Safety of roasted seeds from Plukenetia volubilis L. as a traditional food from a third country pursuant to Regulation (EU) No 2015/2283.

Abstract

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on roasted seeds from Plukenetia volubilis L. as a Traditional Food from a third country (TF) pursuant to Regulation (EU) 2015/2283. Roasted seeds from Plukenetia volubilis L. (commonly known as sacha inchi) have been consumed in Peru for more than 25 years. The applicant intends to place on the European Union (EU) market roasted sacha inchi seeds to be consumed as a whole food. This TF had previously been subject to a TF notification under the provisions of Regulation (EU) 2015/2283. During the assessment of that notification, EFSA identified safety concerns related to uncertainties regarding the presence of alkaloids in the TF. In the current application, the applicant provided additional data addressing the concern on alkaloids. These analyses identified trigonelline as the only quantifiable alkaloid present in the TF, a finding that is also supported by data available in the literature. Dietary exposure to trigonelline, for example, through coffee consumption at amounts higher than those determined in the TF, has not been associated with adverse effects. The Panel considers that the newly submitted evidence sufficiently characterises the alkaloid fraction of the TF, addresses the previously identified uncertainties and resolves the safety objections raised during the earlier assessment of the TF notification. Furthermore, based on the composition and the proposed conditions of use, the Panel considers that the consumption of the TF is not nutritionally disadvantageous. The Panel concludes that the TF, roasted seeds from Plukenetia volubilis L., is safe under the proposed conditions of use.