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10. Challenges related to processing and analysis of Norwegian seaweed, focusing on Sugar kelp and Winged kelp

Author

Blikra, Marthe Jordbrekk, Skipnes, Dagbjørn, Noriega Fernández, Estefanía, and Skåra, Torstein

Abstract

Kelp is a new and exciting ingredient in the food industry, restaurants and in the kitchen that is receiving increasing attention, but some of the components in kelp are potentially unfortunate and should be considered when preparing food. In this report, we have focused on the kelp species sugar kelp and winged kelp, and the component iodine - which we need, but in relatively small doses -, as well as the heavy metals cadmium and arsenic which are undesirable. Several studies have shown that it is possible to remove significant parts of the iodine content from kelp using relatively simple processing methods, such as boiling. There is good reason to believe that newer methods, such as high pressure, ultrasound, and enzyme treatments, have the potential to reduce iodine and heavy metals beyond this level, and perhaps in a more selective way than boiling, which also removes several flavor compounds and nutrients from the kelp. The amount of iodine in kelp varies depending on various conditions (species, location, season, etc.). As of today, it is difficult to predict the amount of iodine in kelp without analyzing the iodine content in each harvest. In Nofima, we are working to establish two methods, a spectroscopic and a faster method, which can be used for various research purposes related to analysis of iodine in kelp and how we can control the content of iodine. There are various recommendations for maximum iodine intake. These seem to depend on how much iodine the population initially ingests in their food. There are few guidelines in relation to the content of iodine and heavy metals in kelp, which places demands on the food industry for controlling the contents in each product as well as for establishment of recommended portion sizes. Based on the research done so far, we have calculated how much sugar kelp can be eaten without exceeding the maximum recommended daily intake of iodine. More than anything else, the result emphasizes the variations. There is great variation both in terms of how much iodine is found in harvested kelp and how much is removed during the cooking process. This provides a great deal of uncertainty regarding the amount of kelp one should eat and reinforces the need for frequent analyzes of specific harvests on the part of the producers, as well as calculation of recommended portion sizes. Nevertheless, it must be acknowledged that there is a need, especially among consumers, to get more clarity on how much kelp is safe to eat. Tare er en ny og spennende ingrediens i matindustrien og på kjøkkenet som får økende oppmerksomhet, men noen av komponentene i tare er mulig uheldige og bør tas hensyn til ved tillaging av mat. I denne rapporten har vi tatt utgangspunkt i tareartene sukkertare og butare, og i komponenten jod – som vi trenger, men i relativt små doser –, samt tungmetallene kadmium og arsen som er uønsket. Flere studier har vist at det er mulig å fjerne betydelige deler av innholdet av jod fra tare ved hjelp av relativt enkle prosesseringsmetoder, som koking. Det er god grunn til å tro at nyere metoder, som høytrykk, ultralyd, og enzymbehandlinger, har potensial til å redusere jod og tungmetaller utover dette, og kanskje på en mer selektiv måte enn koking, som også fjerner flere smakskomponenter og næringsstoffer fra taren. Mengde jod i tare varierer mye avhengig av ulike forhold. Per i dag er det vanskelig å forutsi mengde jod i tare uten å analysere jod i hver avling. I Nofima arbeider vi med å etablere to metoder, en spektroskopisk og en hurtigere metode, som kan brukes til ulike forskningsformål knyttet til analyse av jod i tare og hvordan vi kan styre innholdet av jod. Det finnes ulike anbefalinger for maksimalt inntak av jod. Disse synes å være avhengig av hvor mye jod befolkningen i utgangspunktet får i seg i maten. Anbefalingene tar utgangspunkt i mengder og maksimale mengder av stoffer vi bør spise, og det er få retningslinjer i forhold til innholdet i selve taren. Det setter store krav til matindustri for kontroll på innholdet i sine produkter samt for etablering av anbefalte porsjonsstørrelser. Basert på forskningen som er gjort til nå har vi beregnet hvor mye sukkertare som kan spises uten å overstige maksimal anbefalt dagsinntak av jod. Mer enn noe annet understreker resultatene variasjonen i påviste mengder. Det er stor variasjon både når det gjelder hvor mye jod som finnes i høstet tare samt hvor mye som fjernes under kokeprosessen. Dette gir en stor usikkerhet rundt mengde tare man bør spise og forsterker behovet for hyppige analyser av spesifikke avlinger fra produsentene sin side, samt beregning av anbefalte porsjonsstørrelser. Likevel må man erkjenne at det er et behov, spesielt blant forbrukerne, for å få mer klarhet i hvor mye tare som er trygt å spise, og det er ønskelig å bidra mot dette.

