In November 2022, the Prevention of Future Deaths report issued by the Coroner was published following the inquest into the death of Celia Marsh, who had a known milk allergy and died in 2017 as a result of eating a vegan wrap which contained a product labelled “dairy free coconut yogurt alternative”. Despite this, the food contained a small amount of milk protein, which was the cause of Celia’s anaphylaxis reaction. The Coroner found that the manufacturer of the dairy-free yogurt had documents which flagged the risk of milk cross-contamination during its manufacture but had not passed this information on to its customers. Notably, the meaning of “free from x” is not covered by UK legislation, which means that there are no specific conditions for when a claim such as “dairy free” may be made. Further, and most importantly, food businesses are not expressly required to declare the presence of an allergen unless it is intentionally used as an ingredient or processing aid.
The case is relevant because it highlights the issues with the current law on the provision of allergen information. After a number of high-profile fatalities following the consumption of foods containing undeclared allergens, businesses are calling for change and the Food Standards Agency (FSA) is considering improvements in the provision of allergen information a priority area. This article explains the current regulatory position on precautionary allergen labelling and “free-from” claims, some of the recent developments in this area and what is on the horizon.
Current position on PAL and “free-from” labelling
Food businesses are required to declare the presence of any of the 14 main allergens (such as milk, cereals containing gluten, peanuts and tree nuts) if used deliberately as an ingredient or processing aid in a food product. However, this does not apply when there is a risk of unintentional allergen cross-contamination, for example because different foods are manufactured in the same facility. Equally, except for gluten-free claims, there is no specific legislation covering “free-from” claims, and food businesses are not required to inform consumers with allergies that a food is safe for them to eat.
Instead, any such claims can be made voluntarily by businesses and are regulated in accordance with general food law, including the requirement that food information must not be misleading for consumers. In particular, food businesses may choose to apply precautionary allergen labelling (PAL) to communicate to consumers that the risk of an unintended presence of allergens cannot be sufficiently controlled. PAL is most frequently used on labels for prepacked foods and “may contain x” is one of the most common phrases used by businesses to indicate the possibility of unintentional allergen cross-contamination. Alternatively, food businesses can claim that their product is “free from x” to help consumers with a known allergy assess if a food is safe to consume.
The FSA currently advises that PAL should only be used when, following a thorough risk assessment, a genuine risk of allergen cross-contact within the supply chain is identified which cannot be removed through careful risk management actions, such as segregation and cleaning. Excessive use of PAL can unnecessarily limit consumer choice and may devalue the warning and lead to risk-taking behaviours. It is therefore essential that PAL is applied appropriately. However, there are no UK rules or guidelines on how much of an allergen may be present before PAL should be applied, nor are there any specific requirements or recommendations regarding allergen testing (such as frequency and type of testing).
In respect of a “free-from” claim, the FSA advises on its website that it is a guarantee that the food is suitable for all consumers with an allergy or intolerance to the named ingredient. In the FSA’s response to the Prevention of Future Deaths report in the Celia Marsh case, it reiterated its position that a “free-from” allergen claim is an absolute claim that should only be used following a rigorous assessment of the ingredients, process and environment. The FSA further stated that for a “free-from” claim to be not misleading, it would need to be an analytical zero, which means that the allergen cannot be detected using the best and most appropriate method of detection.
In March 2023, as part of the FSA’s routine review of its Allergen Labelling Technical Guidance, it launched a consultation seeking feedback on updates to the guidance, including new proposals for best practice regarding the application of PAL. One of these proposed practices is that PAL should not be used in conjunction with a “free-from” statement for the same allergen, because a “free-from” claim is a guarantee that the food is suitable for anyone who is allergic or intolerant to the relevant allergen. This reaffirms the FSA’s view once again that PAL and “free-from” claims should be mutually exclusive, and that there must be no detectable presence of the allergen to make a “free-from” claim. Responses to the consultation are required by 22 May 2023.
While there are no officially recognised thresholds to guide the application of PAL in the UK, many UK and international food businesses rely on the reference doses set under the Voluntary Incidental Trace Allergen Labelling (VITAL) Program, which was created by a number of Australian and New Zealand industry bodies and research organisations to standardise allergen risk assessment processes and guide the application of PAL. For example, for milk, 0.2 mg milk protein has been derived as reference dose ED01, meaning this amount is predicted to trigger a reaction in 1% of the allergic population. If the estimated consumption dose in a product equals or exceeds this reference dose, the VITAL approach recommends that PAL should be applied, but not if the estimated consumption dose is below the reference dose. The FSA acknowledges the existence of the VITAL Program but has not endorsed it or recommended UK food businesses to adhere to it.
