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Safety of water lentil powder from Lemnaceae as a Novel Food pursuant to Regulation (EU) 2015/2283 النص الكامل
2021
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) | Dominique Turck | Torsten Bohn | Jacqueline Castenmiller | Stefaan De Henauw | Karen Ildico Hirsch‐Ernst | Alexandre Maciuk | Inge Mangelsdorf | Harry J McArdle | Androniki Naska | Carmen Pelaez | Kristina Pentieva | Alfonso Siani | Frank Thies | Sophia Tsabouri | Marco Vinceti | Francesco Cubadda | Thomas Frenzel | Marina Heinonen | Miguel Prieto Maradona | Rosangela Marchelli | Monika Neuhäuser‐Berthold | Morten Poulsen | Josef Rudolf Schlatter | Henk van Loveren | Eirini Kouloura | Hans Steinkellner | Helle Katrine Knutsen
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 water lentil powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Water lentils refer to aquatic plants belonging to the Araceae family and represented by five genera (Lemna, Wolffia, Wolffiella, Landoltia and Spirodela). The NF is thermally washed and dried water lentils, which are produced as a polyculture crop consisting of species from the Lemna genus (70–100%) and the Wolffia genus (0–30%). The main constituents of the NF are protein, fibre and fat. The Panel notes that the concentration of trace elements and contaminants in the NF is highly dependent on the conditions of cultivation of the plant and the fertiliser composition. The NF is expected to be stable and to comply with the specifications during the suggested shelf life. The NF is intended for human consumption as a food ingredient in herbs, spices and seasonings, sauces, soups and broths, protein products, dietary food for weight control and as a food supplement. The target population is the general population, except for food supplements which are exclusively intended for consumption by adults. The Panel considers that based on the composition of the NF and the proposed intended uses, the NF is not nutritionally disadvantageous, except for the concerns regarding intake of manganese from the NF. No adverse effect was observed in the submitted 90‐day subchronic study, at the highest dose, 1,000 mg/kg body weight (bw) per day of NF. The Panel considers that, based on the protein concentration, the consumption of the NF may trigger allergic reactions. The Panel concluded that an increase in manganese intake from the NF used as food ingredient or food supplements is of safety concern and the safety of the NF cannot be established.
اظهر المزيد [+] اقل [-]Safety of hot water extract of fruits and peduncles of Hovenia dulcis as a novel food pursuant to Regulation 1(EU) 2015/2283 النص الكامل
2020
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) | Dominique Turck | Jacqueline Castenmiller | Stefaan De Henauw | Karen Ildico Hirsch‐Ernst | John Kearney | Alexandre Maciuk | Inge Mangelsdorf | Harry J McArdle | Androniki Naska | Carmen Pelaez | Kristina Pentieva | Alfonso Siani | Frank Thies | Sophia Tsabouri | Marco Vinceti | Francesco Cubadda | Thomas Frenzel | Marina Heinonen | Rosangela Marchelli | Monika Neuhäuser‐Berthold | Morten Poulsen | Josef Rudolf Schlatter | Henk van Loveren | Wolfgang Gelbmann | Helle Katrine Knutsen
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 ‘Hovenia dulcis fruit extract’ as a novel food (NF) for its use in food supplements. The NF concerns a hot water extract of sliced and dried fruits and peduncles of Hovenia dulcis Thun. The production process is described in sufficient detail but contains contradictory information regarding the mixing with another ingredient of the NF. The NF is comprised of mostly carbohydrates (about 90%), about 2% proteins, 5% moisture, less than 1% fat and about 2% ash. In addition, the NF contains small amounts of flavonoids such as dihydromyricetin, myricetin and quercetin. The Panel notes limitations of the data provided from the batch testing regarding proximate analyses and plant secondary metabolites. Given these limitations, the Panel considers that the data provided by the applicant do not demonstrate that different batches produced with the described production process meet the proposed specifications. The target population is the general adult population excluding pregnant and lactating women and people with a chronic disease, such as liver malfunction. Limited information was provided on a history of consumption of Hovenia dulcis fruits and on an extract approved in South Korea. A number of toxicological studies were performed. However, the study reports did not allow to verify that the test item was representative of the NF. The same applied to a human study provided by the applicant. The Panel concludes that the safety of the NF has not been established.
اظهر المزيد [+] اقل [-]