The Netherlands has updated its national legislation on food allergen cross-contamination and precautionary labelling, which includes guidelines that all operators must comply with by 1 January 2026. (1)
The guidelines were prepared by NVWA (Netherlands Food and Consumer Product Safety Authority) in cooperation with national representatives of both the food industry (FNLI) and supermarkets and food service (CBL). (2)
1) The Netherlands, national legislation on allergens and precautionary labelling. Foreword
The Dutch national food allergen legislation has already managed to close the most serious remaining gaps in the implementation of the Food Information Regulation (EU) No 1169/2011. Namely, the risk analysis and labelling of allergens in food as a result of cross contact. In essence:
-the low concentration of the allergen does not in itself determine the absence of risk for allergic and intolerant consumers;
-operators therefore adopt Precautionary Allergen Labelling (PAL), through labelling statements such as ‘contains...’ or ‘may contain…’;
-widespread negligence and lack of consensus on tolerance thresholds, however, lead to the frequent misuse of PAL, without any certainty as to the presence (or absence) of the indicated allergens.
The Netherlands therefore adopted national ‘reference values’ already in 2016 to assess whether the presence of allergens may actually pose a risk to allergic consumers. The value currently used is ED01, i.e. the concentration potentially capable of triggering an adverse reaction (ED, ‘eliciting dose’) in 1% of the allergic population.
1.1) Need for updating
The legal certainty offered by the above-mentioned policy was not enough to save NVWA (Netherlands Food and Consumer Product Safety Authority) from some legal actions by operators.
The Rotterdam Administrative Court even went so far as to condemn NVWA for prescribing precautionary labelling on a chocolate spread that contained hazelnut and milk residues at concentrations higher than those considered safe. NVWA had indeed carried out the risk analysis by applying the VITAL (Voluntary Incidental Trace Allergen Labelling) system – recognised internationally (FAO, WHO) as appropriate to protect allergic consumers (3) – which the Rotterdam Court, however, found to be too ‘conservative’. (4)
The Dutch Ministry of Health, Environment and Sport (VWS) therefore asked the Office for Risk Assessment & Research (BuRO) for a scientific opinion in order to assess the appropriateness of:
-update the reference values on the basis of available scientific data;
-regulate the use of PALs, in the light of ongoing work and the guidelines proposed by the Codex Alimentarius Commission on Food Labelling (CCFL). (5,6).
1.2) BuRO, scientific evaluation
BuRO considered the following requirements in the scientific evaluation requested by the Ministry
1) to re-evaluate reference values suitable for performing a risk analysis on all allergens that may remain in food as a result of cross contact;
2) to introduce reference values in national legislation, pending common rules at EU level;
3) to establish an unambiguous wording to be included on the label to inform consumers about the possible presence of allergens above the reference values (PALs).
2) The Netherlands, updating allergen legislation. Key points
The revision of the Dutch national allergen legislation is based on four key points:
(a) adoption of new reference values based on the outcomes of the CCFL 2023 meeting (CCFL47) and the use of ED05, which is also considered acceptable by allergy patient organisations, although it can trigger allergic reactions with mild to moderate symptoms in the most sensitive people. Equivalent measures have also been taken by other EU Member States;
b) use of the new reference values as the basis for precautionary allergen labelling (PAL). Operators must therefore carry out a risk analysis demonstrating the need to use PAL if, as a result of the correct application of self-control procedures (PRPs, HACCP), a real possibility of cross contact is detected;
c) application of the NFLI-CFL-NVWA guidelines to ensure compliance with the criteria defined above for pre-packaged foodstuffs only;
d) adequate transitional period to apply the new rules, defined on 1 January 2024, by the deadline of 1 January 2026.
Fig. 1 – Reference doses adopted in the Netherlands in 2016 and their update (2024), based on ED05 (source: NVWA)
3) The Netherlands, allergen labelling guidelines
The document takes into account the latest revision of Hygiene 1 Regulation (EC) No 852/04 and the European Commission’s guidelines on food safety management systems, in the parts concerning allergens (7,8). It does not apply to non-prepacked foods, which are subject to the ‘Dutch Commodities Act Regulation – allergen information for non-prepacked foods’.
3.1) Incoming raw materials, information and controls
All information on raw materials and the procedures adopted within their production processes that may result in the entry of an undesirable allergen into the finished product must be known (therefore recorded, in a food safety management system logic).
Operators must receive from their suppliers every possible element to make an appropriate assessment of the actual or potential presence of allergens in ingredients, including additives and processing aids, as well as their actual concentration (to be detected by analysis).
The above information must be kept under continuous review, by means of periodic requests for updates and, if necessary, feedback analyses, in order to detect any changes that may alter the qualitative and quantitative presence of one or more allergens.
3.2) Preventive segregation, cleaning and validation
The spatio-temporal segregation of ingredients and products that may contain allergens is the first indispensable operation. Storage of materials in different areas of the company, processing in separate phases (starting with allergen-free processes), with care taken to adopt suitable and effective sanitisation measures.
