Harmonised guidelines on food allergens information – either for packaged and non prepackaged foods – are urgently needed in the European Union, as underlined in a position paper adopted by researchers from outstanding EU and national research institutes (e.g. ILVO, ISS, BfR, Wageningen, DVFA, Belfast Queen’s University) (1).
1) EU, food allergens guidelines are urgently needed. Position paper
In the 21 years since the introduction of the Food Allergens Directive 2003/89/EC, as amended by the Food Information Regulation (EU) No 1169/11, the European Commission has still not defined a common approach to its implementation. Member States therefore keep diverging views on methods of analysis, risk assessment (either considering or ignoring scientific evidence on reference doses, RfD), information and Precautionary Allergen Labelling.
The position paper therefore calls for the adoption of harmonised guidelines for food allergen monitoring on the European level. It covers gluten, lactose and other substances which may cause intolerances or other immunoglobulin mediated or not-mediated reactions (i.e. hypersensitivities reactions). And it addresses either:
– the current EU rules
– the existence of a system to cope with the risk assessment and management, as a voluntary private system
-the tentative of FAO/WHO to harmonise this approach at Codex level. A brief overview to follow.
2) General Food Law requirements
Unsafe food products (i.e. injurious to health, unfit for human consumption) shall not be put on the market. In determining whether any food is unsafe, under the EU General Food Law, regard shall be had:
(a) to the normal conditions of use of the food by the consumer at each stage of production, processing and distribution, and
(b) to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods (Reg. EC No 178/02, Article 14).
In order to achieve the general objective of a high level of protection of human health and life, food law shall be based on risk analysis, except where this is not appropriate to the circumstances or the nature of the measure. Risk analysis includes its assessment, management and communication.
Risk communication is crucial to inform consumers about unsafe foods already placed on the market (i.e. prepackaged food with undeclared food allergens), and to prevent and/or mitigate their adverse impact on health.
3) Allergens labelling, the EU rules
The list of allergens to be highlighted in the list of ingredients is included in Annex II of the Food Information Regulation (EU) No 1169/2011. Mandatory information on the presence of allergens is provided either on pre-packaged food labels and on foods offered for sale to the final consumer or to mass caterers without prepackaging, or foods packed on the sales premises at the consumer’s request or prepacked for direct sale. Nonetheless, uniform rules are provided only for pre-packaged food labels.
The European Commission, in its answer to the Codex Alimentarius Committee on Food Labelling (CCFL), (2) also clarified what follows:
-the list of allergens provided by FIR derives from EFSA’s scientific opinion on food allergies prevalence in its Member States, and it’s subject to revision; (3)
-a guidance document on the provision of information on products or substances causing allergies or intolerances has been published; (4)
-allergens in the EU must be designated by their specific names, and not by products categories (e.g. cereals containing gluten’, ‘tree nuts’);
-precautionary allergen labelling (PAL) in the EU is qualified as a voluntary information, in the absence of specific rules.
4) Precautionary Allergen Labelling (PAL)
13 years ago, the European Commission was delegated to ‘adopt implementing acts to ensure that information on the possible and unintentional presence in food of substances or products causing allergies or intolerances does not mislead or confuse consumers’ (Reg. EU No 1169/11, Article 36.3.a). Such act has not yet been adopted.
Awaiting for EU harmonized rules, some Member States have adopted national policies and provisions on precautionary allergen labelling (PAL), also by defining reference values, reference amounts, action values and other parameters. (5)
Good examples – mostly based on the Allergen Bureau’s VITAL Program (see next paragraph) – are offered by Holland, Belgium and Germany (6,7,8). Whose national agencies, such as BfR in Germany, (9) are also very active on the subject.
5) VITAL
VITAL® – the Voluntary Incidental Trace Allergen Labelling program – was developed by the Allergen Bureau as a standardised allergen risk assessment for food industry. Its latest version 4.0 was released in August 2024. (10) The system provides a scientific approach for the adoption of PAL and the use of claims such as ‘may contain X, Y, Z’ (where X, Y, Z are the names of the allergens). On the basis of the following parameters:
-action level grids (action level transition points of ppm total protein for each allegen in the product. To be calculated for a single specific product);
-action levels (Level 1 – action not necessary due to low allergen concentration with low chance of significant reaction; Level 2 – significant concentration of the allergen and high chance of severe allergen reactions);
-action level concentrations (ppm);
-reference doses (mg of allergen protein below which only the most sensitive person, calculated as 5% of individuals in the allergic population, is expected to experience an objective allergen reaction);
-reference amount (maximum amount of food containing the allergen that may be eaten in a typical occasion). (11)
6) VITAL recognition
FAO/WHO Expert Committee on food allergens, in its third meeting (2023), recognized ‘the evidence in support of precautionary allergen labelling to address unintended allergen presence in foods’, and ‘unanimously agreed that current PAL systems used in many countries needed to be improved as they were neither uniform nor informative’. ‘The Expert Committee reviewed again the principles and basis of RfD from the second meeting and reached a consensus that the RfD for each priority allergen(…) was a valid risk assessment endpoint for determining when sporadic or unexpected unintended allergens presence’. (12) Its work is still in progress, in view to update the CXS 1-1985 on food labelling (13,14).
