This article was originally prepared by Nick Hughes, together with Footprint Media Group and is also available here.
Whatever the views of precautionary allergen labelling (PAL) may be, there’s no doubting its widespread use by food businesses – most commonly in the form of ‘may contain’ warnings on product labels or menus – elicits strong opinion.
The Food Standards Agency has previously said inconsistency in how PAL is applied can cause a lack of consumer trust in the labels and prevent those with food hypersensitivities being able to enjoy certain foods.
As with allergen policy more broadly, PAL is a dynamic area of food law. Codex, the international body that sets global food standards, has been leading efforts to harmonise the use of PAL and help bring some order to the ‘Wild West’ that many experts believe characterises the current approach. Consistency in approach will benefit the entire supply chain including crucially consumers.
Following a review in 2023 by World Health Organisation (WHO) and Food and Agriculture Organisation (FAO) experts, Codex proposed that countries adopt specific reference doses for when a PAL should be used based on evidence about the likelihood of a reaction to a specific allergen. Codex has settled on an eliciting dose (ED) of 5% (ED05), meaning the dose of allergic protein at which 5% of the allergic population are predicted to have a reaction with objective symptoms.
Some countries, like the Netherlands, have gone full steam ahead and incorporated the recommendation into their own national policies. Others, including the UK, are more circumspect and have expressed concern about the accuracy of ED values for certain allergens and the rigour behind current testing methods, although it is understood the UK has been involved in this work.
So where can we expect PAL policy to settle in the years ahead?
Risky business
For EU member states, the legislative framework for allergen labelling is set out in EU Regulation 1169/2011, which makes it mandatory to alert the consumer about the presence of a designated list of 14 allergens in food and beverages. Information on the possible but unintentional presence of allergens can be included on a voluntary basis so long as the information is accurate, not misleading, and the result of a thorough risk assessment. This recognises the fact that unintended allergens (allergens which are not listed as an ingredient) can be present in food due to cross contamination in the food chain and thus pose a risk to people with food hypersensitivities.
While easy to explain, allergen procedures are some of the most challenging processes in practice and as the various high profile inquests following tragic allergen related deaths show, issues can and do occur at any stage of the supply chain. Even when you go out of your way to exclude an allergen from your supply chain, sometimes intentionally or not it can find its way back in and this is very hard to spot.
Use of a PAL does not necessarily absolve businesses of their responsibilities under food safety law for effectively managing allergens and they could still risk enforcement action if regulators believe proper procedures have not been followed. Equally, if a PAL statement is not applied and a consumer has an adverse reaction to an allergen present due to cross-contamination, there could still be a breach of the law if procedures for managing allergens are deemed to be inadequate.
Post-Brexit, the UK’s approach to PAL continues to follow that of the EU. If food safety management practices cannot remove or adequately reduce the potential risk of cross-contamination, then food businesses can voluntarily use PAL to alert consumers to the potential presence of the allergen. Businesses themselves decide when PAL is necessary; there are no thresholds or standards set out in UK law about when it should be applied, or the wording to be used.
Consumer distrust
This lack of consistency means consumers do not universally trust PAL. An evidence review by the Food Standards Agency (FSA) has found that, although most consumers are aware of PAL, there is low understanding of what it is meant to communicate and it doesn’t help them decide whether something is safe to eat. The only choice it really gives consumers is to not consume a product, otherwise they are potentially risking their life, something no foodstuff is worth. Despite this, the FSA says some consumers disregard PAL information when deciding whether to consume a product.
In 2023, the FSA published new guidance on PAL to improve the clarity and consistency of its use and so address some of those trust issues. The guidance states that PAL statements should only be used following a thorough risk assessment, should specify which of the 14 regulated allergens they refer to (for example, “may contain peanuts and tree nuts” rather than the generic “may contain nuts”), and should not be used in conjunction with a free-from statement for the same allergen (for example, “may contain milk” should not be used in combination with “dairy free”).
