FAO/WHO expert panel recommends the use of allergen-specific reference doses based on ED05

An expert panel jointly initiated by FAO (Food and Agriculture Organization of the United Nations) and WHO (World Health Organization) published on 20 August 2021 a summary of recommendations regarding thresholds for the protection of allergy sufferers and the analytical methods needed for testing to detect allergens.

The convening of the Panel was based on specific requests for scientific expertise from the Codex Committee on Food Hygiene (CCFH) and the Codex Committee on Food Labelling (CCFL) in 2018 and 2019.

The safety objective for setting thresholds was defined as "minimising the likelihood of occurrence of clinically relevant objective allergic reactions to a point where further refinement does not meaningfully reduce the health impact".

The panel agreed that approaches based on clinically determined population-based reference doses (=eliciting doses) and probabilistic hazard assessments are best suited for the establishment of thresholds, as these approaches have already proven themselves (e.g. in the internationally known VITAL concept version 2.0 and the current version 3.0).

In particular, the medically and politically highly explosive decision on which future population-based level of protection should be used to set threshold values was up for evaluation and determination. Specifically, the committee assessed and evaluated the trigger doses for 1% (ED01 (Eliciting dose 01), max. 1 % of the affected persons show allergic reactions) and 5 % (ED05, max. 5 % of the affected persons show allergic reactions) of the respective allergic population.

While the VITAL 3.0 concept is based on ED01 reference doses (although ED05 was also wrestled with for a long time), the panel decided that the threshold based on ED05 provides sufficient protection for allergy sufferers.

This determination was based primarily on the data from the two studies by Remington, et al. (2020) and Houben, et al. (2020) and the recognition that fatal food anaphylaxis is generally extremely rare (1 per 100000 person-years in the allergic population). Furthermore, it was important that no fatal reactions or severe anaphylaxis based on the ED05 occurred.

To simplify the application, the Panel further simplified its recommendations by rounding ED05 values to a significant number (with some exceptions for allergens with limited data). Foods with similar ED05 values were grouped together and a single value for the reference dose was derived, rounding down further if necessary.

The resulting threshold values in mg protein are summarised in Table 1.

Table 1: Protein-based reference doses based on the ED05

Allergenic food Reference dose (mg protein of the allergenic food)
Walnut (and pecan*)  1.0
 Cashew nut (and pecan*) 1.0
 Almond** 1.0
 Peanut 2.0
 Egg 2.0
Hazelnut 3.0
Wheat 5.0
 Fish 5.0
Shrimp 200
 Milk determination still pending; depending on further data evaluation
Sesame determination still pending; depending on further data evaluation

* reference to the (not yet available) full report
** preliminary

With regard to the analytical detection methods, it was found that the portion-dependent concentrations in the end product (assessed up to 510g) associated with the reference doses can be analysed and monitored with limitations using the current analytical possibilities. It was explicitly recommended standardising the reporting of analytical results as mg total protein of the allergenic food per kg analysed food.

In order to address existing known deficiencies in analytics, the establishment of performance criteria for the methods as well as a more extensive provision of accessible reference materials for the assessed allergens was recommended.

In summary, it can be added that these recommendations will receive great attention due to the worldwide recognition of the Codex Alimentarius and that the standstill on the handling of cross-contact allergens, which has existed for more than a decade, will be re-inspired. This will almost certainly also provide new impetus for European legislation on the assessment and management of cross-contact.


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