Eight emerging food allergens in Europe

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Food Times_emerging food allergens

A landmark study published in Clinical & Experimental Allergy has identified eight food allergens without mandatory labelling requirements that contributed to significant numbers of food-induced anaphylaxis cases across French-speaking countries.

This comprehensive analysis of over 21 years of surveillance data from the French Allergy-Vigilance Network reveals critical gaps in current European food labelling regulations and proposes the inclusion of four high-risk allergens in mandatory disclosure requirements.

Introduction

Food-induced anaphylaxis constitutes a severe and potentially life-threatening allergic reaction with a rising global incidence; however, current regulatory frameworks appear insufficient to address the full spectrum of food allergens encountered in contemporary dietary patterns.

Food Information Regulation (EU) No 1169/11 currently provides to label 14 major allergens, including cereals containing gluten, crustaceans, eggs, fish, peanuts, soya, cow’s milk, tree nuts, celery, mustard, sesame, sulphites, lupin, and molluscs. However, emerging dietary trends and food globalisation have introduced novel allergenic exposures that warrant systematic investigation.

The French Allergy-Vigilance Network (AVN), established in 2001, represents one of Europe’s most comprehensive surveillance systems for severe allergic reactions. This associative network of francophone allergologists has systematically documented cases of severe anaphylaxis across France, Belgium, and Luxembourg for over two decades, providing an invaluable epidemiological resource for understanding contemporary food allergy patterns (Moneret-Vautrin et al., 2002).

Methodology

Sabouraud-Leclerc et al. (2025) conducted a retrospective observational study analysing all food-induced anaphylaxis cases reported to the AVN database between 2002 and 2023. The study employed rigorous inclusion criteria, focusing on cases classified as Ring grades 2-4, representing moderate to severe systemic reactions requiring emergency medical intervention.

Study population and data collection

The AVN network comprised 302 participating allergologists, including 267 French practitioners, who prospectively reported cases using a standardised structured questionnaire containing over 70 data points. This comprehensive form captured patient demographics, clinical manifestations, allergenic foods, reaction severity, cofactors, epinephrine administration, and subsequent allergy assessments including skin tests and specific IgE measurements.

Severity classification system

The study utilised the Ring-Messmer classification system to stratify anaphylaxis severity:

  • Grade 2 (cutaneous and mucous membrane involvement with mild systemic symptoms);
  • Grade 3 (life-threatening reactions with cardiovascular or respiratory compromise)
  • Grade 4 (cardiac and/or respiratory arrest).

This validated classification system enables consistent severity assessment across different clinical settings and practitioners.

Emerging food allergen definition

Emerging food allergens (EFA) were defined as allergenic foods responsible for ≥1% of total anaphylaxis cases within the AVN database that are not included in the current European mandatory labelling list.

This threshold was established to identify allergens with sufficient epidemiological significance to warrant regulatory consideration whilst excluding rare or idiosyncratic reactions.

Statistical analysis

For each identified EFA, researchers assessed four key parameters:

  • frequency of occurrence
  • severity distribution using Ring classification
  • recurrence rates in individual patients, and
  • potential for hidden exposure in processed foods.

Temporal trends were examined over the 21-year surveillance period to delineate emerging trajectories in allergenic food consumption and associated reaction patterns.

Major findings

Primary study outcomes

Among 2,999 documented food-induced anaphylaxis cases meeting inclusion criteria, 413 cases (13.8%) were attributed to foods not currently subject to mandatory labelling requirements. Eight distinct allergenic foods or food groups were identified as responsible for ≥1% of total cases:

Goat’s and sheep’s milk emerged as the most frequently implicated EFA, accounting for 84 cases (2.8% of total), followed by buckwheat with 71 cases (2.4%), peas and lentils with 55 cases (1.8%), alpha-gal syndrome with 50 cases (1.7%), pine nuts with 49 cases (1.6%), kiwi with 44 cases (1.5%), beehive products with 30 cases (1.0%), and apple with 30 cases (1.0%).

Severity analysis

The study revealed significant variations in reaction severity across different EFAs. Severe reactions (Ring grades 3 and 4) were reported with goat’s and sheep’s milk (46.8% and 4.8%, respectively, including two fatalities), buckwheat (46.5% and 1.4%), peas-lentils (20% and 1.8%), and alpha-gal (54% and 8%).

Two fatal cases were directly attributed to anaphylaxis induced by goat’s and sheep’s milk, highlighting not only the life-threatening risk posed by these undeclared allergens but also the urgent need for regulatory frameworks to address allergenic sources beyond the currently mandated labelling requirements.

