Exposure

Assessment for Ingredients

Exposure Assessment for Ingredients

by Alan M. Hood, Ph.D.

The use of nutritional ingredients in conventional food (i.e., functional food) is growing at a phenomenal rate. Because new food ingredients, or new uses of existing food ingredients, must be assessed for safety, exposure assessment plays an important role in the transition of dietary supplement ingredients into functional foods. In any safety assessment analysis, it is important to consider all sources of exposure to the ingredient. Sources of exposure to a food ingredient include foods in which the ingredient has been intentionally added and foods in which the ingredient occurs naturally. Only when an estimate of the total exposure to a food ingredient is made can meaningful safety assessments be conducted.

Exposure assessment of a food ingredient depends upon both deliberate addition and natural occurrence in food, which is commonly referred to as a consumption analysis. A consumption analysis is critical in answering the question: Will the addition of ingredient Y at concentration X to food result in a total consumption level that is greater than a threshold of safety, often set in the context of an established allowable daily intake (ADI) for ingredient Y? Food refers to either just one or hundreds of discrete food items, and total consumption refers to intake from the ingredients used as an added ingredient plus intake from its natural occurrence in food. The natural occurrence in food is commonly called daily intake via natural food occurrence.

Figure 1 illustrates the basic equation used for estimating food ingredient consumption. The equation is based on the amount of food consumed and the concentration of the ingredient in the food, i.e., a proposed amount that will be added to food and/or a measured amount at which the ingredient naturally occurs in the food. It is important to point out that only those individuals who actually consume the foods of interest are included in the analysis, and the resulting information is commonly referred to as Eaters Only data.

The complexity of an exposure assessment of a food ingredient is dependent on the number of foods to which the ingredient will be added, the number of individuals consuming the foods and the frequency in which the foods are eaten (once per day, three times per day, etc.). The process of estimating the amount of an ingredient consumed from food can be streamlined if the foods to which the ingredient will be added are well defined and the concentration of the ingredient in each of the foods is known. These decisions (typically influenced by marketing desires) need be communicated at an early phase so as not to delay the progress of the overall project or GRAS determination.

It is common for manufacturers to have an idea of the types of foods to which an ingredient would be added. The exposure assessment process is most efficient when the specific foods to which the ingredient will be added are clearly identified at the earliest point in time possible. Estimating exposure to a food ingredient will be prolonged if the foods to which the ingredient will be added are not well defined or if the list of foods increases over time, resulting in multiple recalculations. This may conversely affect the potential quantity to be sold of an ingredient by inadvertently increasing the exposure to a level that is not supported by existing safety information.

Exposure assessment of ingredients is critical in establishing the safety-in-use in food. The time it takes to estimate the amount of an ingredient consumed by people from the foods they eat can be accomplished in a surprisingly short period by experienced laboratories and other organizations with this expertise. Implementation of a complex consumption analysis is largely dependent upon identifying the specific foods to which the ingredient will be added, knowing the target population and the amount of ingredient that will be added to these foods. The earlier these decisions are made, the more timely the delivery of these calculations; otherwise, the intended launch of the product could be impacted. This critical information can and should be determined during the research and development phaseand earlier, if possible.

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