576 results on '"Poulsen, Morten"'
Search Results
2. PrehospitaL Ultrasound in Undifferentiated DyspnEa (PreLUDE): a prospective, clinical, observational study
- Author
-
Gundersen, Elise Arem, Juhl-Olsen, Peter, Bach, Allan, Rostgaard-Knudsen, Martin, Nielsen, Bent Roni Ranghøj, Skaarup, Søren Helbo, Petersen, Henrik Ømark, Fjølner, Jesper, Poulsen, Morten Gustav Gerstrøm, and Bøtker, Morten Thingemann
- Published
- 2023
- Full Text
- View/download PDF
3. Evaluating the health impact of increased linseed consumption in the Danish population
- Author
-
Outzen, Malene, Thomsen, Sofie Theresa, Andersen, Rikke, Jakobsen, Lea Sletting, Jakobsen, Marianne Uhre, Nauta, Maarten, Ravn-Haren, Gitte, Sloth, Jens Jørgen, Pilegaard, Kirsten, and Poulsen, Morten
- Published
- 2024
- Full Text
- View/download PDF
4. (Dys)functionality of intentions or outcomes? Performance funding of Danish schools
- Author
-
Poulsen, Morten Lund, Bukh, Per Nikolaj, and Christensen, Karina Skovvang
- Published
- 2023
- Full Text
- View/download PDF
5. Performance Funding: Exam Results, Stakes, and Washback in Danish Schools
- Author
-
Bukh, Per Nikolaj, Christensen, Karina Skovvang, and Poulsen, Morten Lund
- Abstract
High-stakes testing is meant to create a positive washback effect on student learning. Performance funding can raise stakes. However, it is not often used, and its washback is uncertain. The purpose of this paper is to examine performance-funding programs based on students' exam results. We study principals' perceptions and interpretations of how this influenced stakes and washback effects of the exit exams. For that purpose, we selected four schools based on theoretical sampling criteria. The empirical data comprise semi-structured interviews with management over the 2-year program and documents describing the performance-funding program. The findings indicate that implementing performance funding increases stakes and has washback effects, but that stakes depend partly on the principal's choices. Although the consequences were unintended, the program and its effects were mostly perceived as positive. The paper shows how unintended consequences call for careful consideration of the pros and cons of accountability systems when high-stakes test-based funding mechanisms are introduced.
- Published
- 2022
- Full Text
- View/download PDF
6. Risk-benefit assessment
- Author
-
Hoekstra, Jeljer, primary, Nauta, Maarten, additional, and Poulsen, Morten, additional
- Published
- 2023
- Full Text
- View/download PDF
7. List of contributors
- Author
-
Adkin, Amie, primary, Allen, Timothy E.H., additional, Almeida, Felipe Alves de, additional, Anelich, Lucia E., additional, Arnold, Mark, additional, Auger, Sandrine, additional, Avermaete, Tessa, additional, Baker-Austin, Craig, additional, Bayer, Forrest L., additional, Bhilegaonkar, Kiran N., additional, Bi, Xiaoyu, additional, Blom, W. Marty, additional, Boobis, Alan R., additional, Boskovic, Marija, additional, Bouwmeester, Hans, additional, Bowering, Gary, additional, Boziaris, Ioannis S., additional, Breen, Christopher J., additional, Brouwer, Hugo, additional, Brown, Ian, additional, Buchanan, Robert L., additional, Buys, Elna M., additional, Caldwell, Jane M., additional, Canellas, Elena, additional, Carneiro, Deisy Guimarães, additional, Carstensen, Karin, additional, Cervantes-Huamán, Brayan R.H., additional, Clemens, Roger, additional, Cocolin, Luca, additional, Cohen, Samuel M., additional, Coles, David, additional, Cossettini, Alessia, additional, Cruz-Martins, Natália, additional, Csikó, György, additional, Danyluk, Michelle, additional, Darwish, Wageh Sobhy, additional, De Coninck, Barbara, additional, Mireles DeWitt, Christina A., additional, Dlamini, B.C., additional, Doe, John, additional, Douglas Kelly, Simon, additional, Dupouy, Eleonora, additional, Eisenbrand, Gerhard, additional, Elegbeleye, James A., additional, Estévez, Pablo, additional, Franco-Duarte, Ricardo, additional, Freitas, Leonardo Luiz de, additional, French, Nigel, additional, Frewer, Lynn J., additional, Fu, Yuqi, additional, Fukushima, Shoji, additional, Gago-Martinez, Ana, additional, Garcia, Alejandro Dorado, additional, Gendel, Steven M., additional, Gerardi, Anne, additional, Ghosh, Anuradha, additional, Glisic, Milica, additional, Godefroy, Samuel Benrejeb, additional, Gooderham, Nigel J., additional, Govers, Gerard, additional, Grenda, Tomasz, additional, Guengerich, F. Peter, additional, Guillou, Sandrine, additional, Gutsell, Steve, additional, Guyard-Nicodème, Muriel, additional, Haddad, Nabila, additional, Haindongo, Ndaindila N.K., additional, Harman, Christie L., additional, Hartung, Thomas, additional, Hayes, A. Wallace, additional, Head, Graham, additional, Hecht, Stephen S., additional, Hoekstra, Jeljer, additional, Hoffman, Louwrens, additional, Honnay, Olivier, additional, Houben, Geert, additional, Jetten, Jan, additional, Jin, Shan, additional, Job, Karen, additional, Kadam, Snehal, additional, Karanth, Shraddha, additional, Karmaus, Agnes, additional, Karvounis, Manos, additional, Kasuga, Fumiko, additional, Kaushik, Karishma S., additional, Kennedy, Marc C., additional, Keogh, John G., additional, Keulemans, Wannes, additional, Khan, Nida, additional, Knowles, Michael E., additional, Kogiannou, Dimitra, additional, Kolesnyk, Serhii, additional, Kolhe, Rahul P., additional, Konold, Timm, additional, Kotsiri, Zoi, additional, Krug, Matt, additional, Kwiatek, Krzysztof, additional, Kwon, Youngjoo, additional, Latronico, Francesca, additional, Leao, José M., additional, LeJeune, Jeffrey T., additional, Li, Wenjing, additional, Linman, Matthew J., additional, López-García, Rebeca, additional, Luechtefeld, Thomas, additional, Magnuson, Bernadene, additional, Manning, Louise, additional, Manouselis, Nikos, additional, Manzano, Marisa, additional, Marin, Marco, additional, Mariotti, María Salomé, additional, Martinez-Urtaza, Jaime, additional, McMullen, Lynn