Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283
International audience Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on shrimp peptide concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a peptide mixture obtained b...
Published in: | EFSA Journal |
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Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
Other Authors: | , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
HAL CCSD
2018
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Subjects: | |
Online Access: | https://hal.univ-lille.fr/hal-04318652 https://hal.univ-lille.fr/hal-04318652/document https://hal.univ-lille.fr/hal-04318652/file/EFSA%20Journal%20-%202018%20-%20-%20Safety%20of%20shrimp%20peptide%20concentrate%20as%20a%20novel%20food%20pursuant%20to%20Regulation%20EU%202015%202283.pdf https://doi.org/10.2903/j.efsa.2018.5267 |
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Archive ouverte HAL (Hyper Article en Ligne, CCSD - Centre pour la Communication Scientifique Directe) |
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ftccsdartic |
language |
English |
topic |
Safety shrimps (Pandalus borealis) bioactive peptides ACE-inhibitors novel food [SDV]Life Sciences [q-bio] |
spellingShingle |
Safety shrimps (Pandalus borealis) bioactive peptides ACE-inhibitors novel food [SDV]Life Sciences [q-bio] Turck, Turck Bresson, Jean-Louis Burlingame, Barbara Dean, Tara Fairweather-Tait, Susan Heinonen, Marina Hirsch-Ernst, Karen-Ildico Mangelsdorf, Inge Mcardle, Harry J. Naska, Androniki Neuhauser-Berthold, Monika Nowicka, Grazyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjodin, Anders Stern, Martin Tome, Daniel Vinceti, Marco Willatts, Peter Engel, Karl-Heinz Marchelli, Rosangela Poting, Annette Poulsen, Morten Schlatter, Josef Rudolf Matijevic, Leonard van Loveren, Henk Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 |
topic_facet |
Safety shrimps (Pandalus borealis) bioactive peptides ACE-inhibitors novel food [SDV]Life Sciences [q-bio] |
description |
International audience Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on shrimp peptide concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a peptide mixture obtained by an enzymatic proteolysis from northern shrimp (Pandalus borealis) shells and heads. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of the NF is sufficient and does not raise safety concerns. The intention of the applicant is to use this NF as an ingredient in food supplements and to market it to adult consumers at a maximum proposed level of intake of 1,200 mg/day (corresponding to 17 mg/kg body weight (bw) per day for a 70 kg person). There are no concerns with regard to genotoxicity. The available human data do not raise safety concerns. Considering the no observed adverse effect level (NOAEL) of 2,000 mg/kg bw per day from a 90-day repeated-dose oral toxicity study, the maximum proposed level of intake and the nature of the NF, the Panel concludes that the margin of exposure (of 117) is sufficient. The Panel concludes that the NF, shrimp peptide concentrate, is safe to be used as a food supplement at the proposed maximum dose of 1,200 mg/day. The target population is adults. The Panel considered that the conclusion on the safety of the NF could not have been reached without the data from the unpublished study report on repeated-dose 90-day oral toxicity and from the unpublished study reports on two human studies. |
author2 |
Lille Inflammation Research International Center - U 995 (LIRIC) Institut Pasteur de Lille Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille) Université de Lille |
format |
Article in Journal/Newspaper |
author |
Turck, Turck Bresson, Jean-Louis Burlingame, Barbara Dean, Tara Fairweather-Tait, Susan Heinonen, Marina Hirsch-Ernst, Karen-Ildico Mangelsdorf, Inge Mcardle, Harry J. Naska, Androniki Neuhauser-Berthold, Monika Nowicka, Grazyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjodin, Anders Stern, Martin Tome, Daniel Vinceti, Marco Willatts, Peter Engel, Karl-Heinz Marchelli, Rosangela Poting, Annette Poulsen, Morten Schlatter, Josef Rudolf Matijevic, Leonard van Loveren, Henk |
author_facet |
