Safety of Tiger Nuts (Cyperus Esculentus) Oil as a Novel food Pursuant to Regulation (EU) 2015/2283

EFSA Journal. 2024;22:e9102. | 1 of 11 https://doi.org/10.2903/j.efsa.2024.9102 efsa.onlinelibrary.wiley.com/journal/1831-4732 SCIENTIFIC OPINION Safety of Tiger nuts (Cyperus esculentus) oil as a novel food pursuant to Regulation (EU) 2015/2283 EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) | Dominique Turck | Torsten Bohn | Montaña Cámara | Jacqueline Castenmiller | Stefaan DeHenauw | Karen Ildico Hirsch- Ernst | Ángeles Jos | Alexandre Maciuk | Inge Mangelsdorf | Breige McNulty | Androniki Naska | Kristina Pentieva | Alfonso Siani | Frank Thies | Margarita Aguilera- Gómez | Francesco Cubadda | Thomas Frenzel | Marina Heinonen | Helle Katrine Knutsen | Monika Neuhäuser- Berthold | Morten Poulsen | Miguel Prieto Maradona | Josef Rudolf Schlatter | Alexandros Siskos | Henk van Loveren | Fernando Rivero- Pino | Ruth Roldán- Torres | Harry J. McArdle Adopted: 30 October 2024 DOI: 10.2903/j.efsa.2024.9102 This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. © 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority. Correspondence: [email protected] 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 the safety of Tiger nuts (Cyperus esculentus) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Tiger nuts (C. esculentus) is an edible tuber with history of consumption as food. The NF is the oil obtained from the nuts through cold pressing of the seeds flour. Oleic acid is the major component, representing 65%–69% of the oil's total fatty acids. The applicant proposed to use the NF as an ingredient in several food categories, and as a cooking oil or added as a condiment. The Panel notes that there are no safety concerns regarding stability if the NF complies with the proposed specification limits during its entire shelflife. Taking into consideration the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The Panel considers that, based on the production process, composition of the NF, history of use of and composition of the source, no toxicological studies are required on the NF. The Panel concludes that the NF is safe under the proposed conditions of use. KEYWORDS Cyperus esculentus, isolated from or produced from a plant, novel foods, oleic acid, safety, tiger nut oil The declarations of interest of all scientific experts active in EFSA's work are available at https:// ess. efsa. europa. eu/ doi/ doiweb/ doise arch 2 of 11 | SAFETY OF TIGER NUTS (CYPERUS ESCULENTUS) OIL AS NF CONTENTS Abstract................................................................................................................................................................................................................................1 1. Introduction ..............................................................................................................................................................................................................3 1.1. Background and Terms of Reference as provided by the requestor .........................................................................................3 2. Data and Methodologies ......................................................................................................................................................................................3 2.1. Data ...................................................................................................................................................................................................................3 2.2. Methodologies..............................................................................................................................................................................................3 3. Assessment ................................................................................................................................................................................................................3 3.1. Introduction ...................................................................................................................................................................................................3 3.2. Identity of the NF .........................................................................................................................................................................................3 3.3. Production process .....................................................................................................................................................................................4 3.4. Compositional data .....................................................................................................................................................................................4 3.4.1. Stability ............................................................................................................................................................................................6 3.5. Specifications ................................................................................................................................................................................................7 3.6. History of use of the NF and/or of its source ......................................................................................................................................8 3.6.1. History of use of the source ......................................................................................................................................................8 3.6.2. History of use of the NF ..............................................................................................................................................................8 3.7. Proposed uses and use levels and anticipated intake ....................................................................................................................8 3.7.1. Target population .........................................................................................................................................................................8 3.7.2. Proposed uses and use levels ..................................................................................................................................................8 3.7.3. Anticipated intake of the NF .....................................................................................................................................................8 3.8. Absorption, distribution, metabolism and excretion (ADME) .....................................................................................................8 3.9. Nutritional information ..............................................................................................................................................................................9 3.10. Toxicological information .........................................................................................................................................................................9 3.11. Allergenicity ...................................................................................................................................................................................................9 4. Discussion...................................................................................................................................................................................................................9 5. Conclusions ................................................................................................................................................................................................................9 6. Steps taken by EFSA ................................................................................................................................................................................................9 Abbreviations ................................................................................................................................................................................................................. 10 Requestor .........................................................................................................................................................................................................................10 Question number ..........................................................................................................................................................................................................10 Panel members ..............................................................................................................................................................................................................10 References........................................................................................................................................................................................................................ 