The Allergen Bureau is exploring a critical issue in allergen management: how cross-contact information should be communicated through the supply chain to support accurate labelling decisions.
This two-part series examines differing industry perspectives and clarifies how the VITAL® Program framework applies at each stage of the supply chain.
Part 1 focuses on ingredient suppliers and a question frequently raised in industry discussions:
How should allergen cross-contact information be communicated to customers?
While the question appears straightforward, the implications for allergen risk management across a global supply chain are significant.
The Question at Hand
When an ingredient supplier identifies allergen cross-contact—despite implementing all reasonable controls—how should that information be shared?
Common approaches include:
- Reporting the measured concentration in parts per million (ppm)
- Applying an “informed Reference Amount” to calculate an Action Level and decide whether to declare the allergen
- Using an “informed Reference Amount” to calculate an Action Level and recommend precautionary allergen labelling (PAL)
Consistency in how this information is shared is essential. Efficient allergen risk review relies on aligned approaches that support the availability of safe, suitable food for consumers with food allergy.
The Current Landscape
Industry practice varies. Ingredient suppliers are acutely aware of market pressure for clean labels and concerns about over-declaration. Some worry that unnecessary allergen statements may reduce consumer confidence or overstate risk.
In response, some suppliers apply Action Levels to their own ingredients using what they consider an “informed Reference Amount,” typically in one of two ways:
Approach 2: Filtering declarations
Suppliers estimate typical use, calculate an Action Level, and only declare cross-contact allergens if concentrations exceed AL2. Levels below AL2 may not be declared, based on assumptions about downstream risk.
Approach 3: Providing PAL recommendations
Suppliers identify the presence of cross-contact and may provide measured concentrations, but also apply an Action Level to recommend whether PAL should be used.
While understandable, these approaches can unintentionally undermine effective allergen risk management.
The Allergen Bureau’s Position: Why This Matters
The Allergen Bureau supports quantitative risk assessment throughout the supply chain. However, using Action Levels to determine ingredient labelling misapplies the VITAL® framework.
The Reference Amount Limitation
Action Levels depend on Reference Amounts— The maximum amount of a food eaten in a typical eating occasion.
Only the manufacturer of the final food has the full context needed to determine this, including:
- final formulation and composition
- food category and subcategory
- target market and intended use
- eating habits and consumption data per category or subcategory
- regulatory labelling requirements
Ingredient suppliers cannot know all potential applications of their products or the populations consuming them. Applying Action Levels therefore requires assumptions that may not hold true downstream.
The Transparency Gap
Filtering information through supplier-applied Action Levels creates several risks:
- Context-specific risk is obscured. A low-risk contribution in one product may be significant in another.
- Cumulative exposure is hidden. Multiple ingredients, each below Action Level 2 (AL2) individually, may collectively exceed AL2 in the finished product. Without transparent concentration data, manufacturers cannot assess this risk.
- Responsibility is misaligned. Under the VITAL® Program, labelling decisions sit with the entity placing the final product on the market. Supplier-level filtering effectively shifts that responsibility upstream, and could represent a risk for the supplier.
Root Cause Analysis Challenges
Manufacturers actively work to reduce allergen presence to the lowest achievable level. When unexpected results occur, transparent ingredient-level data is essential for effective root cause analysis. When cross-contact sources are not fully disclosed, investigations become slower, more complex, and less effective.
What Should Happen Instead
The Allergen Bureau recommends that ingredient suppliers:
- Conduct full VITAL® risk assessments to identify and quantify residual cross-contact allergens
- Report cross-contact concentrations in ppm for readily dispersible allergens and identify particulate cross-contact allergens where present
- Allow manufacturers to determine how this information informs final product labelling
This approach maintains transparency and ensures labelling decisions are made by the party with complete information and accountability.
The “Clean Label” Question
The desire for clean labels is well understood. However, label clarity must not come at the expense of accurate risk assessment.
When applied correctly by manufacturers with full information, the VITAL Program helps avoid both over-labelling. Transparent, verified data enables informed decisions—sometimes resulting in PAL, sometimes not—but always based on a complete understanding of risk.
Moving Forward
This discussion highlights broader questions of responsibility and transparency in complex food supply chains. The strength of the VITAL Program lies in its scientific basis and clear delineation of roles.
Ingredient suppliers play a vital role by providing accurate, verified information, not by filtering data through assumptions about downstream use.
Part 2 of this series will explore agricultural cross-contact allergens and industry considerations when cross-contact is consistently present.
We welcome continued dialogue. Members and VITAL® users can share views via the Allergen Bureau Portal, or contact the Allergen Bureau for guidance on applying VITAL® to ingredients and bulk products.
