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Research project

Risk analysis and Precautionary Allergen Labelling research report

This research aimed to understand the extent to which allergen risk analysis is conducted by micro, small, and medium sized (SME) food businesses, and whether this informs the use of Precautionary Allergen Labelling (PAL). It had a specific focus on whether risk assessment and the identification critical points of allergen cross-contact were undertaken.

Last updated: 6 June 2022
Last updated: 6 June 2022


The research involved interviews with 42 food businesses from England, Wales, and Northern Ireland, between January and March 2022. Of these, 37 were SMEs working across the following sectors: manufacturing, retail, catering, and institutions. A further five interviews were conducted with large food businesses selected as exemplars of good practice in risk analysis for comparison and learning purposes (referred to as ‘gold standard’ businesses).  

Key findings 

There was a good understanding of the concept of ‘risk assessment’ across sectors, and a moderate range of risk assessment conducted by businesses in the study. Risk assessment was greater in manufacturing sectors (across a range of business sizes), medium sized retail businesses, and, to a lesser degree, medium sized institutions. Risk assessment focused on microbiological risks and was driven by HACCP plans. Despite not being designed for this purpose, HACCP was broadly seen to manage all food safety risks, including allergens. There were minor instances of allergen risk assessment being directly integrated into HACCP plans.  

The practice of allergen risk assessment was limited for SME food businesses involved in this study. When undertaken, assessment was piecemeal, rather than a part of a defined and systematic process. Typically, such assessments focused on select allergens, rather than the potential risks from all allergens present during the food production process. It also did not proceed through a stepwise understanding of different control points but focused on tasks more top of mind for cross-contact – particularly during preparation and cleaning. A lack of ability to identify and verify supply chain risks were also cited as a particular concern for manufacturers and retailers.  

It was common for schools, colleges, and care homes to know the dietary requirements of food hypersensitive pupils and residents. This knowledge meant that, even in the absence of risk assessment, the ability to manage allergen risks was likely to be effective.  

Overall, allergen testing by SMEs as part of risk analysis process was minimal. There was some testing of pathogens and particularly cleaning validation for  micro-organisms for manufacturers. There were two examples of an allergen being tested to validate a free from claim. There were no examples of allergen cross-contact being tested to support the use of PAL, either as cleaning validation or a product test.  

Allergen risk management was more comprehensive across SMEs. For smaller manufacturers, actions typically focused on physical separation and secure storage of ingredients. For medium sized manufacturers, separate running of product lines, cleaning between production runs, and managing the packaging, labels and transport of products was common.  

For retailers making pre-packed foods for direct sale, there were reasonably sophisticated processes of separation, food preparation, cooking, and cleaning to manage allergen cross contamination. For certain retailers (for example bakeries), cross-contact risk was perceived as greatest at point of sale when products were out in the store.  

The understanding of PAL was very mixed for business. While knowledge that it related to a ‘may contain’ warning was relatively high, businesses were confused about its voluntary status and its distinction from allergen ingredients labelling. Importantly, no SME business engaged in this study understood the requirement to undertake a formal allergen risk assessment before applying PAL.