M., additional, McNamara, Cronan, additional, Medina, Angel, additional, Mehlomakulu, N.N., additional, Mehta, Jyotigna M., additional, Meijerink, Marjolein, additional, Miller, J. David, additional, Clare Mills, E.N., additional, Mitchell, Stephen C., additional, Moretto, Angelo, additional, Mugadza, Desmond T., additional, Mukherjee, Keya, additional, Naab, Francis Z., additional, Naegeli, Hanspeter, additional, Nascimento, Maristela S., additional, Nastasijevic, Ivan, additional, Nauta, Maarten, additional, Neretin, Lev, additional, Nerín, Cristina, additional, Ntuli, Victor, additional, Olson, Elena G., additional, O’Brien, John, additional, Painuli, Sakshi, additional, Panteleli, Efstratia, additional, Papakonstantinou, Mihalis, additional, Parlapani, Foteini F., additional, Patyra, Ewelina, additional, Pedreschi, Franco, additional, Pigat, Sandrine, additional, Popping, Bert, additional, Poulsen, Morten, additional, Pradhan, Abani K., additional, Pressman, Peter, additional, Prodanchuk, Mykola, additional, Przeniosło-Siwczyńska, Monika, additional, Punt, Ans, additional, Ramel, Alfons, additional, Rejeb, Abderahman, additional, Rich, Katherine, additional, Ricke, Steven C., additional, Rietjens, Ivonne M.C.M., additional, Rigos, George, additional, Ripolles-Avila, Carolina, additional, Rizzotto, Francesco, additional, Rodrigues, Célia Fortuna, additional, Rodríguez-Jerez, José Juan, additional, Rose, Martin, additional, Rosol, Thomas J., additional, Saha, Joyjit, additional, Savidge, Tor, additional, Seifu, Eyassu, additional, Semwal, Prabhakar, additional, Sibanda, Thulani, additional, So, Sik Yu, additional, Socolovsky, Susana, additional, Stoitsis, Giannis, additional, Stull, Katelynn, additional, Taniwaki, Marta H., additional, Taylor, Sean V., additional, Thompson, Lesa A., additional, Topalcengiz, Zeynal, additional, Tzotzos, George T., additional, van den Honert, Michaela, additional, Van Oijen, Femke L.N., additional, Vanetti, Maria Cristina Dantas, additional, Vantarakis, Apostolos, additional, Vera, Paula, additional, Vidic, Jasmina, additional, Vizzini, Priya, additional, Waring, Rosemary H., additional, Wu, Qinglong, additional, Zaid-Kaylani, Khaldoon, additional, and Zwart, Tjitske Anna, additional
- Published
- 2023
- Full Text
- View/download PDF
8. På vej mod en museumsreform
- Author
-
Bukh, Per, primary, Skovvang Christensen, Karina, additional, Lund Poulsen, Morten, additional, and Sandalgaard, Niels, additional
- Published
- 2024
- Full Text
- View/download PDF
9. A systematic review of the nutrient composition, microbiological and toxicological profile of Acheta domesticus (house cricket)
- Author
-
Ververis, Ermolaos, Boué, Géraldine, Poulsen, Morten, Pires, Sara Monteiro, Niforou, Aikaterini, Thomsen, Sofie Theresa, Tesson, Vincent, Federighi, Michel, and Naska, Androniki
- Published
- 2022
- Full Text
- View/download PDF
10. The light in the dark: In-situ biorefinement of crude oil to hydrogen using typical oil reservoir Thermotoga strains
- Author
-
Veshareh, Moein Jahanbani, Poulsen, Morten, Nick, Hamidreza M., Feilberg, Karen L., Eftekhari, Ali A., and Dopffel, Nicole
- Published
- 2022
- Full Text
- View/download PDF
11. Guidance on risk–benefit assessment of foods.
- Author
-
More, Simon John, Benford, Diane, Hougaard Bennekou, Susanne, Bampidis, Vasileios, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández‐Jerez, Antonio F., Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Mullins, Ewen, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Naska, Androniki, Poulsen, Morten, Ranta, Jukka, Sand, Salomon, and Wallace, Heather
- Subjects
CONSUMER behavior ,FOOD safety ,ADVICE ,PROBABILITY theory ,HAZARDS - Abstract
The EFSA Scientific Committee has updated its 2010 Guidance on risk–benefit assessment (RBA) of foods. The update addresses methodological developments and regulatory needs. While it retains the stepwise RBA approach, it provides additional methods for complex assessments, such as multiple chemical hazards and all relevant health effects impacting different population subgroups. The updated guidance includes approaches for systematic identification, prioritisation and selection of hazardous and beneficial food components. It also offers updates relevant to characterising adverse and beneficial effects, such as measures of effect size and dose–response modelling. The guidance expands options for characterising risks and benefits, incorporating variability, uncertainty, severity categorisation and ranking of different (beneficial or adverse) effects. The impact of different types of health effects is assessed qualitatively or quantitatively, depending on the problem formulation, scope of the RBA question and data availability. The integration of risks and benefits often involves value‐based judgements and should ideally be performed with the risk–benefit manager. Metrics such as Disability‐Adjusted Life Years (DALYs) and Quality‐Adjusted Life Years (QALYs) can be used. Additional approaches are presented, such as probability of all relevant effects and/or effects of given severities and their integration using severity weight functions. The update includes practical guidance on reporting results, interpreting outcomes and communicating the outcome of an RBA, considering consumer perspectives and responses to advice. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF
12. ASK US.
- Author
-
Poulsen, Morten Kjerside and Alminde, Esben Jes Schouboe
- Published
- 2024
13. The Disease Burden of Dietary Exposure to Inorganic Arsenic in Denmark, 2018
- Author
-
Jakobsen, Lea S., Fabricius, Freja A., Nissen, Janna, Christensen, Tue, Andersen, Rikke, Poulsen, Morten, and Pires, Sara M.
- Published
- 2020
- Full Text
- View/download PDF
14. A proteomic-based approach to study underlying molecular responses of the small intestine of Wistar rats to genetically modified corn (MON810)
- Author
-
AL-Harbi, Asmaa, Lary, Sahira, Edwards, Martin G., Qusti, Safaa, Cockburn, Andrew, Poulsen, Morten, and Gatehouse, Angharad M. R.
