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Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on betaine as a novel food (NF) pursuant to Regulation (EC) No 258/97. The information provided on the composition, the specifications, the batch‐to‐ba...

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Autores principales: Turck, Dominique, Bresson, Jean‐Louis, Burlingame, Barbara, Dean, Tara, Fairweather‐Tait, Susan, Heinonen, Marina, Hirsch‐Ernst, Karen Ildico, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Neuhäuser‐Berthold, Monika, Nowicka, Grażyna, Pentieva, Kristina, Sanz, Yolanda, Siani, Alfonso, Sjödin, Anders, Stern, Martin, Tomé, Daniel, Vinceti, Marco, Willatts, Peter, Engel, Karl‐Heinz, Marchelli, Rosangela, Pöting, Annette, Poulsen, Morten, Schlatter, Josef Rudolf, Turla, Emanuela, van Loveren, Henk
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009864/
https://www.ncbi.nlm.nih.gov/pubmed/32625349
http://dx.doi.org/10.2903/j.efsa.2017.5057
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author Turck, Dominique
Bresson, Jean‐Louis
Burlingame, Barbara
Dean, Tara
Fairweather‐Tait, Susan
Heinonen, Marina
Hirsch‐Ernst, Karen Ildico
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Neuhäuser‐Berthold, Monika
Nowicka, Grażyna
Pentieva, Kristina
Sanz, Yolanda
Siani, Alfonso
Sjödin, Anders
Stern, Martin
Tomé, Daniel
Vinceti, Marco
Willatts, Peter
Engel, Karl‐Heinz
Marchelli, Rosangela
Pöting, Annette
Poulsen, Morten
Schlatter, Josef Rudolf
Turla, Emanuela
van Loveren, Henk
author_facet Turck, Dominique
Bresson, Jean‐Louis
Burlingame, Barbara
Dean, Tara
Fairweather‐Tait, Susan
Heinonen, Marina
Hirsch‐Ernst, Karen Ildico
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Neuhäuser‐Berthold, Monika
Nowicka, Grażyna
Pentieva, Kristina
Sanz, Yolanda
Siani, Alfonso
Sjödin, Anders
Stern, Martin
Tomé, Daniel
Vinceti, Marco
Willatts, Peter
Engel, Karl‐Heinz
Marchelli, Rosangela
Pöting, Annette
Poulsen, Morten
Schlatter, Josef Rudolf
Turla, Emanuela
van Loveren, Henk
collection PubMed
description Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on betaine as a novel food (NF) pursuant to Regulation (EC) No 258/97. The information provided on the composition, the specifications, the batch‐to‐batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF. The NF is proposed to be used in foods intended to meet additional requirements for intense muscular effort with a maximum intake of 2.5 g/day of betaine for sports people above 10 years of age. Based on the lowest BMDL(05), which was derived from a chronic toxicity study in rats in which a dose‐related increase in platelet counts was observed, and the anticipated daily intake of the NF in the target population, the Margins of Exposure are 3.6 and 5, which are generally regarded as not sufficient. However, the total exposure to betaine from the diet (about 830 mg/day) is not known to be associated with adverse effects. Moreover, no adverse effects on platelet counts were noted in human intervention studies with exposure levels of 4 g/day of betaine for up to 6 months. A significant increase in total and low‐density lipoprotein (LDL)‐cholesterol concentrations was noted at intakes of 4 g/day of betaine in overweight subjects with metabolic syndrome but not in healthy subjects, nor at intakes of 3 g/day. Thus, considering 4 g/day of betaine as a reference point and applying an uncertainty factor of 10 to account for interindividual variability, an amount of 400 mg/day of betaine (i.e. 6 mg/kg body weight (bw) per day for adults) in addition to the background exposure is considered as safe. The Panel considers that the NF is safe to be used at maximum intake of 6 mg/kg bw per day in the target population.
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spelling pubmed-70098642020-07-02 Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97 Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjödin, Anders Stern, Martin Tomé, Daniel Vinceti, Marco Willatts, Peter Engel, Karl‐Heinz Marchelli, Rosangela Pöting, Annette Poulsen, Morten Schlatter, Josef Rudolf Turla, Emanuela van Loveren, Henk EFSA J Scientific Opinion Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on betaine as a novel food (NF) pursuant to Regulation (EC) No 258/97. The information provided on the composition, the specifications, the batch‐to‐batch variability, stability and production process of the NF is sufficient and does not raise concerns about the safety of the NF. The NF is proposed to be used in foods intended to meet additional requirements for intense muscular effort with a maximum intake of 2.5 g/day of betaine for sports people above 10 years of age. Based on the lowest BMDL(05), which was derived from a chronic toxicity study in rats in which a dose‐related increase in platelet counts was observed, and the anticipated daily intake of the NF in the target population, the Margins of Exposure are 3.6 and 5, which are generally regarded as not sufficient. However, the total exposure to betaine from the diet (about 830 mg/day) is not known to be associated with adverse effects. Moreover, no adverse effects on platelet counts were noted in human intervention studies with exposure levels of 4 g/day of betaine for up to 6 months. A significant increase in total and low‐density lipoprotein (LDL)‐cholesterol concentrations was noted at intakes of 4 g/day of betaine in overweight subjects with metabolic syndrome but not in healthy subjects, nor at intakes of 3 g/day. Thus, considering 4 g/day of betaine as a reference point and applying an uncertainty factor of 10 to account for interindividual variability, an amount of 400 mg/day of betaine (i.e. 6 mg/kg body weight (bw) per day for adults) in addition to the background exposure is considered as safe. The Panel considers that the NF is safe to be used at maximum intake of 6 mg/kg bw per day in the target population. John Wiley and Sons Inc. 2017-11-17 /pmc/articles/PMC7009864/ /pubmed/32625349 http://dx.doi.org/10.2903/j.efsa.2017.5057 Text en © 2017 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
Bresson, Jean‐Louis
Burlingame, Barbara
Dean, Tara
Fairweather‐Tait, Susan
Heinonen, Marina
Hirsch‐Ernst, Karen Ildico
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Neuhäuser‐Berthold, Monika
Nowicka, Grażyna
Pentieva, Kristina
Sanz, Yolanda
Siani, Alfonso
Sjödin, Anders
Stern, Martin
Tomé, Daniel
Vinceti, Marco
Willatts, Peter
Engel, Karl‐Heinz
Marchelli, Rosangela
Pöting, Annette
Poulsen, Morten
Schlatter, Josef Rudolf
Turla, Emanuela
van Loveren, Henk
Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97
title Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97
title_full Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97
title_fullStr Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97
title_full_unstemmed Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97
title_short Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97
title_sort safety of betaine as a novel food pursuant to regulation (ec) no 258/97
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7009864/
https://www.ncbi.nlm.nih.gov/pubmed/32625349
http://dx.doi.org/10.2903/j.efsa.2017.5057
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