822 results on '"Heinonen, Marina"'
Search Results
2. Processing improves physical and oxidative stability of cricket protein emulsions
- Author
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Han, Xiaocui and Heinonen, Marina
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- 2022
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3. Faba bean protein: A promising plant-based emulsifier for improving physical and oxidative stabilities of oil-in-water emulsions
- Author
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Liu, Chang, Pei, Ruisong, and Heinonen, Marina
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- 2022
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4. Safety of Acheta domesticus powder as a Novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Maradona, Miguel Prieto, and Neuhäuser‐Berthold, Monika
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CRICKETS (Insect) ,DIETARY fats ,ALLERGIES ,FOOD safety ,POLLUTANTS - 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 Acheta (A.) domesticus powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The main components of the NF are protein, fat and dietary fibre (chitin). The Panel notes that the concentration of contaminants in the NF depends on the occurrence levels of these substances in the insect feed. The Panel further notes that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf‐life. The NF has a high protein content, although the true protein content is overestimated when using the nitrogen‐to‐protein conversion factor of 6.25 due to the presence of non‐protein nitrogen from chitin. The applicant proposed to use the NF as food ingredient in a number of food products. The target population proposed by the applicant is the general population. Considering the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The panel notes that no safety concerns arise from the toxicological information of A. domesticus. The panel considers that the consumption of the NF might trigger primary sensitisation to A. domesticus proteins and may cause allergic reactions in subjects allergic to crustaceans, mites and molluscs. Additionally, allergens from the feed may end up in the NF. The panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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5. Addressing the inter‐individual variation in response to consumption of plant food bioactives: Towards a better understanding of their role in healthy aging and cardiometabolic risk reduction
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Manach, Claudine, Milenkovic, Dragan, Wiele, Tom, Rodriguez‐Mateos, Ana, Roos, Baukje, Garcia‐Conesa, Maria Teresa, Landberg, Rikard, Gibney, Eileen R, Heinonen, Marina, Tomás‐Barberán, Francisco, and Morand, Christine
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Biomedical and Clinical Sciences ,Nutrition and Dietetics ,Nutrition ,Obesity ,Prevention ,3.3 Nutrition and chemoprevention ,Prevention of disease and conditions ,and promotion of well-being ,Oral and gastrointestinal ,Stroke ,Metabolic and endocrine ,Cardiovascular ,Good Health and Well Being ,Cardiovascular Diseases ,Diet ,Diet ,Healthy ,Health Behavior ,Healthy Aging ,Humans ,Metabolic Diseases ,Phytochemicals ,Plants ,Edible ,Randomized Controlled Trials as Topic ,Risk Factors ,Risk Reduction Behavior ,Bioavailability and metabolism ,Biological responsiveness ,Cardiometabolic health ,Inter-individual variation ,Plant food bioactives ,Food Sciences ,Public Health and Health Services ,Food Science ,Nutrition & Dietetics ,Food sciences ,Nutrition and dietetics - Abstract
Bioactive compounds in plant-based foods have health properties that contribute to the prevention of age-related chronic diseases, particularly cardiometabolic disorders. Conclusive proof and understanding of these benefits in humans is essential in order to provide effective dietary recommendations but, so far, the evidence obtained from human intervention trials is limited and contradictory. This is partly due to differences between individuals in the absorption, distribution, metabolism and excretion of bioactive compounds, as well as to heterogeneity in their biological response regarding cardiometabolic health outcomes. Identifying the main factors underlying inter-individual differences, as well as developing new and innovative methodologies to account for such variability constitute an overarching goal to ultimately optimize the beneficial health effects of plant food bioactives for each and every one of us. In this respect, this position paper from the COST Action FA1403-POSITIVe examines the main factors likely to affect the individual responses to consumption of plant food bioactives and presents perspectives for assessment and consideration of inter-individual variability.
- Published
- 2017
6. Safety of vitamin D2 mushroom powder as a Novel food pursuant to Regulation (EU) 2015/2283 (NF 2020/2226).
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, and Neuhäuser‐Berthold, Monika
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ERGOCALCIFEROL ,DIETARY supplements ,VITAMIN D ,VITAMINS ,CULTIVATED mushroom - 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 vitamin D2 mushroom powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced from Agaricus bisporus mushroom powder that has been exposed to ultraviolet (UV) irradiation to induce the conversion of provitamin D2 (ergosterol) to vitamin D2 (ergocalciferol). The NF contains concentrations of vitamin D in the form of vitamin D2 in the range of 245–460 μg/g. The information provided on the production process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF as an ingredient in a variety of foods and beverages in amounts that result in either 1.2 or 2.4 μg vitamin D2 per 100 g or 100 mL of the food as consumed. The applicant also intends to add the NF in food supplements at a maximum of 15 μg vitamin D2/day for individuals above 1 year of age, as well as in foods for special medical purposes (FSMPs). The estimates for combined intake of vitamin D from the NF, the background diet and fortified foods, were below the ULs for vitamin D as established previously by the NDA Panel for children, adolescents and adults, i.e. 50 and 100 μg/day. The estimated combined vitamin D intake in infants (6–12 months) is also below the UL for vitamin D of 35 μg/day. 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 for the proposed target population. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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7. Assembling of the interfacial layer affects the physical and oxidative stability of faba bean protein-stabilized oil-in-water emulsions with chitosan
- Author
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Liu, Chang, Pei, Ruisong, Peltonen, Leena, and Heinonen, Marina
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- 2020
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8. List of Contributors
- Author
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Amaya-Farfan, Jaime, primary, Batista, Ângela Giovana, additional, Bicas, Juliano L., additional, Carle, Reinhold, additional, Chao, Chen, additional, Ertbjerg, Per, additional, Gloria, Maria Beatriz Abreu, additional, Godoy, Helena Teixeira, additional, Gürbüz, Göker, additional, Heinonen, Marina, additional, Kong, Fanbin, additional, Liu, Lingling, additional, Liu, Xia, additional, Lund, Daryl B., additional, Maróstica, Mário Roberto, additional, Masson, Lilia, additional, Mercer, Donald G., additional, Ren, Fei, additional, Rodriguez-Amaya, Delia B., additional, Shahidi, Fereidoon, additional, Silva-Maia, Juliana Kelly da, additional, and Wang, Shujun, additional
- Published
- 2021
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9. Oxidation of proteins
- Author
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Heinonen, Marina, primary, Gürbüz, Göker, additional, and Ertbjerg, Per, additional
- Published
- 2021