10 Appendix A .......................................................................................................................................................................................................................11 18314732, 2024, 11, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.9102 by Readcube (Labtiva Inc.), Wiley Online Library on [04/04/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License | 3 of 11 SAFETY OF TIGER NUTS (CYPERUS ESCULENTUS) OIL AS NF 1 | INTRODUCTION 1.1 | Background and Terms of Reference as provided by the requestor On 29 October 2020, the company “Tigernuts traders, S.L.” submitted a request to the European Commission in accordance with Article 10 of Regulation (EU) 2015/2283 to authorise the placing on the market of tiger nuts (Cyperus esculentus) oil as a novel food. The application requests to authorise the use of tiger nuts (Cyperus esculentus) oil in a number of foods intended for the general population. The applicant has not requested data protection under Article 26 of Regulation (EU) 2015/2283. In accordance with Article 10(3) of Regulation (EU) 2015/2283, the European Commission asks the European Food Safety Authority to provide a scientific opinion on the safety of tiger nuts (Cyperus esculentus) oil as a novel food. 2 | DATA AND METHODOLOGIES 2.1 | Data The safety assessment of this NF is based on data supplied in the application and information submitted by the applicant following EFSA's requests for supplementary information. Administrative and scientific requirements for NF applications referred to in Article 10 of Regulation (EU) 2015/2283 are listed in Commission Implementing Regulation (EU) 2017/2469.1 A common and structured format on the presentation of NF applications is described in the EFSA guidance on the preparation and presentation of a NF application (EFSA NDA Panel,2016). As indicated in this guidance, it is the duty of the applicant to provide all of the available (proprietary, confidential and published) scientific data (including both data in favour and not in favour) that are pertinent to the safety of the NF. This NF application does not include a request for the protection of proprietary data. 2.2 | Methodologies The assessment follows the methodology set out in the EFSA guidance on NF applications (EFSA NDA Panel,2016) and the principles described in the relevant existing guidance documents from the EFSA Scientific Committee. The legal provisions for the assessment are laid down in Article 11 of Regulation (EU) 2015/2283 and in Article 7 of Commission Implementing Regulation (EU) 2017/2469. This assessment concerns only the risks that might be associated with consumption of the NF under the proposed conditions of use, and is not an assessment of the efficacy of the NF with regard to any claimed benefit. 3 | ASSESSMENT 3.1 | Introduction The NF which is the subject of the application is the oil of tiger nuts (Cyperus esculentus). The main component of the oil is oleic acid, which represents 65%–69% of the oil's total fatty acids. The NF falls under the category: ‘food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by: – traditional propagating practices which have been used for food production within the Union before 15 May 1997; or – nontraditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances'. The NF is proposed by the applicant to be used as an ingredient in several food categories. 3.2 | Identity of the NF The NF is the oil produced by cold pressing the tuber of the tiger nut (C. esculentus) plant. The identity of the species has been verified through the Plant List2 as C. esculentus L. 1Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. OJ L 351, 30.12.2017, pp. 64–71. 2http:// www. thepl antli st. org/ . 18314732, 2024, 11, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.9102 by Readcube (Labtiva Inc.), Wiley Online Library on [04/04/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 4 of 11 | SAFETY OF TIGER NUTS (CYPERUS ESCULENTUS) OIL AS NF Scientific classification: •Kingdom: Plantae •Order: Poales •Family: Cuperaceae •Genus: Cyperus •Species: Cyperus esculentus L. Common names of the part of the organism referred to as the edible tuber produced by the herbaceous plant C. esculentus L. are tiger nuts, zulu nuts, yellow nut grass, yellow nutsedge, ground almond, rush nuts, earth almond or chufa. The applicant confirmed the identity through visual inspection, organoleptic and macroscopic characteristics (shape, colour, size, etc.) and morphological analysis of the physical characteristics of tiger nuts plant, such as its leaves, flowers, root and fruit (tubers). 3.3 | Production process The applicant reported that quality control checkpoints and principles of Hazard Analysis and Critical Control Point (HACCP) are applied in the production process. The raw material, tiger nuts, are cultivated and harvested manually in Niger (Africa). The tiger nuts are cleaned and then subject to a drying process by spreading the nuts in the sun until they reach a water content ≤ 11%. The tubers are arranged in layers of 10–20 cm thick. Twice a day, the dry nuts are removed and this is repeated until all nuts are sufficiently dried. Afterwards, the product is placed in bags of 80 kg and taken to the warehouses where the nuts are selected for export from Niger to the EU. Once the raw materials (tiger nuts) arrive in the applicant traders warehouse they are stored on