Principle for permitted level based on ADI
Acceptable Daily Intake (ADI) is defined as an estimate of the amount of a food additive, expressed on a body weight basis, which can be ingested daily over a lifetime without appreciable health risk. (CFSAN, 1993) The ADI is expressed in a range, which is considered to be the zone of acceptability of the substance.
The acceptable daily intake (ADI) is generally estimated by dividing the no-observed-effect level (NOEL) of a test substance by the safety factor. NOEL is the highest exposure that does not produce adverse effect. NOEL may be expressed as mg test substance per kg body weight of the test animal or as percent or ppm (parts per million) of the test diet for the animal. The ADI is usually expressed in mg additive per kg body weight of humans. A food additive generally is considered safe for its intended use if the estimated daily intake (EDI) of the additive is less than, or close to, the ADI. This is because the ADI is calculated to protect against the most sensitive adverse effect, it also protects against other adverse effects occurring at higher exposures to the ingredient.
Safety factor is used in calculation of ADI because even though the toxic substances at the NOEL level might not affect animals, it might affect humans. Thus the safety factor is to account for the differences between animals and humans and differences in sensitivity among humans and also to ensure consumer’s safety by providing an adequate margin of safety. A general rule of safety factor of 100 is used. However, there are exceptions to which the safety factor of 100 is used. For example, if the food additive is going to be used in infant formulas, a higher safety factor would need to be used to ensure safety.
http://www.cfsan.fda.gov/~acrobat/rediiabc.pdf
Estimated daily intake of an additive (x) is calculated based on the following formula:
Where:
F = Total number of foods in which substance "x" can be found
Acceptable Daily Intake (ADI) is defined as an estimate of the amount of a food additive, expressed on a body weight basis, which can be ingested daily over a lifetime without appreciable health risk. (CFSAN, 1993) The ADI is expressed in a range, which is considered to be the zone of acceptability of the substance.
The acceptable daily intake (ADI) is generally estimated by dividing the no-observed-effect level (NOEL) of a test substance by the safety factor. NOEL is the highest exposure that does not produce adverse effect. NOEL may be expressed as mg test substance per kg body weight of the test animal or as percent or ppm (parts per million) of the test diet for the animal. The ADI is usually expressed in mg additive per kg body weight of humans. A food additive generally is considered safe for its intended use if the estimated daily intake (EDI) of the additive is less than, or close to, the ADI. This is because the ADI is calculated to protect against the most sensitive adverse effect, it also protects against other adverse effects occurring at higher exposures to the ingredient.
Safety factor is used in calculation of ADI because even though the toxic substances at the NOEL level might not affect animals, it might affect humans. Thus the safety factor is to account for the differences between animals and humans and differences in sensitivity among humans and also to ensure consumer’s safety by providing an adequate margin of safety. A general rule of safety factor of 100 is used. However, there are exceptions to which the safety factor of 100 is used. For example, if the food additive is going to be used in infant formulas, a higher safety factor would need to be used to ensure safety.
http://www.cfsan.fda.gov/~acrobat/rediiabc.pdf
Estimated daily intake of an additive (x) is calculated based on the following formula:
Where:
F = Total number of foods in which substance "x" can be found
Freqf = Number of eating occasions of food "f" over "N" survey days
Portf = Average portion size for food "f"
Concxf = Concentration of the substance "x" in food "f"
N = Number of survey days
The sources of data can be collected from food consumption survey, food/ingredient disappearance figures, total diet study and body burden/excretion measurements: “Biomakers”. Food consumption data may be collected at the national, household, or individual level. Consumption surveys at the level of the individual provide information on mean food intakes and the distribution of food intakes within sub-populations of individuals defined by demographic factors (e.g., age, gender) and health status (e.g., pregnancy, lactation). These surveys measure food intake by one or more methods: i.e., food records or diaries, 24-hour recalls, food frequency questionnaires (FFQ), and diet history. The data collected from these surveys can then be used to calculate the EDI. This would help to determine the safety of an additive as the EDI should be lower or close to the ADI if the food additive is generally safe.
http://www.cfsan.fda.gov/~dms/opa2cg8.html#Bfoo
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