Finding a Path to Safety in Food Allergy Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy (2017) / Chapter Skim
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7 Management of Packaged Foods
7 Management of Packaged Foods
Pages 277-332
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For this reason, the labeling of allergenic foods is an important public health intervention that assists consumers in avoiding potentially allergenic foods. The food supply chain from production to consumption is complex (see Figure 7-1)
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From the food industry perspective, three general approaches can be used to minimize the risk of a reaction from an allergenic food: (1) eliminate potential allergens or specific allergens from products; (2)
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Within the product development groups in some major food companies, a so-called allergen-gating process has been implemented as a best practice. This process is intended to question and, if desirable or possible, eliminate specific allergenic foods (or ingredients derived from those foods)
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This assessment starts with an assessment of all raw materials to identify those that are allergenic foods or ingredients derived from allergenic foods. Any allergenic raw materials must then be segregated in receiv ing, storage, and handling that occurs ahead of processing.
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Now, some foods are marketed as peanut-free, peanut- and tree nut–free (nut-free) , and allergen-free, which typically means the absence of all of the eight most allergenic foods and food groups (milk, egg, peanut, tree nuts, wheat, soybean, fish, and crustacean shellfish)
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The food industry, however, lacks the ability to conduct allergen risk assessments to determine threshold doses and safe levels. As a result of the uncertainties regarding limits necessary to avoid cross-contact as well as unacceptable risks that could result in litigation, PAL statements have proliferated.
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The FDA recognized that the ingredient label on packaged food products pro vided essential information to consumers following avoidance diets. Food industry awareness of the importance of accuracy in the labeling of food allergens in food ingredient labeling emerged simultaneously.
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The foods on such lists vary around the world due to several factors, including differing eating habits and differing criteria to select the priority allergenic foods (see Table 7-1)
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Other includes foods that are not required, but are on a recommended labeling list include salmon, salmon roe, mackerel, abalone, squid, beef, pork, chicken, soybean, walnut, orange, kiwi, banana, peach, apple, yam, matsutake mushroom, and gelatin.
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The ILSI-EU Task Force recommended a priority food allergens list that included milk, egg, fish, crustacean shellfish, peanut, soy, tree nuts, wheat, and sesame seed. Other groups within ILSI-EU have continued to develop criteria for the selection of allergenic foods of public health importance and have recently recommended that the criteria should encompass consideration of prevalence, severity and potency5 (Bjorksten et al., 2008; Houben et al., 2016; van Bilsen et al., 2011)
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Initially, the CAC sought expert opinion and attempted to use the available scientific information in establishing the 1999 list of priority allergenic foods. Although the list of eight priority allergenic foods or food groups established by the CAC remains valid in general, the list has not been reviewed since 1999 and it should be reconsidered now and periodically thereafter.
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of additional allergenic foods on global priority lists should be based on scientific evidence regarding the prevalence, severity, and potency of allergies to those specific foods. Individual countries may have justifiable reasons for expanding this list due to cultural dietary habits but such decisions also should be made on the basis of scientific and clinical evidence.
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The identification of which tree nuts merit recognition as part of the group covered by the priority allergen labeling regulations differs widely among various countries. As noted, only walnut appears on the priority allergenic foods list in Japan.
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. In the United States, certain ingredients can be grouped as "spices," "flavors," "natural flavors," "artificial flavors," and "artificial colors." In the United States, to circumvent the possibility of a hidden allergen in such ingredients, the priority allergenic foods must be declared if they are contained in flavors, spices, colors, or processing aids.
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However, greater public health concerns exist regarding the potential that residues of allergenic foods may occur inadvertenly as the result of cross-contact due to common food industry practices such as the use of shared equipment. Such practices can result in the presence of detectable levels of allergen residues in various foods.
