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Quantify exposure. Strengthen your U.S. regulatory position.
For ingredients and substances used in foods, beverages, dietary supplements, and other products regulated by the U.S. FDA, it is critical to understand anticipated consumer exposure for a safety and regulatory assessment.
SGS Nutrasource provides Exposure Assessment services to characterize estimated intake based on the proposed conditions of use, consumption patterns, and relevant population groups. Our regulatory and scientific experts help determine whether exposure estimates are appropriately supported and identify potential data gaps that may affect your regulatory strategy.
Supporting science-based regulatory decisions
Our experts can assess exposure as part of a broader GRAS evaluation or as a standalone assessment, helping you build a scientifically sound basis for U.S. regulatory submissions and decision-making.
Our Exposure Assessment services may include:
- Estimated daily intake - Calculate anticipated exposure based on the selected food or product categories, proposed use levels, serving sizes, and U.S. consumption patterns.
- Population exposure assessment - Evaluate exposure across relevant U.S. consumer populations, including consideration of high-consumption scenarios where appropriate.
- Dietary exposure modeling - Use available consumption and use-level data to characterize potential dietary exposure.
- Aggregate exposure considerations - Consider exposure from multiple applicable sources or uses when relevant to the assessment.
- Use-level assessment - Evaluate proposed use levels and conditions of use in the context of anticipated consumer exposure.
- Data gap identification - Identify limitations, uncertainties, and additional information that may be needed to strengthen the exposure assessment.
- Regulatory support - Provide exposure estimates and scientific interpretation to support U.S. regulatory strategies, including GRAS assessments and related FDA-facing work.
Build a stronger foundation for your safety assessment.
A well-supported exposure assessment helps put toxicological data into context and provides an important component of the overall safety evaluation. The FDA's established risk-assessment framework recognizes exposure assessment as one of the core elements used alongside hazard identification, dose-response assessment, and risk characterization.
Whether you are developing a new ingredient, preparing a GRAS assessment, updating a previous GRAS conclusion based on outdated U.S. consumption data, or responding to evolving regulatory expectations, SGS Nutrasource can help ensure your exposure estimates are scientifically robust, transparent, and fit for purpose.
Address uncertainty. Strengthen your regulatory strategy.