Allergen Precautionary Labelling: VITAL®

Regulatory frameworks across the world focus primarily on allergens that are added intentionally. However, it is well known that allergen cross-contact can cause non-allergen-containing products to become contaminated, to potentially hazardous levels.

South Africa’s regulations mandate precautionary allergen labelling (PAL). Under the regulations, the food industry must identify and manage allergen cross-contact (cross-contamination) risks. When cross-contact cannot be controlled, and there is a reasonable risk to allergic consumers, manufacturers are required to apply PAL statements to products.

The regulations state clearly that precautionary labelling may not be used to circumvent the implementation of allergen controls.

What is PAL?

PAL, sometimes called ‘allergen advisory labelling’ or ‘alibi labelling’, is a statement that warns consumers that a specific product may not be suitable for them to consume, e.g. ‘May contain: cow’s”.

It signals to consumers that a product may be contaminated with specific allergens due to unintentional and unavoidable cross-contact. The food industry is often accused of using PAL indiscriminately without implementing appropriate allergen management plans.

So, what is VITAL®?

The Allergen Bureau was formed voluntarily by the Australian food industry to manage the widespread overuse of PAL. In response to the problem, they developed the VITAL® (Voluntary Incidental Trace Allergen Labelling) Program.

The VITAL® Program is a risk-assessment approach, developed to aid food industry members in determining whether their products need to carry precautionary-labelling statements.

How does the VITAL® tool calculate whether or not a PAL is necessary?

It considers cross-contact in raw materials, cross-contact during processing, product composition, and consumer consumption patterns, and calculates a consumption dose. It then compares the consumption dose to the VITAL® Reference Doses to determine whether a PAL is needed.

PAL is necessary if the estimated consumption dose equals or exceeds the reference dose for the allergen. Advisory labelling is discouraged if the estimated consumption dose is below the reference dose.

VITAL® Reference Doses have been developed from clinical data on the distribution of individual threshold doses for individuals with specific food allergies.

Why should I use VITAL®?

Those of you who have used previous versions of VITAL® will know that at first glance, it can seem daunting. It isn’t – if you know what information to gather, and how to enter it into the online tool. The program and the tool support and supplement robust allergen management.

What is the benefit of VITAL® to the South African food industry?

VITAL® represents a uniform, risk-based approach to evaluating the need for PAL. Implementation of VITAL® across the food industry would build confidence with consumers, ensuring that PAL consistently communicates the same level of risk to them, reducing confusion and risk-taking behaviour.

Is VITAL® mandatory?

No, VITAL® is not mandatory; but it neatly fills the need for a robust, scientifically-based, quantitative allergen risk assessment. In Australia, food retailers are increasingly expecting manufacturers to utilise VITAL® for risk assessment of cross-contact allergens on their pre-packaged, private-label-branded products.

How much does the VITAL® tool cost?

Flexible subscription packages are available that can be tailored to meet the size of your organisation and your frequency of use. You can view the pricing structure here.

How can I get access to the VITAL® online tool?

You can click here to register for a VITAL® subscription. Enter your details, and then follow the prompts.

How do I receive training on how to use VITAL®?

FACTS is an Allergen Bureau-endorsed VITAL® trainer; we offer on-site and workshop training. For more information on how to use VITAL® practically, feel free to contact us. You can also review the Allergen Bureau website, and/or attend a training session provided by FACTS.

Other articles you may be interested in:
Allergen Bureau – Partners for best-practice allergen management
VITAL® 4.0 – Here is what you need to know