Are PALs really a consumer’s best friend?
Nick Hughes examines the questions and debate around precautionary allergen labelling.
‘May contain nuts’.
‘Made in premises that handle nut products.’
‘Product made in nut-free area but nuts used elsewhere.’
Such statements will be frustratingly familiar to anyone living with allergies or intolerances to certain foods. Precautionary allergen labelling (PAL), to give this category of statement its official title, is a near ubiquitous presence wherever food is available for sale – from packaged goods in supermarkets to loose food served in out-of-home settings like cafes and restaurants.
Used appropriately, precautionary allergen information or labelling can be hugely beneficial to consumers when it clearly tells them about an unavoidable risk of allergen cross-contamination. But PAL is also a source of annoyance for consumers and businesses alike; the former tend to view such statements as little more than a legal disclaimer from the business while for the latter confusion often reigns over when their use is appropriate.
The wind of change is blowing however; the UK Food Standards Agency (FSA) recently produced new guidance on the use of PAL. Meanwhile, global institutions like the World Health Organisation (WHO) and Food and Agriculture Organisation (FAO) are weighing up whether it’s time to bring PAL into the regulatory sphere, or at the very least develop more standardised guidance and thresholds for when a PAL statement should be used and how the risk to the public should be communicated.
So what are the current approaches to PAL in Ireland and the UK? Why is PAL a source of such debate? And what might change in future to improve outcomes for consumers and businesses?
For EU member states such as Ireland, the legislative framework for allergen labelling is set out in the Food Information to Consumers (FIC) Regulation 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 and unintentional presence in food of substances or products causing allergies or intolerances can be included on a voluntary basis so long as the information is accurate, not misleading, and the result of a thorough risk assessment.
Risk management
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 general food law which states that food must be safe to eat.
It’s all about how you deal with the problem, not about the statement on the label which is the last resort to warn consumers about the risk.
As Cesare Varallo, partner at Italian law firm Legislab, told a recent webinar on PAL run by the Affidia Journal: “If as a company you don’t have very good procedures for managing allergens in a facility […..] you always risk facing liability if an accident happens. It’s all about how you deal with the problem, not about the statement on the label which is the last resort to warn consumers about the risk.”
For now FIC also remains the basis for UK allergen labelling laws, however PAL has been under the spotlight as part of a broader programme of work by the FSA on food hypersensitivities. In March, the agency put newly developed guidance on PAL out for consultation. It 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 statement “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”). Businesses should also provide a straightforward means for consumers to contact them about their allergen cross-contact risk assessment that informs a PAL statement. The FSA said this is of particular importance for consumers with multiple and/or severe allergies who are concerned about a labelling change.
Ingredient or contaminant?
Where PAL is concerned, the key principle for a food business is to distinguish between an ingredient and a contaminant. The distinction is made clear in a guidance note on food allergen declaration for non-prepacked foods in Ireland, first issued by the Food Safety Authority of Ireland (FSAI) in 2014 and updated in 2022. The guidance explains that when frying chicken in peanut oil, for example, “peanut” must be declared as an allergen; however, fries cooked in vegetable oil in which battered fish was previously cooked does not need to declare “fish” or “wheat” as an allergen. In this case, residual fragments of fish or batter in the cooking oil are considered cross-contaminants rather than ingredients.
“If you’re going to use a PAL statement make sure it’s based on a rigorous risk assessment”.
Dr Pat O’Mahony, chief specialist for food science & technology at the FSAI, says the regulator’s advice to the industry is that “if you’re going to use a PAL statement make sure it’s based on a rigorous risk assessment”. He adds, however, there is evidence that “certain businesses put it out there to safeguard themselves from litigation further down the road. People that are allergic to certain foods already have a fairly restricted diet and to needlessly further restrict them just because of the use of these labels is not very helpful.”
Consumer confusion
Research suggests consumers are sceptical of the motives behind business’s use of PAL statements. In 2022, the UK Food Standards Agency (FSA) published the results of a consumer perception study which found that in general people judge PAL as legal cover for the business in the case of accidental consumer harm rather than a beneficial communications tool. Use of PAL was widely judged to be confusing and vague while some people were not even aware that the statements served to communicate cross-contamination risk.
The lack of a standardised format for PAL is another barrier consumers have to overcome. During the Affidia webinar, Bert Popping, CEO of FOCOS Consulting in Germany and a member of the FAO/WHO expert committee on risk assessment of food allergens, noted how “for some of these statements you need a PhD to actually understand what the manufacturer means.” He added that “the consistency of labelling for potential unintended allergen presence varies significantly” with the consumer effectively “left alone to make the risk assessment”.
Business blame
Blame for the issues related to PAL can’t be laid squarely at the door of businesses who face their own set of challenges. Some of these were articulated in a qualitative study with 60 SMEs published by the FSA last year. The study included food businesses from each key food business sector and explored experiences, interpretations, and views of PAL. Smaller food businesses reported a general lack of understanding of their responsibilities and of the distinction between the regulatory requirements of general allergen labelling and the voluntary nature of PAL.
The research suggested that PAL is often applied because businesses are not sure that their food is without any cross-contamination risk following risk management actions, including cleaning and segregation, because without allergen testing there is no validation. This uncertainty increased through the supply chain with food businesses often taking suppliers PAL statements at face value and passing the information on to consumers. In premises serving non-prepacked food, the risk of cross-contact was seen by participants as almost inevitable due to the wide variety of ingredients used and the busy nature of kitchens.
Businesses must grapple with the problem that assessing the risk of cross-contamination is not an exact science and involves a number of variables. Cross-contact with a contaminant typically won’t occur equally across a production batch although a business might still choose to use a PAL statement for all products (the reverse may also be true where a PAL is uniformly not applied), while in food manufacturing the concentration of a contaminant will often be higher shortly after the changeover of a production line. The upshot in both cases is that the level of cross-contamination may be dependent on which pack or batch is selected for sampling and analysis.
Testing times
There are also issues with current analytical methods. Experts on the Affidia webinar noted how testing methods and kits are of variable quality and risk producing different results for the same sample. Even if the test is accurate there is an absence of generally agreed quantitative limits for the unintended presence of allergens that if adopted could help the food industry make more informed choices on whether the use of a PAL statement is appropriate. The food industry, via FoodDrinkEurope, has already asked for official thresholds and for a standard to follow for the correct use of PAL. First, however, there is a clear need to establish standardised, reliable analytical methods without which it’s going to be very difficult to move towards risk-based legal thresholds, says the FSAI’s O’Mahony.
The good news for businesses and consumers is that, after years of making do with policy frameworks on PAL that have clear flaws, these kind of discussions are now happening at the highest level. Experts from the WHO and FAO recently held the final session of a three-part consultation on risk assessment of food allergens to help guide the future work of the Codex Alimentarius Commission. The objective of the meeting was to review and evaluate the evidence in support of PAL on pre-packaged foods. The expert committee reiterated that a PAL statement should only be reserved for those situations where unintended allergen presence cannot be avoided and should not make up for poor allergen management practices or production errors during food manufacturing. But they went further by recommending the creation of a single, unified and harmonised wording for a PAL statement and that PAL be integrated into regulatory frameworks based on agreed risk-based reference doses.
How the EU and individual member states respond, and at what pace, remains to be seen. Ultimately, the acid test for global efforts to tighten up the rules around PAL will be this: do consumers have confidence in those products that carry a PAL statement … and those that do not?