- Published
- 2019
- Full Text
- View/download PDF
15. Overconfidence and ethical contracts
- Author
-
Lambertsen, Nikolaj Niebuhr and Poulsen, Morten Lund
- Published
- 2024
- Full Text
- View/download PDF
16. Investigating the risk-benefit balance of substituting red and processed meat with fish in a Danish diet
- Author
-
Thomsen, Sofie Theresa, Pires, Sara Monteiro, Devleesschauwer, Brecht, Poulsen, Morten, Fagt, Sisse, Ygil, Karin Hess, and Andersen, Rikke
- Published
- 2018
- Full Text
- View/download PDF
17. Primary Hyperparathyroidism in Multiple Endocrine Neoplasia Type 2A in Denmark 1930–2021: A Nationwide Population-Based Retrospective Study
- Author
-
Holm, Magnus, primary, Vestergaard, Peter, additional, Poulsen, Morten, additional, Rasmussen, Åse, additional, Feldt-Rasmussen, Ulla, additional, Bay, Mette, additional, Rolighed, Lars, additional, Londero, Stefano, additional, Pedersen, Henrik, additional, Hahn, Christoffer, additional, Rask, Klara, additional, Nielsen, Heidi, additional, Gaustadnes, Mette, additional, Rossing, Maria, additional, Hermann, Anne, additional, Godballe, Christian, additional, and Mathiesen, Jes, additional
- Published
- 2023
- Full Text
- View/download PDF
18. The Disease Burden of Dietary Exposure to Inorganic Arsenic in Denmark, 2018
- Author
-
Jakobsen, Lea S., Fabricius, Freja A., Nissen, Janna, Christensen, Tue, Andersen, Rikke, Poulsen, Morten, and Pires, Sara M.
- Abstract
Arsenic is a naturally occurring metalloid in soil, air, water and food in organic and inorganic forms. Several epidemiological studies have shown that inorganic arsenic (i-As) is carcinogenic to humans. Previous studies have raised concern about dietary i-As exposure from various sources, including brown rice. We estimated the burden of disease in terms of disability-adjusted life years (DALY) of lung, bladder and skin cancer caused by dietary exposure to i-As in Denmark. Moreover, we investigated the impact of different rice-consumption scenarios of white and brown rice. We combined exposure assessment with dose response relationships of i-As exposure and lifetime risk of each cancer type to estimate the annual incidence due to i-As exposure. Associated DALY was calculated based on national health statistics. We estimated 0.57 extra cancer cases and 4.5 DALY [95% UI 4.2–4.8] in the Danish population in 2018. Even though rice was found not to be the main contributor of i-As, substitution of white and parboiled rice by brown rice resulted in a 32.7% increase in DALY compared to the current consumption of rice. The estimated number of cancer cases due to dietary i-As equals 0.006% of the annual incidence of the three cancer types in Denmark. Our estimates exclude exposure to i-As from drinking water and other beverages, which should be accounted for in future estimates. Our study highlights the need for deriving national-specific estimates of food borne disease burden to allow for comparison and prioritization.
- Published
- 2024
- Full Text
- View/download PDF
19. Considerations for Evaluating Biocidal Efficacy on Biofilm Formation of Oilfield Relevant Microorganisms
- Author
-
Markfoged, Rikke, primary, Larsen Aggerholm, Steffen, additional, Holsten, Lea, additional, Struve, Lisa, additional, Trénel, Philipp, additional, Poulsen, Morten, additional, and Steinhauer, Katrin, additional
- Published
- 2019
- Full Text
- View/download PDF
20. Primary Hyperparathyroidism in Multiple Endocrine Neoplasia Type 2A in Denmark:A Nationwide Population-Based Retrospective Study in Denmark 1930–2021
- Author
-
Holm, Magnus, Vestergaard, Peter, Poulsen, Morten Møller, Rasmussen, Åse Krogh, Feldt-Rasmussen, Ulla, Bay, Mette, Rolighed, Lars, Londero, Stefano, Pedersen, Henrik Baymler, Hahn, Christoffer Holst, Rask, Klara Bay, Nielsen, Heidi Hvid, Gaustadnes, Mette, Rossing, Maria Caroline, Hermann, Anne Pernille, Godballe, Christian, and Mathiesen, Jes Sloth
- Subjects
multiple endocrine neoplasia type 2A ,Denmark ,REarranged during Transfection ,hypercalcemia ,primary hyperparathyroidism ,national cohort - Abstract
Studies of primary hyperparathyroidism (PHPT) in multiple endocrine neoplasia type 2A (MEN 2A) shows divergence in frequency, disease definition, reporting of clinical characteristics and traces of selection bias. This is a nationwide population-based retrospective study of PHPT in MEN 2A, suggesting a representative frequency, with complete reporting and a strict PHPT definition. The Danish MEN 2A cohort 1930-2021 was used. Of 204 MEN 2A cases, 16 had PHPT, resulting in a frequency of 8% (CI, 5-12). Age-related penetrance at 50 years was 8% (CI, 4-15). PHPT was seen in the American Thyroid Association moderate (ATA-MOD) and high (ATA-H) risk groups in 62% and 38% of carriers, respectively. Median age at PHPT diagnosis was 45 years (range, 21-79). A total of 75% were asymptomatic and 25% were symptomatic. Thirteen underwent parathyroid surgery, resulting in a cure of 69%, persistence in 8% and recurrence in 23%. In this first study with a clear PHPT definition and no selection bias, we found a lower frequency of PHPT and age-related penetrance, but a higher age at PHPT diagnosis than often cited. This might be affected by the Danish RET p.Cys611Tyr founder effect. Our study corroborates that PHPT in MEN 2A is often mild, asymptomatic and is associated with both ATA-MOD and ATA-H variants. Likelihood of cure is high, but recurrence is not infrequent and can occur decades after surgery. Studies of primary hyperparathyroidism (PHPT) in multiple endocrine neoplasia type 2A (MEN 2A) shows divergence in frequency, disease definition, reporting of clinical characteristics and traces of selection bias. This is a nationwide population-based retrospective study of PHPT in MEN 2A, suggesting a representative frequency, with complete reporting and a strict PHPT definition. The Danish MEN 2A cohort 1930-2021 was used. Of 204 MEN 2A cases, 16 had PHPT, resulting in a frequency of 8% (CI, 5-12). Age-related penetrance at 50 years was 8% (CI, 4-15). PHPT was seen in the American Thyroid Association moderate (ATA-MOD) and high (ATA-H) risk groups in 62% and 38% of carriers, respectively. Median age at PHPT diagnosis was 45 years (range, 21-79). A total of 75% were asymptomatic and 25% were symptomatic. Thirteen underwent parathyroid surgery, resulting in a cure of 69%, persistence in 8% and recurrence in 23%. In this first study with a clear PHPT definition and no selection bias, we found a lower frequency of PHPT and age-related penetrance, but a higher age at PHPT diagnosis than often cited. This might be affected by the Danish RET p.Cys611Tyr founder effect. Our study corroborates that PHPT in MEN 2A is often mild, asymptomatic and is associated with both ATA-MOD and ATA-H variants. Likelihood of cure is high, but recurrence is not infrequent and can occur decades after surgery.