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10. Safety of magnesium l‐threonate as a novel food pursuant to regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, and Neuhäuser‐Berthold, Monika
- Subjects
MAGNESIUM ,OXALIC acid ,BIOAVAILABILITY ,DIETARY supplements ,CHEMICAL synthesis - 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 magnesium l‐threonate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC. The NF, produced by chemical synthesis, is intended to be used as new source for magnesium in food supplements at a maximum intake level of 3000 mg per day by adults, except for pregnant and lactating women. This dose corresponds to ~ 2730 mg l‐threonate and 250 mg magnesium, which also corresponds to the UL for supplemental magnesium from readily dissociable magnesium salts. Based on results obtained from a dissociation study, two rat studies and one human trial, the Panel considers that magnesium is bioavailable from the NF. The NF may contain up to 1% oxalic acid. The Panel considers that an additional exposure to oxalic acid, that is up to 30 mg daily from the NF, is not to be of safety concern. The Panel concludes that the NF is not nutritionally disadvantageous. In 2008, the EFSA ANS Panel concluded that a human intake of l‐threonate of 2700 mg per day is safe. This intake is similar to the maximum intake of l‐threonate from the NF under the maximum proposed uses, and the NDA Panel concurs with the ANS Panel that this intake is safe. The Panel considers that there are no concerns regarding the genotoxicity of the NF. The Panel concludes that the NF, Mg l‐threonate, is safe under the proposed conditions of use. The Panel concludes that the NF is a source from which magnesium is bioavailable. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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11. Safety of ashitaba sap as a Novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, and Neuhäuser‐Berthold, Monika
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DIETARY supplements ,ANGELICA (Plants) ,PLACE marketing ,BODY weight ,CHALCONES - 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 ashitaba sap as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Ashitaba sap is collected from harvested stems of Angelica keiskei plants. The principal constituents of the sap with regard to the safety assessment are chalcones (1%–2.25%) and furanocoumarins (< 0.01%). The applicant proposed to use the NF in food supplements at a maximum dose of 780 mg per day. The target population is adults excluding pregnant and lactating women. Taking into consideration the composition of the NF and the proposed uses, the composition of the NF is not nutritionally disadvantageous. There are no concerns regarding genotoxicity of the NF. Based on a 90‐day oral toxicity study performed with the product as intended to be placed on the market (30% ashitaba sap powder and 70% cyclodextrins), the Panel establishes a safe dose of 0.5 mg/kg body weight (bw) per day for the product as it is intended to be placed on the market. For the target population, i.e. adults, this safe dose corresponds to 35 mg per day of the product as it is intended to be placed on the market and 137 mg per day of the NF, which is lower than the use level proposed by the applicant. The Panel concludes that the NF is safe for the target population at intake levels up to 137 mg per day. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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12. Extension of use of isomalto‐oligosaccharide as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, and Neuhäuser‐Berthold, Monika
- Subjects
DIETARY supplements ,MANUFACTURING processes ,DISACCHARIDES ,POLYMERIZATION ,OLIGOMERS - 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 extension of use of isomalto‐oligosaccharide (IMO) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of glucose oligomers with degrees of polymerisation of 3–9, along with various amounts of mono‐ and disaccharides. The NF comes in both syrup and powder form. The applicant intends to extend the current uses of the NF as an ingredient in several foods, and use the NF in food supplements aimed at the general population older than 10 years of age. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. Along with literature data, the applicant carried out a tolerability study in adult volunteers with the NF at doses up to 120 g/day. The Panel concludes that this study provides reassurance that the NF is tolerable at doses of 120 g/day. Conservative intake estimates resulting from the use of the NF as an ingredient according to the currently authorised uses and new proposed uses result in a highest intake estimate in adolescents of 112 g/day at the 95th percentile, and reach 142 g/day in adolescents when the use as a food supplement is included. The Panel notes this amount is higher than the dose of 120 g/day for which tolerability has been demonstrated. However, considering the source, compositional characterisation, production process and nature of the NF, as well as the available nutritional and toxicological data on the NF, the Panel considers that the NF does not present safety concerns under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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13. Safety of HelixComplex snail mucus (HSM) as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, and Neuhäuser‐Berthold, Monika
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MUCUS ,DIETARY supplements - 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 HelixComplex Snail Mucus (HSM) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of snail mucus collected from Helix aspersa maxima and is proposed to be used by adults as a food supplement. The data provided by the applicant about the composition and stability of the NF together with the report of the subchronic toxicity study were overall considered unsatisfactory. The Panel noted inconsistencies in the reporting of the certificates of analysis and of the data on the subchronic toxicity provided by the applicant. Owing to these deficiencies, the Panel cannot establish a safe intake level of the NF. The Panel concludes that the safety of the NF has not been established. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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14. Safety of isomaltulose syrup (dried) as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, and Neuhäuser‐Berthold, Monika
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SYRUPS ,MANUFACTURING processes ,DISACCHARIDES ,SUCROSE ,SAFETY - 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 isomaltulose syrup (dried) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of a mixture of mono‐ and disaccharides in powder form, mainly composed of isomaltulose (≥ 75%) and trehalulose (< 13%). The applicant intends to use the NF as a replacement for sucrose already on the market. The information provided on the manufacturing process, composition and specifications of the NF is sufficient and does not raise safety concerns. No absorption, distribution, metabolism and excretion (ADME) or toxicological data were provided for the NF. Instead, the safety of the NF was assessed based on literature data available on isomaltulose and mixtures of isomaltulose and trehalulose. In addition, considering the nature, compositional characterisation and production process of the NF, the Panel considered that such data were sufficient to conclude that the NF is as safe as sucrose. [ABSTRACT FROM AUTHOR]
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- 2024
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15. Aronia (Aronia melanocarpa) phenolics bioavailability in a combined in vitro digestion/Caco-2 cell model is structure and colon region dependent
- Author
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Wu, Ting, Grootaert, Charlotte, Voorspoels, Stefan, Jacobs, Griet, Pitart, Judit, Kamiloglu, Senem, Possemiers, Sam, Heinonen, Marina, Kardum, Nevena, Glibetic, Maria, Smagghe, Guy, Raes, Katleen, and Van Camp, John