Published
2020

11. Utfordringer knyttet til prosessering og analyse av norsk tare, med fokus på sukkertare og butare

Author

Blikra, Marthe Jordbrekk, Skipnes, Dagbjørn, Noriega Fernández, Estefanía, and Skåra, Torstein

Abstract

Tare er en ny og spennende ingrediens i matindustrien og på kjøkkenet som får økende oppmerksomhet, men noen av komponentene i tare er mulig uheldige og bør tas hensyn til ved tillaging av mat. I denne rapporten har vi tatt utgangspunkt i tareartene sukkertare og butare, og i komponenten jod – som vi trenger, men i relativt små doser –, samt tungmetallene kadmium og arsen som er uønsket. Flere studier har vist at det er mulig å fjerne betydelige deler av innholdet av jod fra tare ved hjelp av relativt enkle prosesseringsmetoder, som koking. Det er god grunn til å tro at nyere metoder, som høytrykk, ultralyd, og enzymbehandlinger, har potensial til å redusere jod og tungmetaller utover dette, og kanskje på en mer selektiv måte enn koking, som også fjerner flere smakskomponenter og næringsstoffer fra taren. Mengde jod i tare varierer mye avhengig av ulike forhold. Per i dag er det vanskelig å forutsi mengde jod i tare uten å analysere jod i hver avling. I Nofima arbeider vi med å etablere to metoder, en spektroskopisk og en hurtigere metode, som kan brukes til ulike forskningsformål knyttet til analyse av jod i tare og hvordan vi kan styre innholdet av jod. Det finnes ulike anbefalinger for maksimalt inntak av jod. Disse synes å være avhengig av hvor mye jod befolkningen i utgangspunktet får i seg i maten. Anbefalingene tar utgangspunkt i mengder og maksimale mengder av stoffer vi bør spise, og det er få retningslinjer i forhold til innholdet i selve taren. Det setter store krav til matindustri for kontroll på innholdet i sine produkter samt for etablering av anbefalte porsjonsstørrelser. Basert på forskningen som er gjort til nå har vi beregnet hvor mye sukkertare som kan spises uten å overstige maksimal anbefalt dagsinntak av jod. Mer enn noe annet understreker resultatene variasjonen i påviste mengder. Det er stor variasjon både når det gjelder hvor mye jod som finnes i høstet tare samt hvor mye som fjernes under kokeprosessen. Dette gir en stor usikkerhet rundt mengde tare man bør spise og forsterker behovet for hyppige analyser av spesifikke avlinger fra produsentene sin side, samt beregning av anbefalte porsjonsstørrelser. Likevel må man erkjenne at det er et behov, spesielt blant forbrukerne, for å få mer klarhet i hvor mye tare som er trygt å spise, og det er ønskelig å bidra mot dette. Kelp is a new and exciting ingredient in the food industry, restaurants and in the kitchen that is receiving increasing attention, but some of the components in kelp are potentially unfortunate and should be considered when preparing food. In this report, we have focused on the kelp species sugar kelp and winged kelp, and the component iodine - which we need, but in relatively small doses -, as well as the heavy metals cadmium and arsenic which are undesirable. Several studies have shown that it is possible to remove significant parts of the iodine content from kelp using relatively simple processing methods, such as boiling. There is good reason to believe that newer methods, such as high pressure, ultrasound, and enzyme treatments, have the potential to reduce iodine and heavy metals beyond this, and perhaps in a more selective way than cooking, which also removes several flavor compounds and nutrients from the kelp. The amount of iodine in kelp varies depending on different conditions. As of today, it is difficult to predict the amount of iodine in kelp without analyzing iodine in each harvest. In Nofima, we are working to establish two methods, a spectroscopic and a faster method, which can be used for various research purposes related to analysis of iodine in kelp and how we can control the content of iodine. There are various recommendations for maximum iodine intake. These seem to depend on how much iodine the population initially ingests in their food. There are few guidelines in relation to the content of iodine and heavy metals in kelp, which places demands on the food industry for controlling the contents in each product as well as for establishment of recommended portion sizes. Based on the research done so far, we have calculated how much sugar kelp can be eaten without exceeding the maximum recommended daily intake of iodine. More than anything else, the result emphasizes the variations. There is great variation both in terms of how much iodine is found in harvested kelp and how much is removed during the cooking process. This provides a great deal of uncertainty regarding the amount of kelp one should eat and reinforces the need for frequent analyzes of specific harvests on the part of the producers, as well as calculation of recommended portion sizes. Nevertheless, it must be acknowledged that there is a need, especially among consumers, to get more clarity on how much kelp is safe to eat.

