Case study Acesulfame

The extent of safety studies necessary to obtain food additive approval can be demonstrated by the studies carried out on acesulfame K (trade name Sunett ), one of the sweeteners developed in course of the last 25 years,7 which has been endorsed for food use by the Joint Expert Committee on Food Additives (JECFA) of the WHO and FAO and the Scientific Committee for Foods (SCF) of the EU and has meanwhile been approved in more than 100 countries. This program shows the wide range of studies necessary. 

The acute toxicity of acesulfame K is so low it can be regarded as virtually nontoxic. The oral LD50 was determined to be approximately 7.4 g/kg of body weight which corresponds to human doses by magnitudes higher than those which could be expected for inadvertent overdosage.7 

A full range of studies aimed at detecting genotoxic effects was carried out. In none of the studies, using different genotoxicity mechanisms, was there any indication of genotoxicity.7 

Reproductive toxicity of acesulfame K was studied in test systems aimed at detecting teratogenicity, oral embiyotoxicity and in a multigeneration study. No teratogenicity, no embryotoxicity, and no effects on reproduction, development of the fetuses and lactation performance were found.7 

In a screening system used for potential new drugs, acesulfame K was inert in all test systems except where potassium has an effect, like a transient influence on blood pressure after injection or reduction of digoxin toxicity.7 

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Schifferstein, H. N. J. 1996. An equiratio mixture model for non-additive components a case study for aspar-tame/acesulfame-K mixtures. Chem. Senses 21, 1—12. 

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