pallets until they are processed. The tiger nuts are subsequently pasteurised and then airdried at room temperature to eliminate the remaining moisture from the product. After pasteurisation, the tiger nuts are sieved and sorted by size. The last step before milling involves an X- ray sorting step and metal detection to remove impurities. The tiger nuts are then ground within a hammer mill using a 1 mm safety mesh. The resulting flour is spread on different skimmers and consequently piled up and coldpressed to extract the tiger nut oil, resulting in a yield of 17.5%. The extracted oil is filtered to remove impurities, labelled and stored before distribution. The Panel considers that the production process is sufficiently described and does not raise safety concerns. 3.4 | Compositional data The NF is an oil composed mainly of long chain triglycerides containing mostly oleic acid. In order to confirm that the manufacturing process is reproducible and adequate to produce on a commercial scale, several data on independent NF batches with characteristics and compositional data were provided (Tables1 and 2). Upon EFSA's request, the applicant provided panisidine values for 5 additional batches and values were all < 1. TABLE 2 Batch to batch analysis of the NF (physicochemical parameters). Parameter (unit) Batch number Method of analysis#3 #7 #8 #9 #10 #11 #6 Peroxide value (meq O2/kg) 0.8 9.7 1.9 1.2 3.8 n.a. 0.7 Titrimetric Saponification value (mg KOH/g) n.a. n.a. 184 184 183 197 186 Titrimetric ISO 3657:2013 Abbreviations: ISO, International Organization for Standardization; n.a, not analysed. TABLE 1 Batch to batch analysis of the NF (proximate and compositional). Parameter Batch number Method of analysis#1 #2 #3 #4 #5 Protein (N × 6.25) % < 0.5 < 0.5 < 0.5 < 0.5 < 0.5 Internal method based on Kjeldahl method Carbohydrates % 0.0 0.0 0.1 0.0 1.3 Calculated Total fat % 100 100 99.9 100 98.7 Internal method based on extraction/ gravimetry Moisture % < 1 < 1 < 1 < 1 < 1 Internal method based on drying, gravimetric Ash % < 0.5 < 0.5 < 0.5 < 0.5 < 0.5 Internal method (incineration 550°C, gravimetric) 18314732, 2024, 11, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.9102 by Readcube (Labtiva Inc.), Wiley Online Library on [04/04/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License | 5 of 11 SAFETY OF TIGER NUTS (CYPERUS ESCULENTUS) OIL AS NF Food composition parameters are reported in Table3. Oleic acid represents 65%–69% of the oil's total fatty acids, followed by palmitic acid (12%–15%) and linoleic acid (9%– 12%) (AppendixA). Free fatty acids (FFA) were measured in 10 different batches, and results ranged from 0.42% to 2.21% of total fatty acids. The applicant also provided analysis of vitamins in the NF: vitamin A (< 10 μg/100 g), vitamin B1 (0.27 μg/100 g), vitamin B12 (< 0.1 μg/100 g), vitamin B3 (4.9 μg/100 g), vitamin C (< 0.01 μg/100 g) and vitamin E, which is the only vitamin with substantial concentration analysed in the NF (264–276 mg/kg as αtocopherol). The applicant also provided data for the phytosterol and carotenoid content in five batches. The main phytosterol class identified in the NF was 4- desmethyl sterols and its dominant component was βsitosterol. In relation to carotenoids, βcarotene was the predominant one. Contaminants and microbiological parameters Additional parameters, including contaminants (heavy metals) and microbiological quality, are reported in Tables4 and 5. TABLE 3 Batch to batch analysis of the NF (food composition parameters). Parameter (unit) Batch number Method of analysis#1 #2 #3 #4 #5 Energy (kcal/100 g) 900 900 899 900 894 Calculated Fat (g/100 g) 100 100 99.9 100 98.7 Internal method (extraction/ gravimetric) Saturated fat (g/100 g) 21.9 22.2 21.3 22.0 21.6 Internal method based on GCFID Monounsaturated fat (g/100 g) 68.2 68.8 68.6 68.5 67.2 Internal method based on GCFID Polyunsaturated fat (g/100 g) 9.69 9.01 9.95 9.26 9.56 Internal method based on GCFID Carbohydrates (g/100 g) 0.0 0.0 0.1 0.0 1.3 Calculated Of which sugars (g/100 g) < 1 < 1 < 1 < 1 < 1 Internal method based on ICPAD Protein (g/100 g) < 0.5 < 0.5 < 0.5 < 0.5 < 0.5 Internal method based on Kjeldahl method Sodium (g/100 g) < 0.005 < 0.005 0.015 < 0.005 < 0.005 Internal method based on ICPMS Abbreviations: GCFID, gas chromatography with flame ionisation detector; ICPAD, ion chromatographicpulsed amperometric detector; ICPMS, inductively coupled plasmamass spectrometry. TABLE 4 Batch to batch analysis of the NF (heavy metals). Parameter (unit) Batch number Method of analysis#17 #18 #1 #2 #19 Cadmium (mg/kg) < 0.020 < 0.020 < 0.020 < 0.020 < 0.020 Internal method based on ICPMS Lead (mg/kg) < 0.020 < 0.020 < 0.020 < 0.020 < 0.020 Internal method based on ICPMS Arsenic (mg/kg) < 0.010 < 0.010 < 0.010 < 0.010 < 0.010 Internal method based on ICPMS Mercury (mg/kg) < 0.030 < 0.030 < 0.030 < 0.030 < 0.030 Method B- HG- AMADTa Copper (mg/kg) 0.017 0.017 0.017 0.018 0.017 Internal method based on ICPMS Nickel (mg/kg) < 0.001 < 0.001 < 0.001 < 0.001 < 0.001 Internal method based on ICPMS Abbreviation: ICPMS, inductively coupled plasmamass spectrometry. aDetermination of Hg by atomic absorption spectrometry. Sample was homogenised and mineralised by acids and hydrogen peroxide prior to analysis. 