Two Approaches, One Goal: Comparing EU and UK Exposure Assessments
02 May 2025
Exposure assessments are a fundamental part of the risk assessment process for regulated products such as novel foods, food additives, and food enzymes. These assessments rely on the most up-to-date, nationally representative food consumption data, combined with information on the intended uses and maximum use levels of the ingredient of interest. To ensure public safety, risk assessments always adopt a conservative approach by considering high-level (95th percentile) estimates of exposure.
The European Food Safety Authority (EFSA) recently released an updated novel food guidance, advising that exposure assessments for novel food applications in the European Union (EU) use either the Food Additive Intake Model (FAIM) or the Dietary Exposure (DietEx) tool. Similar requirements apply to exposure assessments for food additives and food enzymes. Both tools draw on individual consumption data from the EFSA Comprehensive Food Consumption Database (“Comprehensive Database”).[1]
Since Brexit, the United Kingdom (UK) has continued to follow EU food regulations (as “assimilated” regulations) until its own laws are established, and the UK Food Standards Agency (FSA) has indicated that EFSA’s guidance remains relevant in the UK.[2] As such, the UK FSA currently accepts exposure estimates made using the EFSA Comprehensive Database. However, applicants may also submit exposure estimates using data from the UK National Diet and Nutrition Survey (NDNS).
This article describes the key differences between the EU- and the UK-based food consumption data, and presents a short case study illustrating potential differences in exposure assessment outcomes from using either data source.
Methodological Differences
EU
Exposure assessments in the EU are conducted using data from the EFSA Comprehensive Database. Last updated in December 2024, the database includes food consumption data from various dietary surveys conducted across 29 different European countries.[3] While this includes a broad geographical range beyond the EU, tools like FAIM and DietEx focus on data from EU Member States specifically, using data from 22 EU member countries.
The EFSA Comprehensive Database covers a wide range of age groups, including infants, toddlers, children, adolescents, adults, and the elderly. Since multiple surveys provide data for the same age groups, exposure estimates are presented as a range. One advantage of the database is that it provides an overview of the potential maximum exposure to an ingredient across the EU. However, due to data variability, the intake ranges determined from the database can vary significantly. The sample sizes may vary widely across surveys, and the data collection methods (e.g., 24- vs. 48-hour recalls, 2- vs. 3-day food diaries) are not standardized across all EU countries. Such methodological differences can lead to significant differences in exposure estimates. Moreover, the food categorizations themselves differ across the various surveys. Nevertheless, EFSA has organized the food consumption data into the FoodEx2 food categorization system, whereby foods and beverages are codified into a hierarchical classification structure. As a result of the above limitations, the greatest 95th percentile intake estimates in the EU—those used for risk assessment—often represent conservative estimates of overall exposure.
UK
The UK government funds the NDNS, a nationally representative cross-sectional survey to monitor food consumption, nutrient intake, and nutritional status of the general population ages 1.5 years and older. The NDNS is a rolling survey conducted in waves, ensuring ongoing data collection and capturing trends in dietary habits and nutrient intake over time. Food consumption data are collected using a 4-day consecutive food diary completed by participants.
The most recent NDNS data represent Years 9 to 11 of the survey, covering 2016 to 2017 and 2018 to 2019, and capturing a total of 3,558 individuals. This sample size ensures the data are statistically reliable and representative of the broader UK population, enabling the identification of diverse dietary trends across different demographic groups.
The NDNS also collects biological samples (e.g., blood and urine) to assess nutritional biomarkers, and measures physical characteristics such as height, weight, and blood pressure to provide a broad picture of health status. The food consumption data are collated and codified with high differentiation between similar foods, resulting in an extensive set of codes that map to the food consumption data. This allows for a more accurate estimate of exposure to specific nutrients and ingredients.
Case Study – EU vs. UK Exposure Estimates
Intertek created a fictional novel food and assessed its relevant dietary exposure estimates in the EU and the UK using the most recent EFSA and NDNS food consumption data. The exposure to the novel food was calculated considering its addition to common foods, including meat and dairy imitates, protein bars, protein shakes, and breakfast cereals, with maximum use levels ranging from 10 to 95%.
In this hypothetical case, the mean and 95th percentile intakes in adults in the EU were estimated to be in the range of 3 to 14 g/day and 9 to 61 g/day, respectively, using the EFSA DietEx tool. Whereas the mean and 95th percentile intakes in adults in the UK were estimated to be 17 g/day and 49 g/day, respectively, using the NDNS.
From a risk assessment perspective, the greatest 95th percentile intakes should typically remain below the established safety limit. In the current scenario, due to differences in the EU and UK food consumption data, there is a 12-g discrepancy between the 95th percentile intake of the EU‑based assessment and that of the UK‑based assessment. As such, depending on the intended uses and the established safety limit for a particular ingredient, using the NDNS rather than the EFSA Comprehensive Database to conduct an exposure assessment for UK novel food applications may allow additional food uses to be selected and/or higher maximum use levels to be set.
Conclusion
For regulated product applications in the EU, exposure estimates must be conducted using the EFSA Comprehensive Database. At present, the UK FSA also accepts exposure estimates using the EFSA Comprehensive Database; however, the NDNS is also an option for UK-regulated product applications.
Given that the EU exposure tools contain data from 22 countries with differing patterns of consumption, collected using varying methodologies, it typically leads to higher exposure estimates than those derived from the UK NDNS, which is a single dietary survey. This was illustrated in the case study, where a 12-g difference in 95th percentile intake was observed between the EU and UK datasets. Depending on the ingredient’s intended use and safety limit, using UK-specific data may therefore support broader or higher-use-level applications.
Notwithstanding the above, it is important to note that the UK FSA’s acceptance of EU data may change when the agency updates its regulations. There is no clear timeline for the UK’s departure from assimilated EU law, but it is reasonable to expect that future regulated product applications in the UK will require UK-specific food consumption data.
For guidance on the best option for your ingredient, feel free to reach out to us at food.assuris@intertek.com
Intertek’s Exposure Assessment Expertise
Intertek has extensive expertise conducting dietary intake assessments in multiple jurisdictions using various modeling methods. Our comprehensive understanding of the food-regulatory landscape allows us to develop dietary exposure assessment strategies customized to—and optimized for—ingredients and regions of interest.
For more information, please visit: www.intertek.com/assuris/food/dietary-exposure-assessment/
[1] Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283
[2] https://www.food.gov.uk/business-guidance/regulated-products/novel-foods-guidance
[3] https://www.efsa.europa.eu/en/data-report/food-consumption-data