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Increasingly, food companies in many countries are providing consumers with voluntary PAL statements to alert them to products that are at risk of inadvertent allergen contamination. PAL is not required in any country; instead, many countries (United States, EU-member nations,
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Otherwise, consumers with a food allergy will never know whether the packaged food lacks a PAL statement because it does not need one or because the food manufacturing company did not apply the risk assessment process. A NEW PARADIGM: AVOIDING FOOD ALLERGENS AT LEVELS THAT PRESENT RISKS Avoiding Allergens Is Important There is no question that avoidance diets remain essential to prevent adverse reactions among individuals with a food allergy (de Silva et al.,
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A risk assessment approach would lead to a decrease in the occurrence of allergic reactions while maximizing the quality of life of individuals with a food allergy. However, Low Doses of Allergenic Foods May Not Always Pose a Problem The first evidence that individuals with food allergy could safely be exposed to low doses of allergens perhaps occurred with the development of hypoallergenic infant formulas for infants with milk allergy.
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Although the appropriateness of using these concepts in the setting of allergenic foods was questionable in the past, improved understanding of the mechanism for allergic reactions to food, together with emerging data from individuals with food allergy has led to the realization that the classical principles, terminology, and methodologies of chemical toxicology risk assessment can be applied to food allergens. A common,
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Risk assessment incorporates a number of features, which are defined in Box 7-5, and encompasses four steps: hazard identification, hazard characterization, exposure assessment, and risk characterization, which are defined in Box 7-6. Application of Risk Assessment to Allergenic Foods As noted, the risk assessment process can be applied to allergenic foods.
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The more widespread use of low-dose OFCs in clinical practice has confirmed the fact that individuals with food allergy have a threshold dose below which they ordinarily will not experience an adverse reaction upon ingesting the allergenic food (Hourihane et al., 1997a; Taylor et al., 2002)
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For allergenic foods (with effects that are not cumulative) , the Reference Dose would be an amount of the allergenic food that would pose some defined level of risk (perhaps risk of mild, transitory allergic symptoms that resolve without pharmacological interven tion)
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. ICSA assigns individual thresholds to an interval range rather than a fixed value by assigning equal probability to the likelihood that the true threshold dose could lie anywhere along that continuum.
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Determining population thresholds for a risk assessment: Dose distribution and probabilistic modeling The use of probabilistic modeling12 in risk assessment of food allergens requires the use of individual NOAELs and LOAELs. Increasing amounts of quality NOAEL and LOAEL data from clinical low-dose OFCs from a number of different allergenic foods continue to become available (Ballmer-Weber et al., 2015; Blom et al., 2013; Dano et al., 2015)
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Figure 7-3 presents the three probabilistic approaches to the dose–response for peanut. The probabilistic models allow the derivation of an ED, where EDp refers to the dose of total protein from the allergenic food that is predicted to produce an objective response in FIGURE 7-2 Figure prepresenting the concept of probabilistic risk assessment.
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Thus, exposure assessment is another component of the overall risk assessment. Because allergenic foods are required to carry labels whenever they are used as intentional ingredients, the risk to the consumer is only actually imposed from exposure to any unintended presence of allergens (e.g., contamination due to cross-contact)
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Risk characterization involves three key input distributions: the dose-distribution of individual threshold doses, the intake distribution, and the contamination distribution. Highlighted below are two approaches to conduct a risk characterization: examining the individual threshold dose-distribution to arrive at acceptable Reference Doses or using probabilistic modeling.
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. The results can predict objective allergic reactions in an estimated fraction of the population with food allergy.
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provides a list of the number of data points for each of the priority allergenic foods used to establish Reference Doses as of 2014 (Taylor et al., 2014)
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. Although peanut is recognized among the allergenic foods as most likely to provoke severe reactions (Blumchen et al., 2014; Zhu et al., 2015)
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also have recommended the use of statistical dose-distribution modeling as the ideal approach to estimating population thresholds for various allergenic foods. The VITAL Program The Allergen Bureau of Australia and New Zealand (an industry consortium)
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. The Reference Doses for 11 allergenic foods taken from priority lists in Australia and New Zealand and the EU are provided in Table 7-2.
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Fish had insufficient clinical data and, therefore, an arbitrary RD was selected. Likewise, celery had insufficient clinical data; however, celery is not included in the food allergen priority list of Australia and New Zealand, and therefore, a recommendation for celery was not needed.