18314732, 2024, 11, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.9102 by Readcube (Labtiva Inc.), Wiley Online Library on [04/04/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 6 of 11 | SAFETY OF TIGER NUTS (CYPERUS ESCULENTUS) OIL AS NF No safety concerns arise from the microbiological data or the heavy metals content in the NF. The results of analyses in five batches analysed by liquid chromatography–mass spectroscopy (LC–MS) of the NF showed that the mycotoxins analysed were below the respective limits of quantification (LOQs): ochratoxin A and individual aflatoxins B1, B2, G1, G2 < 1 μg/kg; sum of aflatoxins < 4 μg/kg; fumonisins B1, B2, zearalenone each < 25 μg/kg; deoxynivalenol < 50 μg/kg. The applicant also provided data of batches of the NF for polycyclic aromatic hydrocarbons, and dioxins. Their concentrations are below LOQs and within the EU limits established in the respective regulations3 for fats and oils and do not present safety concerns. Data of NF batches for pesticides were also provided and the results are all compliant with the applicable MRLs for tiger nuts. Information was provided on the accreditation of the laboratories that conducted the analyses presented in the application. The Panel considers that the information provided on the composition is sufficient for characterising the NF. 3.4.1 | Stability Stability in the NF The applicant performed stability tests with five independently produced batches of the NF. The tests were carried out under accelerated conditions at 40°C for a period of 3.6 months, according to the applicant equivalent to 12 months at room temperature. The applicant used a factor of 2.5 to carry out the extrapolation for real time conditions. The batches were analysed for organoleptic, physicochemical and microbiological parameters. The Panel notes that the microbiological data provided in this study is not relevant for the assessment since the accelerated conditions are not expected to promote the growth of microorganisms as in normal conditions. The results indicated that the characteristics of the product remained the same during the period. Therefore, the applicant proposes a shelflife of 12 months after packaging. Data for panisidine values provided for the 5 batches was also measured at the end of the proposed shelflife at the values remained complying with the proposed specifications (< 1). Based on the stability tests the applicant recommends storage in a dry and fresh place (10°C–18°C), protected from direct sunlight and heat. Stability of the NF under the intended conditions of use The NF is intended to be consumed as a whole food (as an alternative to other commonly consumed oils) or incorporated in several food categories. During the assessment, EFSA requested information on the stability of the NF when used as an ingredient, as well as stability studies with the pure oil in high temperature conditions. The applicant provided literature 3Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and repealing Regulation (EC) No 1881/2006. TABLE 5 Batch to batch analysis of the NF (microbiological). Parameter (unit) Batches Method of analysis#17 #18 #1 #2 #19 Aerobic mesophilic bacteria (CFU/g) < 10 < 10 < 10 < 10 < 1 ISO 4833- 1:2013 Coliform colony count (CFU/g) < 10 < 10 < 10 < 10 < 1 ISO 4832:2006 Betaglucuronidase- positive Escherichia coli (CFU/mg) < 10 < 10 < 10 < 10 < 1 Internal method based on ISO 16649 Enterobacteriaceae (CFU/g) < 10 < 10 < 10 < 10 < 1 Internal method based on ISO 21528 Yeasts and moulds (CFU/g) < 10 < 10 < 10 < 10 < 1 Internal method based on ISO 21527 Presumptive Bacillus cereus (CFU/g) < 10 < 10 < 10 < 10 < 10 Internal method based on ISO 7932:2004 Coagulase positive staphylococci (CFU/g) < 10 < 10 < 10 < 10 < 1 Internal method based on ISO 6888 Salmonella spp. in 25 g Not detected Not detected Not detected Not detected Not detected Internal method based on ISO 6579 Listeria monocytogenes in 25 g Not detected Not detected Not detected Not detected Not detected Internal method based on ISO 11290 Abbreviations: CFU, colony forming unit; ISO, International Organization for Standardization. 