ReMaGI - The new reference materials for allergens
The historical lack of reference materials for food allergens limited the possibility to evaluate the performances of detection methods. Generon makes available a new range of reference materials suitable for any downstream detection method.
Food allergies are a growing health burden worldwide. Although the true prevalence of food allergies is not well known, the trend has been rising in recent decades in industrialized western countries. The prevalence of these allergies is higher in infants than in adults. Currently, there are no accessible cure and strict allergen avoidance remains the most efficient management to avoid an allergic reaction, which can be severe and occasionally life-threatening (Muraro et al. 2014). Consequently, there is a strong health imperative for reducing the risk of accidental consumption of an allergen by food-allergic individuals. To enable consumers to immediately identify relevant allergens, the European Union (EU) food information regulation (Regulation EU 1169/2011, 2011) requires the mandatory labelling of 14 allergenic foods or food groups when used as ingredients in the manufacturing of foods. Yet, despite many efforts and actions of the food industry, it is very hard to achieve complete elimination of cross-contact with allergens during food manufacturing, transport, and storage. The lack of correlation between voluntary precautionary allergen labelling (PAL) and the presence of allergens, frequently leads allergenic people to ignore the labeling (Marchisotto et al. 2016). In addition, the absence of regulatory thresholds for allergens does not help food producers establish trustworthy labeling. To help food producers, thresholds have been set by the Allergen Bureau’s Voluntary Incidental Trace Allergen Labeling Program (VITAL) (Allen et al. 2014; Taylor et al. 2014), but despite manufacturers’ improvements and the emergence of allergen thresholds, it remains necessary to check for possible contaminations using reliable analytical methods.
Although several methods are available for detecting allergens, a lack of harmonization between laboratories remains common and consequently limits the possibility to compare results obtained by different parties. The main cause of this is due to the lack of appropriate reference materials (Lacorn and Immer 2011). Problems such as the absence of conversion factors between reporting units and the lack of correspondence between analytical methods such as PCR (DNA copies) and ELISA or MS (ingredients, soluble proteins, and total proteins) further complicate comparing the performances of methods used for food allergen detection.
In many cases, no certified reference materials for allergenic foodstuffs are available. Although, incurred reference materials for the analysis of allergens in food matrices are desirable, a well characterized spiked material is superior to no material at all (Holzhauser et al. 2020). Generon addressed the increased urgency for certified reference materials expressed by the food industry, food analysis laboratories, by governmental authorities, as well as by suppliers of food allergens testing means, developing and producing ReMaGI (Reference Material by Generon Industries). ReMaGIs were produced by Generon laboratories under an ISO 9001 registered Quality Management System and according to the principles of ISO 17034: 2017.
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