Dietary Exposure Assessments Services

A dietary exposure assessment estimates the amount of a substance (novel ingredient, additives etc.)  that people may consume through food and beverages. It combines information such as the concentration or proposed use level of a substance in foods, food consumption data and population characteristics to estimate dietary exposure. Dietary exposure assessments can form an important part of food safety evaluations and regulatory submissions.

A dietary exposure assessment may be required when introducing a new food, ingredient or substance, or when proposing new uses or use levels for an existing substance. Exposure assessments are commonly undertaken to support GRAS and Novel Food applications, food additive evaluations and safety assessments of ingredients, nutrients, bioactive compounds and other substances. The specific requirements depend on the substance, intended uses, target population and applicable regulatory framework.

Intertek supports dietary exposure assessments across North America, Europe, Latin America, Asia-Pacific, and other international markets. Our capabilities include assessments based on nationally representative food consumption databases such as the National Health and Nutrition Examination Survey (NHANES) (United States), Canadian Community Health Survey (CCHS) (Canada), EFSA Comprehensive European Food Consumption Database (European Union), National Diet and Nutrition Survey (NDNS) (United Kingdom), Encuesta Nacional de Salud y Nutrición (ENSANUT) (Mexico), and Pesquisa de Orçamentos Familiares (POF) (Brazil).

In addition to these established databases, Intertek can develop tailored dietary exposure assessment approaches for countries where food consumption data are less readily available. We support country-specific, regional, and global exposure assessments for regulatory submissions, novel food applications, food additive evaluations, GRAS notifications, and other food safety assessments worldwide.

Depending on complexity, typically total project timelines run for 4 to 6 weeks, during this period, it would be typical to expect up to 4 iterations of a dietary exposure assessment, and a complete report and dossier section outlining the methodologies, results and conclusions.

The cost of a dietary exposure assessment depends on factors such as the number of markets being assessed, the complexity of food uses, available data and regulatory requirements. Following an initial review of the project scope, Intertek can provide a tailored quotation.

The European Food Safety Authority (EFSA) commonly requires dietary exposure estimates as part of evaluations for novel foods, food additives, enzymes, flavourings, and other regulated food substances. The required methodology depends on the specific application type and applicable EFSA guidance. Depending on the assessment, exposure estimates may be generated using EFSA tools such as FAIM, FEIM, or DietEx.

Deterministic exposure assessments use predefined assumptions and point estimates, whereas probabilistic assessments model variability and uncertainty across a population using statistical techniques. Deterministic methods are commonly used for regulatory submissions, whereas probabilistic approaches may be used when a more refined assessment is required. The appropriate approach depends on the assessment objectives, available data and regulatory expectations.

Mean exposure represents the average estimated intake within a population group, while high consumer exposure estimates (such as the 95th percentile) represent intake among a relatively small proportion of consumers with higher dietary exposure. Reporting both values provides a more complete understanding of population exposure and helps ensure that safety assessments are protective of both average and high consumers.

For food additive applications, EFSA may require consumer-only exposure assessments for food categories that are consumed by only a subset of the population, such as food supplements or dietary foods for infants and young children for special medical purposes. In these cases, calculating exposure across the entire population, including non-consumers, can underestimate intake among actual users. A consumer-only assessment focuses solely on individuals who consume the product, providing a more representative estimate of dietary exposure for those most likely to be exposed.

Per capita dietary exposure estimates are calculated across the entire population, including both consumers and non-consumers of a particular food or product. In contrast, consumer-only dietary exposure estimates are calculated using only individuals who consume the food or product of interest.

As a result, consumer-only estimates are typically higher than per capita estimates because they reflect exposure among actual consumers rather than averaging intake across the whole population. Reporting both approaches can provide valuable context, helping to characterise exposure within the general population as well as among those most likely to be exposed.

EFSA requests both maximum and typical use levels to evaluate dietary exposure under different scenarios. Maximum use levels represent the highest concentration expected to be used in a food and are typically used to generate conservative exposure estimates. Typical use levels represent the concentrations more commonly used in commercial products and can provide a more realistic estimate of consumer exposure. By considering both values, EFSA can assess potential exposure under both worst-case and more representative conditions of use, helping to ensure a robust safety evaluation.