A Guide to Risk Assessment Using Food Allergen Reference Doses

December 20, 2023

One of the most challenging problems the food industry experiences related to food allergens is answering the question, “How much is too much?” From a regulatory standpoint, there are not any defined thresholds below which food is considered safe in almost all cases. There is, however, more information that has historically been available to allow for informed decision-making and risk assessment. Most of this information is data-driven from clinical patients and is widely published.

“A Guide to Risk Assessment Using Food Allergen Reference Doses” was created by Anthony J. Lupo, Sr., Director of Technical Services at Neogen®, in conjunction with the University of Nebraska FARRP (Food Allergy Research and Resource Program) , which was directly involved in providing the risk-based modeling used to derive these values.

By collecting data generated from various double-blinded, placebo-controlled human challenge studies that have taken place throughout the world, it can be statistically determined at what level allergic individuals are likely to begin to react. It should be noted that this does not in any way predict the severity of the reaction.

Reference Dose Table
AllergenNumber of Individuals2019 VSEP Ref Dose (mg protein) [ED01]*2019 VSEP Ref Dose (mg protein) [ED05]
Egg4310.22.3
Hazelnut4110.13.5
Lupin252.615.3
Milk4500.22.4
Mustard330.050.4
Peanut13060.22.1
Sesame400.12.7
Shrimp7525280
Soy (Milk + Flour)870.510.0
Wheat990.76.1
Cashew2450.050.8
Celery820.051.3
Fish (finfish)821.312.1
Walnut740.030.8

 

Take a look at this exercise and how it can be carried out for any allergen and test kit, provided that the reporting scale is known.

With this information, you can use a data-based risk assessment to determine if the test kit is sensitive to the desired range. Since different test kits express results on different scales (ppm food vs. ppm protein vs. ppm allergenic protein fraction), it is imperative to standardize the reporting scale to mg of protein when performing these calculations.

Learn more about our Veratox VIP allergen testing , which is one of the most robust ELISA allergen testing kits on the market. It offers the same ease of use as standard Veratox allergen tests but with significantly enhanced sensitivity, allowing users to detect extremely low levels of target allergens in a wide variety of sample types, including heat-processed and complex samples—all with a 30-minute time-to-result.

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Category: Food Safety, Consumer Goods, Dietary Supplements, Food & Beverage, Pet Food, Allergens, Environmental Monitoring