- Published
- 2017
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16. Safety of oil from Schizochytrium sp. (strain CABIO‐A‐2) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Prieto Maradona, Miguel
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INFANT formulas ,DOCOSAHEXAENOIC acid ,PETROLEUM ,FATTY acids ,MANUFACTURING processes ,MARINE parks & reserves ,MARINE natural products - 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 Schizochytrium sp. (strain CABIO‐A‐2) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. S. sp. is a single‐cell microalga. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 38%–44% of fatty acids. The applicant proposed to use the NF in infant formulae (IF) and follow‐on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. The evidence provided demonstrated that the strain S. sp. CABIO‐A‐2 is phylogenetically closely related to the strain S. sp. ATCC 20888. The assessment of some already authorised S. sp. oils in the Union list were also based on similarities with the strain ATCC 20888. The applicant provided a 90‐day repeated dose toxicity study in rats with the NF. No adverse effects were observed up to the highest dose tested, i.e. 10.2 g/kg body weight (bw) per day. Taking into account the toxicity studies performed with the NF and with DHA‐oils derived from strains belonging to the genus Schizochytrium, its phylogenetical profile, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers that there are no concerns with regard to the toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
17. Safety of oil from Schizochytrium limacinum (strain TKD‐1) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Prieto Maradona, Miguel
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INFANT formulas ,DOCOSAHEXAENOIC acid ,MARINE natural products ,FATTY acids ,MANUFACTURING processes ,BASE oils ,TOXINS ,MARINE parks & reserves - 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 Schizochytrium sp. (TKD‐1) oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Schizochytrium sp. is a single‐cell microalga. The strain TKD‐1, used by the applicant (ATK Biotech Co. Ltd.), belongs to the species Schizochytrium limacinum. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 53%–61% of fatty acids. The applicant proposed to use the NF in infant formulae (IF) and follow‐on formulae (FOF). The use levels proposed by the applicant were derived from Regulation (EU) 2016/127, which states the mandatory addition of DHA to IF and FOF at the level of 20–50 mg/100 kcal. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only'. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from Schizochytrium sp., the QPS status of the source of the NF, the production process, the composition of the NF and the absence of marine biotoxins and viable cells in the NF, the Panel considers there are no concerns with regard to toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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18. Safety of lacto‐N‐fucopentaose I/2'‐fucosyllactose (LNFP‐I/2'‐FL) mixture as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, and Marchelli, Rosangela
- Subjects
ESCHERICHIA coli ,WEIGHT in infancy ,BREAST milk ,DIETARY supplements ,BABY foods - 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 lacto‐N‐fucopentaose I (LNFP‐I)/2′‐fucosyllactose (2'‐FL) mixture as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharides (HiMO) LNFP‐I and 2'‐FL, but it also contains d‐lactose, lacto‐N‐tetraose, difucosyllactose, 3‐fucosyllactose, LNFP‐I fructose isomer, 2′‐fucosyl‐d‐lactulose, l‐fucose and 2′‐fucosyl‐d‐lactitol, and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain (Escherichia coli K‐12 DH1 MDO MP2173b) of E. coli K‐12 DH1 (DSM 4235). The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF in a variety of foods, including infant formula (IF) and follow‐on formula, foods for infants and toddlers, foods for special medical purposes and food supplements (FS). The target population is the general population. The anticipated daily intake of LNFP‐I from use in IF is similar to the estimated natural mean highest daily intake in breastfed infants. Overall, the anticipated daily intake of LNFP‐I from the NF as a food ingredient at the maximum proposed use levels is unlikely to exceed the intake level of breastfed infants on a body weight basis. The intake in breastfed infants on a body weight basis is expected to be safe also for other population groups. The anticipated 2'‐FL intake is generally rather low. The use of the NF in FS is not intended if other foods with added NF components or human milk (for infants and young children) are consumed on the same day. The Panel concludes that the NF, a mixture of LNFP‐I and 2'‐FL, is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
19. Safety of monosodium salt of l‐5‐methyltetrahydrofolic acid as a novel food pursuant to Regulation (EU) 2015/2283 and the bioavailability of folate from this source in the context of Directive 2002/46/EC, Regulation (EU) No 609/2013 and Regulation (EC) No 1925/2006
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Maradona, Miguel Prieto, and Marchelli, Rosangela
- Subjects
FOLIC acid ,BIOAVAILABILITY ,SALT ,CHEMICAL synthesis ,AGE groups - 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 monosodium salt of l‐5‐methyltetrahydrofolic acid (5‐MTHF) as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of folate from this source in the context of Directive 2002/46/EC, Regulation (EU) No 609/2013 and Regulation (EC) No 1925/2006. The NF is produced by chemical synthesis and consists of at least 95% (w/w) of 5‐MTHF and 4%–5% (w/w) of sodium. It is proposed to be used as a partial or complete substitute to folic acid and other sources of added folate in a number of food categories. The production process, composition, specifications and stability of the NF do not raise safety concerns. When used as an ingredient in different food matrices, proper processing/storage conditions need to be considered to preserve the stability of the NF. Regarding bioavailability, the Panel considers that the NF readily dissociates into Na and l‐methylfolate ions, which subsequently are absorbed and enter the circulation. Thus, the bioavailability of 5‐MTHF from the NF is comparable to that of other currently authorised salts of 5‐MTHF. The Panel considers that the consumption of the NF is not nutritionally disadvantageous as long as the combined intake of the NF and the other supplemental forms of folate under their authorised conditions of use is below the ULs established for the different age groups of the general population. The Panel concludes that the NF is safe under the proposed conditions of use. The Panel also concludes that the NF is a source from which folate is bioavailable. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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- View/download PDF
20. Safety of an extension of use of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, and Marchelli, Rosangela
- Subjects
BIOMASS ,YEAST ,SAFETY ,ALLERGENS ,NUTRITION - 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 an extension of use of Yarrowia (Y.) lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension of use pertains to the use of the NF as a food ingredient in a number of food categories, in foods for special medical purposes and in foods for total diet replacement for weight control. In 2018, Y. lipolytica was attributed the qualified presumption of safety (QPS) status for production purposes, including food and feed products based on biomass. The Panel considers that the data provided sufficient information with respect to the stability of the NF, also when used as a food ingredient. The concentrations of the analysed processing contaminants do not raise safety concerns. The Panel also considers that consumption of the NF is not nutritionally disadvantageous under the proposed conditions of use. The Panel concludes that the NF, Y. lipolytica yeast biomass, is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
