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Technical Report on the notification of xuta (edible variety of Jatropha curcas L.) roasted and ground seed kernels as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

on the Wiley Online Library

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Abstract

A notification from Jatropower AG (Switzerland) was submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market xuta (edible variety of Jatropha curcas L.) roasted and ground seed kernels as a traditional food from a third country (TF). 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. In the compositional analyses phorbol esters (PEs) were reported to be below the detection limit in five batches of raw xuta powder. PEs represent the potential major hazard in the use of Jatropha kernels and thus in the TF. PEs do not induce tumours per se but promote tumour growth and may act as cocarcinogens. Despite the measures implemented by the applicant to select edible Jatropha plants and to analyse the TF for PEs, low levels might still be present in the flour. In 2015 the CONTAM Panel assessed the toxicity of PEs in non‐edible Jatropha kernel meals and identified a no observed adverse effect level (NOAEL) for PEs. The CONTAM Panel concluded that due to limitations in the toxicological dataset and the characteristics of PEs (protein kinase C activation and structural alert for genotoxicity), a sufficient margin of exposure (MOE) was not defined. Taking into account (i) the insufficient information on the intended uses and use levels of the TF to allow for a proper intake exposure assessment, (ii) the resulting impossibility to calculate a MOE based on the NOAEL for PEs, and (iii) the limited knowledge and the uncertainties regarding the genotoxic potential of PEs and thus of 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.