Recurrence and hidden exposure patterns

Recurrent anaphylactic episodes were documented with concerning frequency across several EFAs. Recurrent reactions and hidden exposures were reported with goat’s and sheep’s milk (56% and 15.5%), buckwheat (49.3% and 16.9%), peas-lentils (7.3% and 9.0%), and pine nuts (12.2% and 4.1%). These data suggest that certain EFAs pose ongoing risks due to inadvertent exposure through processed foods and cross-contamination.

Temporal trends

The 21-year surveillance period revealed evolving trends in EFA-related anaphylaxis. Certain allergens — notably peas and lentils, alpha-gal, and apple — showed an increasing frequency over time, likely reflecting changes in dietary habits, the growing use of plant-based proteins in food production, and the geographic expansion of alpha-gal syndrome.

Regulatory and clinical implications

Risk stratification

On the basis of a comprehensive risk assessment – including frequency, severity, recurrence, and the potential for hidden exposure – Sabouraud‑Leclerc et al. (2025) recommend adding four emerging food allergens to the EU list of allergens requiring mandatory labelling: goat’s and sheep’s milk, buckwheat, peas and lentils, and pine nuts.

The authors note that whilst alpha-gal syndrome demonstrates significant severity (54% Grade 3 reactions, 8% Grade 4), its unique pathophysiology and relatively straightforward avoidance strategies may not justify mandatory labelling inclusion. Similarly, kiwi, beehive products, and apple typically present in easily recognisable forms with lower hidden exposure potential.

Clinical recognition patterns

The study findings align with recent observations in clinical allergy across Europe and North America. As noted by Kim (cited in Medscape, 2025), the rising prevalence of legume-based allergies correlates with the expanding use of pea protein powder in processed foods, meat alternatives, and protein supplements. This trend reflects broader dietary shifts towards plant-based nutrition and the introduction of novel protein sources (Dongo et al., 2025).

Cross-reactivity considerations

Goat’s and sheep’s milk pose specific clinical challenges because of cross-reactivity with cow’s milk proteins. The study’s reported 56% recurrence rate indicates that many patients may unknowingly consume these alternative milk products, assuming they are safer. This highlights the critical need for comprehensive allergen education and strict labelling requirements.

Discussion

Public health significance

The identification of 413 anaphylaxis cases attributed to non-labelled allergens over 21 years represents a substantial public health concern. With an estimated 15,000-30,000 severe allergic reactions occurring annually in France alone (Moneret-Vautrin et al., 2002), the contribution of EFAs to overall anaphylaxis burden warrants serious regulatory consideration.

The two documented fatalities from goat’s and sheep’s milk anaphylaxis highlight the life-threatening potential of these exposures. Given that fatal food anaphylaxis remains rare, with food allergies accounting for approximately 60% of fatal anaphylactic reactions (Pouessel et al., 2023), these deaths represent a significant proportion of preventable mortality.

Methodological strengths and limitations

The AVN database represents one of Europe’s most comprehensive anaphylaxis surveillance systems, with over 3,500 documented cases spanning two decades. The network’s systematic approach, utilising standardised reporting forms and expert validation, ensures high data quality and clinical relevance. The 21-year observation period provides sufficient temporal depth to identify genuine trends whilst minimising the impact of annual variations.

However, the study’s francophone geographical focus may limit generalisability to other European populations with different dietary patterns and allergenic exposures. The reliance on voluntary reporting by allergologists may introduce selection bias towards more severe cases or those managed in specialist centres, potentially underestimating milder reactions managed in primary care settings.

Global regulatory context

The study’s findings contribute to ongoing international discussions regarding food allergen labelling harmonisation. The United States recently expanded its major allergen list to include sesame, following the Food Allergen Labeling and Consumer Protection Act amendments. Similarly, other jurisdictions are actively reviewing their mandatory disclosure requirements based on emerging epidemiological evidence.

The authors’ evidence-based approach, considering frequency, severity, recurrence, and hidden exposure potential, provides a robust framework for regulatory decision-making. This methodology could be adapted for use in other geographic regions to identify locally relevant emerging food allergens.

Towards evidence-based regulatory reform: the case for Reference Dose implementation

The identification of emerging food allergens through the AVN study provides an opportunity for a broader reflection — already advanced by the present author — on the critical gaps that persist in the European Union’s regulatory framework. Despite 21 years since the introduction of the Food Allergens Directive 2003/89/EC, the European Commission has still not defined a common approach to implementation, with Member States maintaining divergent views on risk assessment methods.

The FAO/WHO Expert Committee has approved Reference Doses (RfDs) scientifically derived from ED05 values — the threshold expected to elicit mild to moderate symptoms in 5% of the allergic population — as the basis for evidence-based allergen management. This RfD-based approach would transform current Precautionary Allergen Labelling (PAL) from problematic ‘may contain’ statements that confuse consumers into risk assessments grounded in scientific evidence.

