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Parameters of “Safety” in the Food Additive Industry: A Review of Risks and Benefits

Paul J. Flaer, Sepideh Badri


“Safety is in the eye of the beholder.” What is deemed “safe” by one observer may seem dangerous or risky to others. To approach this apparent quandary and assure ongoing scientific input, most food additives should be tested on laboratory animals and subsequently monitored if approved for human or animal consumption (i.e., parallel to the pathway for the approval of drugs). The term “safety” in the study of the toxicology of food additives is based on the situational concept “acceptable risk” for the benefits that may subsequently be gained at a given level of risk. Determination of risk/benefit ratios attempts at quantifying these risks and relating them to possible benefits of human consumption. Furthermore, the risk of using a substance relates not only to the benefits ascertained, but to sociocultural parameters like preference and demand. The determination of “safety” is almost always dose-dependent in the approval process and research analysis regulating the consumption of a particular food additive. However, the high-intensity sweetener saccharin does not seem to closely follow dose-dependent models for studies of carcinogens. On the other hand, sensitive organotropic models for the male rat bladder have been developed and tested with saccharin. This unusual toxicology of saccharin has led to misinterpretation by research studies and subsequent mishandling of previous results by industry. After extensive toxicology studies in male rats in the 1970s, saccharin came under statutory control of Federal actions requiring labeling as a carcinogen. Manufacturing corporations of saccharin countered the labeling by employing organized pressure from marketing studies and political lobbying. Furthermore, the extensive studies of laboratory animals in the 1970s were re-interpreted by 2001, but the damage was done. The decreased public consumption of saccharin use continues to this day. As a result of this re-analysis, saccharin was re-categorized as a “probable but not definite carcinogen” (i.e., weak bladder carcinogen) and warning labels were subsequently removed from all products. Although it now has a somewhat damaged reputation, saccharin remains approved today for human consumption by the rules of risk/benefit ratios.


Keywords: Toxicology, food additives, risk/benefit ratios, cancer, saccharin

Cite this Article

Flaer Paul J, Badri Sepideh.Parameters of “safety” in The Food Additive Industry: A Review of Risks and Benefits. Research and Reviews: Journal of Toxicology (RRJoT). 2015; 5(2): 7–13p.

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