21. Safety of the extension of use of 2′‐fucosyllactose (2′‐FL) as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, and Marchelli, Rosangela
- Subjects
INFANT formulas ,BREAST milk ,INFANTS ,SAFETY ,NUTRITION ,MILK yield - 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 the extension of use of 2′‐fucosyllactose (2′‐FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is already authorised as ingredient in several food categories, including infant formula (IF) and follow‐on formula (FOF). The applicant proposed to increase the maximum use levels of the NF in IF and FOF. EFSA estimated the anticipated daily intake of the NF from the proposed extension of use, including the already authorised conditions of use in other food categories. Additionally, a new intake estimate limited to the already authorised conditions of use of the NF was carried out following EFSA's current approach. The estimated daily intake of the NF from high consumption of IF alone at the proposed maximum use level in infants < 16 weeks of age is similar to the estimated natural highest mean daily intake of 2′‐FL from human milk in breastfed infants. The estimated highest P95 daily intakes of the NF from the proposed extension of use in IF and FOF (including the authorised uses in other food categories) and from the already authorised conditions of use, are comparable and both higher than the estimated natural highest mean daily intake of 2′‐FL from human milk in infants and to a lesser extent in young children. The Panel considers that the proposed extension of use of the NF in IF and FOF only marginally affects the highest P95 daily intake estimate from the authorised conditions of use, and therefore does not affect the safety of the NF. The Panel concludes that the NF, 2′‐FL, is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
22. Safety of 2′‐fucosyllactose (2'‐FL) produced by a derivative strain (Escherichia coli SGR5) of E. coli W (ATCC 9637) as a Novel Food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, and Marchelli, Rosangela
- Subjects
ESCHERICHIA coli ,BREAST milk ,DIETARY supplements ,DATABASES ,MANUFACTURING processes - 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 2′‐fucosyllactose (2'‐FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) 2'‐FL, but it also contains d‐lactose, l‐fucose, fucosylgalactose, difucosyllactose, d‐glucose and d‐galactose, and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain (Escherichia coli SGR5) of E. coli W (ATCC 9637). The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant applies for the same use and use levels as already authorised for 2'‐FL and included in the Union list of NFs, with the general population as target population. The Panel noted that the available intake estimate is not recent (2015) and based on a different database (2008–2010 UK data) than that used by EFSA. For this reason, the Panel decided to perform a new intake estimate according to the current EFSA approach. The Panel notes that the highest P95 daily intake of the NF from the use as food ingredient is higher than the estimated natural highest mean daily intake in breastfed infants and marginally higher in young children. The applicant also proposes to extend the use of 2'‐FL in food supplements (FS) for infants at the use level of 1.2 g/day. The resulting estimated intake in infants from the proposed use in FS is within the natural intake of 2'‐FL in breastfed infants. FS are not intended to be used if other foods with added 2'‐FL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
23. Safety of a change in specifications of the novel food oleoresin from Haematococcus pluvialis containing astaxanthin pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Marchelli, Rosangela
- Subjects
ASTAXANTHIN ,DIETARY supplements ,ISOMERIZATION ,ATTITUDE change (Psychology) ,ISOMERS - 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 a change of specifications of the novel food (NF) oleoresin from Haematococcus pluvialis containing astaxanthin (ATX) pursuant to Regulation (EU) 2015/2283. The NF is already authorised as ingredient for the use in food supplements as defined in Directive 2002/46EC in accordance to Regulation (EU) 2017/2470. The NF concerns an oleoresin which contains ~ 10% ATX, obtained by supercritical CO2 extraction of the homogenised and dried biomass of cultivated H. pluvialis. This NF has been assessed by the Panel in 2014. With the present dossier, the applicant proposed to lower the minimum specification limits for protein and ATX monoesters for the NF, and to increase the maximum specification limit for the relative amount of ATX diesters in total ATX. An increase of the maximum specification limit for the 9‐cis isomer is also applied for. Although the data are limited regarding bioavailability and distribution in humans of these three naturally occurring ATX isomers, the available in vitro and in vivo data suggest that the 13‐cis rather than the 9‐cis ATX is selectively absorbed, i.e. has a higher bioavailability and/or possibly emerges from isomerisation of all‐trans ATX. The Panel notes that the toxicity of the individual ATX isomers has not been studied individually. However, the ADI of 0.2 mg/kg, which was established for synthetic ATX and ATX from H. pluvialis, applies also for ATX in the oleoresin from H. pluvialis with the proposed changes of specifications. The Panel concludes that the NF, oleoresin from H. pluvialis containing ATX, is safe with the proposed specification limits. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
24. Oxidative and physical stability of oil-in-water emulsions prepared with quinoa and amaranth proteins
- Author
-
Gürbüz, Göker, Kauntola, Vilja, Ramos Diaz, Jose Martin, Jouppila, Kirsi, and Heinonen, Marina
- Published
- 2018
- Full Text
- View/download PDF
25. Hybrid Sausages Using Pork and Cricket Flour: Texture and Oxidative Storage Stability
- Author
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Han, Xiaocui, primary, Li, Binbin, additional, Puolanne, Eero, additional, and Heinonen, Marina, additional
- Published
- 2023
- Full Text
- View/download PDF
26. Safety of whole seeds of oilseed rape (Brassica napus L emend. Metzg.) as a novel food pursuant to Regulation (EU) 2015/2283
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhauser-Berthold, Monika, Poulsen, Morten, Maradona, Miguel Prieto, Schlatter, Josef Rudolf, van Loveren, Henk, Dumont, Antonio Fernandez, and Knutsen, Helle Katrine
- Subjects
Agriculture and Food Sciences ,safety ,ALLERGENS ,oilseed rape ,Veterinary (miscellaneous) ,PROTEIN ,TURNIP RAPE ,CHILDREN ,rapeseed ,novel foods ,Brassica ,Plant Science ,Microbiology ,SENSITIZATION ,RATS ,SPROUTS ,ACID ,Medicine and Health Sciences ,MYROSINASES ,Animal Science and Zoology ,Parasitology ,Food Science - 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 whole seeds of oilseed rape as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF consists of seeds of oilseed rape, in particular double low white flowering varieties of Brassica napus (oilseed rape Brassica napus L. emend. Metzg). The NF's oilseed rape is produced following drying, cleaning and storage procedures traditionally used for oilseed rape in oil production. The NF is proposed to be used as an ingredient in 'Bread and rolls with special ingredients added' and 'Gluten free bread'. The target population is the general population. The highest daily intake of the NF was estimated for young children as 92.6 mg/kg body weight (bw) per day. The Panel notes that intakes of the NF can result in considerably increased levels of glucosinolates consumption as compared to intakes of glucosinolates from background diets. The Panel asked the applicant for additional studies to support the safety of the NF, but these were not provided. The Panel concludes that the safety of whole seeds of oilseed rape under the proposed conditions of use has not been established.
