D-alpha-tocopheryl polyethylene glycol 1000 succinate (TPGS) in use for food for particular nutritional purposes

The Panel concluded that in the absence of genotoxic effects the safety of TPGS can be assessed on the basis of the overall NOAEL equivalent to 1000 mg TPGS/kg body weight per day, established in a subchronic toxicity study in rats. TPGS is only to be used for food for special medical purposes under medical supervision at estimated intakes varying from 5 mg TPGS /kg bw in teenagers to 13 mg TPGS /kg bw in 1 month old infants. Potential intake would be lower in adults. This provides an adequate margin of safety (ratio between the NOAEL and the intake) compared with the NOAEL of 80 to 200 for infants and young children. The Panel also noted that these estimated intakes to TPGS would correspond to intakes to PEG 1000 at levels equivalent to 3.3 – 8.5 mg/kg bw/day. This is within the range of the group Acceptable Daily Intakes established by the EC Scientific Committee on Food (5 mg/kg bw for PEG 300 - 4000) and the Joint FAO/WHO Expert Committee on Food Additives (10 mg/kg bw for PEGs 200 - 10000). The Panel noted that under the current Community legislation foods for special medical purposes should be used under medical supervision. The supervising physician will be in a position to weigh up any risks and benefits to the patient and to ensure that the patient receives an adequate dose of vitamin E. The Panel noted that studies in healthy humans showed that the administration of TPGS, in contrast to fat-soluble vitamin E sources, only slightly elevated the plasma α-tocopherol level. Therefore, TPGS is not a useful source of vitamin E in healthy humans with a normal fat absorption. The Panel therefore concluded that the use of TPGS in foods for special medical purposes is not of safety concern at the anticipated exposure level. However, the Panel noted that it is advised not to apply the TPGS treatment in children with severe impairment of kidney function.