Published
2020

13. Impact of Plasma-Activated Water Treatment on Quality and Shelf-Life of Fresh Spinach Leaves Evaluated by Comprehensive Metabolomic Analysis.

Author

Daniel Rangel-Huerta, Oscar, Ivanova, Lada, Uhlig, Silvio, Sivertsvik, Morten, Izumi Sone, Noriega Fernández, Estefanía, and Kruse Fæste, Christiane

Abstract

Fresh baby spinach leaves are popular in salads and are sold as chilled and plastic-packed products. They are of high nutritional value but very perishable due to microbial contamination and enzymatic browning resulting from leaf senescence. Therefore, innovative food processing methods such as plasma-activated water (PAW) treatment are being explored regarding their applicability for ensuring food safety. PAW’s impact on food quality and shelf-life extension has, however, not been investigated extensively in vegetables so far. In the present study, a comprehensive metabolomic analysis was performed to determine possible changes in the metabolite contents of spinach leaves stored in a refrigerated state for eight days. Liquid chromatography high-resolution mass spectrometry, followed by stringent biostatistics, was used to compare the metabolomes in control, tap-water-rinsed or PAW-rinsed samples. No significant differences were discernible between the treatment groups at the beginning or end of the storage period. The observed loss of nutrients and activation of catabolic pathways were characteristic of a transition into the senescent state. Nonetheless, the presence of several polyphenolic antioxidants and γ-linolenic acid in the PAW-treated leaves indicated a significant increase in stress resistance and health-promoting antioxidant capacity in the sample. Furthermore, the enhancement of carbohydrate-related metabolisms indicated a delay in the senescence development. These findings demonstrated the potential of PAW to benefit food quality and the shelf-life of fresh spinach leaves. [ABSTRACT FROM AUTHOR]

Published
2021
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16. 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

Nutricion y Bromatologia, Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Peláez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, Loveren, Henk van, Colombo, Paolo, Noriega Fernández, Estefanía, Knutsen, Helle Katrine, Nutricion y Bromatologia, Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Peláez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, Loveren, Henk van, Colombo, Paolo, Noriega Fernández, Estefanía, and Knutsen, Helle Katrine

Abstract

[EN] 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 and up to 1.2 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 and up to 0.6 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.

17. Safety of lacto‐N‐fucopentaose I/2’‐fucosyllactose (LNFP‐I/2’‐FL) mixture as a novel food pursuant to Regulation (EU) 2015/2283

Author

Nutricion y Bromatologia, 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, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Peláez, Carmen, Poulsen, Morten, Schlatter, Josef Rudolf, Siskos, Alexandros, van Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, Knutsen, Helle Katrine, Nutricion y Bromatologia, 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, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Peláez, Carmen, Poulsen, Morten, Schlatter, Josef Rudolf, Siskos, Alexandros, van Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, and Knutsen, Helle Katrine

Abstract

[EN] 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

18. 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

Nutricion y Bromatologia, Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Peláez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Schlatter, Josef Rudolf, Siskos, Alexandros, van Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, Knutsen, Helle Katrine, Nutricion y Bromatologia, Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J., Naska, Androniki, Peláez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Schlatter, Josef Rudolf, Siskos, Alexandros, van Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, and Knutsen, Helle Katrine

Abstract

[EN] 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

19. 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

Nutricion y Bromatologia, Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Peláez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Schlatter, Josef Rudolf, Siskos, Alexandros, van Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, Knutsen, Helle Katrine, Nutricion y Bromatologia, Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Peláez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Aguilera Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Prieto Maradona, Miguel, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Schlatter, Josef Rudolf, Siskos, Alexandros, van Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, and Knutsen, Helle Katrine