- Published
- 2023
27. Safety of 3′‐sialyllactose (3′‐SL) sodium salt produced by a derivative strain (Escherichia coli NEO3) of E. coli W (ATCC 9637) as a Novel Food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, and Neuhäuser‐Berthold, Monika
- Subjects
ESCHERICHIA coli ,SODIUM salts ,DIETARY supplements ,INFANT formulas ,SIALIC acids ,INFANTS - 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 3′‐sialyllactose (3′‐SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) 3′‐SL (sodium salt), but it also contains sialic acid, d‐glucose, d‐lactose, 3′‐sialyllactulose and 6′‐sialyllactose sodium salts and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain (Escherichia coli NEO3) of E. coli W (ATCC 9637). The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow‐on formula, food for special medical purposes and food supplements (FS). The target population is the general population. The applicant applies for the same uses and use levels as already assessed for 3′‐SL sodium salt produced by a genetically modified strain of E. coli K‐12 DH1, with the exception for the use in FS, which is proposed to be higher (from 0.5 to 1.0 g/day) in individuals from 3 years of age. Since the NF as a food ingredient would be consumed at the same extent as the already assessed 3′‐SL sodium salt, no new estimates of the intakes have been carried out. The Panel notes that the maximum daily intake of 3′‐SL from the proposed use of the NF in FS for individuals from 3 years of age (1.0 g/day) is lower than the estimated highest mean daily intake of 3′‐SL in breastfed infants. FS are not intended to be used if other sources of 3′‐SL are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
28. Safety of partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Aguilera‐Gómez, Margarita, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Prieto Maradona, Miguel
- Subjects
BARLEY ,RICE ,DIETARY proteins ,BAKED products ,DAIRY products ,RICE farming ,PADDY fields ,RICE oil - 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 partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced by enzymatically treating the pasteurised spent barley and rice residues of the mash step of beer production. Several mechanical treatment steps of the partial hydrolysate are employed to obtain the final product. The NF consists mainly of partially‐hydrolysed proteins from spent barley and rice and it is in powdered form. The Panel notes that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf life of 15 months. The NF is proposed to be used as an ingredient in various foods such as dairy products, bakery products, pasta, fruit and vegetable spreads, snacks, and single meal replacements for weight reduction. The target population is the general population. Considering protein quality aspects, the Panel concludes that the NF is not a suitable protein source for the nutrition of infants. The Panel notes that, considering the composition of the NF, the proposed conditions of use and that the NF will not be the sole source of dietary protein, the consumption of the NF is not nutritionally disadvantageous. Taking into account the production process, the extensive compositional characterisation of the NF and the history of use of the source the Panel considers that no toxicological studies are required on the NF. Moreover, the Panel considers that the NF has the potential capacity to sensitise individuals and to induce allergic reactions in individuals allergic to barley and rice. With the exception of possible allergenicity, the Panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
29. Safety of an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Marchelli, Rosangela
- Subjects
PHAEODACTYLUM tricornutum ,BIOMASS ,POISONS ,DIETARY supplements ,MANUFACTURING processes ,VEGETABLE oils - 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 an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an ethanolic extract of the dried biomass of the microalga P. tricornutum diluted in a medium‐chain triglyceride oil carrier, with standardised fucoxanthin and tocopherol content. The main component of the NF is fat (78% on average), followed by crude protein (10% on average). The Panel is of the view that a consistent and safe production process has not been demonstrated. Additionally, the Panel considers that the information provided on the composition of the NF is not complete and may raise safety concerns. The applicant proposed to use the NF as a food supplement at the use level of 437 mg/day, with the target population being adults, excluding pregnant and breastfeeding women. There is no history of use of the NF or of its source, i.e. P. tricornutum. The Panel notes that the source of the NF, P. tricornutum, was not granted the qualified presumption of safety (QPS) status by the EFSA Panel on Biological Hazards (BIOHAZ), due to the lack of a safe history of use in the food chain and on its potential for production of bioactive compounds with toxic effects. There were no concerns regarding genotoxicity of the NF. In the 90‐day study provided, a number of adverse effects were observed, some of them seen already at the lowest dose tested (750 mg/kg body weight (bw) day), which was identified by the Panel as the lowest‐observed‐adverse‐effect‐level (LOAEL). The potential phototoxicity of pheophorbide A and pyropheophorbide A in the NF was not addressed in this study. Although noting the uncertainties identified by the Panel regarding the analytical determination of these substances in the NF and the limitations in the publicly available toxicity data, a low margin of exposure (MoE) was calculated for these substances at the proposed use levels. The Panel concludes that the safety of the NF under the proposed uses and use levels has not been established. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
30. Safety of apple fruit cell culture biomass as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, and Poulsen, Morten
- Subjects
FRUIT culture ,CELL culture ,BIOMASS ,ORGANIC acids ,ORCHARDS ,DIETARY supplements ,SYNTHETIC lubricants - 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 an apple fruit cell culture biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and intended as an ingredient for food supplements in adults. The cells have been sourced from the callus grown on a piece of apple placed on a solid medium under sterile conditions. The de‐differentiated apple cells are then cultivated in liquid medium. The medium contains sucrose, vitamins, minerals, trace elements and the two synthetic plant hormone analogues, benzylaminopurine (< 0.1 mg/kg) and 2,4‐dichlorophenoxyacetic acid (< 0.25 mg/kg). These plant hormones are regulated under the EU pesticide legislation and their residue levels in the NF are in compliance with the EU maximum residue levels. The main components of the NF are carbohydrates (including sugars and non‐digestible carbohydrates), ash, proteins and smaller amounts of fatty acids and organic acids. Except for the amount of total fat and the organic acids (succinic and l‐malic acid), the quantities of the compositional parameters of the NF and apple have little in common. The Panel considers that a provided subchronic toxicity study was not needed to establish the safety of this NF, when taking into account the source of the NF, i.e. apples, the production process, the low intended use level and the composition of the NF, despite the noted differences to apple. The Panel considers that the NF contains proteins, which were not detected in apple and which may be allergenic. The Panel concludes that the NF, an apple fruit cell culture biomass, is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
31. LC–MS investigations on interactions between isolated β-lactoglobulin peptides and lipid oxidation product malondialdehyde
- Author
-
Gürbüz, Göker and Heinonen, Marina
- Published
- 2015
- Full Text
- View/download PDF
32. Safety of 6′‐sialyllactose (6’‐SL) sodium salt produced by derivative strains of Escherichia coli BL21 (DE3) as a novel food pursuant to Regulation (EU) 2015/2283
- Author
-
Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhauser-Berthold, Monika, Poulsen, Morten, Maradona, Miguel Prieto, Schlatter, Josef Rudolf, van Loveren, Henk, Colombo, Paolo, Fernandez, Estefania Noriega, Knutsen, Helle Katrine, and Nutr Novel Foods Food A, EFSA Panel
