Pantethine as source for pantothenic acid added as a nutritional substance in food supplements - Scientific Opinion of the Panel on Food Additives and Nutrient Sources added to Food (ANS)

2008 EFSA Journal  
Following a request from the Commission, the Panel on Food Additives, Nutrients and Food Supplements (ANS) was asked to evaluate the safety and bioavailability of pantethine as a source for pantothenic acid when added for nutritional purposes in food supplements. Pantothenic acid has been evaluated by the Scientific Committee on Food in 2002 (SCF, 2002) who concluded that no numerical upper limit could be derived. The present opinion deals only with the safety and bioavailability of a
more » ... lity of a particular source of pantothenic acid, intended to be added to food supplements. The safety of pantothenic acid itself, in terms of amounts that may be consumed, is outside the remit of this Panel. Pantethine is the disulphide of pantetheine, the metabolic substrate which constitutes the active part of coenzyme A and acyl carrier proteins. After oral intake, pantethine can be metabolized into pantetheine in the intestinal lumen. Pantetheine is, in its turn, absorbed and hydrolysed in the intestinal mucosa cells into pantothenic acid. From subchronic toxicity studies in rats and dogs, the Panel identified NOAELs of respectively 36 and 50 mg pantethine/kg bw/day. Daily intakes up to 8.3 to 15 mg/kg bw/day would result in margins of safety compared to the NOAELs from the animal studies of only 2.4 to 6.0. Daily intakes of 10 mg/day would amount to 0.167 mg/kg bw/day for a 60 kg person and would give rise to margins of safety of 216 to 300. Results from clinical studies reveal that pantethine is well tolerated although there are occasional reports of heartburn, mild pruritis, gastrointestinal discomfort and diarrhea, most frequently when administered in higher doses i.e. 350-1200 mg/day and higher. The Panel concludes that the bioavailability of pantothenic acid from pantethine upon oral intake might be comparable to or lower than that of pantothenic acid. Given the facts that: i) the bioavailability studies in rats indicate that part of the pantethine might be absorbed unmodified and that in first instance only part may be converted to pantothenic acid,
doi:10.2903/j.efsa.2008.865 fatcat:zykcuastv5a7vmfk6zn6ekqure