Notification of dried flowers of Clitoria ternatea L. as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Following a notification from Sensient Technologies Europe GmbH (Germany) and Tsujiko Co., Ltd (Japan), submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market dried flowers of Clitoria ternatea L. as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. EFSA considers that the composition of the TF has been sufficiently characterised. The compositional analyses include information on cyclotides, small cyclic proteins, which have been reported to have a high thermal, chemical and enzymatic stability due to their specific chemical structure. EFSA also notes the in vitro haemolytic and cytotoxic effects reported for some cyclotides present in the TF as well as data which indicate possible effects on the immune system and on the uterus for one cyclotide (albeit not detected in Clitoria ternatea). Furthermore, there are only limited data available on the digestibility, bioavailability, toxicokinetics, and possible in vivo toxicological effects of cyclotides including some of those present in the TF. EFSA also notes that the available information demonstrates the traditional use of the TF for food colouring purposes, in Asian countries without apparent adverse health effects. A traditional use of the TF for the preparation and consumption of herbal infusions has not been established. Given the potential exposure to cyclotides resulting from the intended use for the preparation of herbal infusions, and the unknown toxicological profile of the cyclotides present in the TF, EFSA considers that the TF may pose a safety risk to human health. Thus, EFSA raises safety objections to the placing on the market within the EU of the TF (dried flowers of Clitoria ternatea L.).