Allergens: the Netherlands and Spain lead the shift towards VITAL

The scenario is now finally changing thanks to national initiatives that serve as trailblazers for the entire European Union. The Netherlands and Spain have recently introduced pioneering guidelines that officially integrate the quantitative risk assessment (QRA) approach. While the Netherlands has established specific thresholds based on scientific reference doses, (1) Spain promotes voluntary standards aimed at overcoming the ambiguity of Regulation (EU) No 1169/2011. (2) These national developments represent fundamental stimuli towards EU harmonisation, pushing the European Commission to define uniform criteria that guarantee both the free movement of goods and maximum protection for consumers with food allergies.

In this context of regulatory transition, the VITAL® system (Voluntary Incidental Trace Allergen Labelling) emerges as the international reference standard. Through the calculation of ‘Action Levels’ and the integration of advanced analytical methods such as ELISA, companies can now move from precautionary management to scientific management of food safety.

Precautionary allergen labelling

Precautionary allergen labelling (PAL) consists of an indication of the possible presence of allergens in food products due to causes other than the operator’s intention to include them in the product formula itself (e.g. accidental contamination). The correct indication to apply in these cases is: ‘May contain [name of allergen]‘. (3)

The application of PAL postulates an actual risk assessment based on scientific criteria, the outcome of which determines that — despite the operator having implemented all necessary measures to prevent potential contamination by food allergens — it is not technically possible to eliminate the risk of ‘cross-contact’.

The current limitation of PAL application is represented by the frequent absence of the scientific validation necessary for its use. The most evident consequence is the widespread presence of labels with PAL referring to allergens whose actual possible inclusion in the product is unknown, thus limiting the effectiveness of the information for consumers suffering from food allergies.

Rules and indications on the use of PAL

PAL falls within the scope of the Food Information to Consumers (FIC) Regulation (EU) No 1169/2011, and the Commission is called upon to define harmonised rules for the implementation of its conditions of use. Until then, its use remains entrusted to the realm of voluntary food information, which in any case must comply with the general criteria of fair information practices:

• prohibition on misleading the consumer about the composition of the product;

• duty to provide unambiguous information;

• obligation to base information on relevant scientific data (Art. 36.2).

The use of PAL in the absence of an actual risk assessment may therefore constitute non-compliance with EU rules on food product labelling. Its widespread use is moreover also dictated by national policies that in fact apply ‘zero tolerance’ to the accidental presence of allergens — even at the limits of analytical detectability thresholds, as well as in the absence of any actual risk even for allergic consumers with the most pronounced sensitivity — and by the European Commission’s inertia in this regard.

The FAO/WHO Codex Alimentarius Committee (CAC) has for some time stimulated the overcoming of the ‘zero tolerance’ approach, with the introduction of reference doses (RfDs), useful for assessing when the application of PAL is actually necessary, based on the eliciting dose (ED) necessary to cause an allergic reaction in a given percentage of the reference population (4,5).

RfDs are expressed in mg of total proteins contained in the allergenic food, and when they are put in relation to the quantity of food consumed (expressed in kg) it is possible to calculate the Action Level (AL), based on predefined Reference Amounts (RfA). The two possible AL scenarios are:

• Action Level 1: a low concentration of an unintentional allergen has been identified, and the use of PAL is not necessary;

• Action Level 2: the unintentional allergen is present in a significant and substantial concentration, therefore the use of PAL is required.

Use of PAL in the Netherlands

The Dutch government has applied specific guidelines since 2024 that define the criteria to be respected for the use of PAL on products legally placed on the market in its territory, regardless of their origin (i.e. national and non-national products). (6) The objective of this policy is precisely to fill the aforementioned gaps, deriving from improper use of PAL which on the one hand can reduce the availability of safe foods for consumers subject to food allergies, and on the other hand can lead to unjustified recalls of safe foods due to contamination with allergens at levels devoid of any actual risk for vulnerable consumers. (6)

The guidelines have provided food business operators (FBOs) with the operational instructions useful to ensure compliance from 1 January 2026 (date of application of the new rules), organising risk management procedures that include relationships with suppliers, cleaning operations and segregation of raw materials and finished products that contain or do not contain food allergens.