Abstract

[EN] 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

20. Safety of Beta‐lactoglobulin as a Novel food pursuant to Regulation (EU) 2015/2283

Author

Nutricion y Bromatologia, Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Peláez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, van Loveren, Henk, Fernández Dumont, Antonio, Noriega Fernández, Estefanía, Knutsen, Helle Katrine, Nutricion y Bromatologia, Turck, Dominique, Bohn, Torsten, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Maciuk, Alexandre, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Peláez, Carmen, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Tsabouri, Sophia, Vinceti, Marco, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Marchelli, Rosangela, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, van Loveren, Henk, Fernández Dumont, Antonio, Noriega Fernández, Estefanía, and Knutsen, Helle Katrine

Abstract

[EN] 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.

21. 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

Nutricion y Bromatologia, 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, Neuhäuser‐Berthold, Monika, Peláez, Carmen, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, Siskos, Alexandros, van Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, Knutsen, Helle Katrine, Nutricion y Bromatologia, 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, Neuhäuser‐Berthold, Monika, Peláez, Carmen, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, Siskos, Alexandros, van Loveren, Henk, Colombo, Paolo, Noriega Fernández, Estefanía, and Knutsen, Helle Katrine

Abstract

[EN] 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

22. Statement on how to interpret the QPS qualification on ‘acquired antimicrobial resistance genes’

Author

Tecnologia de los Alimentos, Koutsoumanis, Konstantinos, Allende, Ana, Álvarez Ordóñez, Avelino, Bolton, Declan, Bover‐Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Nonno, Romolo, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Suárez, Juan Evaristo, Noriega Fernández, Estefanía, Istace, Frédérique, Aguillera, Jaime, Brozzi, Rosella, Liébana, Ernesto, Guerra, Beatriz, Correia, Sandra, Herman, Lieve, Tecnologia de los Alimentos, Koutsoumanis, Konstantinos, Allende, Ana, Álvarez Ordóñez, Avelino, Bolton, Declan, Bover‐Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Nonno, Romolo, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Suárez, Juan Evaristo, Noriega Fernández, Estefanía, Istace, Frédérique, Aguillera, Jaime, Brozzi, Rosella, Liébana, Ernesto, Guerra, Beatriz, Correia, Sandra, and Herman, Lieve

Abstract

[EN] The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms intended for use in the food or feed chains. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’ which should be assessed at strain and/or product level by EFSA's Scientific Panels. The generic qualification ‘the strains should not harbour any acquired antimicrobial resistance (AMR) genes to clinically relevant antimicrobials’ applies to all QPS bacterial TUs. The different EFSA risk assessment areas use the same approach to assess the qualification related to AMR genes. In this statement, the terms ‘intrinsic’ and ‘acquired’ AMR genes were defined for the purpose of EFSA's risk assessments, and they apply to bacteria used in the food and feed chains. A bioinformatic approach is proposed for demonstrating the ‘intrinsic’/’acquired’ nature of an AMR gene. All AMR genes that confer resistance towards ‘critically important’, ‘highly important’ and ‘important’ antimicrobials, as defined by the World Health Organisation (WHO), found as hits, need to be considered as hazards (for humans, animals and environment) and need further assessment. Genes identified as responsible for ‘intrinsic’ resistance could be considered as being of no concern in the frame of the EFSA risk assessment. ‘Acquired’ AMR genes resulting in a resistant phenotype should be considered as a concern. If the presence of the ‘acquired’ AMR gene is not leading to phenotypic resistance, further case-by-case assessment is necessary

23. Susceptibility and transcriptomic response to plasma-activated water of Listeria monocytogenes planktonic and sessile cells

Author

Tecnologia de los Alimentos, Fernández Gómez, Paula, Cobo Díaz, José Francisco, Sousa Oliveira, Marcia Patricia de, González Raurich, María Montserrat, Álvarez Ordóñez, Avelino, Prieto Maradona, Miguel, Walsh, James L., Sivertsvik, Morten, Noriega Fernández, Estefanía, López Fernández, María Mercedes, Tecnologia de los Alimentos, Fernández Gómez, Paula, Cobo Díaz, José Francisco, Sousa Oliveira, Marcia Patricia de, González Raurich, María Montserrat, Álvarez Ordóñez, Avelino, Prieto Maradona, Miguel, Walsh, James L., Sivertsvik, Morten, Noriega Fernández, Estefanía, and López Fernández, María Mercedes

