While food and drink labelling requirements vary internationally, the Codex Alimentarius (standards, guidelines and codes of practice adopted by the Codex Alimentarius Commission) exists to help good practice encompass the globe. The UK is one of 189 members of the Codex Alimentarius Commission.

What is precautionary allergen labelling?

Food labelling law in the UK, as in the EU, sets out specific requirements for mandatory information in respect of 14 allergens. Precautionary allergen labelling ('PAL') refers to information which is not mandatory but can be applied to let people with allergies know that there is a risk of cross-contamination, such as “may contain allergen x” or “not suitable for someone with x allergy”. 

Although voluntary, this information must be accurate and the published position is that it should only be used where there is an unavoidable risk of allergen cross-contamination and not as a catch-all. Using PAL doesn’t release food business operators from their obligations to implement robust allergen management systems. 

The new Codex Alimentarius standard

The Food Standards Agency (FSA) covers England, Wales and Northern Ireland. In June, the FSA executive recommended to the FSA Board that it should support the Codex proposals for a global standard taking into account the evidence base and risk assessments made.

In July, the Codex Alimentarius Commission agreed to adopt the new guidance to ensure that PAL such as 'may contain' is only used when that risk has been scientifically assessed and cannot be adequately controlled through good allergen management practices.

The Codex standard for PAL includes setting allergen thresholds for when it can be applied to ensure that PAL is only used when there is a genuine risk that cross-contamination has caused allergens to be present at a level which poses a genuine risk. The specific threshold is 'ED05'.

Understanding the ED05 threshold

ED05 refers to circumstances where the eliciting dose (the total protein of the allergenic food at which a given percentage of the allergic population are predicted to have a reaction with objective symptoms) is 5%; i.e. 5% of people with the relevant allergy who are exposed to the allergen at this level will react.

The FSA notes the following in terms of risk:

“set the threshold too high and there is the risk that some may experience severe reactions on non-PAL labelled goods, set it too low and PAL will be so prevalent people either ignore it, or it unnecessarily reduces choice.”

What this means for food businesses

For businesses sourcing products (including alternative protein ingredients) across global supply chains, this is an imminent change, and may require labelling frameworks to be reviewed promptly. It’s important that businesses remember that ED05 is not a target.

It is the threshold for labelling and if the recommendation is adopted by the FSA as expected, food manufacturers should be using risk management to ensure levels of contamination are as low as possible.