On the question of establishing specific thresholds for the use of PAL, however, the FSA continues to prevaricate and when it last considered the matter in September 2024 the Board: “had concerns about the use of ED05 as a threshold and felt there would need to be more evidence from scientists, businesses and consumers, particularly those with food hypersensitivity, to support it”.
The idea behind establishing thresholds is that they help food businesses understand what levels of unintentional allergens in food products should trigger the use of PAL. This in turn benefits consumers by ensuring PAL describes the potential risk accurately and consistently across all products.
Codex wants to create a global standard for use of PAL based on reference doses, something many experts have been championing for a long time. “[In Europe] we have been trying to set levels for many years,” said Bert Popping, CEO of FOCOS, a European food safety consultancy. “There have been, dare I say, countless requests to EFSA (the European Food Safety Authority) to provide guidance values so that industry and enforcement could operate to a certain level when precautionary allergen labelling is used. Up until today, we have not seen these [reference] values.”
Dutch take the lead
Topping was speaking during a webinar hosted in June this year by the Affidia Journal. It also featured Marjan van Ravenhorst, director at Netherlands-based Allergenen Consultancy, who explained how the country has already moved to incorporate the new Codex thresholds into its own PAL policy. The Netherlands’ food authorities now consider anything above EDO5 to be a safe limit when a PAL should not be used, with anything below that limit requiring a PAL. “It’s about [consumer] trust,” said van Ravenhorst.
Officials in Belgium and Germany have reportedly said their governments are also likely to adopt the Codex recommendations in due course.
Other countries are taking a ‘wait and see’ approach. “A lot of eyes from a regulatory perspective are on the Netherlands, just to see exactly how this pans out,” said Simon Flanagan, global lead for food allergens at Cadbury and Oreo-owner Mondelēz International, during the Affidia Journal webinar. He went on to explain how Mondelēz already uses ED05 as the basis for its own decision-making over when to use PAL.
UK caution
Following the Codex recommendation, the FSA commissioned its own Committee on Toxicity (COT) to review the findings from the FAO/WHO document. While the COT did not disagree with the use of thresholds, it expressed concern about the accuracy of ED values based on the current global evidence base. It also took the view that if derived ED values are going to be adopted, then ED01 values (the dose where 1% of the allergic population are predicted to have a reaction with objective symptoms), rather than ED05 values, would be more protective of those with food allergies.
The COT added that the final decision regarding the use of ED values will need to consider the availability of reliable and sensitive techniques for measuring specific food allergens, alongside the potential impacts on the restriction of consumer choice, and the possible unintended consequences of the over-use of PAL.
On that first point, the FSA has previously expressed concern about the accuracy of allergen testing and the risk that differences in analytical methods will result in different results from lab to lab. A 2022 review of allergen analytical testing methodologies found that robust tests were not available for all 14 UK priority allergens. The review also found that analysis can cost between £55 and £141 per food sample and sometimes tests can be inconclusive resulting in food being held back or wasted. “Ultimately, if tests can’t be relied upon then we are back to square one with a position akin to what we have now,” says Watkins. “We need clear and widely adopted testing standards and a consistent understanding of safety to drive this forward and for everyone, including consumers, to benefit.”
Such concerns aren’t confined to the UK. “I think there is an urgent need to harmonise the method of detection and quantification of these allergens, because otherwise we risk having differences and continuous appeals to courts because of questions regarding how the amount was calculated and measured,” said food safety consultant Nicola Bortoletto during the Affidia Journal webinar.
As to the question of whether reference doses will be adopted at scale, globally, experts expressed doubt that key regulators like EFSA would be prepared to move at pace. “What is likely to be the case is that we will be working on national regulations for some time,” said Popping. “I don’t foresee that in the next one to two years we’re going to have, all of a sudden, a harmonised regulation in place.”
If you have any questions on the above and how it may impact your business, please contact Dominic Watkins.