Implementation of such a system would be particularly relevant also for the four emerging allergens identified in this study, potentially enabling more precise risk stratification and targeted consumer protection whilst reducing unnecessary dietary restrictions that currently compromise quality of life for allergic individuals.

Interim conclusions

This comprehensive analysis of the French Allergy-Vigilance Network database provides compelling evidence for updating European food labelling regulations to include four additional allergens: goat’s and sheep’s milkbuckwheatpeas and lentils, and pine nuts. These findings reflect evolving dietary patterns, increasing globalisation of food supply chains, and the emergence of novel allergenic exposures in contemporary European populations.

The study’s rigorous methodology, substantial sample size, and extended observation period provide a robust evidence base for regulatory reform. The documentation of fatal outcomes and high recurrence rates associated with certain EFAs underscores the urgent need for enhanced consumer protection through mandatory labelling requirements.

Future research should focus on validating these findings in other European populations, investigating the underlying mechanisms driving EFA emergence, and developing standardised frameworks for ongoing surveillance of food allergen trends. The integration of such surveillance data into regulatory decision-making processes will be essential for maintaining pace with evolving food allergy epidemiology.

Clinical practice implications

For practicing allergologists, these findings emphasise the importance of comprehensive allergen testing beyond the traditional ‘big 14’ allergens, particularly in patients presenting with unexplained anaphylaxis or recurrent reactions. The high recurrence rates observed with several EFAs highlight the critical need for detailed patient education regarding potential sources of hidden exposure.

Healthcare providers should maintain heightened awareness of emerging food allergens, particularly goat’s and sheep’s milk products, buckwheat-containing foods, legume-based ingredients, and pine nut preparations. The increasing prevalence of these allergies necessitates updated clinical protocols and enhanced diagnostic approaches to ensure comprehensive patient care.

Dario Dongo

Cover art copyright © 2025 Dario Dongo (AI-assisted creation)

References

  • Dölle-Bierke, S., Höfer, V., Francuzik, W., Worm, M., & Cardona, V. (2023). Food-induced anaphylaxis: Data from the European anaphylaxis registry. Journal of Allergy and Clinical Immunology: In Practice11(7), 2069-2079. https://doi.org/10.1016/j.jaip.2023.03.026
  • Food and Agriculture Organization of the United Nations, & World Health Organization. (2022). Risk assessment of food allergens: Part 2: Review and establish threshold levels in foods for the priority allergens: Meeting report. World Health Organization. https://www.who.int/publications/i/item/9789240065420
  • Moneret-Vautrin, D. A., Kanny, G., Morisset, M., Rancé, F., Fardeau, M. F., & Beaudouin, E. (2004). Severe food anaphylaxis: 107 cases registered in 2002 by the Allergy Vigilance Network. European Annals of Allergy and Clinical Immunology36(2), 46-51. (PMID: 15061394)
  • Official Journal of the European Union. (2011). Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers. Consolidated text: 01/04/2025 http://data.europa.eu/eli/reg/2011/1169/2025-04-01
  • Pouessel, G., Alonzo, S., Divaret-Chauveau, A., Dumond, P., Bradatan, E., Liabeuf, V., Beaumont, P., Tscheiller, S., Diesnis, R., Renaudin, J. M., & Sabouraud-Leclerc, D. (2023). Fatal and near-fatal anaphylaxis: The Allergy-Vigilance Network data (2002-2020). Allergy78(6), 1628-1638. https://doi.org/10.1111/all.15645
  • Ring, J., & Behrendt, H. (1999). Anaphylaxis and anaphylactoid reactions: Classification and pathophysiology. Clinical Reviews in Allergy & Immunology17(4), 387-399. https://doi.org/10.1007/BF02737644
  • Sabouraud-Leclerc, D., Mariotte, D., Bradatan, E., Divaret-Chauveau, A., Metz-Favre, C., Beaumont, P., Dumond, P., Serrier, J., Karaca-Altintas, Y., Tscheiller, S., Pouessel, G., & Van der Brempt, X. (2025). Food anaphylaxis: Eight food allergens without mandatory labelling highlighted by the French Allergy-Vigilance Network. Clinical & Experimental Allergy, advance online publication. https://doi.org/10.1111/cea.70130
  • Wood, R. A., Camargo, C. A., Jr., Lieberman, P., Sampson, H. A., Schwartz, L. B., Zitt, M., Collins, C., Tringale, M., Wilkinson, M., Boyle, J., & Simons, F. E. R. (2014). Anaphylaxis in America: The prevalence and characteristics of anaphylaxis in the United States. Journal of Allergy and Clinical Immunology133(2), 461-467. https://doi.org/10.1016/j.jaci.2013.08.016
Dario Dongo
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Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.