Update new allergen labelling policy: publication document ‘Guidelines on cross-contamination of allergens’

The underlying considerations for the new policy included that PAL was sometimes used unnecessarily and too often, and that overuse of PAL is harmful: credibility is adversely affected and consumers ignore the warning. Strange PAL sometimes appeared as "may contain nuts" on a head of lettuce.

When the new policy was announced, the arrival of a comprehensive document called 'Guidelines on cross-contamination of allergens' (hereinafter 'Guidelines Document') was also announced, intended to provide guidance to companies regarding the new policy and the use of PAL. Recently, the Guidelines Document was published.[1] In this blog, we discuss its contents.  

Guidance document: background 

The Guideline Document has eighteen pages and was published by the FNLI[2] in consultation with the CBL[3] and the NVWA[4]. The background to the document is a Commission Notice[5] by the European Commission to Regulation (EC) No 852/2004, which provided an explanation of the legal obligations under that regulation.

In that Commission Notice, the European Commission stressed, among other things, that the requirements resulting from Regulation (EC) No 852/2004 regarding the prevention of cross-contamination and the use of PAL are a best-efforts obligation. Food manufacturers must avoid cross-contamination of allergens as much as possible. If there is a chance that allergens are present, a risk analysis must be carried out. If that risk analysis shows that such a risk is present, then a PAL statement on the food label is required. Only after such a risk analysis may PAL be used, and therefore not (anymore) as a precautionary measure or to conveniently omit investigation.

The Guidance Document provides guidance to companies to fulfil the abovementioned effort obligation, and is composed of the following topics: (1) raw material information and management, (2) separation, cleaning and validation, (3) risk assessment and (4) risk communication (PAL). We discuss these topics below.

Raw material information and management

The Guideline Document emphasises the need to know which allergens are or may be present in a product. This applies not only to all raw materials or ingredients present in a product, but also to process and processing aids that are processed in or come into contact with a product. The amount of allergen present should also be clear. This information must be up-to-date, emphasising that a revision once every three years is sufficient in many cases if nothing changes in the process.

Separation, cleaning and validation

Next, the Guidance document emphasises that cross-contamination should be avoided by separating raw materials during food production. It also stresses that a comprehensive cleaning plan should be drawn up, describing all stages of production where different allergens are processed, and specifying which cleaning methods should be used. The plan should indicate when a certain type of cleaning should be used to prevent cross-contamination, based on factors such as microbiological hazards, colour, taste and allergen profile. A cleaning matrix or production sequence defines which cleaning is required, distinguishing between products without and with allergens, and between products with different allergens.

In addition, validation of the cleaning plan should be performed to test the effectiveness of cleaning measures and determine the residual risk of allergens. The validation should examine the amount of residual allergenic protein in the worst-case practical situation. All cleaning methods used to prevent cross-contamination, including externally performed cleanings, should be validated. A validation plan should include the rationale for the method chosen to determine product residues, the worst-case scenario chosen, and the suitability of the analytical method. The interpretation of the results of the validation in doing so is also important: the results should, if possible, be converted to mg protein of an allergen/kg of product so that comparison is possible with the prescribed action limits[6] .

Risk assessment

Next, a risk assessment should determine whether cross-contamination with allergens poses a real risk to consumers, based on scientific data such as the reference dose (RfD) and related action limits. The RfD, based on 'ED05' since the new policy takes effect in 2024, is the amount of allergenic protein that is safe for allergic consumers without causing serious symptoms. At ED05, a reaction can be expected in five per cent of the allergic population at that dose. The action limit is calculated by dividing the RfD by the consumption size, a realistic estimate of the amount of product consumed at one meal time.

The risk assessment should examine all 14 legal allergens, evaluating cross-contamination from raw materials and the in-house production process. Data such as validation of cleaning, assessment of product residues left behind, and calculations based on recipes should be used to determine total cross-contamination. These should be compared with the safe limit (action limit or reference dose), where an excess indicates a risk to the allergic consumer, while a lower amount, even if the allergen has been detected, implies a low risk of severe symptoms.

Risk communication (PAL)

Finally, the Guidance Document emphasises that if all preventive steps have been taken and then the validation and risk assessment show that there is a risk of cross-contamination, use of PAL is required. The use of a PAL must be supported by information showing that cross-contamination can actually occur, a risk assessment showing that the amount of allergen exceeds the safe limit, and documentation proving that preventive measures have been taken. The prescribed wording of a PAL is 'May contain xxx' or 'Not suitable for xxx', and should be as specific as possible in terms of the wording of the allergen.

In conclusion

In brief, the Guideline Document gives food producers guidance on how to meet their best-effort obligation in relation to the new allergen policy. It follows that if, despite preventive measures, there is still a risk of cross-contamination, a risk assessment should be carried out. This risk assessment should be supported by evidence that cross-contamination actually occurs and in quantities exceeding the action limits used. If it follows that there is actual risk of cross-contamination, PAL should be used. If there is no demonstrable risk then PAL should not be used.

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

Do you have questions about labelling or other food-related issues? The specialists in our International Trade, Customs and Food and Commodities Practice team will be happy to assist you. Thanks to our many years of experience in Food and Commodities Practice, among others, we can provide you with quick and effective assistance. If you have any questions on this topic or on other issues surrounding 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).