- Published
- 2023
21. Burden of disease of dietary exposure to acrylamide in Denmark
- Author
-
Jakobsen, Lea Sletting, Granby, Kit, Knudsen, Vibeke Kildegaard, Nauta, Maarten, Pires, Sara Monteiro, and Poulsen, Morten
- Published
- 2016
- Full Text
- View/download PDF
22. Safety of whole seeds of oilseed rape (Brassica napus L emend. Metzg.) 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, 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
23. Safety of apple fruit cell culture biomass as a novel food pursuant to Regulation (EU) 2015/2283.
- Author
-
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
24. Toxicological risk assessment of elemental gold following oral exposure to sheets and nanoparticles – A review
- Author
-
Hadrup, Niels, Sharma, Anoop K., Poulsen, Morten, and Nielsen, Elsa
- Published
- 2015
- Full Text
- View/download PDF
25. Novel foods: allergenicity assessment of insect proteins
- Author
-
Liguori, Biase, primary, Sancho, Ana Isabel, additional, Poulsen, Morten, additional, and Lindholm Bøgh, Katrine, additional
- Published
- 2022
- Full Text
- View/download PDF
26. Risk–Benefit assessment of foods: Development of a methodological framework for the harmonized selection of nutritional, microbiological, and toxicological components
- Author
-
Boué, Géraldine, primary, Ververis, Ermolaos, additional, Niforou, Aikaterini, additional, Federighi, Michel, additional, Pires, Sara M., additional, Poulsen, Morten, additional, Thomsen, Sofie T., additional, and Naska, Androniki, additional
- Published
- 2022
- Full Text
- View/download PDF
27. 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
28. 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
29. 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
30. Burden of diseases estimates associated to different red meat cooking practices
- Author
-
Berjia, Firew Lemma, Poulsen, Morten, and Nauta, Maarten
- Published
- 2014
- Full Text
- View/download PDF
31. Short-term resveratrol supplementation stimulates serum levels of bone-specific alkaline phosphatase in obese non-diabetic men
- Author
-
Poulsen, Morten Møller, Ornstrup, Marie Juul, Harsløf, Torben, Jessen, Niels, Langdahl, Bente Lomholt, Richelsen, Bjørn, Jørgensen, Jens Otto Lunde, and Pedersen, Steen Bønløkke
- Published
- 2014
- Full Text
- View/download PDF
32. Primary Hyperparathyroidism in Multiple Endocrine Neoplasia Type 2A in Denmark: A Nationwide Population-Based Retrospective Study in Denmark 1930–2021.
- Author
-
Holm, Magnus, Vestergaard, Peter, Poulsen, Morten Møller, Rasmussen, Åse Krogh, Feldt-Rasmussen, Ulla, Bay, Mette, Rolighed, Lars, Londero, Stefano, Pedersen, Henrik Baymler, Hahn, Christoffer Holst, Rask, Klara Bay, Nielsen, Heidi Hvid, Gaustadnes, Mette, Rossing, Maria Caroline, Hermann, Anne Pernille, Godballe, Christian, and Mathiesen, Jes Sloth
- Subjects
CONFIDENCE intervals ,RETROSPECTIVE studies ,HYPERPARATHYROIDISM ,SIPPLE syndrome ,DESCRIPTIVE statistics ,LONGITUDINAL method ,SYMPTOMS - Abstract
Simple Summary: Multiple endocrine neoplasia 2A (MEN 2A) is a rare hereditary cancer syndrome, in which primary hyperparathyroidism (PHPT) is reported in up to 35% of affected individuals. Recent studies suggest a lower frequency and a milder course of PHPT in MEN 2A, but these studies often lack a strict definition of PHPT and are frequently carried out at smaller research centers. This could result in diverging and incomplete data. Consequently, we aimed to investigate PHPT in a complete nationwide cohort of MEN 2A to suggest a representative frequency and clinical course of PHPT. This may alter the information given to MEN 2A patients by their caretakers on the likelihood of developing PHPT and on the clinical course of PHPT. Studies of primary hyperparathyroidism (PHPT) in multiple endocrine neoplasia type 2A (MEN 2A) shows divergence in frequency, disease definition, reporting of clinical characteristics and traces of selection bias. This is a nationwide population-based retrospective study of PHPT in MEN 2A, suggesting a representative frequency, with complete reporting and a strict PHPT definition. The Danish MEN 2A cohort 1930–2021 was used. Of 204 MEN 2A cases, 16 had PHPT, resulting in a frequency of 8% (CI, 5–12). Age-related penetrance at 50 years was 8% (CI, 4–15). PHPT was seen in the American Thyroid Association moderate (ATA-MOD) and high (ATA-H) risk groups in 62% and 38% of carriers, respectively. Median age at PHPT diagnosis was 45 years (range, 21–79). A total of 75% were asymptomatic and 25% were symptomatic. Thirteen underwent parathyroid surgery, resulting in a cure of 69%, persistence in 8% and recurrence in 23%. In this first study with a clear PHPT definition and no selection bias, we found a lower frequency of PHPT and age-related penetrance, but a higher age at PHPT diagnosis than often cited. This might be affected by the Danish RET p.Cys611Tyr founder effect. Our study corroborates that PHPT in MEN 2A is often mild, asymptomatic and is associated with both ATA-MOD and ATA-H variants. Likelihood of cure is high, but recurrence is not infrequent and can occur decades after surgery. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
33. Essays on Performance Funding and Intentions, Interpretations, Actions, and Consequences in Danish Basic Education
- Author
-
Poulsen, Morten Lund
- Published
- 2022
34. Safety of freeze‐dried mycelia of Antrodia camphorata 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, Turla, Emanuela, Knutsen, Helle Katrine, and Nutr Novel Foods Food A, EFSA Panel
- Subjects
Agriculture and Food Sciences ,safety ,Antrodia camphorata ,Veterinary (miscellaneous) ,Biology and Life Sciences ,novel foods ,Plant Science ,Microbiology ,food supplement ,CINNAMOMEA ,Taiwanofungus camphoratus ,Taiwanofungus ,Animal Science and Zoology ,Parasitology ,camphoratus ,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 freeze-dried mycelia of Antrodia camphorata as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced by solid-state cultivation from tissue cultures derived from the fungus Antrodia camphorata. The applicant intends to market the NF in food supplements at a maximum dose of 990 mg per day. The target population is the general population. The NF mainly consists of carbohydrates, proteins and fats, and it contains numerous constituents, such as beta-glucans, antroquinonol and triterpenoids. 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. Based on a 90-day repeated dose toxicity study and a prenatal developmental toxicity study performed with the NF, the Panel derives a safe level of 16.5 mg/kg body weight per day. The Panel concludes that the NF, freeze-dried mycelia of Antrodia camphorata, is safe at the proposed use level for individuals aged 14 years and above.
