Interpretation stating cross-contamination on label sometimes still unclear

Listing the possible presence of allergens during the manufacturing process is not required by law. However, the possible presence of allergens is often mentioned on the label in order to warn consumers. This is called the PAL statement. Recently, the judge in Rotterdam addressed the question of whether the PAL statement was sufficient.

PAL listing stands for "Precautionary Allergen Labeling." This is a voluntary statement that warns consumers that one or more allergens may be unintentionally but unavoidably present in a product. As a result, the product may pose a risk to consumers with allergies. This PAL statement may be indicated on the label by stating, for example, "may contain. It is also often referred to as cross-contamination. A recent ruling by the Rotterdam District Court shows that the interpretation of the PAL statement is sometimes still unclear.

Reference values BuRo

NVWA's Bureau of Risk Assessment & Research (BuRo) established reference values for cross-contamination with allergens in 2016 through the "Opinion on provisional reference doses for allergens in food". Recently, BuRO issued a second advisory with options for new reference values and the possible consequences of the choices. A reference value is the absolute amount of allergen protein (mg) that creates an acceptable risk of reactions in an allergic consumer. Therefore, if an allergen is present above the reference value, the product poses a risk to the consumer.

Pronunciation Chocopasta

In the ruling, a manufacturer of chocolate spreads was banned from marketing chocolate spreads. This was because the chocolate spreads contained allergens that had entered the foodstuff via cross-contamination to levels well above the BuRo reference values. According to the NVWA, the chocolate spreads were therefore harmful to consumers. The manufacturer had included the following PAL statement on the label: 'May contain:...'. However, the Minister of Health, Welfare and Sport (VWS) has concluded that the statement 'may contain' is insufficient to indicate the presence of the allergen above the reference value. The statement "Not suitable for people with ... allergy" would be acceptable, according to the minister.

Judge's verdict

DThe Interim Injunction Judge concludes that the contested decision must be suspended and the ban imposed lapses. The producer is thus vindicated. The Court in preliminary relief proceedings based its conclusion on recent developments regarding the reference values. The interim relief judge is of the opinion that the PAL statement does have a value and that allergic consumers are therefore sufficiently warned of the possible presence of allergens via 'may contain'. This statement is also accepted by patient associations of allergic consumers.

Reference values WHO/FAO

In its conclusion, the preliminary injunction judge indicated that developments are underway regarding reference values for allergens. Indeed, in 2021, the Expert Committee of the Food and Argiculture Organization/World Health Organization (FAO/WHO) issued an opinion on reference values for allergens. In addition, FAO/WHO has also issued two opinions on establishing priority allergens and guidelines for the use of PAL. These opinions should make it clearer for producers when a label should warn of the presence of allergens. In response to the proposed FAO/WHO reference values, BuRO has also issued a new opinion. This advisory evaluates the previously established reference values from 2016. The Ministry of Health, Welfare and Sport is currently in discussions with stakeholders about the BuRo's new advice and how it will be implemented.