Food additives toxicological concerns

Information and data from toxicological tests are essential requirements of the food additive petition. The Redbook 2000 Toxicology Principles for the Safety Assessment of Food Ingredients (16) provides guidance to industry concerning the appropriate tests for the determination of safety. The Redbook discusses concern levels as a method to determine recommended toxicology tests for food and color additives. A level of concern can be assigned based on the potential health risk of the food additive. 

In some instances additional specialized studies may be required to assess drug-specific toxicological concerns. For example, hypersensitivity tests may be required for the -lactam antibiotics FDA has recently been concerned with how this standard human food safety assessment process accurately determines the safe concentration of antibiotic residues based on the traditional toxicological end-points. Of particular concern was the impact of low levels of antibiotics on the intestinal microflora. 

Direct food additives that fall into Concern Level III require comprehensive, long-term toxicology studies, including ... 

As mentioned earlier, the "Redbook" decision-tree system for determining toxicological testing of food additives falls Into three levels of concern 13.111. whereas there are four FEMA concern levels, each determined by combining Information about the human exposure levels to a compound with the Information about Its chemical structure derived from a 33-questlon "decision tree" Q2). 

MUNRO I. c. and kroes r. (1998), Application of a threshold of toxicological concern in the safety evaluation of certain flavouring substances . Safety Evaluation of certain food additives and contaminants (Annex 5). WHO Food Additives Series N. 40. 

Toxicology is now a multidisciplinary science concerned with the biological effects of a wide variety of chemicals encountered in the environment. Such compounds include food additives, industrial wastes, air and... 

Additionally, problems may arise if the preclinical data on which the assessment is made are old and unreliable and raise specific toxicological concerns. Considering all these factors, it is probable that a robust expert review of available preclinical and human exposure data for a food additive may satisfy a regulatory body. As noted above, there is an indication in Europe that new pharmaceutical excipients already used in food for orally administered products or for topical cosmetics may not have to be considered new chemical entities, and therefore full evaluation may be bypassed. ... 

Taylor, J.M. 1981. Personal communication to the World Health Organization concerning impublished studies on beta-asarone and calamus oils. Cited in WHO. 1981. P-Asarone. Toxicological evaluation of certain food additives. WHO Food Additives Series 16. Joint FAO/WHO Expert Committee on Food Additives. 

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