- Published
- 2022
35. Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283
- Author
-
Turck, Dominique, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Kearney, John, 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, Maradona, Miguel Prieto, Marchelli, Rosangela, Neuhauser-Berthold, Monika, Poulsen, Morten, Schlatter, Josef Rudolf, van Loveren, Henk, Gelbmann, Wolfgang, Knutsen, Helle Katrine, and Nutr Novel Foods Food A, EFSA Panel
- Subjects
Agriculture and Food Sciences ,SERUM OSTEOPONTIN ,EXPRESSION ,FORMULA ,SITES ,Novel Foods ,follow-on formula ,Veterinary (miscellaneous) ,infant formula ,Plant Science ,whey protein ,infants and young children ,Microbiology ,bovine milk osteopontin ,children ,infants and young ,GROWTH ,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 bovine milk osteopontin (bmOPN) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns OPN derived from bovine whey. The NF is intended to be used at a maximum use level of 151 mg/L, in infant formula (IF), follow-on formula (FoF) and ready-to-eat dairy-based meals for children up to 35 months of age. As compared to the concentrations naturally present in cow's milk and concentrations found in IF on the market reported in the literature, the proposed use level of the NF represents an about 10-fold higher concentration of bmOPN. The intended use levels of the NF would provide bmOPN at a concentration within the range of human milk (hm) OPN. In a 6-month study, 14, 72 and 140 mg bmOPN/L in reconstituted (as consumed) IF were given to 279 infants in order to study possible effects on frequency and severity of adverse events, and growth, formula intake and stool consistency. Despite that a number of inconsistencies and limitations were noted in the study report, the Panel considers that the results obtained from this study do not raise safety concerns. Considering the source of the NF, that neither the toxicological studies nor the provided infant study do raise safety concerns, and the low bmOPN plasma levels in infants resulting from the consumption of the NF, the Panel considers that the margin of exposure (i.e. 36) between the NOAEL of the subchronic toxicity study (1,200 mg/kg bw per day) and the highest P95 estimate for infants (33.4 mg/kg bw per day) is sufficient. The Panel concludes that the NF is safe under the proposed conditions of use.
- Published
- 2022
36. Safety of 3‐fucosyllactose (3‐FL) produced by a derivative strain 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 Novel Foods Food A, EFSA Panel Nutr
- Subjects
Agriculture and Food Sciences ,3-FL ,safety ,URINARY-EXCRETION ,FORMULA ,novel ,food ,HUMAN-MILK OLIGOSACCHARIDES ,HMO ,Veterinary (miscellaneous) ,MASS-SPECTROMETRY ,3-fucosyllactose ,Plant Science ,Microbiology ,BREAST-FED INFANTS ,C-13-LABELED OLIGOSACCHARIDES ,HiMO ,human milk oligosaccharide ,novel food ,GROWTH ,Animal Science and Zoology ,Parasitology ,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 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, d-glucose and d-galactose, and a small fraction of other related saccharides. The NF is produced by fermentation with a genetically modified strain of Escherichia coli BL21 (DE3). 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 infants and young children, food for special medical purposes and food supplements. 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. Food supplements 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.
- Published
- 2022
37. Safety of lacto‐N‐tetraose (LNT) 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 ,novel ,HUMAN-MILK OLIGOSACCHARIDES ,SECRETOR ,HMO ,food ,Veterinary (miscellaneous) ,INFANTS ,MASS-SPECTROMETRY ,Plant Science ,LNT ,Microbiology ,OLIGOSACCHARIDES ,NEUTRAL ,lacto-N-tetraose ,Medicine and Health Sciences ,human milk oligosaccharide ,HiMO ,novel food ,BOVINE ,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 lacto-N-tetraose (LNT) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a powdered mixture mainly composed of the human-identical milk oligosaccharide (HiMO) LNT, but it also contains d-lactose, lacto-N-triose II and para-lacto-N-hexaose, and a small fraction of other related saccharides. 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 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 and follow-on formula, food for infants and young children, food for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of LNT from the NF at the maximum proposed use levels does not exceed the intake level of naturally occurring LNT in breastfed infants on a body weight basis. The intake of LNT 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 LNT is also considered of no safety concern. Food supplements are not intended to be used if other foods with added LNT or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.