- Subjects
Agriculture and Food Sciences ,safety ,6’-SL sodium salt ,6′-sialyllactose ,HiMO ,HMO ,human milk oligosaccharide ,novel food ,HUMAN-MILK OLIGOSACCHARIDES ,Veterinary (miscellaneous) ,INFANTS ,PREBIOTICS ,Plant Science ,BIFIDOBACTERIA ,Microbiology ,REVEALS ,FORMULA ,GUT MICROBIOTA ,6'-SL sodium salt ,PROBIOTICS ,Chemistry ,Animal Science and Zoology ,Parasitology ,6'-sialyllactose ,PRECIPITATE ,LACTOSE ,Food Science - 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 6'-sialyllactose (6'-SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 6'-SL, but it also contains d-lactose, 6'-sialyllactulose, sialic acid, N-acetyl-d-glucosamine and a small fraction of other related oligosaccharides. The NF is produced by fermentation with two genetically modified strains of Escherichia coli BL21 (DE3), the production strain and the optional degradation strain. The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow-on formula, food for special medical purposes and food supplements. The target population is the general population. In some scenarios at the maximum use levels, the estimated intakes per kg body weight were higher than the high average natural intake of 6'-SL from human milk. However, given the intrinsic nature of human milk oligosaccharides (HMOs), the wide range of intakes from human milk, and considering that infants are naturally exposed to similar amounts of these substances, the Panel considers that the consumption of the NF at the proposed conditions of use does not raise safety concerns. The intake of 6'-SL in breastfed infants on a body weight basis is also expected to be safe for other population groups. The intake of other carbohydrate-type compounds structurally related to 6'-SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added 6'-SL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. (C) 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
- Published
- 2022
33. Safety of Lemna minor and Lemna gibba whole plant material as a novel food pursuant to Regulation (EU) 2015/2283
- Author
-
Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J. J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Maradona, Miguel Prieto, Marchelli, Rosangela, Neuhauser-Berthold, Monika, Poulsen, Morten, Schlatter, Josef Rudolf, van Loveren, Henk, Kouloura, Eirini, Knutsen, Helle Katrine, and Nutr Novel Foods Food, EFSA Panel
- Subjects
Agriculture and Food Sciences ,Veterinary (miscellaneous) ,Biology and Life Sciences ,plant ,Plant Science ,Microbiology ,Lemna gibba ,Lemna minor ,water lentils ,ELEMENTS ,novel food ,Animal Science and Zoology ,Parasitology ,WOLFFIA-ARRHIZA ,DUCKWEED ,Food Science - 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 Lemna minor and Lemna gibba whole plant material as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Lemna minor and Lemna gibba are aquatic plants commonly named water lentils. The NF is produced by cultivation of Lemna minor and Lemna gibba plants, washing with water and heat treatment. The main constituents of the NF are water, protein and fibre. 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 intended to be used as a vegetable, similar to other leafy vegetables. The target population is the general population. The Panel considers that, with the exception of concerns related to the manganese intake, taking into account the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The Panel considers that the risk that the consumption of the NF may trigger allergic reactions in humans is low. The Panel concludes that the NF, in consideration of its proposed uses and the concentration of manganese as compared to the normally present concentration of manganese in other leafy vegetables, may be of safety concern, therefore, the safety of the NF cannot currently be established.
- Published
- 2022
34. Safety of cellobiose as a novel food pursuant to regulation (EU) 2015/2283
- Author
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EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, Dominique, Heinonen, Marina, Department of Food and Nutrition, Helsinki One Health (HOH), and Food Quality & Safety
- Subjects
Cellobiose ,416 Food Science ,Novel foods ,Food supplement - Published
- 2022
35. Safety of an aqueous ethanolic extract of Labisia pumila as a novel food pursuant to Regulation (EU) 2015/2283
- Author
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EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, Dominique, Heinonen, Marina, Department of Food and Nutrition, Helsinki One Health (HOH), and Food Quality & Safety
- Subjects
416 Food Science ,Food supplement ,Safety ,Novel food ,aqueous ethanolic extract of Labisia pumila - Published
- 2022
36. Safety of beta-hydroxybutyrate salts as a novel food pursuant to Regulation (EU) 2015/2283
- Author
-
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, Dominique, Heinonen, Marina, Department of Food and Nutrition, Helsinki One Health (HOH), and Food Quality & Safety
- Subjects
Beta-hydroxybutyrate ,416 Food Science ,Food supplements ,Sodium ,Calcium ,Magnesium ,Chemical synthesis ,Novel food - Published
- 2022
37. Statement on safety of cannabidiol as a novel food: data gaps and uncertainties
- Author
-
Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhaeuser-Berthold, Monika, Poulsen, Morten, Maradona, Miguel Prieto, Schlatter, Josef Rudolf, Trezza, Viviana, van Loveren, Henk, Albert, Oceane, Dumas, Celine, Germini, Andrea, Gelbmann, Wolfgang, Kass, Georges, Kouloura, Eirini, Fernandez, Estefania Noriega, Rossi, Annamaria, Knutsen, Helle Katrine, Nutr Novel Foods Food, EFSA Panel, Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, Mcardle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thoma, Heinonen, Marina, Marchelli, Rosangela, Neuhäuser-Berthold, Monika, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, Trezza, Viviana, van Loveren, Henk, Albert, Océane, Dumas, Céline, Germini, Andrea, Gelbmann, Wolfgang, Kass, George, Kouloura, Eirini, Noriega Fernandez, Estefania, Rossi, Annamaria, and Knutsen, Helle Katrine
- Subjects
Agriculture and Food Sciences ,safety ,Veterinary (miscellaneous) ,REPRODUCTIVE FUNCTIONS ,data gaps ,Cannabidiol ,Novel Food ,Plant Science ,IMPAIRMENTS ,CANNABINOID EXPOSURE ,Microbiology ,ENDOCANNABINOID SYSTEM ,RECEPTOR AGONISTS ,EXPOSURE INFLUENCES NEUROENDOCRINE ,DOUBLE-BLIND ,data gap ,Medicine and Health Sciences ,Animal Science and Zoology ,Parasitology ,SEIZURES ,MOTOR ,MALE-MICE ,Food Science ,ORAL CANNABIDIOL - Abstract
The European Commission has determined that cannabidiol (CBD) can be considered as a novel food (NF), and currently, 19 applications are under assessment at EFSA. While assessing these, it has become clear that there are knowledge gaps that need to be addressed before a conclusion on the safety of CBD can be reached. Consequently, EFSA has issued this statement, summarising the state of knowledge on the safety of CBD consumption and highlighting areas where more data are needed. Literature searches for both animal and human studies have been conducted to identify safety concerns. Many human studies have been carried out with Epidyolex(R), a CBD drug authorised to treat refractory epilepsies. In the context of medical conditions, adverse effects are tolerated if the benefit outweighs the adverse effect. This is, however, not acceptable when considering CBD as a NF. Furthermore, most of the human data referred to in the CBD applications investigated the efficacy of Epidyolex (or CBD) at therapeutic doses. No NOAEL could be identified from these studies. Given the complexity and importance of CBD receptors and pathways, interactions need to be taken into account when considering CBD as a NF. The effects on drug metabolism need to be clarified. Toxicokinetics in different matrices, the half-life and accumulation need to be examined. The effect of CBD on liver, gastrointestinal tract, endocrine system, nervous system and on psychological function needs to be clarified. Studies in animals show significant reproductive toxicity, and the extent to which this occurs in humans generally and in women of child-bearing age specifically needs to be assessed. Considering the significant uncertainties and data gaps, the Panel concludes that the safety of CBD as a NF cannot currently be established.
