New recommendations for allergen thresholds

Increased assessment values for official surveillance in Germany

Aug. 2024 (Update). In line with recent publications by the FAO and WHO, ALS and ALTS have adopted new assessment values for allergens^[1]. Most of these guidance values for official surveillance are higher than the previous values from 2019.

We will give you an overview of the changes to the assessment values, explain the methodological requirements for allergen detection and how we can support you in analysing allergens.

Background to the new assessment values

On 7 November 2023, the working group on food allergens of the two expert committees ALS and ALTS defined updated assessment values for allergens. These provide guidance to the official food authority laboratories on the level of a detected but unlabelled allergen (neither as an ingredient nor as trace evidence) at which the food control should take action to ensure correct allergen labelling.

A particular difficulty in determining the reference doses is the variance with which allergy sufferers can react to the allergens in question. Not only the trigger dose which must be present to cause an allergic reaction is taken into account, but also the severity of the symptoms.

ED05 instead of ED01

The new ALS/ALTS assessment values are no longer based on the ED01 doses (Eliciting Dose 01) as before, but largely on the reference doses (Eliciting Dose 05, ED05) published and recommended by the FAO and WHO in 2022, and refer these to a 100 g portion. The Allergen Bureau of Australia and New Zealand also uses these data as the basis for the VITAL 4.0 concept in the latest version of 2024^[4].

The eliciting dose ED05 is defined as sufficiently safe. This dose can trigger a reaction in a maximum of 5% of the allergic population. The risk of severe or even fatal consequences when using the ED05 values was intensively analysed and classified as very low.

Some ALS and ALTS assessment values, e.g. for the allergens lupin and mustard, deviate slightly from the FAO and WHO recommendation (2023). The assessment value for crustaceans was retained from 2019 and is thus significantly below the FAO and WHO recommendation (2022).

Results of the meetings of the FAO/WHO expert panel

In 2019, the FAO and WHO were commissioned by the Codex Committee on Food Labelling (CCFL) to provide scientific advice to the Codex Committee on allergen labelling. In the following years, a panel of experts held several meetings and published its findings in a total of five reports between 2022 and 2024.

At the first meeting, the expert panel agreed on the eight most important allergens to be labelled. Threshold values and reference doses were established for these eight allergens at the second meeting (FAO/WHO 2022)^[2]. In relation to a portion size, this results in allergen concentrations, so-called action levels, which, according to the third meeting, should be clearly labelled for consumers if they are exceeded. Labelling should be part of an allergen management. At the fourth meeting, the expert panel discussed exemptions from allergen labelling, and at the fifth meeting, threshold values were set for other nuts and other non-priority allergens (FAO/WHO 2023)^[3].

Method requirements for allergen detection

The FAO/WHO expert panel also expressed requirements for the methods used to detect allergens:

Protein-based methods should be used, with results reported in mg/kg total protein.
Due to the known high measurement uncertainty, the limits of quantification of the methods should be three times below the respective action values.

However, methodological limitations were also identified that need to be taken into account when selecting the test methods and interpreting the available laboratory results. These include, for example, the frequently insufficient recovery of allergens in processed and complex food matrices and the absence of suitable reference materials.

Impact of the recommendations on the handeling of allergen traces

The FAO/WHO recommendations do no only have a legal impact on the handling of allergen traces in Germany. The Netherlands, for example, has incorporated the values into national legislation.

We support you

Our competence centre for allergens in the Eurofins Food & Feed Testing laboratory network in Germany offers you suitable methods for protein detection for the listed allergens. We regularly check our tests in interlaboratory comparisons, so-called ring trials. We pay particular attention to the suitability of our tests for processed matrices, but also for swabs and cleaning waters, and offer product-specific validations.

We report most results as required in mg/kg total protein and thus enable targeted risk management in your production. We can also support you choose the right test for your product, with the necessary conversions and answer other questions relating to allergens. Please get in touch with your personal account manager or contact our expert Dr Sandra Kerbach.

Abbreviations

ALS: Arbeitskreis Lebensmittelchemischer Sachverständiger der Länder und des Bundesamtes für Verbraucherschutz und Lebensmittelsicherheit (Working group of food chemistry experts of the Federal States and the Federal Office of Consumer Protection and Food Safety)
ALTS: Arbeitskreis der auf dem Gebiet der Lebensmittelhygiene und der Lebensmittel tierischer Herkunft tätigen Sachverständigen (Working group of experts in the field of food hygiene and food of animal origin)
FAO: Food and Agriculture Organization of the United Nations
WHO: World Health Organization
VITAL: Voluntary Incidental Trace Allergen Labelling
ED01: Eliciting Dose 01 / trigger dose that leads to reactions in 1% of the allergic population
ED05: Eliciting Dose 05 / trigger dose that leads to reactions in 5% of the allergic population

Relevant sources

[1] In German: ALS/ALTS-AG „Lebensmittelallergene“, 7. November 2023, Beurteilungswerte Allergene. Erschienen in: 92. Arbeitstagung des ALTS. J Consum Prot Food Saf (2024)
[2] FAO and WHO. 2022. Risk assessment of food allergens – Part 2: Review and establish threshold levels in foods for the priority allergens. Meeting Report. Food Safety and Quality Series No. 15. Rome
[3] FAO and WHO. 2023. Risk Assessment of Food Allergens – Part 5: Review and establish threshold levels for specific tree nuts (Brazil nut, macadamia nut or Queensland nut, pine nut), soy, celery, lupin, mustard, buckwheat and oats. Meeting report. Food Safety and Quality Series, No. 23. Rome
[4] Allergen Bureau. 2024. Get Ready for VITAL 4.0