As any toxicologist will tell you, “the dose makes the poison” (for example, both cyanide and water are toxic, the difference is only in the amount to which a person is exposed). In this series of articles, the goal is to present the key concepts that will benefit individuals involved in developing ingredients for use in food. The following topics will be addressed: (1) the rationale for performing consumption analysis, (2) the information required for the analysis, (3) critical differences between “eater’s-only” and per capita consumption and (4) integrated versus non-integrated analysis.
Consumption analysis (also known as “Exposure Assessment”) is an important part of the determination of the safety-in-use for food ingredients; whether for generally recognized as safe (GRAS) determinations, food additive petitions, safety assessment, or opinion letters. Consumption analysis is critical in answering the question: “Will the addition of food ingredient “Y” at concentration “X” result in a total consumption level that is greater than the established allowable daily intake (ADI) for ingredient Y?” It is important to understand the terms used in this sentence. For instance, “food” refers to either just one or hundreds of food items. Also, “total consumption level” refers to intake from the ingredients used as an added ingredient plus intake from natural sources in food. The natural occurrence in food is commonly called “daily intake via natural food occurrence” (DINFO). Therefore, the overall question is whether the safety data will support the proposed level of use for the particular food ingredient. Consumption analysis is critical in establishing the safety-in-use of food ingredients.