- Published
- 2022
38. Safety of iron milk proteinate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of iron from this source in the context of Directive 2002/46/EC
- Author
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EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, Dominique, Heinonen, Marina, Department of Food and Nutrition, Helsinki One Health (HOH), and Food Quality & Safety
- Subjects
Bioavailability ,416 Food Science ,Iron milk proteinate ,Iron ,Nutrient source ,Safety ,Novel food - Published
- 2022
39. Safety of an extension of use of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283
- Author
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EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, Dominique, Heinonen, Marina, Department of Food and Nutrition, Helsinki One Health (HOH), and Food Quality & Safety
- Subjects
Yarrowia lipolytica ,Single meal replacement ,416 Food Science ,Novel foods ,Extension of use ,Safety ,Yeast - Published
- 2022
40. Safety of frozen and freeze-dried formulations of the lesser mealworm (Alphitobius diaperinus larva) as a Novel food pursuant to Regulation (EU) 2015/2283
- Author
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EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, Dominique, Heinonen, Marina, Department of Food and Nutrition, Helsinki One Health (HOH), and Food Quality & Safety
- Subjects
Alphitobius diaperinus larva ,416 Food Science ,Novel foods ,Entomophagy ,Food supplement ,Insect powder ,Lesser mealworm ,Food safety - Published
- 2022
41. Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain of Escherichia coli K‐12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Prieto Maradona, Miguel
- Subjects
ESCHERICHIA coli ,BREAST milk ,WEIGHT in infancy ,DIETARY supplements ,INFANT formulas ,MILK yield - 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 3‐fucosyllactose (3‐FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) 3‐FL, but it also contains d‐lactose, l‐fucose, 3‐fucosyllactulose and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain (Escherichia coli K‐12 DH1 MDO MAP1834) of E. coli K‐12 DH1 (DSM 4235). The information provided on the manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow‐on formula, food for special medical purposes and food supplements (FS). The target population is the general population. The anticipated daily intake of 3‐FL from both proposed and combined (authorised and proposed) uses at their respective maximum use levels in all population categories does not exceed the highest intake level of 3‐FL from human milk in infants on a body weight basis. The intake of 3‐FL in breastfed infants on a body weight basis is expected to be safe also for other population groups. The intake of other carbohydrate‐type compounds structurally related to 3‐FL is also considered of no safety concern. FS are not intended to be used if other foods with added 3‐FL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
42. Safety of 6′‐sialyllactose (6′‐SL) sodium salt produced by a derivative strain (Escherichia coli NEO6) of E. coli W (ATCC 9637) as a Novel Food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Prieto Maradona, Miguel
- Subjects
ESCHERICHIA coli ,SODIUM salts ,BREAST milk ,DIETARY supplements ,INFANT formulas - 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 6′‐sialyllactose (6′‐SL) sodium salt as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human‐identical milk oligosaccharide (HiMO) 6′‐SL (sodium salt), but it also contains sialic acid, d‐glucose, d‐lactose, 6′‐sialyllactulose sodium salt, 3′‐sialyllactose (3′‐SL) sodium salt and a small fraction of other related saccharides. The NF is produced by fermentation by a genetically modified strain (Escherichia coli NEO6) of E. coli W (ATCC 9637). The information provided on the identity, manufacturing process, composition and specifications of the NF does not raise safety concerns. The applicant intends to add the NF to a variety of foods, including infant formula and follow‐on formula, food for special medical purposes and food supplements (FS). The target population is the general population. The applicant applies for the same uses and use levels already assessed for 6′‐SL sodium salt produced by fermentation by a genetically modified strain of E. coli K‐12 DH1. Therefore, since the NF would be consumed at the same extent as the already assessed 6′‐SL sodium salt, no new estimates of the intake have been carried out. Similarly, FS are not intended to be used if other foods with added 6′‐SL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
43. Safety of UV‐treated powder of whole yellow mealworm (Tenebrio molitor larva) as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Marchelli, Rosangela
- Subjects
TENEBRIO molitor ,DIETARY proteins ,LARVAE ,POWDERS ,CHOLECALCIFEROL - 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 UV‐treated powder of whole yellow mealworm (Tenebrio molitor larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term yellow mealworm refers to the larval form of the insect species T. molitor. The NF is the UV‐treated powder of the whole, thermally dried yellow mealworm. The NF consists mainly of crude protein, fat, digestible carbohydrates and fibre (chitin). The Panel notes that the levels of contaminants in the NF highly depend on the occurrence levels of these substances in the insect feed. The Panel notes furthermore that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf life. The NF has a high protein content, although the true protein content in the NF is overestimated when using the nitrogen‐to‐protein conversion factor of 6.25, due to the presence of non‐protein nitrogen. The applicant proposed to use the NF as an ingredient in various food products, such as bakery products, pasta, compotes of fruit/vegetables and cheese. The target population is the general population. The Panel notes that considering the composition of the NF, the proposed conditions of use and that the NF will not be the sole source of dietary protein, the consumption of the NF is not nutritionally disadvantageous. Despite the UV treatment, the Panel notes that the NF is not a significant dietary contributor of vitamin D3. The submitted toxicity studies from the literature did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to yellow mealworm proteins and may cause allergic reactions in subjects with allergies to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. With the exception of possible allergenicity, the Panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
44. Safety of paramylon as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Prieto Maradona, Miguel
- Subjects