The new policy presents a point of balance compared to the previous approach which had proved excessively conservative following the use of ED01 by the national authority (Netherlands Food and Consumer Product Safety Authority, NVWA) as a criterion for risk analysis. The Dutch government has therefore aligned its guidelines with the parameters indicated in the CAC documents on the use of PAL, thus harmonising the values of RfD, ED (now defined as ED05), and RfA, in order to determine the AL.

Questions and answers on Dutch policies

NVWA has published a series of questions and answers (Q&A) — in collaboration with the Dutch Food Industry Federation (FNLI), the Central Bureau for Food Trade (CBL) and Allergen Consultancy — which have been verified and validated by various stakeholders such as the Food Allergy Foundation, the Dutch Coeliac Association, ProVeg Nederland and the Ministry of Health, Welfare and Sport (VWS).

The prerequisite for all food products is compliance with Community regulations on food legislation and food hygiene (i.e. Reg. EC No 178/2002; Reg. EC No 852/2004), with particular regard to the absence of ‘risk’ for consumers (Reg. EC No 178/2002, Art. 14), which also contemplates the provision of information on labelling such as to avoid harmful effects on consumers’ health, including allergic reactions and food intolerances.

A) Correct expression of PAL

The use of PAL on labelling, in addition to requiring a scientifically substantiated risk assessment, is determined by an actual unintentional presence of the allergen in the food product placed on the market.

PAL cannot therefore be used in both cases of absence of the prerequisites for the necessary Action Level (AL) and of known presence of the allergen in the food product. In this latter case, the general labelling rules must in fact be applied, i.e. the indication and graphic prominence of the allergen in the ingredient list (e.g. underlining, capital letters, bold). Consequently, the following wording is not permitted for PAL purposes: ‘Contains [name of allergen]’.

The only permitted wordings are ‘May contain [name of allergen]’ or ‘Not suitable for [name of condition]’ (e.g. ‘May contain peanuts’, or ‘Not suitable for people with peanut allergies’). This second option, although permitted, is considered to constitute a potential cause of confusion where it refers only to the allergens indicated in the PAL but not also to those present in the ingredient list. Furthermore, the use of terms such as ‘May contain traces of [name of allergen]’ is prohibited, in the absence of objective reference terms. (7)

B) Denomination of the allergen

Allergens listed in PAL must follow the same methods required for the expression of allergens in the ingredient list (EU Reg. No 1169/2011, Annex II). Some examples follow:

• ‘May contain milk’: every reference must be made to ‘milk’ and not to its derivatives such as whey or to its constituents such as lactose;

• cereals containing gluten and tree nuts: individual denominations provided must be listed (e.g. ‘may contain wheat’; ‘may contain walnuts’), and generic or summary terms cannot be used (e.g. ‘may contain cereals containing gluten’ or ‘tree nuts’);

• fish products: fish, crustaceans and molluscs do not list distinct species, therefore PAL may refer to the name of the allergen group to be indicated. For crustaceans and molluscs, the indication is also valid for seaweed (e.g. ‘it may contain crustaceans and molluscs’).

C) Specific conditions for tree nuts

The specific distinction of tree nut species (e.g. walnuts, almonds, hazelnuts) is dictated by the fact that people generally do not present an allergic reaction to all types, but only to some specific types. Therefore, inappropriate use would not allow, on the one hand, an informed choice by these consumers and, on the other hand, adequate marketing of products by the FBO following ‘self-boycotting’ deriving from the exclusion of consumer segments suitable for consuming their products following the adoption of a generic PAL such as ‘may contain tree nuts’.

