Conference - Precautionary Allergen Labelling: the new policy in the Netherlands

On 14th November 2024 LAN (Luxembourg Allergy Network) and ALIG (Association Luxembourgeoise des Intolérants au Gluten) jointly organised a conference on PAL (Precautionary Allergen Labelling) that took place at the CHL.

Key speaker Angèle van den Heuvel, from the Dutch Allergen Consultancy in the Netherlands, presented a new policy concerning PAL which they are actively involved with and that will come into force in the Netherlands on 1 January 2026. This policy has set out and adjusted the reference doses, status and wording of the PAL, which unfortunately is often used too extensively by the food industry and therefore considerably limits the choice of products for allergic or intolerant consumers. The starting point in establishing the new policy was that PAL should not be used too often, but only if there is real risk to the allergic consumer.

Studies in the Netherlands have shown that the majority of food allergic consumers ignore PAL statements. Due to the overuse of warning statements, such as "may contain traces of", "made on equipment that also produced products containing...", people are increasingly losing trust in the food industry and believe that they are merely used to "cover themselves". There is a gap between the consumer and the food industry that needs to be bridged, in the interest of all parties. 

Unfortunately, PAL is not regulated and harmonised amongst EU member states. Some countries have their own interpretations on PAL labelling (eg. wording of PAL), but most countries have no requirements on PAL or any risk assessment. The Netherlands is the first member state to have national legislation on PAL for pre-packaged foods. The European Parliament has been asked to draft a EU-legislation on PAL but they are awaiting further developments from Codex Alimentarius (who deals with food security on an international level), which will be a lengthy process. The Dutch Allergen Consultancy believes that EU member states should take matters into their own hands and pro-actively start drafting a legislation to encourage harmonisation.

The change in the PAL policy started in 2022, when a major Dutch nut paste manufacturer was sued for wrongly using PAL on their product, but with the court eventually ruling a valid risk communication of the use of PAL. The need for a legal framework around PAL became imperative and lead to round table discussions with major actors:

Dutch Ministry of Health, Welfare and Sport - Dutch Food and Consumer Product Safety  Authority - Dutch Food Industry Federation - Dutch Food Retail Association - Patient Organisations.

 

In 2023 an Allergy Policy was determined and published, giving the food industry a two years transition period to put the new policy into practice, before it will come into force on 1st January 2026. The policy consists of the following three elements:

1. Reference doses based on ED05

2. Wording of PAL:

• "May contain", or
• "not suitable for"

3. Guidance document 

 

The guidelines for the food industry focus on key points, such as the prevention of cross-contamination in production. Manufacturers must do everything they can to avoid cross-contamination. Evidence is collected throughout the supply chain, from the raw materials to the production itself, followed by a calculation of the quantatitive risk. If a risk exists PAL must be put on the food label. If there is no evidence of risk, PAL is not allowed to be used. This leads to a better consumer choice.

 

A reference dose (a safe dose of a certain amount of allergen protein) was defined based on food provocation studies with patients, where the threshold of an allergic reaction is measured. The eliciting dose ED05, recently also approved by Codex, was chosen as the safe reference dose. ED05 means that 95% of food allergic consumers are protected and that 5% of allergic consumers are at risk of having a reaction. However, recent studies demonstrate that reactions in terms of anaphylaxis remain extremely low so that ED05 strikes the right balance between safety information for food allergic consumers while safeguarding their food choices. 

A mandatory PAL should reduce uncertainty around the risks posed by food products while increasing consumer trust in foods. So are other EU member states ready to join the quantative risk-based approach to PAL and work towards harmonisation in the European Union?

Find out more about the new policy in the Netherlands: https://www.allergenenconsultancy.nl/en/nieuws/nederlands-allergenenbeleid-aangepast-en-nieuwe-referentiedosissen