18314732, 2024, 11, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.9102 by Readcube (Labtiva Inc.), Wiley Online Library on [04/04/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License | 7 of 11 SAFETY OF TIGER NUTS (CYPERUS ESCULENTUS) OIL AS NF to support that tiger nuts oil is stable at high temperatures used in cooking and also provided specific stability tests of the NF under the proposed conditions of use. Three products were selected by the applicant: sponge cake, snack (cracker) and a sauce, under traditional recipes and production methods. The products were analysed for physicochemical and organoleptic parameters after production, and after 2–3 weeks of storage. Sponge cake and snack were stored at room temperature, whereas the sauce was stored refrigerated. The results demonstrated that changes were observed in the texture of the sauce and sponge cake after 2 weeks. According to the applicant those changes could be due to the packaging and storage conditions. In relation to the physicochemical characteristics, no major changes were found (peroxide value measured after 2 weeks, panisidine values reported after 3 weeks). Only in the sponge cake, the anisidine value increased to 15 at the end of the study. In addition, the applicant was requested to provide stability data under cooking conditions comparing the NF with olive oil, since the NF is proposed to replace cooking oils. The applicant provided a study in which three samples of the NF and three samples of olive oil (control) were subjected to frying at 180°C for 20 min and organoleptic, physicochemical and oxidation parameters were evaluated. All measured parameters remained within acceptable ranges after frying, indicating that the NF stability and quality were preserved under the tested conditions. The Panel considers that the data provided sufficient information with respect to the stability of the NF. 3.5 | Specifications The specifications of the NF are indicated in Table6. The Panel considers that the information provided on the specifications of the NF is sufficient and does not raise safety concerns. TABLE 6 Specifications for the NF. Description: The NF is obtained from a coldpressing process of tiger nuts Source: Cyperus esculentus Parameter Specification Fatty acid composition Palmitic acid 12%–15% Stearic acid 5%–8% Oleic acid 65%–69% Linoleic acid 9%–12% Heavy metals Lead ≤ 0.1 mg/kg Cadmium ≤ 0.1 mg/kg Mycotoxins Aflatoxins total (Σ B1,B2, G1,G2) < 4 μg/kg Aflatoxin B1 < 1 μg/kg Ochratoxin A < 3 μg/kg Microbiological TAMC ≤ 103 CFU/g TYMC ≤ 102 CFU/g Coliforms ≤ 10 CFU/g Salmonella Not detected in 25 g Listeria monocytogenes Not detected in 25 g Enterobacteriaceae < 102 CFU/g Acidity ≤ 2% Peroxide value ≤ 20 meq/kg Saponification value ≤ 189 panisidine < 1 Abbreviations: CFU, colony forming units; TAMC, total aerobic microbial count; TYMC, total yeast and mould count. 18314732, 2024, 11, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.9102 by Readcube (Labtiva Inc.), Wiley Online Library on [04/04/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License 8 of 11 | SAFETY OF TIGER NUTS (CYPERUS ESCULENTUS) OIL AS NF 3.6 | History of use of the NF and/or of its source 3.6.1 | History of use of the source The source of the NF, tiger nuts (C. esculentus) is a tuber, eaten raw, roasted, dried or used to prepare beverages (Gambo & Da'u,2014). It is cultivated and widely consumed in Africa, North and South America, Australia, parts of Europe, particularly Spain, as well as in the Arabian Peninsula (Mohdaly,2019). 3.6.2 | History of use of the NF The NF is marketed in the United States (Mintel's Global New Products Database query for 2015). 3.7 | Proposed uses and use levels and anticipated intake 3.7.1 | Target population The target population proposed by the applicant is the general population. 3.7.2 | Proposed uses and use levels The NF is proposed by the applicant to be used as an ingredient in several food products, and as a cooking oil or added as a condiment. These food products and the maximum use levels are reported in Table7. In relation to the use of the NF in the proposed uses (Table7), the applicant confirmed that the NF is not subjected to any hydrogenation or refining process for its application in the proposed foods. The NF is proposed to be used under the same conditions as other vegetable oils currently used in or to prepare the proposed foods. 3.7.3 | Anticipated intake of the NF Considering that no hazard has been identified taking into account the production process, composition, specifications and proposed uses of the NF, the Panel considers that intake estimates are not needed for this assessment. 