Roasted seeds from Plukenetia volubilis L., commonly known as sacha inchi, are safe for human consumption under proposed conditions of use, the European Food Safety Authority concluded in a scientific opinion adopted on 1 July 2026 and published on 24 July 2026. The opinion, issued by EFSA's Panel on Nutrition, Novel Foods and Food Allergens, resolves earlier safety objections related to the presence of alkaloids and paves the way for the European Commission to authorise the traditional food from Peru for the EU market.
The assessment follows a lengthy regulatory process. On 30 November 2018, a consortium of Peruvian companies submitted a notification under Article 14 of the Novel Food Regulation (EU) 2015/2283 to market roasted sacha inchi seeds as a traditional food from a third country. EFSA raised duly reasoned safety objections within the four-month period, citing uncertainties about the quantity and type of alkaloids present. The Commission subsequently issued an implementing decision not authorising the product. The applicant then submitted a formal application under Article 16 of the regulation on 17 March 2021, providing additional data to address the safety concerns.
In the new application, the applicant analysed five batches of the roasted seeds using liquid chromatography–tandem mass spectrometry targeting tropane and pyrrolizidine alkaloids, finding them below limits of quantification. Further metabolomic profiling, including a study by Le et al. (2024) on raw seeds, identified trigonelline as the only quantifiable alkaloid, at concentrations of 52–111 mg/kg dry weight in roasted seeds. The panel noted that dietary exposure to trigonelline, for instance through coffee consumption at higher levels, has not been associated with adverse effects. The panel concluded that the newly submitted evidence sufficiently characterises the alkaloid fraction, resolves the previously identified uncertainties, and that the consumption of the roasted seeds is not nutritionally disadvantageous.
The opinion impacts several stakeholders. For the applicant companies—Promperu, Agroindustrias Osho SAC, Amazon Health Products SAC, Candela, and Shanantina SAC—the positive safety opinion removes a key regulatory barrier to accessing the EU market, potentially opening new export opportunities. EU consumers will gain access to a novel whole food with a history of safe use in Peru, though exposure to trigonelline is already common from other dietary sources. EU food business operators may incorporate sacha inchi seeds into products such as snacks or bakery items, subject to final authorisation and compliance with labelling requirements. National food safety authorities in EU member states will need to monitor compliance with the proposed conditions of use once the Commission adopts an authorisation decision.
The Commission is now expected to proceed with an implementing act authorising the placing on the market of roasted sacha inchi seeds as a traditional food, in line with the EFSA opinion.