EFSA publishes a positive assessment of the safety of Vitamin E TPGS

EFSA conducted scientific evaluation of the safety of Vitamin E TPGS (d-α-tocopheryl polyethylene glycol 1000 succinate) in its review of a food additive application, supported by Antares Health Products, Inc. (Antares). In its report, published in the EFSA Journal, the Scientific Panel concluded that the use of Vitamin E TPGS as a new food additive does not raise a safety concern at the proposed use and use levels.

The EFSA report provides updated, authoritative, and independent scientific evaluation of the safety of Vitamin E TPGS based on extensive clinical studies including the National Institutes of Health, and record of safe use for over 30 years. Following the positive EFSA opinion, the European Commission will decide on the food additive authorization in few months.

Vitamin E TPGS is derived from the naturally occurring d-α-tocopherol. It was initially used to overcome severe malabsorption in cholestatic children. The observation that it also increased the absorption of vitamin D stimulated clinical evaluation of its excipient function for increasing solubility, absorption, and bioavailability of lipophilic and poorly soluble compounds. Its current applications include pharmaceuticals, dietary supplements, food and beverage, personal care, and animal health products.

“EFSA’s safety assessment marks an important milestone in the use of Vitamin E TPGS in the European market and beyond” says Dr. Andreas Papas, CEO of Antares. Its safety and unique functions in formulation, delivery, transport, and cellular uptake are expanding its applications in emerging novel drug categories, including mRNA, peptide, and others.

The EFSA report is available at EFSA Journal 2025;23(9):9605.