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Safety of a change in the conditions of use of galacto‐oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283

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 change in the conditions of use of galacto‐oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly co...

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Autores principales: 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, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Maradona, Miguel Prieto, Schlatter, Josef Rudolf, van Loveren, Henk, Colombo, Paolo, Knutsen, Helle Katrine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7838825/
https://www.ncbi.nlm.nih.gov/pubmed/33531972
http://dx.doi.org/10.2903/j.efsa.2021.6384
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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
Neuhäuser‐Berthold, Monika
Poulsen, Morten
Maradona, Miguel Prieto
Schlatter, Josef Rudolf
van Loveren, Henk
Colombo, Paolo
Knutsen, Helle Katrine
author_facet 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
Neuhäuser‐Berthold, Monika
Poulsen, Morten
Maradona, Miguel Prieto
Schlatter, Josef Rudolf
van Loveren, Henk
Colombo, Paolo
Knutsen, Helle Katrine
collection PubMed
description 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 change in the conditions of use of galacto‐oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of GOS, consisting of different galactosyl residues (two to nine) linked to a terminal glucose by a β‐glycosidic bond but also contains lactose and its monomers (galactose and glucose). The NF is a syrup containing ≥ 55% GOS (w/w dry matter) and is produced enzymatically by two β‐galactosidases. GOS produced by β‐galactosidases according to the same production process is already authorised and included in the EU Union list of novel foods. This application is limited to an assessment of the proposed increase of the use level as food supplement. The proposed change in the conditions of use increases the maximum level in food supplements from 0.333 kg GOS/kg food supplement (33.3%) to 0.450 kg GOS/kg food supplement (45.0%). Since it is recommended that individuals consume no more than 3 servings of 12 g/day, the maximum recommended daily intake would be no more than 16.2 g GOS. No new food uses or other increases to the already approved use levels are being proposed. The information provided on the proposed use levels and anticipated intake do not raise safety concerns. The Panel concludes that the proposed increase in the maximum level of galacto‐oligosaccharides as a NF in food supplements is safe under the proposed changes in conditions of use.
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spelling pubmed-78388252021-02-01 Safety of a change in the conditions of use of galacto‐oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283 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 Neuhäuser‐Berthold, Monika Poulsen, Morten Maradona, Miguel Prieto Schlatter, Josef Rudolf van Loveren, Henk Colombo, Paolo Knutsen, Helle Katrine EFSA J Scientific Opinion 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 change in the conditions of use of galacto‐oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of GOS, consisting of different galactosyl residues (two to nine) linked to a terminal glucose by a β‐glycosidic bond but also contains lactose and its monomers (galactose and glucose). The NF is a syrup containing ≥ 55% GOS (w/w dry matter) and is produced enzymatically by two β‐galactosidases. GOS produced by β‐galactosidases according to the same production process is already authorised and included in the EU Union list of novel foods. This application is limited to an assessment of the proposed increase of the use level as food supplement. The proposed change in the conditions of use increases the maximum level in food supplements from 0.333 kg GOS/kg food supplement (33.3%) to 0.450 kg GOS/kg food supplement (45.0%). Since it is recommended that individuals consume no more than 3 servings of 12 g/day, the maximum recommended daily intake would be no more than 16.2 g GOS. No new food uses or other increases to the already approved use levels are being proposed. The information provided on the proposed use levels and anticipated intake do not raise safety concerns. The Panel concludes that the proposed increase in the maximum level of galacto‐oligosaccharides as a NF in food supplements is safe under the proposed changes in conditions of use. John Wiley and Sons Inc. 2021-01-27 /pmc/articles/PMC7838825/ /pubmed/33531972 http://dx.doi.org/10.2903/j.efsa.2021.6384 Text en © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
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
Neuhäuser‐Berthold, Monika
Poulsen, Morten
Maradona, Miguel Prieto
Schlatter, Josef Rudolf
van Loveren, Henk
Colombo, Paolo
Knutsen, Helle Katrine
Safety of a change in the conditions of use of galacto‐oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283
title Safety of a change in the conditions of use of galacto‐oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283
title_full Safety of a change in the conditions of use of galacto‐oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283
title_fullStr Safety of a change in the conditions of use of galacto‐oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283
title_full_unstemmed Safety of a change in the conditions of use of galacto‐oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283
title_short Safety of a change in the conditions of use of galacto‐oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283
title_sort safety of a change in the conditions of use of galacto‐oligosaccharides as a novel food ingredient in food supplements pursuant to regulation (eu) 2015/2283
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7838825/
https://www.ncbi.nlm.nih.gov/pubmed/33531972
http://dx.doi.org/10.2903/j.efsa.2021.6384
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