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Michael Walker is a consulting chemist, expert witness and Honorary Professor at the Institute of Global Food Security at Queen’s University, Belfast. Michael has had a career-long interest in food allergy and the analysis of allergens. His publications include a seminal paper “Is food allergen analysis flawed?” and with Hazel Gowland, he published the first analysis of food allergy cases in the UK courts. An update to this paper has recently been accepted for publication by the journal Perspectives in Public Health . Michael is co-chair of the ILSI-Europe expert group on Food Allergen Quantitative Risk Assessment.
One business success
- Food allergy is a major public health concern. It is an increasing problem for those affected, their families or carers, the food industry and regulators. It affects up to 6% of young children and 2% of adults. Allergy-triggered anaphylaxis causes fatalities. The risk of such deaths, though comparatively rare, contributes to the well-documented detriment to the quality of life for people with allergies and their families. Lifelong avoidance of the eliciting food(s) is required. Allergen issues dominate food recalls and allergy-related court action has increased. Food allergen risk assessment (RA) is crucial to enable businesses to provide safe food for customers with allergies. Quantitative RA (QRA) facilitates decision-making for labelling, recalls and incidents but there is a lack of consensus on how to go about it. Aiming to improve allergen QRA across the food sector, ILSI-Europe set up an expert group on allergen QRA. From February 2020 the expert group engaged with a wide range of international multidisciplinary stakeholders in multiple workshops. An estimated 10,000 expert hours were expended in developing, refining and seeking consensus on allergen QRA. The guidance was published in June 2022, is open access and is a major step forward in harmonising food allergen QRA.
Two challenges for the sector
- Precautionary Allergen Labelling, PAl - The use of PAL (‘may contain’) is voluntary. Although intended to inform consumers with allergies, over-utilisation and lack of harmonisation have led to miscommunicated risks, reduced trust of PAL, and restrictions on the diets of consumers with food allergy. Often it is not clear to what extent, if at all, the PAL was based on a risk assessment. This was recognised by a high-level expert report from Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO). The FAO/WHO panel recommendations included that a risk assessment must be undertaken as part of a regulated framework. If unintended allergen presence (UAP) exceeds the relevant reference dose PAL in a harmonised format must be applied. If UAP does not exceed the relevant reference dose PAL must not be applied. Moreover, the label must bear an indication that a qualified risk assessment has been undertaken, irrespective of whether the outcome indicates that a PAL should be used or not. While these recommendations remain to be ratified by any competent authority, the Food Standards Agency (FSA) recently held a public consultation on the harmonisation of PAL. FSA support more standardisation of PAL but does not seem to favour legislating at this stage. The challenge for the food industry is two-fold: (a) to demonstrate that voluntary standardisation of PAL is a goal and is possible and (b) to prepare for legislation in the absence of effective voluntary standardisation.
- Allergen QRA - putting it into operation - But a rational risk assessment for PAL means one of two main things. Knowing a high standard of assurance that no unintended allergens are present or, if present, whether or not they pose a risk. The latter is where ‘quantitative’ comes in, comparing the amount of unintended allergen with a reference dose that is protective of a given proportion of the population with the allergy. That’s where the ILSI-Europe expert guidance can help. It deals with communication across the supply chain, management of operations, management of incidents, and the core concepts that underpin QRA. You may balk at wading through the 188 pages of the guidance. But it's well laid out with hyperlinks to assist in navigating between the sections you need. And there is a 60-minute support webinar that walks you through the guidance. A cross-contact / cross-contamination estimate calculator, other tools and resources are also downloadable and training videos are in development. Thus my second challenge to the food sector is to watch the webinar, download the guidance and put it into operation.
Three forecasts for the sector
- Precautionary Allergen Labelling, PAL, will be harmonised. There is momentum building for change. My feeling is that the preference all-round would be for harmonisation to come from within the industry rather than being imposed by regulators. That requires action now to build on the consensus the ILSI-Europe guidance achieved.
- Allergen recalls will continue to dominate recalls in general. The number of allergen recalls in the UK climbed steadily until 2019, with a decline thereafter in 2020 and 2021. Its likely this decline owed more to the Covid-19 pandemic than to inherent improvement in allergen management. I hope I’m wrong but I think the upward trend will resume unless more attention is paid to allergen risk assessment and risk management.
- Personal allergen analysis using a smartphone attachment is being advocated as an answer. The prospect of a person with a food allergy checking the food they are about to eat certainly has attractions. Not least in giving back control. However, the concept is fraught with difficulties. If unintended allergens are present uniformly throughout the food, a single point-of-use test would leaving aside the question of its sensitivity, be valuable. But often the contamination is intermittent and irregular. The tested spoonful may be negative but allergen may be lurking elsewhere on the plate. A device capable of scanning the whole meal would be the answer, but such a device remains to be developed. Thus, painstaking information gathering and careful allergen management within your supply chain, supplemented by a risk assessment, preferably quantitative, if unintended allergen presence cannot be avoided will persist as the only viable recourse to protect consumers, guard against recalls, avoid litigation and safeguard the reputation of your business.
October 2022
