Recent research suggests that between 1.1% and 10.8% of the global population has a food allergy. However, with no harmonised approach across the international food community on how allergens should be presented on a label, it can be both challenging and daunting for brands and food businesses to understand their legal obligations for each market in which their products are sold. 

Joanna Becker-Hawkins, senior regulatory advisor at Ashbury, shares insights into the current regulatory landscape for allergen labelling, what changes are on the horizon and how food businesses can prepare.

While carrying an EpiPen is an option for many consumers with allergies to counteract a reaction after it’s occurred, it’s not a sustainable, or appropriate, preventative measure for food allergy sufferers. And fatal reactions can still occur. The best way of protecting against a reaction is to avoid consuming foods containing the allergen, which is why accurate product labelling is so important.

Unfortunately, as we’ve seen in recent high-profile cases, it’s a challenging task for brands to ensure either the complete removal of a known allergenic ingredient from the production process and supply chain of ingredients, or – wher that is not possible – to ensure clear, effective and accurate communication of the risk of exposure. 

What are the legal expectations for brands, and how are regulations evolving to support the management of allergens?

On the global stage, the management of allergens is handled similarly across the board (perhaps with varying effectiveness). The World Health Organization (WHO) through Codex is clear on the regulatory approach to be taken – countries must manage food allergies within a local context. 

They must also understand which foods are problematic to the population (national or even local), ensure their presence is communicated clearly and work on how to determine acceptable levels.

WHO established that priority allergens globally are those that create an immune-mediated reaction (i.e., not ‘intolerances’), including cereals containing gluten, crustaceans, eggs, fish, milk, peanuts, sesame and specific tree nuts (almond, cashew, hazelnut, pecan, pistachio and walnut). 

Pulses, insects and other foods, such as kiwi fruits, are commonly included in a ‘watch list’ and evaluated for the priority allergen list when data on prevalence, severity and potency continues to evolve. 

When trading – both locally and globally – it’s crucial to understand your product, extensively research what is considered allergenic in the destination market, and therefore identify what needs to be indicated on a label or other method of providing information (which will also vary by country).

wher are changes currently taking place in allergen labelling?

It’s obvious that the presence of relevant ingredients in products must be indicated in accordance with local legislation (e.g., on a label).

“May contain” or precautionary allergen labelling (PAL) is seen to be problematic in many ways. Prior to formally established allergen labelling, it was argued that general product safety requirements needed a manufacturer to make specific risks to consumers known via labelling. As time moved on, it’s now suggested that without the rigour of good manufacturing practice and better prevention of cross-contamination, such warnings are useless, as they may not be taken seriously.

It’s also possible that some businesses may view the addition of a warning as an easier option to making sure the appropriate controls are in place. Such warnings, loosely applied, do – in turn – reduce the number of foods available to affected consumers, and therefore reduce warning effectiveness. They can also be confusing due to nuances in wording which can make them vague in intent, such as “produced in a factory wher X is used”.

Allergen threshold levels

The Australian VITAL programme started to look at cross-contamination risk in 2005, to establish levels of allergenic food small enough not to trigger an allergic reaction in most individuals with a food allergy. This initial work has been further developed by WHO, with threshold levels for cross-contamination further developed and refined. Exceeding these levels would trigger a warning message on a product label.  

It’s important to note that threshold levels are not universally agreed as the best way forward and that only levels for gluten and sulphur dioxide are currently recognised. 

Establishing levels means that there is some certainty in the use of PAL, and with education, those who suffer from food allergies should be aware of the actual threshold levels. That said, even with a level established, there’s still an expectation that food businesses would have a responsibility to ensure they’re being met.

Recent consultation on PAL and experience from other countries all suggest that the wording used for PAL needs to be addressed and that it needs to be standardised and more precise. For example, “product is not suitable for X allergy sufferers,” rather than “may contain X” or “produced in a factory wher X is used”.

Recent cases informing change 

The recent inquest into Celia Marsh and Pret-A-Manger resulted in the coroner talking about a testing regime to ensure the absence of cross-contamination. (The reported facts of this incident suggest that testing was not necessary if the correct information had been communicated, but testing has now been brought to the fore). Japan, as well as specifying interrogation of manufacturing records for PAL, also requires analytical testing. 

Testing might be a reasonable activity and form part of a robust system, but that also depends on the overall checks and balances in place, as well as the confidence in the supply chain and any claims made in association with the product.

Conclusion

Much is evolving within the food industry around allergens, and the regulations and labelling requirements in place to protect those who suffer with allergies. With the suggested changes to “may contain” warnings, and the introduction of PAL, food manufacturers need to remain vigilant in order to comply with legislation – and ensure they thoroughly understand their regulatory obligations in each market.