The only exception for the use of such wording is the actual scientific demonstration that the products are actually contaminated by all types of tree nuts listed in Annex II of Reg. (EU) No 1169/2011, and that for them the AL level has been exceeded in such a way as to require the use of PAL. It is not required that cross-contamination always occurs simultaneously, but it must be demonstrated that such circumstance is based on variations in production and/or choice of raw materials (used in other productions or themselves subject to PAL).

The conditions for tree nuts are applicable only for the species indicated in Annex II to Regulation (EU) No 1169/11. For other tree nut species (e.g. pine nuts) the requirements established for voluntary indications for food products apply instead.

D) Specific conditions for cereals containing gluten

Cereals containing gluten must also be listed in PAL using specific denominations (e.g. wheat, barley, rye). In the case of wheat, further characterisation of the species is permitted on an optional basis (e.g. common wheat, spelt, khorasan), as is the presence of gluten. This latter term cannot be a substitute, since there are subjects who have allergies to specific proteins present in individual cereals.

E) Packages with assorted products

Assorted packages contain two or more different products not individually considered as sales units (e.g. sweets with different flavours, mixed snack trays, mixed biscuits and crisps, salads in trays with dressings). The presence of an allergen in one product and the possible unintentional presence in another product (e.g. hazelnut in chocolates) entails the obligation to indicate its presence in the ingredient list and in the PAL. To avoid confusion, it is suggested to list separate ingredient lists for each product, each with its own PAL.

Cross-contact can also occur between products contained in the same package that are not individually packaged and can come into contact with each other (e.g. frozen snacks). In this case, separate information is not necessary as long as the unified information on the presence of any allergens is reported on the labelling.

F) Application of adhesive labels

PAL always applies under normal production conditions, never in exceptional cases. Abnormal conditions (e.g. fires, line failures) may however determine variations in production, with impacts on the unintentional presence of allergens.

The application of a new complete label is a permitted solution to comply with this problem (before placing on the market), but the use of an additional label bearing only the PAL is an exceptional measure to be employed if described in the HACCP plan and well documented, to be assessed on a case-by-case basis with the competent authority.

Batches considered at risk for non-compliance with Art. 14 of Reg. (EC) No 178/2002 must be withdrawn or recalled from the market, unless the exceptional addition of an adhesive label with PAL on products already segregated in the meantime is agreed with the competent authorities.

G) Company procedures

The operator must acquire and carefully manage the information obtained from its suppliers, requesting under the standard to have all information on the undesired presence of allergens in the products they supply, based on the guidelines. The lack of provision of this information constitutes serious non-compliance, to be managed as such in the risk assessment.

The assessment must be carried out for all products in the company range, taking into account the ingredients used and the production process adopted. The effectiveness of the sanitation procedure must therefore be assessed, through validation of the complete removal of allergens, and the periodic and punctual execution of chemical analyses. This assessment must also be carried out individually for the components of an assorted product (see above).

The only exception permitted is for artisanal food products, in relation to which an actual demonstration of exceeding the reference thresholds is not required, but simply the possibility that cross-contamination with the allergen has presumably occurred.

Spanish guidelines

Spain is entering for the first time into a harmonised adoption of FAO/WHO recommendations, so far contemplated in the EU only by the Netherlands, Belgium and Germany. The Spanish choice is in line with the assessment of non-compliance of improper use of PAL and aligns both with FAO/WHO recommendations and with the Commission’s guidelines (2022) on good hygiene practices.

The Spanish guidelines of the Spanish Agency for Food Safety and Nutrition (AESAN) on the use of PAL report considerations equivalent to those reported in the Dutch guidelines. There are some additional elements that can further support compliance with the provisions, although adherence to the guidelines in Spain is indicated as voluntary.

A) Definition of food consumed on one occasion

The Reference Amount (RfA) value presents different identification methods, based on operator data, surveys on national or EU food consumption or other reliable sources (e.g. EFSA database).

The FAO/WHO recommendation reports the use of the 50th percentile value (P50) as a reference and, in its absence, the average consumption value of the population.