The efficiency of sanitisation must be the subject of an appropriate risk assessment. The amount of allergen protein transferred to the product (and to the line after cleaning, where applicable) must therefore be analysed, also assuming a ‘worst-case scenario’. If several cleaning methods are used, or external services are relied upon, validation is even more important for each and in combination.
Based on the amount of allergen (mg/kg) that may be residual in the food, a decision must then be made whether or not to use PAL. If the unit of measurement is not the one indicated, it must be converted, taking care to consider comparable analytical results. The quantity of allergen in the volume of air, for example, can only be considered as a qualitative measurement, and not to identify an action limit, as this is difficult to compare with the allergen in a food.
3.3) Evaluation
The risk assessment is necessary for deciding on a possible use of PAL and must be based on the reference dose (RfD), which represents the amount of allergenic protein (mg) in a portion or consumption occasion of a food that is scientifically proven to be safe for allergic consumers. Therefore, to define the action limit (action limit), the ED (reference dose in mg/kg) is calculated.
The conversion of an RfD into an action limit requires a careful estimation of the amount of food that can generally be consumed in a single consumption occasion (within about half an hour), even regardless of portion or consumption unit. To this end, operators may consider literature, consumer use of the product (i.e. surveys) and other data, including package size.
The total cross contact is the sum of the allergens in the raw materials and those brought in during the production process, storage systems (i.e. big bags) or facilities. The physical form of the ingredients must also be considered, which may result in a different distribution of allergens. The data used for risk assessment must also be used to calculate ‘action limits’ or RfDs for particulates.
3.4) Precautionary Allergens Labelling (PAL)
Precautionary Allergens Labelling (PAL) must only be used after all precautionary measures have been taken, following a risk assessment demonstrating the existence of an unavoidable cross contact that may lead to a health risk for the consumer.
The only permissible wording is ‘may contain…’ or ‘not suitable for consumers allergic to…’, followed by the specific mention of the individual allergens (and not also their category. E.g. walnuts, hazelnuts and not ‘nuts’).
The use of PAL, on the other hand, is not permitted when the presence of the allergen is certain and unavoidable, since it is, for example, found in almost all of the samples analysed. In this case, the allergen must be indicated in the ingredients.
3.5) Special cases
Special precautions regarding the use (or non-use) of nutrition labelling relating to allergens (PAL) are required in the cases of
– products manufactured in different factories, yet bearing the same EAN (European Article Number) code. (9) Since cases of cross-contact may have different causes, the risk analysis must be performed on products made in the establishment with the highest risk levels;
– ‘free from’. For some ‘free-from’ claims, legal thresholds or other limits apply (e.g. ‘lactose-free’. See NVWA, Nutrition and Health Claims Handbook). On the other hand, no PALs are permitted on labels of products bearing a ‘free-from’ claim related to the same matrix (i.e. ‘gluten-free’, ‘may contain wheat’), as this would be confusing for consumers;
– Novel foods. Attention should be paid to specific labelling requirements regarding the cross reaction that some novel foods may trigger (e.g. insects with molluscs, crustaceans and dust mites).
4) Interim conclusions
The uniform adoption of PAL at the international and European level is still a long way off, but some Member States such as the Netherlands have correctly adopted a number of national measures that can serve as an example for achieving a common approach.
The national policy and guidelines for operators will have the task of avoiding problems that have arisen in the past on the subject of allergens, and will entail real experimentation for a harmonisation of PAL, based on the outcomes of the last CCFL Committee.
Important steps have been taken precisely in this context, identifying the importance of including wheat in the list of reference doses (also applicable to gluten), recognising the critical issues for coeliac and wheat-allergic individuals, previously not considered.
Dario Dongo and Andrea Adelmo Della Penna
Footnote
(1) Ministere van volksgezondheid. Allergenenbeleid https://tinyurl.com/y6at8h7a
(2) FNLI – CBL – NVWA. Guidelines on cross-contact of allergens. Version April 2024 https://tinyurl.com/2yzhkktt
(3) Dario Dongo. Analisi del rischio allergeni. FAO, WHO e ILSI confermano Vital 3.0. GIFT (Great Italian Food Trade). 4.7.22
(4) Warenwet. Onbedoelde aanwezigheid allergenen in chocopasta. Gelet op alle nationale en internationale ontwikkelingen mbt referentiewaarden en PAL-vermeldingen weegt belang verzoekster zwaarder. Toewijzing vovo. ECLI:NL:RBROT:2022:5609. https://tinyurl.com/4mjchxja
(5) Advies van BuRO over referentiewaarden voor allergenen in voedingsmiddelen. 21.9.22 https://tinyurl.com/bdz972wn
(6) Codex Committee on Food Labelling. Forty-seventh Session (CCFL47), Gatineau, Quebec, Canada, 15-19 May 2023. Food Allergen Labelling https://tinyurl.com/3p3htewb
(7) Dario Dongo. Reg. EU 2021/382. Allergen management, safety culture, food redistribution. FT (Food Times). 9.3.21
(8) Dario Dongo. Food safety management systems, EC guidelines 2022. FT (Food Times). 23.12.22
(9) Dario Dongo. EAN, QR Code, RFID, NFC. ABC of global standards. FT (Food Times). 2.4.23
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.