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Second, the PAL system for warning consumers about the presence of low levels of allergens in food is not effective. Initially, preventive approaches related to packaged foods centered on mandatory labeling of intentionally added allergenic foods or ingredients.
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VITAL has established Reference Doses for allergenic foods based on clinical data on the distribution of individual threshold doses for individuals with spe
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RECOMMENDATIONS The committee recommends that the Codex Alimentarius Commis sion and public health authorities in individual countries decide on a periodic basis about which allergenic foods should be included in their priority lists based on scientific and clinical evidence of regional prevalence and severity of food allergies as well as allergen potency. For example, in the United States, some foods listed by the FDA as tree nuts (i.e., beech nut, butternut, chestnut, chinqua pin, coconut, gingko nut, hickory nut, lichee nut, pili nut, shea nut)
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The FDA and the USDA should establish Reference Doses (thresholds) for allergenic foods, where possible.
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. To fill gaps in knowledge in this area, studies should be conducted to accomplish the following objectives: • Strengthen current knowledge about food allergen risk assessment and management, including continued assessment of threshold doses for individual allergens; single dose oral challenges for con firmation of threshold doses; the development, application, and improvement of parametric dose-distribution modeling approaches for allergen risk assessment; food consumption patterns of popula tions with food allergy; and methods to detect allergen residues in food matrices.
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2013. Threshold dose distributions for 5 major allergenic foods in children.
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J Allergy Clin Immunol 126(2)
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2016. Prioritisation of allergenic foods with respect to public health relevance: Report from an ILSI Europe Food Allergy Task Force Expert Group.
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2009. Approaches to risk assessment in food allergy: Report from a workshop "developing a framework for assessing the risk from allergenic foods." Food Chem Toxicol 47(2)
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2002. Factors affecting the determination of threshold doses for allergenic foods: How much is too much?
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2014. Establishment of Reference Doses for residues of allergenic foods: Report of the VITAL Expert Panel.
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in 20 to 30 minutes. However, by recording both the discrete and cumulative doses that provoke the first objective signs and comparing these two doses in the probabilistic modeling, this concern is abated due to the small 15 There are three types of oral food challenges (OFCs)
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• Individual day-to-day variability differences that occur at the lowest doses. In fact, the estimated population threshold for peanut obtained by Blumchen et al.
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. For some allergenic foods, such as milk and egg, challenges should ideally use less processed forms of food, such as pasteurized, spray-dried or even raw, where possible in order to ensure an elicitation will occur at the lowest possible dose (Crevel et al., 2014; Taylor et al., 2014)
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This initial OFC provides the patient's individual threshold dose. A patient selection bias might occur in such studies, as the selection of highly 17 The subscript represents the percentage of the allergic population in whom the dose of total protein from the allergenic food is predicted to produce an objective response.
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. The possible under-representation of patients with histories of severe reactions in datasets used for probabilistic modeling has been an expressed concern because patients with histories of severe allergic reactions are excluded from OFCs in some clinics (Luccioli and Kwegyir-Afful, 2014)
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Further studies are needed on allergic reactions occurring within the community setting to determine whether exposure dose is the key determinant of reaction occurrence and severity and identify any role that these other factors might play. Despite these host
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Several variables must be considered in developing an accurate exposure assessment. Concentration of the Allergenic Residues in Foods The overall food allergen distribution also requires knowledge of the concentration of allergenic food residue (or protein from the allergenic source)
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However, the use of national food surveys for food allergen risk assessments assumes that the food intake of people with allergies is the same as that of the general population. Ideally, for the quantitative risk assessment of allergenic foods, the focus should be placed on the risk for those who consume the foods as opposed to the overall mean intake levels of the food (Crevel et al., 2014)
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; and (4) the extraction of allergenic foods can be affected by aggregation, which reduces solubility (Downs and Taylor, 2010)
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Threshold dose distributions for 5 food allergens. J Allergy Clin Immunol 135(4)
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2004. A consensus protocol for the determination of the threshold doses for allergenic foods: How much is too much?
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2014. Establishment of Reference Doses for residues of allergenic foods: Report of the VITAL Expert Panel.
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