Food allergen management continues to be one of the most challenging aspects of food safety.

A recent report by the European Court of Auditors highlighted precautionary allergen labelling as an area for urgent attention, with a recommendation to adopt harmonised rules for allergen statements by 2027.

While intentionally added allergens can be clearly declared on labels, managing and communicating cross-contamination risks poses a more complex challenge. That's where the VITAL system comes in - offering food producers a standardised approach to allergen risk assessment and labelling.

‍What is VITAL?

VITAL (Voluntary Incidental Trace Allergen Labelling) is a standardised risk assessment programme developed by Australia and New Zealand’s Allergen Bureau to help food manufacturers evaluate and communicate product allergen risks. 

First launched in 2007, the system provides a scientific, risk-based methodology for assessing the impact of allergen cross-contact and determining when precautionary allergen labelling (PAL) is needed.

The key objective of the VITAL system is to ensure manufactured food is safe for the vast majority of consumers with food allergies. It achieves this by providing a consistent labelling framework that declares the presence of allergens from documented, unavoidable and sporadic cross-contamination. 

Consumers with food allergies (and their carers) can use the VITAL system to decide which foods may present a personal risk.

‍Why was the VITAL system developed?

Even under strict Good Manufacturing Practice (GMP) conditions, completely eliminating allergen cross-contact can be highly challenging. 

Cross-contamination can occur at any point along the food chain - from primary production and raw materials to manufacturing.

Before VITAL, there was no standardised approach for assessing or communicating these risks to consumers. This led to inconsistent use of precautionary allergen statements, which risked either:

• Over-cautious labelling that unnecessarily restricted food choices for consumers with allergies 
• Inadequate labelling that failed to warn consumers of genuine risks

VITAL was developed to provide food manufacturers with a systematic way to evaluate cross-contact risks and apply precautionary labelling when scientifically justified. The programme aims to preserve the value of precautionary statements as a genuine risk management tool while maximising safe food choices for allergic consumers.

How does the VITAL system work?

VITAL uses a systematic approach based on three key elements:

1. Risk assessment process

The risk assessment system helps manufacturers identify and quantify potential allergen cross-contact from:

• Raw materials and ingredients
• Processing equipment and environment
• Manufacturing processes
  

2. Action levels

VITAL employs a two-level action grid to determine when precautionary labelling is needed:

• Action level 1: Low concentration with low chance of adverse reaction - no precautionary statement required
• Action level 2: Significant concentration with a significant chance of reaction - precautionary statement required
  

These levels are calculated using:

• Reference dose: The protein level below which only the most sensitive individuals (5%) in the allergic population might react
• Reference amount: The maximum amount of food eaten on a typical eating occasion

3. Standardised labelling

When action level 2 is reached, VITAL specifies a standardised precautionary statement: "May be present: allergen x, allergen y.” This consistent approach helps consumers understand the level of risk indicated by the warning.

The introduction of VITAL 4.0

The latest version of the guidelines, VITAL 4.0, was released in August 2024, incorporating the latest scientific understanding and international best practices. 

Key updates include:

Science-based improvements:

• Adoption of ED05-based reference doses (the dose predicted to produce symptoms in 5% of the allergic population)
• Alignment with recommendations from the FAO/WHO Expert Committee
• Updated data sets for allergens, including sesame seed and cow's milk

Enhanced usability:

• Regrouping of tree nuts to place those with the same value in the same group
• Alphabetical ordering of allergens
• Additional jurisdictional coverage, including European and Canadian requirements
• Improved risk management values for specific allergens

What does the VITAL system mean for food and drink brands?

While VITAL is voluntary, food brands that implement it can gain significant advantages. Some multinational food manufacturers producing many of the world's prepacked foods have already adopted the system, recognising its value as a comprehensive approach to allergen risk management.

The VITAL system provides a robust, scientifically validated framework for assessing allergen risks, offering clear guidance on when precautionary labelling is needed. 

The programme also supports allergen management as an integral part of Hazard Analysis and Critical Control Point (HACCP)-based food safety programmes, helping manufacturers meet their regulatory obligations.

In addition, VITAL helps build consumer trust through consistent, meaningful precautionary statements that consumers can rely on. By providing a standardised approach to allergen labelling, VITAL 4.0 reduces the risk of over-cautious warnings that might unnecessarily restrict consumer choice while ensuring transparency in allergen risk communication.

On the operational side, manufacturers benefit from access to VITAL Online, a web-based calculator that simplifies the assessment process. The system provides precise documentation requirements for recording assumptions and ongoing monitoring, while seamlessly integrating with existing food safety certification programmes.

However, it's important to note that VITAL is only a partial solution, which should not be considered in isolation. The system must be supported by:

• Robust allergen management practices
• Good Manufacturing Practice (GMP)
• Regular validation and verification of control measures
• Ongoing monitoring of any changes that might affect allergen status

Should your food company adopt VITAL labelling? 

While VITAL doesn't guarantee zero risk, it provides food brands with a systematic approach to managing and communicating allergen risks, helping protect consumers and brands. 

As allergen management practices continue evolving, staying current with VITAL updates will help food and drink manufacturers remain committed to food safety excellence.

If you’d like further help with food allergen labelling, including the VITAL system, get in touch with Hooley Brown. 

This blog post was published in December 2024. Information was correct at the time of publishing.