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Until recently, analytical tests for food were performed primarily in laboratories, but technical developments now enable consumers to use devices to test their food at home or when dining out. Current consumer devices for food can determine nutritional values, freshness, and, most recently, the presence of food allergens and substances that cause food intolerances. The demand for such products is driven by an increase in the incidence of food allergies, as well as consumer desire for more information about what is in their food. The number and complexity of food matrixes creates an important need for properly validated testing devices with comprehensive user instructions (definitions of technical terms can be found in ISO 5725-1:1994 and the International Vocabulary of Metrology). This is especially important with food allergen determinations that can have life-threatening consequences. Stakeholders-including food regulators, food producers, and food testing kit and equipment manufacturers, as well as representatives from consumer advocacy groups-have worked to outline voluntary guidelines for consumer food allergen- and gluten-testing devices. These guidelines cover areas such as kit validation, user sampling instructions, kit performance, and interpretation of results. The recommendations are based on (1) current known technologies, (2) analytical expertise, and (3) standardized AOAC INTERNATIONAL allergen community guidance and best practices on the analysis of food allergens and gluten. The present guidance document is the first in a series of papers intended to provide general guidelines applicable to consumer devices for all food analytes. Future publications will give specific guidance and validation protocols for devices designed to detect individual allergens and gluten, as statistical analysis and review of any validation data, preferably from an independent third party, are necessary to establish a device's fitness-for-purpose. Following the recommendations of these guidance documents will help ensure that consumers are equipped with sufficient information to make an informed decision based on an analytical result from a consumer device. However, the present guidance document emphasizes that consumer devices should not be used in isolation to make a determination as to whether a food is safe to eat. As advances are made in science and technology, these recommendations will be reevaluated and revised as appropriate.

Food allergens and intolerances have been diagnosed by doctors for decades, but have received heightened attention in the last two decades because diagnosis and awareness have increased. Consequently, regulators in many jurisdictions have addressed this topic by introducing labeling requirements for substances causing allergies and intolerance reactions in affected individuals. Mandatory labeling of food allergens allows persons suffering from these to make informed choices. However, regulations in some geographic areas have resulted in significant problems for manufacturers as well as consumers. This has been mainly due to frequent changes and amendments, and it has been difficult for all stakeholders to follow and understand the status quo of legislation. The present paper describes the development of European directives and regulations for the labeling of food allergens and intolerances to substances like gluten over the past decades and provides an outlook of what can reasonably be expected to change in the coming years. It also identifies existing gaps, like a lack of threshold levels for adventitious contamination and consequently a proliferation of precautionary allergen labeling, which neither benefits the consumer nor the food industry in its current form.

Food allergen labeling regulations have been implemented in several countries since 2006. Currently, experts are still discussing the introduction of thresholds or action levels, which should lead to the reduction of the widespread use of advisory statements (e.g., "may contain") for the benefit of the allergic consumer. However, the establishment of threshold requires supporting analytical methodologies to enforce and comply with the regulations. This article discusses the possibilities and limitations of existing and emerging methodologies for the purpose of enabling compliance with and enforcement of allergen action levels.