Recent developments regarding PAL
Studies by the FSA have found that while consumers with hypersensitivities appreciate PAL when it is clear about an unavoidable risk of allergen cross-contamination, at the moment consumers and food businesses are confused about how to interpret and apply it, leading to inconsistent approaches in assessing and controlling risk and applying PAL. These concerns were reiterated by stakeholders such as food businesses, consumers, local authority food teams, healthcare professionals and allergy charities who responded to the FSA’s consultation on the use of PAL. The consultation was launched in December 2021 and the responses were published in June 2022.
While a number of issues with PAL were highlighted under four different themes, respondents to the consultation repeatedly emphasised the lack of clear standards and common risk assessment methods as one of the major problems with the current PAL guidance. While some respondents identified challenges, such as the difficulty to determine that any presence of an allergen is safe and the limits on resources for smaller food businesses, the consultation found a consensus among all stakeholder groups that allergen thresholds should be set as part of the standardisation of PAL, with established wording to be provided when set thresholds for allergens are exceeded.
At the June 2022 FSA Board meeting, the FSA’s Food Hypersensitivity (FHS) Programme proposed working towards a standardised system for applying PAL to prepacked food products, which would include a review of emerging evidence to establish whether best practice or legally enforceable allergen thresholds should be set for some or all of the 14 regulated allergens for the purpose of establishing a level of allergen cross-contamination above which PAL should be applied. Ahead of the September 2022 Board meeting, the FHS Programme came back with multiple, more detailed proposals for how it would continue its work to improve PAL.
One of the proposals presented was a potential consultation on a system for applying PAL, which would take place once the review of the evidence had been completed, with a suggested launch of late 2024. The paper indicated that the consultation would likely have four elements: whether to set thresholds (and at what levels) for each of the 14 allergens, what the single standardised wording on prepacked food products should be to indicate that a threshold level has been exceeded, whether there should be a regular allergen testing requirement for food businesses over a certain size and whether products should be marked to indicate that allergen testing has been conducted on a representative sample of products.
Meanwhile, in March 2023, several leading food businesses wrote an open letter to the UK government and the FSA through the Natasha Allergy Research Foundation, calling for two specific actions to help save lives and build trust in the UK food industry for people with allergies. As the first action, the letter argued that the FSA needs to make a decision on allergen thresholds and provide a strong recommendation to ministers so that clear thresholds can be set for precautionary allergen labelling and “free-from” labelling.
What this means and next steps
The revised Allergen Labelling Technical Guidance, especially when read in conjunction with the FSA’s response to the Prevention of Future Deaths following the Celia Marsh inquest, makes the FSA’s view clear: a “free-from” claim is a guarantee that the product is absent from the allergen referred to. Given that 95% of respondents to the FSA’s December 2021 consultation agreed that it may be misleading if PAL and “free-from” wording are used on the same label, it is likely that this position will be reaffirmed following the end of the consultation on the updated technical guidance. If so, the new guidance is due to be published in June 2023. In testing terms, this means that there should be no detectable trace of the allergen in the food product. As mentioned above, there is currently no legislation or guidance prescribing exactly how products should be tested, how often, or even that they must be tested. Instead, testing may be one aspect of the risk assessment and management plan that food businesses must carry out to ensure that the food is safe. However, given that this is a focus area for UK regulators and the potentially serious consequences of getting it wrong, testing should always be carried out before applying “free-from” labelling to food products.
As regards thresholds for applying PAL, it is clear that the FSA has listened to the industry and commenced work to assess whether allergen thresholds should be implemented. However, since these proposals, the FSA has declared that certain areas of work have placed significant and unanticipated demands on its workload, inevitably forcing the FSA to deprioritise its plans. This includes the Retained EU Law (Revocation and Reform) Bill 2022, which was introduced into the House of Commons on 22 September 2022. The Bill, as currently drafted, will effectively remove all retained EU law from UK legislation by the end of 2023 unless action is taken to retain it, meaning the FSA is required to review all retained EU law by that deadline. In November 2023, the FSA highlighted in paper FSA 22/12/05 that the volume and breadth of the law to be assessed had resulted in significant reprioritisation to find sufficient resources for the review, resulting in a clear and immediate impact on the FSA’s work programme going forward. Despite this, the paper still identified PAL as a priority area, including the planned PAL consultation, but confirmed that the improvements to PAL would be by way of guidance and not legislative change, and that the plans laid out would take place over a slightly longer timescale. This indicates that the consultation will take place sometime in 2025 at the earliest, and that the FSA is not envisaging recommending legally binding allergen thresholds. Businesses and consumers will therefore have to wait some time before a decision may be made on whether allergen thresholds should be set and a potential resolution to the issues surrounding PAL. Whether non-binding guidance will be sufficient to resolve these issues remains to be seen.
