Last month, we explored the application of VITAL® by suppliers of raw materials and ingredients. Central to the VITAL philosophy is a hierarchy of allergen management:
- Avoid introducing allergens into the site wherever possible.
- Where avoidance is not possible, eliminate allergens from production lines through hygienic design, effective allergen management programs, and validated cleaning.
- If elimination cannot be achieved, manage and control allergens to the lowest practical level.
The Allergen Bureau maintains that appropriate application of the VITAL Program — a quantitative framework — requires suppliers to:
- complete an Allergen Risk Review,
- assess the effectiveness of their Allergen Management Programs (AMP), and
- quantify the remaining cross contact risk through an Allergen Risk Assessment.
Information provided to customers from raw material and ingredient suppliers, should therefore reflect the presence of particulate (having verified the particulate meets the definitions under the VITAL program) or verified worst-case level of cross contact allergen (ppm) identified through risk review — not theoretical “what-if” scenarios.
When Cross Contact Becomes Consistent
A frequent question posed to the Allergen Bureau is:
What should a supplier do when a cross contact allergen is persistent in a raw material rather than intermittent?
This situation is often reported in relation to agricultural cross contact. Is it appropriate in such cases to declare the allergen as intentionally present?
Views differ internationally. Recent Dutch policy guidance has been interpreted by some stakeholders as supporting ingredient-style declaration where agricultural cross contact is consistently unavoidable (present 100% of the time)1.
In other jurisdictions, we are also hearing of products manufactured using ingredients with consistent agricultural cross contact — particularly gluten-containing cereals — being encouraged to label as though the allergen were intentionally added.
The VITAL framework does not support converting a cross contact allergen risk into an ingredient or raw material labelled as if the allergen is intentionally present. There is no provision for this within the Program*, and particularly within the supply chain, no practical need.
Why? The answer lies in returning to the fundamentals of the VITAL Program.
What Is a Cross Contact Allergen?
A cross contact allergen is defined as:
A residue or other trace amount of a food allergen that is unintentionally incorporated into another food.
Cross contact sources may include ingredients, raw materials, personnel practices, equipment design limitations, cleaning effectiveness, or concurrent and/or co-located processes. Cross contact allergen is also known in other parts of the world as Unintentional Allergen Presence (UAP).
By definition, a cross contact allergen is not intended to be present in the raw material, ingredient, processing aid, or food.
Consider lupin in wheat flour. Lupin may grow adjacent to wheat crops, share harvesting equipment, and therefore be routinely detected at varying levels. However, the crop being produced is wheat. Lupin is present due to agricultural practices — not product design.
It may be detected whenever testing is conducted, but can we ever be certain it is present in every unit or batch? In reality, we cannot.
The Role of the Allergen Risk Review
An Allergen Risk Review is:
The systematic assessment of end-to-end production to determine whether cross contact allergens may be present.
The final stage of the review is verification, typically through analytical testing where appropriate.
In developing the Assessing Agricultural Cross Contact guidance, the working group examined how qualitative evidence gathered during risk review should be translated into quantitative information suitable for supply-chain communication. The focus was placed on understanding presence and prevalence, and on recommending risk-based sampling approaches that allow suppliers to estimate a credible worst-case allergen level.
This work recognised several important realities of agricultural cross contact:
- the allergen is rarely present in every batch,
- concentrations vary between and within batches, and
- testing alone cannot define risk without the context of a structured risk review.
Accordingly, consistency of detection does not change the classification of the allergen. Where presence arises from agricultural cross contact, it remains a cross contact allergen and should be quantified in ppm — where appropriate — following milling or further processing or noted as present in particulate form if that risk remains.
If risk review demonstrates a strong likelihood of allergen presence and sampling verification confirms this, the allergen should be:
- identified as a cross contact allergen, and
- communicated on the specification with its verified level in ppm or identified as particulate where the allergen meets the VITAL Program definition.
Is Intentional Labelling “Better or Safer”?
It is sometimes argued that declaring a consistently present cross contact allergen as intentionally added is a safer and better approach. The Allergen Bureau challenges this assumption.
Better for whom? Safer in what way?
Food regulation aims to ensure consumers have access to safe and suitable food. Safety is critical — accessibility is also important in this aim. Labelling a cross contact allergen as if it were intentionally present may unnecessarily restrict food choice for consumers living with food allergy without improving safety outcomes.
Modern food risk management evaluates risk through exposure, a principle foundational to food safety science.
The VITAL framework is grounded in extensive clinical data examining allergic reactions relative to exposure levels. For nearly two decades, this approach has supported best-practice precautionary allergen labelling in Australia, New Zealand, and increasingly worldwide.
In 2022, an expert consultation convened by FAO/WHO endorsed the use of Reference Doses in quantitative allergen risk assessment, recommending an ED05-based reference dose as an exposure level without appreciable health risk. This approach explicitly balances safety with consumer access.
Treating consistent agricultural cross contact as intentionally present disregards this scientific progress and risks reverting either to:
- over labelling, potentially reducing food access, or
- a “free-from” paradigm that is impractical and unnecessarily restrictive and costly.
Applying Quantitative Risk Assessment
Quantitative risk assessment remains the appropriate mechanism for managing cross contact allergens within the supply chain.
When suppliers provide a verified worst-case estimate — even where levels are consistent or relatively high — finished product manufacturers can determine, using quantitative assessment, whether precautionary allergen labelling (PAL) is required for the packaged finished product.
Consistent agricultural cross contact is therefore not fundamentally different from any other form of cross contact and should be managed within the same science-based framework.
Similarly, where ingredient processing results in a cross contact allergen risk that remains consistently present despite efforts to eliminate or reduce it to the lowest practical level, there is no basis for treating that allergen as intentionally present.
Conclusion
Persistent cross contact presents practical challenges, but consistency of presence does not alter the fundamental definition of cross contact. The distinction between intentional inclusion and unintended presence remains critical for accurate risk communication.
The Allergen Bureau’s position is clear: decisions should remain grounded in science, structured risk assessment, and consumer outcomes. Verified data, robust allergen risk review, and quantitative assessment enable informed labelling decisions that protect consumers with food allergy while preserving access to safe and suitable food.
Reclassifying cross contact allergens as intentionally present simply because they occur consistently, risks undermining decades of scientific progress in allergen risk management. Instead, industry should continue applying risk-based frameworks such as the VITAL® Program as intended — using evidence-based quantitative assessment to support transparent, proportionate, and globally aligned allergen labelling decisions.
* Within Australia and New Zealand, only after a very specific circumstances have been determined through risk assessment, for Dark Chocolate “Chocolate Anomalies” a recommendation to label milk as an ingredient is permitted. If you wish to know more please contact the Allergen Bureau.
Do you have a topic you would like our opinion on. Feel free to let us know.
- https://technical-regulation-information-system.ec.europa.eu/sl/notification/26499/stakeholder-contribution/file/5044
