignoring on pack advice, putting themselves at risk. Development of training for consumers explaining the risk from declared allergenic ingredients and possible unintended allergen presence will help them understand the relevance of on pack allergen information. Improved consistency across industry over the application and wording of precautionary labelling will also greatly assist consumer understanding. At the most basic level of public health protection, allergic consumers need to read the ingredient list to ensure that a product does not contain their allergen. Beyond that, those who are very reactive also need to understand, with the help of health professionals, that absence of a precautionary label does not equate to free-from, although the product would be well-tolerated by most people with that allergy. The proposed approach would recognise that these very reactive people exist as a distinct group, who would benet from specially designed (free-from) foods, in the same way as those who suffer from coeliac disease or diabetes mellitus. Such recognition would foster the provision of such foods, which could be made to standards dened as part of the overall vision presented in this paper. All allergic individual also needs to understand, in the context of new, harmonised action levels, that the presence of a precautionary label indicates a signicant probability that a non-ingredient allergen is present in an amount that would present a risk and that they should not eat that product. Conclusion The FDF Vision has been drawn up with the aim of minimising the risk to our allergic consumers whilst maximising their choices. We rmly believe that industry risk management practices are sufciently capable to deliver this vision to the highest standards. The risk-based approach serves both consumers and industry better than a hazard-based approach and together we can leverage the full power of industry capability to manage allergens and allow consumers to make the right choices. To establish this vision we must ensure consistent risk assessment across the supply chain with consistent decision-making for consumer risk communication. Stakeholder reinforcement of principles is important and as a matter of some urgency we need agreement on action

levels for allergen risk management. Availability of data for risk assessment as well as analytical methods to validate processes and verify that quantitative limits have been achieved are critical. Sufcient data are still currently only available for relatively few allergenic foods (Taylor et al., 2010), but this number will rapidly increase as recent research projects bear fruit (Mills et al., 2007). Similarly, analytical methodologies are developing rapidly to a point where they can be reliably used in operational settings (Taylor et al., 2009; Van Hengel, 2007). References
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