- Published
- 2022
38. Safety of Beta‐lactoglobulin 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, Maradona, Miguel Prieto, Marchelli, Rosangela, Neuhauser-Berthold, Monika, Poulsen, Morten, Schlatter, Josef Rudolf, van Loveren, Henk, Fernandez, Antonio, Knutsen, Helle Katrine, and Nutr Novel Foods Food A, EFSA Panel
- Subjects
Agriculture and Food Sciences ,WHEY PROTEINS ,DAIRY ,ALPHA-LACTALBUMIN ,beta-lactoglobulin ,Veterinary (miscellaneous) ,novel food ,whey protein isolate ,HUMANS ,COWS MILK ,DISSOCIATION ,Plant Science ,Microbiology ,Medicine and Health Sciences ,CASEIN ,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 beta-lactoglobulin (BLG) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF (>= 90% w/w dry matter protein) consists of BLG as primary component (>= 90% of total protein), which is equivalent to BLG present in bovine milk and whey protein isolate (WPI). The NF is produced from bovine whey by crystallisation under acidic or neutral conditions. The NF is proposed to be used as a food ingredient in isotonic and sport drinks, whey powder and milk-based drinks and similar products, and in food for special medical purposes as defined in Regulation (EU) No 609/2013. The target population is the general population. The highest daily intake of the NF was estimated for children of 3 to < 10 years of age as 667 mg/kg body weight (bw) per day. The NF presents proximate composition and content of essential amino acids similar to those in WPI. The Panel notes that the highest mean and highest 95th percentile daily protein intakes from the NF are below the protein population reference intakes for all population groups. Although a tolerable upper intake level has not been derived for protein, the protein intake from the NF may nevertheless further contribute to an already high dietary protein intake in Europe. The exposure to the reported minerals does not raise concerns. The Panel considers that the consumption of the NF is not nutritionally disadvantageous. No genotoxic concerns were identified from the standard in vitro test battery. No adverse effects were observed in the subchronic toxicity study, up to the highest dose tested, i.e. 1,000 mg NF/kg bw per day. The Panel concludes that the NF is safe under the proposed conditions of use.
- Published
- 2022
39. Risk–benefit assessment of seaweed Allergenicity risk assessment of novel protein
- Author
-
Garciarena, Irene Nuin, primary, Poulsen, Morten, additional, and Lindholm Bøgh, Katrine, additional
- Published
- 2022
- Full Text
- View/download PDF
40. (Dys)functionality of intentions or outcomes? Performance funding of Danish schools
- Author
-
Poulsen, Morten Lund, primary, Bukh, Per Nikolaj, additional, and Christensen, Karina Skovvang, additional
- Published
- 2022
- Full Text
- View/download PDF
41. Safety of oil from Schizochytrium sp. (strain ATCC 20889) for use in infant and follow‐on formula as a novel food pursuant to Regulation (EU) 2015/2283
- Author
-
Turck, Dominique, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch-Ernst, Karen Ildico, Kearney, John, 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, Turla, Emanuela, Knutsen, Helle Katrine, and Nutr Novel Foods Food A, EFSA Panel
- Subjects
young children ,Agriculture and Food Sciences ,safety ,Nutrition. Foods and food supply ,Novel foods ,infants ,young ,Veterinary (miscellaneous) ,Chemical technology ,Schizochytrium ,Plant Science ,TP1-1185 ,docosahexaenoic acid ,Microbiology ,alga ,Scientific Opinion ,children ,Medicine and Health Sciences ,Animal Science and Zoology ,Parasitology ,TX341-641 ,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 the safety of Schizochytrium sp. oil as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF which is the subject of the application is an oil rich in docosahexaenoic acid (DHA) that is produced by the microalgae Schizochytrium sp. (strain ATCC‐20889). The applicant proposed to add the NF in infant formulae (IF) and follow‐on formulae (FOF) at use levels in accordance with Regulation (EU) No 609/2013. The evidence provided by the applicant does not demonstrate to which species the strain Schizochytrium sp. ATCC 20889 belongs. As the source organism of the NF is not characterised at species level, no assessment for inclusion in the Qualified Presumption of Safety (QPS) list can be performed by EFSA. Marine biotoxins (including cyanotoxins) in the NF were below their limits of quantification. However, since it is unknown to which species the strain Schizochytrium sp. ATCC 20889 belongs, the concern that this strain has the potential to produce other toxins remains. No toxicological studies with the NF were provided by the applicant. Toxicological studies are available with DHA‐rich algal oils produced from other strains of Schizochytrium sp. However, the Panel considers that those toxicological studies cannot be used to establish the safety of the oil produced by the strain which is under assessment in this application (Schizochytrium sp. ATCC 20889). Therefore, based on the information provided by the applicant, the Panel concludes that the safety of the NF has not been established.
- Published
- 2022
42. Novel foods:allergenicity assessment of insect proteins
- Author
-
Liguori, Biase, Sancho, Ana Isabel, Poulsen, Morten, and Bøgh, Katrine Lindholm
- Subjects
Insects ,Allergenicity assessment ,Black soldier fly ,Alternative proteins ,Hermetia Illucens ,Novel food - Abstract
Insects represent a promising source of proteins and have been reported as a great potential for being used as novel food and feed proteins. This makes them a valuable source of nutrients to face the increasing demand of food necessitated by the growing global population. The current European food legislation on novel food (EU Reg. 2015/2283), which entered into force in 2018, provides the provisions that should be considered in the applications for the authorisation of novel foods in the European market. Insects, intended as an alternative source of food proteins for human consumption, are considered novel foods. Since food allergens are mostly proteins, the analysis and identification of the potential allergenicity of novel proteins should be a fundamental activity that enables the applicants to fulfil the requirements for the application and authorisation to bring a novel food into the European market and ensures a high level of food safety for the European consumers. The main aims of the work of the EU-FORA fellow were to: (i) Review, assess and identify gaps in the current strategies for predicting allergenicity of novel foods and new alternative protein sources; and (ii) Familiarise, understand and perform an allergenicity assessment of a novel food protein source by: (a) Working on an allergenicity assessment case study of insect proteins from black soldier fly larva (Hermetia Illucens); and (b) Taking into consideration other risk assessment aspects of insects as novel food, including toxicological, nutritional and microbial risks. The project contributed to the continuous learning of the fellow on practical assays and methodologies for the in silico, in vitro and in vivo analysis principles and complemented personal skills related to the food risk assessment requirement for the preparation and submission of an application for authorisation of a novel food.
