Safety of the extension of use of galacto‐oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283

Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the extension of use of galacto‐oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a syrup contain...

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Autores principales: EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Rosangela Marchelli, Monika Neuhäuser‐Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Henk van Loveren, Paolo Colombo, Helle Katrine Knutsen
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Lenguaje:EN
Publicado: Wiley 2021
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GOS
Acceso en línea:https://doaj.org/article/b6c759fd8a744cfda2630cc7c4cb7b75
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spelling oai:doaj.org-article:b6c759fd8a744cfda2630cc7c4cb7b752021-11-23T08:30:51ZSafety of the extension of use of galacto‐oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/22831831-473210.2903/j.efsa.2021.6844https://doaj.org/article/b6c759fd8a744cfda2630cc7c4cb7b752021-10-01T00:00:00Zhttps://doi.org/10.2903/j.efsa.2021.6844https://doaj.org/toc/1831-4732Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the extension of use of galacto‐oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a syrup containing ≥ 57% w/w GOS (w/w dry matter), consisting of different galactosyl residues linked to a terminal glucose by a β‐glycosidic bond and also containing lactose and the constituent monomers of lactose (galactose and glucose). The NF is already authorised and included in the Union list of NFs and is produced according to the same production process. This application is limited to an assessment of the extension of use as a food ingredient in dairy confectionary, cheese and processed cheese, butter and spreads. There is a 10–30% increase in total GOS intake from the requested extension of use compared to the currently authorised uses at the highest 95th percentile. It is noted that the total intake at the highest mean (8.7–22.0 g/day) is below the adequate intake (AI) of 25 g/day for dietary fibre set to ensure a normal laxation in adults, while the highest 95th percentile (27.2–41.6 g/day) is higher than the AI. When the maximum use as a food supplement is added to the highest 95th percentile combined intake from all proposed and authorised food categories a total intake up to 58 g GOS/day is estimated. This highest intake level would exceed the AI for dietary fibre; however, no tolerable upper intake level for dietary fibre has been set and only transient gastrointestinal symptoms may be related to high intake of fibre. The Panel concludes that the NF, that is composed of ≥ 57% GOS dry matter, lactose and related saccharides, is safe under the proposed extension of use.EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)Dominique TurckTorsten BohnJacqueline CastenmillerStefaan De HenauwKaren Ildico Hirsch‐ErnstAlexandre MaciukInge MangelsdorfHarry J McArdleAndroniki NaskaCarmen PelaezKristina PentievaAlfonso SianiFrank ThiesSophia TsabouriMarco VincetiFrancesco CubaddaThomas FrenzelMarina HeinonenRosangela MarchelliMonika Neuhäuser‐BertholdMorten PoulsenMiguel Prieto MaradonaJosef Rudolf SchlatterHenk van LoverenPaolo ColomboHelle Katrine KnutsenWileyarticleGalacto‐oligosaccharidesGOSdietary fibrenovel foodfood supplementextension of useNutrition. Foods and food supplyTX341-641Chemical technologyTP1-1185ENEFSA Journal, Vol 19, Iss 10, Pp n/a-n/a (2021)
institution DOAJ
collection DOAJ
language EN
topic Galacto‐oligosaccharides
GOS
dietary fibre
novel food
food supplement
extension of use
Nutrition. Foods and food supply
TX341-641
Chemical technology
TP1-1185
spellingShingle Galacto‐oligosaccharides
GOS
dietary fibre
novel food
food supplement
extension of use
Nutrition. Foods and food supply
TX341-641
Chemical technology
TP1-1185
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
Dominique Turck
Torsten Bohn
Jacqueline Castenmiller
Stefaan De Henauw
Karen Ildico Hirsch‐Ernst
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Carmen Pelaez
Kristina Pentieva
Alfonso Siani
Frank Thies
Sophia Tsabouri
Marco Vinceti
Francesco Cubadda
Thomas Frenzel
Marina Heinonen
Rosangela Marchelli
Monika Neuhäuser‐Berthold
Morten Poulsen
Miguel Prieto Maradona
Josef Rudolf Schlatter
Henk van Loveren
Paolo Colombo
Helle Katrine Knutsen
Safety of the extension of use of galacto‐oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283
description Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the extension of use of galacto‐oligosaccharides (GOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a syrup containing ≥ 57% w/w GOS (w/w dry matter), consisting of different galactosyl residues linked to a terminal glucose by a β‐glycosidic bond and also containing lactose and the constituent monomers of lactose (galactose and glucose). The NF is already authorised and included in the Union list of NFs and is produced according to the same production process. This application is limited to an assessment of the extension of use as a food ingredient in dairy confectionary, cheese and processed cheese, butter and spreads. There is a 10–30% increase in total GOS intake from the requested extension of use compared to the currently authorised uses at the highest 95th percentile. It is noted that the total intake at the highest mean (8.7–22.0 g/day) is below the adequate intake (AI) of 25 g/day for dietary fibre set to ensure a normal laxation in adults, while the highest 95th percentile (27.2–41.6 g/day) is higher than the AI. When the maximum use as a food supplement is added to the highest 95th percentile combined intake from all proposed and authorised food categories a total intake up to 58 g GOS/day is estimated. This highest intake level would exceed the AI for dietary fibre; however, no tolerable upper intake level for dietary fibre has been set and only transient gastrointestinal symptoms may be related to high intake of fibre. The Panel concludes that the NF, that is composed of ≥ 57% GOS dry matter, lactose and related saccharides, is safe under the proposed extension of use.
format article
author EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
Dominique Turck
Torsten Bohn
Jacqueline Castenmiller
Stefaan De Henauw
Karen Ildico Hirsch‐Ernst
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Carmen Pelaez
Kristina Pentieva
Alfonso Siani
Frank Thies
Sophia Tsabouri
Marco Vinceti
Francesco Cubadda
Thomas Frenzel
Marina Heinonen
Rosangela Marchelli
Monika Neuhäuser‐Berthold
Morten Poulsen
Miguel Prieto Maradona
Josef Rudolf Schlatter
Henk van Loveren
Paolo Colombo
Helle Katrine Knutsen
author_facet EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
Dominique Turck
Torsten Bohn
Jacqueline Castenmiller
Stefaan De Henauw
Karen Ildico Hirsch‐Ernst
Alexandre Maciuk
Inge Mangelsdorf
Harry J McArdle
Androniki Naska
Carmen Pelaez
Kristina Pentieva
Alfonso Siani
Frank Thies
Sophia Tsabouri
Marco Vinceti
Francesco Cubadda
Thomas Frenzel
Marina Heinonen
Rosangela Marchelli
Monika Neuhäuser‐Berthold
Morten Poulsen
Miguel Prieto Maradona
Josef Rudolf Schlatter
Henk van Loveren
Paolo Colombo
Helle Katrine Knutsen
author_sort EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)
title Safety of the extension of use of galacto‐oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283
title_short Safety of the extension of use of galacto‐oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283
title_full Safety of the extension of use of galacto‐oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283
title_fullStr Safety of the extension of use of galacto‐oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283
title_full_unstemmed Safety of the extension of use of galacto‐oligosaccharides as a Novel food pursuant to Regulation (EU) 2015/2283
title_sort safety of the extension of use of galacto‐oligosaccharides as a novel food pursuant to regulation (eu) 2015/2283
publisher Wiley
publishDate 2021
url https://doaj.org/article/b6c759fd8a744cfda2630cc7c4cb7b75
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