Dietary Exposure

Dietary exposure estimates are an essential component of food or feed additive petitions, novel food submissions, GRAS determinations, and food contact material notifications, as a comparison of the estimated consumption of a substance to the estimated acceptable daily intake or available safety data forms a critical part of the risk assessment process. These intake assessments include the intake from proposed use levels, as well as background intake resulting from natural occurrence in food or existing approved levels. Accurate intake estimates also are a critical component of health claims submissions as they are required to demonstrate that an efficacious dose can reasonably be consumed on a daily basis by the typical consumer.

Dietary exposure estimates may not be limited only to your proposed food uses. You also may have to consider currently approved uses, natural occurrence, and intake through dietary supplement consumption. Increasingly, the regulatory authorities are asking that submissions include a comprehensive assessment of intake from all sources. Additionally, an assessment of background intakes can be an important step in establishing a case of need to help justify the addition of your compounds to foods, as required for some jurisdictions.

Our services include:

• Selection of the most appropriate food uses and representative food codes for your ingredient;
• Estimation of dietary exposure based on a range of methodologies and the most up-to-date international food consumption databases;
• Estimation of background intakes of food ingredients and nutrients from all sources;
• Calculation of theoretical mean and/or percentile dietary exposure estimates based on international regulatory requirements;
• Determination of acute and chronic estimates of dietary exposure for all age groups within the total population; and
• Integration of dietary exposure estimates into safety assessments for product development or regulatory purposes.