EUGLENA gracilis ,MICROBIAL products ,BETA-glucans ,DIETARY supplements ,MANUFACTURING processes - 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 paramylon as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Paramylon is a linear, unbranched beta‐1,3‐ᴅ‐glucan polymer that is isolated from the single‐cell microalga Euglena gracilis. The NF consists of at least 95% beta‐glucan and minor amounts of protein, fat, ash and moisture. The applicant proposed to use the NF in food supplements, as a food ingredient added to a number of food categories and in foods for total diet replacement for weight control. In 2019, E. gracilis was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only', which includes food products based on microbial biomass of the microalga. Based on the information provided, E. gracilis is not expected to survive the manufacturing process. The submitted toxicity studies did not raise safety concerns. No adverse effects were observed in the subchronic toxicity studies, up to the highest dose tested, i.e. 5,000 mg NF/kg body weight per day. In view of the QPS status of the source of the NF, supported by the manufacturing process, compositional data and lack of toxicity observed in the toxicity studies, the Panel has no safety concerns and concludes that the NF, i.e. paramylon, is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
45. Safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Marchelli, Rosangela
- Subjects
FRUIT extracts ,FOOD additives ,BARS (Desserts) ,DIETARY supplements ,LYCOPENE - 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 yellow/orange tomato extract used as a novel food (NF) pursuant to Regulation (EU) 2283/2015. The NF which is the subject of the application is a carotenoid‐rich extract from the yellow/orange tomato containing predominantly phytoene and phytofluene, as well as a lesser amount of beta‐carotene, zeta‐carotene and lycopene. The NF is produced from the tomato pulp using supercritical CO2 extraction. The applicant proposes the use of the NF in cereal bars, functional drinks and as a food supplement in individuals above 15 years of age. For the use of the NF in cereal bars and functional drinks, the Panel considers, the target population is the general population. According to EFSA's latest exposure assessment for lycopene as a food additive (EFSA ANS Panel, 2017), the highest P95 intakes for children (< 10 and 10–17 years) and adults when combined to the use of lycopene as a food colour from natural occurrence would exceed the established acceptable daily intake (ADI) for lycopene (0.5 mg/kg body weight (bw) day). The estimated intakes of the NF would lead to an exceedance of the ADI when considering natural occurrence and exposure to lycopene when used as a food additive. Due to the absence of safety data regarding phytoene and phytofluene intake from the NF, and the contribution of the NF to the estimated high daily intakes of lycopene, the Panel considers that it cannot be established whether or not the consumption of the NF is nutritionally disadvantageous. The Panel concludes that the safety of the NF has not been established under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
46. Safety of the extension of use of partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
-
Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Marchelli, Rosangela
- Subjects
CHIA ,SALVIA ,POWDERS ,SEEDS ,MANUFACTURING processes ,AGRICULTURAL economics ,POWDER coating - 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 the extension of use of partially defatted chia seed (Salvia hispanica L.) powder with a high fibre content as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is already authorised and included in the Union list of NFs and is produced according to the same production process. This application is limited to an assessment of the extension of use of the NF as a food ingredient in several food categories with a high moisture content that are subject to thermal processing. The target population for the extension of use is the general population. The information provided on the formation of process contaminants (acrylamide, furan and methylfurans) in a selected food category with added NF (bread) subjected to heat treatment is sufficient for this assessment and does not raise safety concerns. Noting that no safety concerns were identified from the information available on the production process, composition, specifications and proposed uses of the NF, the Panel considers that intake estimates for the NF are not needed for this assessment. The Panel concludes that the NF, partially defatted chia seeds powder with a high fibre content, is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
47. Safety of water lentil protein concentrate from a mixture of Lemna gibba and Lemna minor as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
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Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Pelaez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, and Prieto Maradona, Miguel
- Subjects
LEMNA minor ,LENTILS ,AQUATIC sports safety measures ,DIETARY supplements ,SPRAY drying - 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 water lentil protein concentrate from a mixture of Lemna gibba and Lemna minor as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Water lentil protein concentrate is produced from two water lentil species (L. gibba and L. minor) by separation of the protein fraction of the plant material from fibres, followed by pasteurisation and spray drying. The NF consists mainly of protein, fibre, fat and ash. The applicant proposed to use the NF as a food ingredient in a variety of food categories and as a food supplement. The target population is the general population when used as a food ingredient and exclusively adults when used as a food supplement. 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. There are no concerns regarding genotoxicity of the NF. The Panel considers that the risk of the NF triggering allergic reactions is low. The Panel concludes that the NF, water lentil protein concentrate from a mixture of L. gibba and L. minor, is safe under the proposed conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
48. Safety of freeze-dried mycelia of Antrodia camphorata as a novel food pursuant to regulation (EU) 2015/2283
- Author
-
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, Dominique, Heinonen, Marina, Department of Food and Nutrition, Helsinki One Health (HOH), and Food Quality & Safety
- Subjects
Antrodia camphorata ,416 Food Science ,Taiwanofungus camphoratus ,Novel foods ,Food supplement ,Safety - Published
- 2022
49. Safety of zinc l-carnosine as a Novel food pursuant to Regulation (EU) 2015/2283 and the bioavailability of zinc from this source in the context of Directive 2002/46/EC on food supplements
- Author
-
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, Dominique, Heinonen, Marina, Department of Food and Nutrition, Helsinki One Health (HOH), and Food Quality & Safety
- Subjects
Novel Foods ,Zinc ,Bioavailability ,416 Food Science ,Food supplement ,Nutrient source ,Zinc l-carnosine ,Safety - Published
- 2022
50. Statement on safety of cannabidiol as a novel food : data gaps and uncertainties
- Author
-
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Turck, Dominique, Heinonen, Marina, Department of Food and Nutrition, Helsinki One Health (HOH), and Food Quality & Safety
- Subjects
Novel Food ,416 Food Science ,Data gaps ,Cannabidiol ,Safety - Published
- 2022
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