The Safety Assessment of Food Additives by Reproductive and Developmental Toxicity Studies

Abstract

The overall consumption of food additives is 139 lbs/year/person. If the common additives like spices, sugars, salt, honey, pepper, mustard, dextrose etc. are excluded, the consumption decreases to 5 lbs/year. Due to widespread consumption, it is necessary to evaluate the implications for the health of consumers because of the presence of newly synthesized food additives before commence production according to accepted guidelines such as Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA) and European Food Safety Authority (EFSA). “Redbook 2000” is one of the revised form of Redbook II guideline published in 1993 by FDA; also defined as “Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food”. This document is a guidance for determining toxicity studies, for designing and reporting the results of toxicity studies, conducting statistical analyses of data, the review of histological data and the submission of this information to FDA. The toxicological testing should provide not only information relevant to the average consumer, but also relevant to those population groups whose pattern of food consumption, physiological or health status may make them vulnerable such as young age, pregnancy and other metabolic disorders. Possible toxicological effects due to additive consumption should be tested especially in reproduction and developmental studies which are designed to evaluate effects on sexuality and fertility of males and females, developing organisms (mortality, structural abnormality and functional deficiencies). Besides, multigenerational reproductive toxicity studies provide information about the effects of a test substance on gonadal function, estrous cycle, mating behavior, lactation and development of the offspring.