New allergen labeling policy for pre-packaged foods

PAL (Precautionary Allergen Labeling)

First of all, what exactly is PAL? Labels on products in supermarkets and elsewhere regularly carry warnings such as "may contain traces of X" or "made in a factory where X is also processed". X stands for one or more allergens, such as peanuts or other nuts, for instance. Such warnings are typical examples of PAL. PAL alerts the consumer that the product in question may contain traces of allergens due to cross-contamination. Cross-contamination could occur, for example, because the factory where the product is produced also processes allergens.

Until now, manufacturers enjoyed a great deal of freedom regarding placing PAL warnings on their products. As a result, PAL warnings were expressed using various terms, and there were no specific regulations governing when a product should or should not bear a PAL warning.

This is because that there is limited legal regulation regarding PAL. With Regulation (EU) No. 1169/2011[2] , the European legislator has established a list of fourteen allergens that must be declared on a label if present. However, nothing is specifically regulated about how and when to warn that an allergen in a product might occur through cross-contamination. In this regard, many European countries have established national guidelines and interpretations, including the Netherlands.

Current allergen policy and PAL

In the Netherlands, the Netherlands Food and Consumer Product Safety Authority[3] (NVWA) supervises, among other things, the correct listing of allergens on labels. The NVWA uses as a standard a 'reference dose' determined per allergen. A reference dose stands for a certain amount of allergenic protein per portion of food at which its presence in a product can induce a reaction in (part of) the allergic population. If an excess of the reference dose used in a product is measured, the allergen in question must be explicitly stated as present on the label of that product. If that listing is missing, the NVWA may order that that product be removed from the market (‘recall’). A PAL warning is usually not sufficient in that case; the NVWA considers PAL to be a 'notification without legal status' to which no special significance should be attributed. Therefore, no further rules were prescribed by the NVWA for the wording or conditions of PAL.[4]

Until recently, the NVWA used the reference doses published by the Bureau of Risk Assessment & Research[5] (BuRO) in a 2016 advisory. This uses the starting point 'ED01', where 'ED' stands for 'Eliciting Dose' and '01' stands for that at that reference dose, a reaction can only be expected in 1% of the allergic population.

Reason for adjusting policy

For some time, there have been criticisms of the reference doses used by the NVWA. The reference doses established in BuRO's 2016 advisory are considered unnecessarily conservative and more stringent than what is applied elsewhere in Europe. There has been and continues to be criticism regarding the (low) value that the NVWA appears to assign to PAL warnings. In 2022, this led to a ruling by a judge of the Rotterdam District Court.[6] In that case, the necessity of a recall of a product ordered by the NVWA was successfully challenged; the judge ruled that, given (inter)national developments regarding reference doses and PAL warnings, the PAL warning on the products in question was sufficient to warn the allergic consumer and that those products did not have to be withdrawn from the market.  

In addition, practice shows that PAL warnings are not always accurate and effective. The frequent use of PAL gives the impression that producers place PAL on their products without it being clear whether there is actually a risk of cross-contamination of allergens. Manufacturers would do this partly because low amounts of allergens are sometimes difficult to measure and/or to avoid risk 'just to be sure'. Notable PAL statements could therefore sometimes be found, such as "may contain nuts" on a head of lettuce.

As a result, potentially unnecessary PAL statements occur, unnecessarily limiting the allergic consumer's choice of products. It also appears that some allergic consumers do not always take PAL statements into account as a result, with all the risks that this entails. The new allergen policy therefore seeks to address the foregoing problems.

The new allergen policy

The new allergen policy includes three major modifications to the current allergen policy:

1. New reference doses for allergens

New reference doses are used in the enforcement of allergen policies. The reference doses are based in part on recommendations from FAO and WHO expert groups. [7]

For these new reference doses, ED05 has been used as a starting point. This means that in the presence of the recommended reference dose in a product, a reaction can be expected in 5% of the allergic population. This is less strict compared to the previously used ED01, where a reaction could be expected in 1% of the allergic population. This increase from ED01 to ED05 was considered acceptable by patient organizations. 

2. Rules regarding the use of PAL

The new reference doses are linked to the obligation to use PAL. If there is a risk of exceeding the reference dose, PAL is now mandatory. If no risk of exceeding those reference doses is identified, then PAL should not be used. It is up to manufacturers to conduct a risk assessment and review its findings against the new reference doses. So use of PAL without a risk assessment but simply "just to be safe" is no longer allowed. 

In addition, PAL's freedom of wording is restricted. The wording that may be used with PAL according to the new policy is "May contain X" or "Not suitable for X." The goal here is to use strict wording so that legal value can be placed on the use of PAL warnings. Wording such as "made in a factory where X is also processed" is too ambiguous and should no longer be used.

3. Guidelines on cross-contamination of allergens

In addition, a comprehensive document called "Guidelines on cross-contamination of allergens"[8] will be published. This document will be prepared by the food industry in consultation with the NVWA. It will describe options and measures to prevent cross-contamination with allergens and will cover several topics, including production process cleaning, risk assessment, use of a PAL warning, allergen analysis and different types of contamination (point contamination vs. homogeneous contamination). At the moment, the document has not yet been published.

Implementation

The new allergen policy is effective from 1 January 2024. Manufacturers are given two years to implement the policy and possibly adjust the PAL on their food products. From 1 January 2026, manufacturers must have adjusted PAL statements on their labels. The Ministry of Health, Welfare and Sport is expected to publish more on the implementation of the new allergen policy in the near future. 

About Ploum's International Trade, Customs and Food and Commodities practice team

If you have any questions on this topic or other issues regarding International Trade, Customs or Food Safety and Legislation, please contact one of our team members or contact Marijn van Tuijl directly (m.vantuijl@ploum.nl).