Using Precautionary Allergen Labelling (PAL) – What’s The Risk?

With the number of food allergy cases affecting children and adults globally on the rise, if you’re a food and beverage manufacturer, it’s vital that your products comply with the official food allergen labelling laws in each country / region you supply your products to. 

One area of allergen labelling legislation that companies often get wrong is the use of a ‘May contain’ statement on their product’s labelling. 

Often referred to as an allergen advisory statement or PAL (Precautionary Allergen Labelling) statement, this legislation relates to the product’s risk of accidental exposure to allergens during the food manufacturing process, as opposed to the declared allergens in its ingredients.  

Known as cross-contamination / cross-contact, supposedly allergen-free foods can accidentally come into contact with allergen proteins from foods produced in the same factory on the same equipment, even after the equipment in question has been cleaned.  

Food & beverage brands often misunderstand or are unaware of, the specific legislation governing this type of advisory statement in certain countries / regions.  

In the UK, EU, United States and Canada, brands can include a PAL statement voluntarily, to highlight this potential risk of unintentional cross-contamination during the manufacturing process.  

However, there is a common misconception that it can be added to any product, and some brands are incorrectly using it as a ‘cover everything’ allergen statement to legally protect themselves against the risk of any food allergens becoming present unintentionally in their product at any stage in their ingredients supply chain.  

As a result, consumers with an allergy or allergy intolerance are having their food choices unnecessarily limited as PAL adoption increases, or they’re now ignoring advisory statements completely – putting their safety at risk. 

To be clear – you must use PAL correctly

In the UK, the PAL legislation is provided by the Food Standards Agency (FSA), and can be viewed in full here. 

The legislation is currently in line with the EU food labelling legislation directive EU1169/2011, but it may differ in future.  

Whilst in many countries PAL is unregulated and there is little or no guidance on its usage, the UK’s Trading Standards is now clamping down on brands using PAL, to ensure its correct application. Those who fail to satisfy the required criteria for PAL could face penalties, or be forced to recall and reissue products with replacement labelling. 

We’ve therefore summarised the key takeaways from the UK / EU legislation, below. 

In order to use PAL, you MUST have undertaken a thorough risk assessment which proves that you’ve done everything possible to remove that allergen/s’ unintentional cross-contamination of your product through risk management actions.  

This is a legal requirement for any company using PAL, whether a small start-up or a large multi-national. 

There must be a potential risk during a stage/s of the product supply chain, including any risk to the ingredients themselves – which if the case, should be highlighted to you by the ingredient suppliers on their specification sheets – plus all stages of food processing and preparation. Remember to check the risk to ingredients with suppliers every time you change the source of an existing ingredient, or add a new type of ingredient.  

If a risk is identified at any stage/s, brands must undertake a risk assessment, which should consider all potential sources of allergens, including processing aids, raw material handling, storage, transport, people, cleaning, shared equipment, re-work, air particles in preparation area, supply chain, and packaging.    

When the product in question is not pre-packed, the PAL can be communicated via signage or orally by staff, instead of via a label.  

In the USA and Canada, the FDA’s and Health Canada’s legislation take a similar stance to the UK and EU. They both state that PAL should not be a substitute for good manufacturing practices in brands’ facilities, every precaution should have been taken to avoid cross-contact, and such advisory statements should be truthful, clear and non-ambiguous.   

If you have satisfied all the criteria for using PAL in the countries / regions your products are going to be sold, with our NutriCalc nutrition calculation & labelling software, you can create a custom ingredient declaration to add a ‘May contain’ statement as part of it on your product’s labelling.  

Whilst there is currently no standardised wording in place for ‘May contain’ statements, in a 2023 FSA consultation regarding potential updates to the legislation, stakeholders stated that PAL should specify which of the 14 official allergens is being referred to. E.g. businesses should apply the statement ‘May contain peanuts and tree nuts’ rather than the generic statement ‘May contain nuts’, to be as clear as possible.   

Highlighting allergens when PAL shouldn’t be used

Unless there’s a risk of allergens in your product due to accidental cross-contamination, our stance at NutriCalc has always been that products either do or don’t contain the standard allergens recognised by different world regions.  

If selling your product in the UK / EU and it doesn’t meet the FSA’s criteria for PAL, you should follow the UK / EU food labelling legislation EU1169/2011, Annex II, and indicate in your ingredient declaration, any of the 14 official allergens that need to be highlighted (emboldened) on food label ingredients. 

For more information on this, read our global food allergens expert paper and visit our allergen guidance for food businesses page. 

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