- Published
- 2022
43. Safety of the extension of use of 2'-fucosyllactose/difucosyllactose (2'-FL/DFL) mixture and lacto-N-tetraose (LNT) as novel foods in food supplements for infants 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 ,extension of use ,infants ,Veterinary (miscellaneous) ,Plant Science ,2’-fucosyllactose/difucosyllactose ,food supplement ,HiMO ,lacto-N-tetraose ,Novel Foods ,Microbiology ,difucosyllactose ,Foods ,2'-fucosyllactose ,Medicine and Health Sciences ,Animal Science and Zoology ,Parasitology ,Novel ,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 the safety of the extensions of use of the authorised novel foods (NFs) 2'-fucosyllactose/difucosyllactose (2'-FL/DFL) mixture and lacto-N-tetraose (LNT) in food supplements (FS) for infants pursuant to Regulation (EU) 2015/2283. The NFs are produced by fermentation with genetically modified strains of Escherichia coli K-12 DH1 and already included in the EU list of NF. The applicant stated that no changes in the production process or the identity of the NFs occurred. The applicant proposes an extension of use of the NF containing 2'-FL/DFL mixture in FS intended for infants (< 1 year), at a maximum use level of 1.6 g/day for infants 6 months. The applicant also proposes an extension of use of LNT in FS intended for infants (< 1 year), at a maximum use level of 0.8 g/day for infants 6 months. The intake per kg body weight of 2'-FL/DFL and LNT from the proposed maximum use levels of the respective NFs in FS for infants does not exceed the lowest estimated mean intake of naturally occurring 2'-FL/DFL and it is similar to the highest estimated mean intake of LNT by breastfed infants. In addition, the Panel notes that the proposed uses of the NFs in FS for infants result in lower maximum daily intakes than those from the already authorised uses of the NFs for the same population group. The Panel concludes that the uses of the NFs containing either 2'-FL/DFL or LNT in FS for infants are safe under the proposed conditions of use.
- Published
- 2022
44. Risk-benefit assessment of seaweed Allergenicity risk assessment of novel protein
- Author
-
Garciarena, Irene Nuin, Poulsen, Morten, and Lindholm Bøgh, Katrine
- Subjects
Allergenicity risk assessment ,Risk–benefit ,Novel protein ,Seaweed ,Novel food - Abstract
As the world population rapidly grows, there is a clear need for alternative food sources, particularly for the provision of protein. Seaweed is one such alternative source of protein that requires greater investigation. In this context, a working programme within the European Food Risk Assessment (EU-FORA) Fellowship Programme framework was developed at National Food Institute - Technical University of Denmark. This Programme is an initiative of the EFSA with the aim to build a European risk assessment community. The purpose of this technical report is to describe the activities in which the fellow was involved. As part of the Research Group for Risk-Benefit, the fellow performed a risk-benefit assessment of seaweed Palmaria palmata gaining an in-depth expertise in all the steps. The health impact of Palmaria palmata consumption was estimated, considering its high nutritional value but also highlighting concerns towards some components. Simultaneous to the work on the risk-benefit, the fellow also worked within the Research Group for Food Allergy, specifically on the allergenicity risk assessment of a plant-based novel protein (seaweed protein) using different laboratory assays. Seaweed protein digestibility was assessed, and its digestion products were characterised and assessed for immunogenicity. Finally, the fellow collaborated with the Research Group for Microbial Biotechnology and Biorefining in the development of a novel food (alfalfa protein) application dossier to be submitted to EFSA, gaining expertise in the risk assessment of a novel food. In conclusion, the present working programme, together with additional activities and training provided by different institutions, enabled the fellow to gain a broader perspective in food safety, particularly concerning seaweed, novel foods and the safety assessment of novel proteins.
- Published
- 2022
45. 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
-
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, Loveren, Henk van, Roldan-Torres, Ruth, and Knutsen, Helle Katrine
- Subjects
Agriculture and Food Sciences ,safety ,Novel Foods ,POLAPREZINC ,Veterinary (miscellaneous) ,zinc ,bioavailability ,food supplement ,nutrient source ,zinc l-carnosine ,Plant Science ,Microbiology ,THERAPY ,TOXICITY ,Chemistry ,Animal Science and Zoology ,Parasitology ,COMBINATION ,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 zinc l-carnosine as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and as a source of zinc for use in food supplements. The NF is produced by chemical synthesis and is proposed to be used in food supplements as a source of zinc. The target population proposed by the applicant is individuals above the age of 12, excluding pregnant and lactating women. The NF which is the subject of the application is a chelate-complex, formed between Zn2+ and l-carnosine and is present as a mixture of a monomer and a dimer. The material is a powder with particulate nature and is insoluble in water at neutral pH. No relevant data using an existing zinc source as comparator have been made available by the applicant and the actual bioavailability of the zinc provided by the NF at the proposed use levels remains uncharacterised. Owing to the lack of a correct characterisation of the fraction of small particles, including nanoparticles of the NF, the Panel is not in the position to evaluate specification limits for the size of the constituent particles in the NF. Owing to the lack of information on the size distribution and the physico-chemical properties of the particles constituting the NF, the Panel is not in the position to confirm whether the ADME studies and the toxicological studies provided by the applicant are appropriate to assess the safety of the NF. The Panel concludes that the NF is absorbed and provides zinc, but as it is in an insufficiently characterised particulate form, its safety has not been established and the bioavailability has not been determined.
- Published
- 2022
46. Safety of the extension of use of 2'-fucosyllactose (2'-FL) and lacto-N-neotetraose (LNnT) as novel foods in food supplements for infants 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, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, van Loveren, Henk, Colombo, Paolo, Noriega Fernandez, Estefania, Knutsen, Helle Katrine, and Nutr Novel Foods Food, EFSA Panel
- Subjects
Agriculture and Food Sciences ,Novel Foods ,2’-FL ,extension of use ,food supplement ,HiMO ,infants ,LNnT ,Veterinary (miscellaneous) ,Plant Science ,Microbiology ,OLIGOSACCHARIDES ,MILK ,2'-FL ,Medicine and Health Sciences ,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 the safety of the extensions of use of the authorised novel foods (NFs) 2'-fucosyllactose (2'-FL) and lacto-N-neotetraose (LNnT) in food supplements (FS) for infants pursuant to Regulation (EU) 2015/2283. The NFs are produced by fermentation with genetically modified strains of Escherichia coli K-12 and already included in the EU list of NFs. The applicant stated that no changes in the production process or the identity of the NFs occurred. The applicant proposes an extension of use of the NF containing 2'-FL in FS intended for infants (< 1 year), at a maximum use level of 1.2 g/day. The applicant also proposes an extension of use of LNnT in FS intended for infants, at a maximum use level of 0.6 g/day. The intake of 2'-FL per kg body weight from the proposed maximum use levels in FS for infants is lower than the lowest estimated mean intake of naturally occurring 2'-FL from human milk. Similarly, the intake of LNnT per kg body weight is lower than the highest estimated mean intake of naturally occurring 2'-FL from human milk. Furthermore, the Panel notes that the proposed uses of 2'-FL in FS for infants are lower than the estimated intake from the already authorised uses of the NF for the same population group. The Panel also notes that the proposed uses of LNnT in FS for infants are similar to the estimated intake from the already authorised uses of the NF for the same population group. The Panel concludes that the use of the NFs containing 2'-FL or LNnT in FS for infants is safe under the proposed conditions of use.