3.8 | Absorption, distribution, metabolism and excretion (ADME) No ADME studies with the NF were submitted. The applicant indicated that the NF consists of mainly fatty acids and no specific ADME studies would be required. The Panel concurs and considers that no further ADME testing is necessary for the safety assessment of the NF. TABLE 7 Food categories and maximum use levels intended by the applicant. Food category Max use level (mL NF/100 g) As a replacement of other oils (used for cooking or added as a condiment) 100 Pasta and similar products 30 Bread and similar products 30 Snacks other than chips and similar (crackers) 30 Salad dressing 50 Margarines and similar 80 Various pastry 30 Cream and cream products 60 18314732, 2024, 11, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.9102 by Readcube (Labtiva Inc.), Wiley Online Library on [04/04/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License | 9 of 11 SAFETY OF TIGER NUTS (CYPERUS ESCULENTUS) OIL AS NF 3.9 | Nutritional information The NF is mainly composed of lipids (99%–100%). The applicant provided results from proximate composition, fatty acid profile, vitamins and sodium in the NF. The Panel considers that, taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. 3.10 | Toxicological information No toxicological studies with the NF were provided. Taking into account the production process, composition of the NF and the history of safe use of its source, C. esculentus, which contains between 20% and 45% lipids w/w (Edo etal.,2024; Zhang etal.,1996), the Panel considers that no toxicological studies are required on the NF. 3.11 | Allergenicity The applicant provided a proximate analysis of the NF, which indicates that proteins were below the LOQ (0.5 g/100 g) in the batch to batch analysis (Section3.4 Compositional data). Tiger nut allergy seems to be rare, with no data available on its prevalence (Galindo Bonilla etal.,2002; Gonzalez de Olano etal.,2013). A case of occupational hypersensitivity pneumonitis in a patient exposed to tiger nuts dust has been described (Barranco etal.,1999). The Panel notes that individuals sensitised to respiratory allergens usually are able to ingest the corresponding allergen without acquiring clinical symptoms of food allergy (Armentia etal.,2009; Cullinan & Newman Taylor,1997; Poulsen,2004). The Panel considers that the NF is unlikely to trigger allergic reactions in the general population or subgroups thereof under the proposed conditions of use. 4 | DISCUSSION The NF which is the subject of the application is the oil of tiger nuts (C. esculentus L.). Tiger nuts are widely consumed in different regions including the EU, with demonstrated history of consumption. The production of the NF from tiger nuts involves cold pressing, which is a commonly used process to obtain oils. The NF is an oil in which oleic acid represents 65%–69% of total fatty acids, followed by palmitic acid (12%–15%) and linoleic acid (9%–12%). The Panel considers that the information provided on the production process and composition is sufficient and does not raise safety concerns. The Panel notes that there are no safety concerns regarding stability if the NF complies with the proposed specification limits during its entire shelflife. The applicant intends to market the NF as an ingredient in a number of food products and/or as an alternative oil for cooking. The target population proposed by the applicant is the general population. No exposure assessment was carried out considering the NF characterisation and the proposed conditions of use. Toxicological tests with the NF were not performed. However, based on the source of the NF and its history of use, the production process and the composition of the NF, the Panel considers that there are no concerns with regard to the toxicity of the NF. 5 | CONCLUSIONS The Panel concludes that the NF, tiger nuts oil, is safe under the proposed conditions of use. 6 | STEPS TAKEN BY EFSA 1. On 08/11/2022 EFSA received a letter from the European Commission with the request for a scientific opinion on the safety of tiger nuts (Cyperus esculentus) oil as a novel food Ref. Ares(2022)7703252. 2. On 08/11/2022, a valid application on the safety of tiger nuts (Cyperus esculentus) oil as a novel food, which was submitted by “Tigernuts traders, S.L”, was made available to EFSA by the European Commission through the Commission esubmission portal (NF 2020/1746) and the scientific evaluation procedure was initiated. 3. On 11/05/2023, 27/07/2023, 20/09/2023, 12/10/2023, 31/10/2023, 01/12/2023, 12/01/2024, 06/02/2024, 23/05/2024 and 19/08/2024 EFSA requested the applicant to provide additional information or clarifications to accompany the application and the scientific evaluation was suspended. 4. On 07/10/2024, complete additional information was provided by the applicant through the Commission esubmission portal and the scientific evaluation was restarted. 5. During its meeting on 30/10/2024, the NDA Panel, having evaluated the data, adopted a scientific opinion on the safety of tiger nuts (Cyperus esculentus) oil as a NF pursuant to Regulation (EU) 2015/2283. 18314732, 2024, 11, Downloaded from https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2024.9102 by Readcube (Labtiva Inc.), Wiley Online Library on [04/04/2025]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License