The European Commission has finally asked the European Food Safety Authority (EFSA) to review the scientific validity, for the EU population, of the allergen Reference Doses that FAO/WHO proposed and the Codex Committee on Food Labelling recommended in May 2026, later formally adopted by the Codex Alimentarius Commission on 6 July 2026. EFSA must also derive Reference Amounts, the consumption quantities for different food categories that feed into the Action Levels used to decide when a ‘may contain’ statement is actually warranted (Allergen Bureau, 2026).
The deadline set for this evaluation, 31 July 2028, makes the timeline previously announced for the EU Precautionary Allergen Labelling (PAL) Implementing Regulation, Q4 2027, unlikely to hold (Allergen Bureau, 2026). It is a delay, not a retreat. Read against the sequence of events this outlet has followed since 2022, the mandate to EFSA is the next, foreseeable step of a process this author had already mapped out, and pressed for, well before Brussels moved.
Where it started: the 2022 ‘blackout’
In July 2022, following alerts on peanut contamination in Indian soy lecithin, 24 member states responded to the same risk signal in mutually contradictory ways: some ordered sweeping recalls over negligible exposure, others took no action at all. This author described the episode as a ‘European blackout‘ in allergen risk management, and called on the Commission to ‘exercise the delegation of authority… to define detailed rules regarding the use of Precautionary Allergens Labelling (PAL)‘, binding any ‘may contain… (allergen)‘ claim to a prior cross-contact risk analysis performed under the VITAL system (Dongo, 2022). That delegation, under Regulation (EU) No 1169/2011, empowers the Commission to adopt implementing acts ensuring that information on the possible and unintentional presence of allergens does not mislead consumers (Regulation (EU) No 1169/2011, Article 36.3, point ‘a’).
Thirteen years after the regulation entered into force, that power was still unused. A position paper published in September 2024 by eleven researchers from Wageningen Food Safety Research and other European institutes, and reported on by this outlet in November 2024, restated the same request for harmonised EU guidelines, noting that RASFF had by then logged 348 allergen notifications and that VITAL still had no uniform recognition across member states (Smits et al., 2024; Dongo & Della Penna, 2024).
Weeks earlier, this outlet had also covered the FDA’s enforcement action against a major US bakery group for mislabelling ‘may contain‘ claims, a reminder that the absence of internationally agreed tolerance thresholds leaves both allergic consumers and food business operators exposed, on either side of the Atlantic (Dongo, 2024).
The evidence accumulated
The scientific case for Reference Doses built steadily through 2025. In April, this outlet reported on Blom et al.’s analysis of more than 1,100 food challenges across eleven priority allergens, which found that reactions occurring at or below the ED05 threshold are mild to moderate, supporting the FAO/WHO Reference Doses of 0.2 mg for milk and egg up to 1.5 mg for soy (Dongo, 2025a). In September, a 21-year French study covered in these pages identified eight allergens, including goat’s and sheep’s milk and buckwheat, responsible for severe anaphylaxis yet still outside the EU’s mandatory labelling list (Dongo, 2025b).
By early 2026, individual member states had stopped waiting for Brussels. This outlet reported in February that the Netherlands had introduced, from 1 January 2026, national guidelines setting thresholds through quantitative risk assessment, while Spain adopted voluntary standards aligned with the FAO/WHO recommendations (Dongo & Della Penna, 2026a).
In May, the 49th session of the Codex Committee on Food Labelling, held in Ottawa, recommended the guidelines on PAL and Reference Doses that the Commission has now sent to EFSA for scrutiny, including a distinct 4.0 mg reference dose for wheat gluten (Dongo & Della Penna, 2026b). The Codex Alimentarius Commission formally adopted those guidelines on 6 July 2026, at its 49th session in Geneva (FAO, 2026).
What businesses should take from this
For food business operators, the practical consequence of the EFSA mandate is that legal certainty on PAL at EU level will arrive later than Q4 2027, not that the underlying obligation is in doubt. The mandatory allergen declaration duties under Regulation (EU) No 1169/2011 remain unaffected by this timeline and continue to require precise identification of the allergen concerned, as this outlet’s sister publication FARE has recently set out in its review of a mislabelled gastronomic product (Dongo, 2026).
Four years on from the ‘European blackout’, the direction Brussels has now taken, Codex Reference Doses subjected to an EU-specific EFSA review before a binding PAL Implementing Regulation, is exactly the one this outlet argued for from the outset. The delay to 2028 measures how long harmonisation takes. It does not change where it is heading.
Our FARE (Food and Agriculture Requirements) unit supports food business operators and retailers in guaranteeing full compliance of their food labels, with particular regard to allergen information, and in aligning their food safety management systems with the VITAL approach — already a scientifically sound basis for precautionary allergen labelling, ahead of the EU’s own binding rules.
Dario Dongo
References
Scientific studies
Smits, N. G. E., Ballin, N. Z., Bruggeman, C., Fæste, C. K., Pastorelli, A. A., van Poucke, C., Voorhuijzen-Harink, M. M., Westphal, Y., Walker, M., Winkel, M., & Koops, A. J. (2024). The changing food allergen landscape in Europe calls for harmonised food allergen monitoring: Position paper. Food Control, 168, Article 110915. https://doi.org/10.1016/j.foodcont.2024.110915
EU legislation
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, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council. Consolidated text: 01/04/2025. http://data.europa.eu/eli/reg/2011/1169/2025-04-01
Institutional sources
Allergen Bureau. (2026, September 4). An important step towards harmonised Precautionary Allergen Labelling (PAL) in Europe. https://allergenbureau.net/an-important-step-towards-harmonised-precautionary-allergen-labelling-pal-in-europe/
FAO. (2026, July 6). FAO/WHO 49th session of the Codex Alimentarius Commission adopts new standards. https://www.fao.org/newsroom/detail/fao-who-49th-session-of-the-codex-alimentarius-commission-adopts-new-standards/en
Food Times prior articles
Dongo, D. (2022, July 13). Allergens and RASFF, European blackout. Food Times. https://www.foodtimes.eu/planet/allergens-and-rasff-european-blackout/
Dongo, D. (2024, June 19). Allergens, FDA denounces ‘may contain’ abuse. Food Times. https://www.foodtimes.eu/consumers-and-health/allergens-fda-denounces-may-contain-abuse/
Dongo, D., & Della Penna, A. A. (2024, November 1). EU, food allergens guidelines are needed. Position paper. Food Times. https://www.foodtimes.eu/food-safety/eu-food-allergens-guidelines-are-needed-position-paper/
Dongo, D. (2025a, April 21). Mild symptoms, clear science: time to implement allergens Reference Doses. Food Times. https://www.foodtimes.eu/food-safety/food-allergens-evidence-demands-regulatory-action/
Dongo, D. (2025b, September 3). Eight emerging food allergens in Europe. Food Times. https://www.foodtimes.eu/food-safety/emerging-food-allergens-europe/
Dongo, D., & Della Penna, A. A. (2026a, February 16). Allergens: the Netherlands and Spain lead the shift towards VITAL. Food Times. https://www.foodtimes.eu/consumers-and-health/allergens-the-netherlands-spain-vital/
Dongo, D., & Della Penna, A. A. (2026b, May 26). Codex Alimentarius: PAL and Reference Doses ready for takeoff. Food Times. https://www.foodtimes.eu/consumers-and-health/codex-pal-allergens-reference-doses-2026/
FARE (Food and Agriculture Requirements)
Dongo, D. (2026, August 14). Etichette alimentari: problematiche e normative da seguire. FARE. https://fareagrifood.com/2026/08/14/health-claim-operatore-responsabile-quid-allergeni/
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