- Published
- 2022
47. Safety of 2′-fucosyllactose (2’-FL) produced by a derivative strain (APC199) of Corynebacterium glutamicum ATCC 13032 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 ,2′‐fucosyllactose ,safety ,novel ,food ,HUMAN-MILK OLIGOSACCHARIDES ,Veterinary (miscellaneous) ,HMO ,INFANTS ,2’‐FL ,HiMO ,human milk oligosaccharide ,novel food ,Plant Science ,Microbiology ,METABOLOME ,2'-FL ,2'-fucosyllactose ,Medicine and Health Sciences ,NEUTRAL OLIGOSACCHARIDES ,Animal Science and Zoology ,Parasitology ,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 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, 3-fucosyllactose, difucosyllactose, D-glucose and D-galactose. The NF is produced by fermentation with a genetically modified strain (APC199) of Corynebacterium glutamicum ATCC 13032. 2'-FL, when chemically synthesised or produced by fermentation with derivative strains of Escherichia coli K-12 DH1 or E. coli BL21 (DE3), is already authorised and included in the EU list of NFs. This application refers to a change in the production process and specifications, while target population, conditions of use and consequently, the anticipated intake remain unchanged. The information provided on the identity, production process, composition and specifications of the NF does not raise safety concerns. The intake of other carbohydrate-type compounds structurally related to 2'-FL is also considered of no safety concern. In line with other milk oligosaccharides that are natural components of human milk, the safety assessment of this NF is mainly based on the comparison between the intake of breastfed infants and the estimated intake as NF. Given that the NF would be consumed at the same extent as the already authorised 2'-FL, the Panel considers that the consumption of the NF at the proposed uses and use levels does not raise safety concerns. 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
48. Safety of pea and rice protein fermented by Shiitake (Lentinula edodes) mycelia 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, Roldan-Torres, Ruth, Knutsen, Helle Katrine, and Nutr Novel Foods Food A, EFSA Panel
- Subjects
Agriculture and Food Sciences ,pea protein ,Shiitake ,Novel Foods ,Veterinary (miscellaneous) ,Plant Science ,DIGESTIBILITY ,Microbiology ,food safety ,Lentinula edodes ,rice protein ,ACID ,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 pea and rice protein fermented by Shiitake mushroom (Lentinula edodes) mycelia as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mixture of fermented pea and rice protein concentrates (65% and 35%, respectively). The NF is proposed to be used as a food ingredient in specific food categories. The target population is the general population. The major constituent of this NF is protein (>= 75% dry weight), which is well digestible and provides sufficient amounts of essential amino acids. Although a tolerable upper intake level (UL) has not been derived for protein, the protein intake from the NF may nevertheless further contribute to an already high dietary protein intake in Europe. The Panel notes that the cumulative exposure to the nutrients and contaminants analysed does not raise concern. The reported values for the levels of antinutritional factors in the NF are comparable to those in other foodstuffs. The Panel considers that taking into account the composition of the NF and the proposed conditions of use, consumption of the NF is not nutritionally disadvantageous. No toxicological studies with the NF were provided by the applicant; however, the Panel considers that no toxicological studies are required for this NF. The NF has the potential capacity to sensitise individuals or to induce allergic reactions in individuals allergic to pea, rice and Shiitake mushroom. However, this risk is expected not to be higher than that resulting from the normal consumption of pea, rice or the fruiting body of the Shiitake mushroom. The Panel considers that the NF is safe at the proposed conditions of use.
- Published
- 2022
49. Safety of 3'-sialyllactose (3'-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 Novel Foods Food A, EFSA Panel Nutr
- Subjects
Agriculture and Food Sciences ,safety ,FORMULA ,3’-sialyllactose ,3’-SL sodium salt ,HiMO ,HMO ,human milk oligosaccharide ,novel food ,3'-sialyllactose ,Veterinary (miscellaneous) ,HUMAN-MILK OLIGOSACCHARIDES ,GUT MICROBIOTA ,INFANTS ,Plant Science ,PREBIOTICS ,BIFIDOBACTERIA ,Microbiology ,PROBIOTICS ,REVEALS ,3'-SL sodium salt ,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 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, but it also contains d-lactose, 3'-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 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 infants and young children, food for special medical purposes and food supplements. The target population is the general population. The anticipated daily intake of 3'-SL 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'-SL from human milk in infants on a body weight basis. The intake of 3'-SL 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'-SL is also considered of no safety concern. Food supplements are not intended to be used if other foods with added 3'-SL or human milk are consumed on the same day. The Panel concludes that the NF is safe under the proposed conditions of use.
- Published
- 2022
50. 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
-
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, Maradona, Miguel Prieto, Marchelli, Rosangela, Neuhaeuser-Berthold, Monika, Poulsen, Morten, Schlatter, Josef Rudolf, van Loveren, Henk, Acker, Reinhard, Knutsen, Helle Katrine, and Nutr Novel Foods Food A, EFSA Panel
- Subjects
Agriculture and Food Sciences ,safety ,Veterinary (miscellaneous) ,Plant Science ,Microbiology ,iron ,DIGESTION ,bioavailability ,iron milk proteinate ,novel food ,nutrient source ,BINDING ,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 iron milk proteinate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of iron from this source in the context of Directive 2002/46/EC. The NF is a complex of iron, casein and phosphate, which is produced from iron salts (i.e. ferric chloride or ferric sulfate), sodium caseinate and potassium orthophosphate. The NF is proposed by the applicant to be used as a source of iron, of which the NF contains 2-4%. The applicant intends to market the NF as an ingredient in a number of food categories; in food supplements, in total diet replacement for weight control and in foods for special medical purposes. The Panel considers that, taking into account the composition of the NF and the proposed conditions of use, consumption of the NF is not nutritionally disadvantageous. The studies provided for ADME and bioavailability indicate that iron from the NF is bioavailable. Overall, the evidence indicates that upon ingestion the NF undergoes digestion into small peptides to yield iron-bound caseinophosphopeptides that are normal constituents of the human diet, and that the iron from the NF does not bypass the homeostatic control of iron as a nutrient. The Panel concludes that the NF, iron milk proteinate, is safe under the proposed conditions of use. The Panel also concludes that the NF is a source from which iron is bioavailable.
- Published
- 2022
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.