B) Laboratory determination of allergens

The analytical determination of allergens requires the use of validated and reliable methods to quantify the concentration of the allergen expressed in mg of allergenic protein per kg of food. Standardisation is necessary for the comparison of results obtained on different food matrices.

The main methods suggested are:

• ELISA method: the ELISA (Enzyme-Linked Immunosorbent Assay) method allows qualitative and quantitative identification of allergen concentration, through specific recognition of an antigen. Different commercial methods should allow obtaining uniform values of protein concentrations in mg/kg and, where this is not possible, obtaining this value using conversion factors (which should be harmonised);

• PCR: the polymerase chain reaction (PCR) identifies the DNA encoding the allergen protein. Not identifying the protein, it is defined as an indirect method, and the absence of reference standards currently does not allow conversions to be made. PCR analysis is nonetheless considered to be a valid semi-quantitative method;

• Mass spectrometry: methods currently under development.

Provisional conclusions

The evolution of allergen management marks the definitive demise of a purely precautionary approach in favour of a quantitative risk culture. Recent regulatory initiatives in the Netherlands and Spain do not represent isolated cases alone, but act as true ‘laboratories’ of harmonisation, indicating to the European Commission the necessary path to undertake towards a common standard based on science.

In this scenario, the VITAL® system confirms itself as the most reliable operational tool for companies wishing to combine compliance and transparency. The adoption of Action Levels allows overcoming the abuse of PAL, transforming the label from a mere ‘legal shield’ of uncertain effectiveness to a real information tool for the consumer.

The future of food safety will inevitably pass through the integration of these scientific thresholds into national legislations. For the food industry, anticipating this change by adopting risk assessment models (QRA) means not only guaranteeing maximum protection for allergic consumers, but also reducing the risks of crisis management related to any contamination and acquiring a competitive advantage in a market that increasingly demands precision and clarity.

Dario Dongo and Andrea Adelmo Della Penna

Photo by Thang Nguyen

Notes

(1) Nederlandse Voedsel- en Warenautoriteit (NVWA). (2025, October 28). Vragen en antwoorden nieuw allergenenbeleid (PAL). https://www.nvwa.nl/onderwerpen/allergenen/documenten/consument/eten-drinken-roken/allergenen/publicaties/vragen-en-antwoorden-pal

(2) Agencia Española de Seguridad Alimentaria y Nutrición (AESAN). (2025, December 17). Procedimiento para la gestión del contacto cruzado de alérgenos y el empleo del etiquetado precautorio de alérgenos (EPA). Comisión Institucionalx https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_alimentaria/interpretaciones/nutricionales/Procedimiento_gestion_alergenos_EPA.pdf

(3) Dongo D. (2018, 28 November). Food Allergies and PAL, Codex Alimentarius. FT (Food Times). https://www.foodtimes.eu/consumers-and-health/food-allergies-and-pals-codex-alimentarius/

(4) Dongo D. (2025, 21 April). Mild symptoms, clear science: time to implement allergens Reference Doses. FT (Food Times). https://www.foodtimes.eu/food-safety/food-allergens-evidence-demands-regulatory-action/

(5) E.g. the ED05 is the dose that triggers a reaction in no more than 5% of the allergic .population sensitive to a given allergen. Scientific evidence has demonstrated that this value does not determine allergic reactions other than mild or moderate ones in subjects who are part of this population.

(6) Dongo D., Della Penna A.A. (2024, 3 November). The Netherlands, guidelines on allergen labelling. FT (Food Times). https://www.foodtimes.eu/consumers-and-health/labels-the-netherlands-guidelines-on-allergen-labelling/

(7) Taking into account the example on peanuts, the indication ‘Not suitable for people with peanut allergies’ could mislead the consumer into believing that the product is suitable if they have an allergy to another food ingredient (e.g. celery) present in the ingredient list, but absent in the PAL. Indeed, the indication ‘Not suitable for people with celery allergies’ is not information that can be used as it is not unintentionally present in the finished product.