In 2015 EFSA published a scientific opinion in the re-evaluation of the food additive E 304(i). In this opinion EFSA concluded that there is no safety concern for the use of ascorbyl palmitate as food additive at the reported use and use level for the general population. However,
EFSA noticed that the current re-evaluation of ascorbyl palmitate as a food additive is not considered to be applicable for infants under the age of 12 weeks (later 16 weeks) (EFSA Journal 2015;13(11):4289).
The re-evaluation for infants below 16 weeks of age has been published on 30/06/2020. In this opinion EFSA concluded that the current use of ascorbyl palmitate as a food additive in infant formula or in food for special medical purposes (iFSMP) does also not raise safety concerns in this vulnerable population group. (EFSA Journal 2020;18(6):6153)