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Safety of dried aerial parts of Hoodia parviflora 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 a scientific opinion on the dried aerial parts of Hoodia parviflora as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The information provided...

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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, Ackerl, Reinhard, 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/PMC7010034/
https://www.ncbi.nlm.nih.gov/pubmed/32625297
http://dx.doi.org/10.2903/j.efsa.2017.5002
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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
Ackerl, Reinhard
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
Ackerl, Reinhard
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 a scientific opinion on the dried aerial parts of Hoodia parviflora as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The information provided on the composition, the specifications, the production process, the batch‐to‐batch variability and the stability of the NF is sufficient and does not raise safety concerns. The applicant intends to use the NF in a number of energy‐reduced/sugar‐free/no‐added‐sugar foods in quantities of up to 15 mg per serving. The applicant also proposes to provide the NF as a food supplement. The target population proposed by the applicant is adults. The highest intake estimates were found in the group of elderly (≥ 65 years) individuals, with a high intake of 1.0 mg/kg body weight (bw) per day. One 90‐day toxicity study in rodents was provided from which a benchmark dose lower confidence limit (BMDL (05)) of 53.5 mg/kg bw per day was derived for effects of the NF on bodyweight. The Panel concludes that the addition of the NF to foods as a food ingredient at the uses and use levels as proposed by the applicant would exceed intake levels considered safe in humans. The Panel considers that the NF is safe to be used as a food supplement at a maximum dose of 9.4 mg/day. The target population is adults.
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spelling pubmed-70100342020-07-02 Safety of dried aerial parts of Hoodia parviflora 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 Ackerl, Reinhard 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 a scientific opinion on the dried aerial parts of Hoodia parviflora as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The information provided on the composition, the specifications, the production process, the batch‐to‐batch variability and the stability of the NF is sufficient and does not raise safety concerns. The applicant intends to use the NF in a number of energy‐reduced/sugar‐free/no‐added‐sugar foods in quantities of up to 15 mg per serving. The applicant also proposes to provide the NF as a food supplement. The target population proposed by the applicant is adults. The highest intake estimates were found in the group of elderly (≥ 65 years) individuals, with a high intake of 1.0 mg/kg body weight (bw) per day. One 90‐day toxicity study in rodents was provided from which a benchmark dose lower confidence limit (BMDL (05)) of 53.5 mg/kg bw per day was derived for effects of the NF on bodyweight. The Panel concludes that the addition of the NF to foods as a food ingredient at the uses and use levels as proposed by the applicant would exceed intake levels considered safe in humans. The Panel considers that the NF is safe to be used as a food supplement at a maximum dose of 9.4 mg/day. The target population is adults. John Wiley and Sons Inc. 2017-10-19 /pmc/articles/PMC7010034/ /pubmed/32625297 http://dx.doi.org/10.2903/j.efsa.2017.5002 Text en © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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
Ackerl, Reinhard
van Loveren, Henk
Safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97
title Safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97
title_full Safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97
title_fullStr Safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97
title_full_unstemmed Safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97
title_short Safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97
title_sort safety of dried aerial parts of hoodia parviflora as a novel food pursuant to regulation (ec) no 258/97
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010034/
https://www.ncbi.nlm.nih.gov/pubmed/32625297
http://dx.doi.org/10.2903/j.efsa.2017.5002
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