ILSI (International Life Science Institute) Europe also recognised the importance of VITAL in food allergy management, to develop general and dedicated guidelines (15,16). Even so, EU Member States still have opposite views on the opportunity to recognise the role of VITAL in the management of unintended allergens presence in food products. Whereas only some of them (i.e. Germany) currently use it in the organisation and execution of official controls and internal risk analysis. (17)
TNO, the Netherlands Organisation for Applied Scientific Research, has developed a similar system – the ‘Contamination Estimate Calculator’ (CEC) – in the context of its IFAAM (Integrated Approaches to Food Allergen and Allergy Risk Management) project (18,19). CEC indeed includes some VITAL elements from VITAL, and VITAL development has been inspired by the IFAAM project results (e.g. the use of IFAAM consumption database). This system is also described in ILSI guidelines, and it’s now being revised in accordance to the new Dutch policy on food allergens. (20)
6) Food safety alerts, the missing data
RASFF, the EU Rapid Alert System for Food and Feed, includes 348 notifications of allergens not declared or above the permitted limits (i.e. lactose and gluten, in the respective ‘free from’ products). (21)
The actual number of food safety alerts for undeclared allergens in the Old Continent is certainly much higher, since RASFF records cases involving several Member States, but not those that only occur at national level. And there is still a lack of data on the latter.
Incidents caused by undeclared allergens in food sold loose or served by food services, canteens and cafeterias are not even notified to the competent authorities, except for lethal cases.
6) Provisional conclusions
‘Although food allergy is a condition affecting up to 10 % of the consumers worldwide, a European harmonised approach for the management of precautionary allergen labelling, allergen reference doses, analytical methods or food product monitoring is not in place. This leads to limited food choices for consumers with food allergies but can also result in the occurrence of serious allergic incidents. The current state of non-harmonised and unregulated food allergen monitoring in Europe means risks and considerable costs for the individual consumer, but also for society in general’. (1,22)
Dario Dongo, Andrea Adelmo Della Penna
Footnotes
(1) Smits N.G.E. et al. (2025). The changing food allergen landscape in Europe calls for harmonised food allergen monitoring: Position paper. Food Control 168:110915, https://doi.org/10.1016/j.foodcont.2024.110915
(2) Codex Alimentarius Committee on Food Labels (CCFL). Questionnaire on allergens labelling, 2018 https://food.ec.europa.eu/system/files/2018-07/codex_ccfl_cl-2018-24_ann-02.pdf
(3) EFSA NDA Panel (2014) Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes. EFSA Journal 12(11):3894, https://doi.org/10.2093/j.efsa.2014.3894
(4) Commission Notice of 13 July 2017 relating to the provision of information on substances or products causing allergies or intolerances as listed in Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers. EUR-Lex OJ C 428(60):1-15, https://tinyurl.com/355eyr53
(5) Dario Dongo, Andrea Adelmo Della Penna. The Netherlands, guidelines for allergens labelling. FT (Food Times). November 3, 2024
(6) FNLI. Guidelines document provide company with new tools for the new allergens policy. April 22, 2024 https://tinyurl.com/33uuj4z2
(7) FASFC. Food allergens legislation https://tinyurl.com/3rmck9ar
(8) BfR (2020). VITAL 3.0′: New and updated proposals for reference doses of food allergens https://tinyurl.com/3z87v6pf
(9) BfR. Food allergies https://tinyurl.com/yc3fv7me
(10) Allergen Bureau. VITAL (Voluntary Incidental Trace Allergen Labelling) https://vital.allergenbureau.net/
(11) VITAL science https://tinyurl.com/yc3t6k2w
(12) Risk assessment of Food Allergens – Part 3: Review and establish precautionary labelling in foods of the priority allergens – Meeting report https://tinyurl.com/ywzz92pv
(13) CCFL. 48th session. Guidelines on the use of allergen labelling (Step 4) https://tinyurl.com/3e63kztj
(14) CXS 1-1985 (revised in 2018). General standard on prepackaged food labelling https://tinyurl.com/2s44yvn6
(15) Dario Dongo. Allergen risk analysis. FAO, WHO and ILSI confirm Vital 3.0. GIFT (Great Italian Food Trade). 4.7.22
(16) ILSI. Food allergy https://ilsi.eu/scientific-activities/food-safety/food-allergy/
(17) Holzhauser T. et al. (2020) Are current analytical methods suitable to verify VITAL® 2.0/3.0 allergen reference doses for EU allergens in foods? Food and Chemical Toxicology 145:111709, https://doi.org/10.1016/j.fct.2020.111709
(18) TNO. Contamination estimate calculator https://diamonds.tno.nl/projects/cec
(19) IFAAM (Integrated Approaches to Food Allergen and Allergy Risk Management) https://cordis.europa.eu/project/id/312147
(20) TNO research lays foundation for more reliable allergen information on food labels. February 6, 2024 https://tinyurl.com/ycyyeesa
(21) RASFF window. Search by ‘allergens’ risk’, performed on November 14,2024 https://tinyurl.com/y2v24jzu
(22) Dario Dongo. Allergens and RASFF, European blackout. FT (Food Times). July 13, 2022
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Food Technologies and Biotechnologies, qualified food technologist, he follows the research and development area. With particular regard to European research projects (in Horizon 2020, PRIMA) where the FARE division of WIISE Srl, a benefit company, participates.
