In 2023, allergens were responsible for a large number of recalls. In the Netherlands, allergens were the cause of 48% of recalls, while in Belgium it was 23%. A cause analysis showed that the main problem was often that the required allergen information was not on the labels (21% in the Netherlands and 17% in Belgium). The NVWA imposed new strict requirements on cross-contamination prevention and risk communication: Precautionary Allergen Labelling (PAL).

Legal and scientific basis

European legislation (Regulation (EU) No 1169/2011) requires labelling of 14 allergens. In addition, the FAO/WHO has established reference doses (RDs) for eight priority allergens, which the Belgian Scientific Committee has extended for the other allergens. In addition, a new NVWA policy on cross-contamination and Precautionary Allergen Labelling (PAL) applies. 

Key principles from reference dose advice:

RDs are based on the lowest amount of protein causing a reaction in 5% of the allergic population (ED05 value). The FAO/WHO grouping of ED05 values resulted in five reference dose groups: 1 mg, 2 mg, 3 mg, 5 mg and 200 mg. RDs should not be used to claim a product as "allergen-free". Only if cross-contamination is above the reference dose may a warning be given on the label.

Reference doses per allergen (FAO/WHO and SciCom findings)

Practical application:
The RDs help companies assess whether cross-contamination is a real risk and whether warning labels are needed. For gluten, allergies must be distinguished from celiac disease, for which stricter limits apply.

Risk communication:

Since 1 January 2024, there has been a new NVWA policy on cross-contamination and Precautionary Allergen Labelling (PAL). Companies have a two-year transition period to comply with the new policy so until 1 January 2026. Therefore, wise to get started now, See guidelines FNLI. Non-prepackaged products are not covered by this new policy.

Process steps and Opinions

Normec Foodcare has elaborated the advice below in a white paper, a summary of which can be found here.

1. Inventory of allergens in the production environment

List all allergens in the production process, including ingredients, excipients and possible sources of cross-contamination.

• Identifies potential risks throughout the process.
• Forms the basis for labelling and risk assessment.

Opinion:
✔ Visualise allergens per production line on a floor plan.
✔ Keep an up-to-date allergen list.

2. Analysis of points of contamination

Investigate where cross-contamination may occur, e.g. through transport, storage or shared machinery.

• Prevents unexpected contamination of allergen-free products.
• Helps determine preventive measures.

Opinion:
✔ Check transport equipment such as forklifts and conveyor belts.
✔ Assess storage methods: are allergens stored separately?

3. Remove or minimise contamination risks

Take measures to reduce allergen contamination, such as adaptation of processes or physical separation of allergen-free products.

• Reduces risk of cross-contamination.
• Reduces the need for warning labelling.

Opinion:
✔ Work with separate production lines whenever possible.
✔ Provide a fixed production route of no to well allergens.

4. Employee awareness and training

Employees must understand the importance of allergen management and act correctly.

• Prevents errors in production and labelling.
• Increases effectiveness of allergen policy.

Opinion:
✔ Train staff, including temporary staff, on allergen management.
✔ Use practical examples and visual aids.

5. Communication and visual support

Clear communication on allergen management with memos, signs and newsletters.

• Keeps employees alert and avoids confusion.
• Increases compliance with prescribed procedures.

Opinion:
✔ Use colour codes and labels to mark allergens.
✔ Make procedures and instructions visible on the shop floor.

6. Product development and procurement

Checking allergen information in raw materials and recipes.

• Prevents unexpected allergens in raw materials.
• Ensures correct labelling.

Opinion:
✔ Check supplier specifications carefully.
✔ Only work with reliable suppliers who are transparent about allergens.

7. Receipt and storage of raw materials

Allergens must be received and stored correctly.

• Damaged or mislabelled packaging can pose risks.
• Incorrect storage can cause cross-contamination.

Opinion:
✔ Perform visual checks on delivery.
✔ Store allergens recognisably in a separate storage area / at the bottom.

8. Internal transport and production process

Manage the transport of raw materials and products to prevent the spread of allergens.

• Transport equipment can spread allergens.
• Production sequence affects contamination risks.

Opinion:
✔ Clean transport equipment regularly.
✔ Work with a production sequence of clean to infected.

9. Cleaning and validation

Cleaning of equipment and production lines after production with allergens.

• Poor cleaning can leave allergen residues.
• Validation ensures effective removal.

Opinion:
✔ Use validated cleaning protocols.
✔ Check cleaning with allergen and ATP tests.

10. Packaging and labelling

Make sure labels contain correct allergen information.

• Faulty labelling is a major cause of recalls.
• Consumers should be able to choose safely.

Opinion:
✔ Check that all ingredients and cross-contamination risks are correctly listed.
✔ Use appropriate warning texts if necessary.

11. Risk communication (PAL - Precautionary Allergen Labelling)

Only warn about cross-contamination if it cannot be avoided.

• Overuse of warnings can confuse consumers.
• Ensures reliable allergen information.

Opinion:
✔ Only use "May contain XXX" or "Not suitable for XXX" warnings if cross-contamination is above RD.

Source: https://normecfoodcare.com/kennis/whitepaper-allergenenmanagement/ and https://scicom.favv-afsca.be/wetenschappelijkcomite/adviezen/2022/_documents/Advies08-2022_SciCom2021-22_Referentiedosisallergenen.pdf