Abstract

[EN] Plasma-Activated Water (PAW) was generated from tap water using a surface dielectric barrier discharge at different discharge power (26 and 36 W) and activation time (5 and 30 min). The inactivation of a three-strain Listeria monocytogenes cocktail in planktonic and biofilm state was evaluated. PAW generated at 36 W-30 min showed the lowest pH and the highest hydrogen peroxide, nitrates, nitrites contents and effectiveness against cells on planktonic state, resulting in 4.6 log reductions after a 15-min treatment. Although the antimicrobial activity in biofilms formed on stainless steel and on polystyrene was lower, increasing the exposure time to 30 min allowed an inactivation >4.5 log cycles. The mechanisms of action of PAW were investigated using chemical solutions that mimic its physico-chemical characteristics and also RNA-seq analysis. The main transcriptomic changes affected carbon metabolism, virulence and general stress response genes, with several overexpressed genes belonging to the cobalamin-dependent gene cluster.

24. Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283.

Author

Turck D, Bohn T, Castenmiller J, de Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera Gómez M, Cubadda F, Frenzel T, Heinonen M, Neuhäuser-Berthold M, Peláez C, Poulsen M, Prieto Maradona M, Schlatter JR, Siskos A, van Loveren H, Ackerl R, Albert O, Azzollini D, Fernández Dumont A, Gelbmann W, Germini A, Glymenaki M, Kass GEN, Kouloura E, Laganaro M, Matijevic L, Mendes V, Noriega Fernández E, Nuin Garciarena I, Precup G, Roldán Torres R, Rossi A, Turla E, Valtueña Martinez S, Ververis E, and Knutsen HK

Abstract

The European Commission requested EFSA to update the scientific guidance for the preparation of applications for authorisation of novel foods, previously developed following the adoption of Regulation (EU) 2015/2283 on novel foods. This guidance document provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food. Requirements pertain to the description of the novel food, production process, compositional data, specifications, proposed uses and use levels and anticipated intake of the novel food. Furthermore, information needed in sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, toxicological information, nutritional information and allergenicity is also described. The applicant should integrate and interpret the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they are to be discussed in relation to the anticipated intake of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Published
2024
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25. Safety of lacto-N-fucopentaose I/2'-fucosyllactose (LNFP-I/2'-FL) mixture as a novel food pursuant to Regulation (EU) 2015/2283.

Author

Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Prieto Maradona M, Marchelli R, Neuhäuser-Berthold M, Peláez C, Poulsen M, Schlatter JR, Siskos A, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Published
2023
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26. 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

Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Prieto Maradona M, Marchelli R, Neuhäuser-Berthold M, Peláez C, Poulsen M, Schlatter JR, Siskos A, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Published
2023
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27. Safety of the extension of use of 2'-fucosyllactose (2'-FL) as a novel food pursuant to Regulation (EU) 2015/2283.

Author

Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Prieto Maradona M, Marchelli R, Neuhäuser-Berthold M, Peláez C, Poulsen M, Schlatter JR, Siskos A, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Published
2023
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28. 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

Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Peláez C, Poulsen M, Prieto Maradona M, Schlatter JR, Siskos A, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Published
2023
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29. 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

Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Prieto Maradona M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Schlatter JR, Siskos A, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Published
2023
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30. 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

Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Aguilera-Gómez M, Cubadda F, Frenzel T, Heinonen M, Prieto Maradona M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Schlatter JR, Siskos A, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Published
2023
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31. 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 D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Published
2022
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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 D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Published
2022
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33. 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 D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Published
2022
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34. 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 D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Published
2022
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35. 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 D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Published
2022
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36. 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 D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Published
2022
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37. Safety of Beta-lactoglobulin as a Novel food pursuant to Regulation (EU) 2015/2283.

Author

Turck D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Fernández Dumont A, Noriega Fernández E, and Knutsen HK

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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Published
2022
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38. 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 D, Bohn T, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhäuser-Berthold M, Poulsen M, Prieto Maradona M, Schlatter JR, van Loveren H, Colombo P, Noriega Fernández E, and Knutsen HK

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 and up to 1.2 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 and up to 0.6 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., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)

Published
2022
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