Turck, Turck Bresson, Jean-Louis Burlingame, Barbara Dean, Tara Fairweather-Tait, Susan Heinonen, Marina Hirsch-Ernst, Karen-Ildico Mangelsdorf, Inge Mcardle, Harry J. Naska, Androniki Neuhauser-Berthold, Monika Nowicka, Grazyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjodin, Anders Stern, Martin Tome, Daniel Vinceti, Marco Willatts, Peter Engel, Karl-Heinz Marchelli, Rosangela Poting, Annette Poulsen, Morten Schlatter, Josef Rudolf Matijevic, Leonard van Loveren, Henk |
author_sort |
Turck, Turck |
title |
Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 |
title_short |
Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 |
title_full |
Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 |
title_fullStr |
Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 |
title_full_unstemmed |
Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 |
title_sort |
safety of shrimp peptide concentrate as a novel food pursuant to regulation (eu) 2015/2283 |
publisher |
HAL CCSD |
publishDate |
2018 |
url |
https://hal.univ-lille.fr/hal-04318652 https://hal.univ-lille.fr/hal-04318652/document https://hal.univ-lille.fr/hal-04318652/file/EFSA%20Journal%20-%202018%20-%20-%20Safety%20of%20shrimp%20peptide%20concentrate%20as%20a%20novel%20food%20pursuant%20to%20Regulation%20EU%202015%202283.pdf https://doi.org/10.2903/j.efsa.2018.5267 |
genre |
northern shrimp Pandalus borealis |
genre_facet |
northern shrimp Pandalus borealis |
op_source |
ISSN: 1831-4732 EISSN: 1831-4732 EFSA Journal https://hal.univ-lille.fr/hal-04318652 EFSA Journal, 2018, EFSA Journal, 16, ⟨10.2903/j.efsa.2018.5267⟩ |
op_relation |
info:eu-repo/semantics/altIdentifier/doi/10.2903/j.efsa.2018.5267 info:eu-repo/semantics/altIdentifier/pmid/32625904 hal-04318652 https://hal.univ-lille.fr/hal-04318652 https://hal.univ-lille.fr/hal-04318652/document https://hal.univ-lille.fr/hal-04318652/file/EFSA%20Journal%20-%202018%20-%20-%20Safety%20of%20shrimp%20peptide%20concentrate%20as%20a%20novel%20food%20pursuant%20to%20Regulation%20EU%202015%202283.pdf doi:10.2903/j.efsa.2018.5267 PUBMED: 32625904 |
op_rights |
http://creativecommons.org/licenses/by-nd/ info:eu-repo/semantics/OpenAccess |
op_doi |
https://doi.org/10.2903/j.efsa.2018.5267 |
container_title |
EFSA Journal |
container_volume |
16 |
container_issue |
5 |
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1792051958133030912 |
spelling |
ftccsdartic:oai:HAL:hal-04318652v1 2024-02-27T08:43:52+00:00 Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 Turck, Turck Bresson, Jean-Louis Burlingame, Barbara Dean, Tara Fairweather-Tait, Susan Heinonen, Marina Hirsch-Ernst, Karen-Ildico Mangelsdorf, Inge Mcardle, Harry J. Naska, Androniki Neuhauser-Berthold, Monika Nowicka, Grazyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjodin, Anders Stern, Martin Tome, Daniel Vinceti, Marco Willatts, Peter Engel, Karl-Heinz Marchelli, Rosangela Poting, Annette Poulsen, Morten Schlatter, Josef Rudolf Matijevic, Leonard van Loveren, Henk Lille Inflammation Research International Center - U 995 (LIRIC) Institut Pasteur de Lille Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille) Université de Lille 2018-05-01 https://hal.univ-lille.fr/hal-04318652 https://hal.univ-lille.fr/hal-04318652/document https://hal.univ-lille.fr/hal-04318652/file/EFSA%20Journal%20-%202018%20-%20-%20Safety%20of%20shrimp%20peptide%20concentrate%20as%20a%20novel%20food%20pursuant%20to%20Regulation%20EU%202015%202283.pdf https://doi.org/10.2903/j.efsa.2018.5267 en eng HAL CCSD European Food Safety Authority info:eu-repo/semantics/altIdentifier/doi/10.2903/j.efsa.2018.5267 info:eu-repo/semantics/altIdentifier/pmid/32625904 hal-04318652 https://hal.univ-lille.fr/hal-04318652 https://hal.univ-lille.fr/hal-04318652/document https://hal.univ-lille.fr/hal-04318652/file/EFSA%20Journal%20-%202018%20-%20-%20Safety%20of%20shrimp%20peptide%20concentrate%20as%20a%20novel%20food%20pursuant%20to%20Regulation%20EU%202015%202283.pdf doi:10.2903/j.efsa.2018.5267 PUBMED: 32625904 http://creativecommons.org/licenses/by-nd/ info:eu-repo/semantics/OpenAccess ISSN: 1831-4732 EISSN: 1831-4732 EFSA Journal https://hal.univ-lille.fr/hal-04318652 EFSA Journal, 2018, EFSA Journal, 16, ⟨10.2903/j.efsa.2018.5267⟩ Safety shrimps (Pandalus borealis) bioactive peptides ACE-inhibitors novel food [SDV]Life Sciences [q-bio] info:eu-repo/semantics/article Journal articles 2018 ftccsdartic https://doi.org/10.2903/j.efsa.2018.5267 2024-01-28T00:18:24Z International audience Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on shrimp peptide concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a peptide mixture obtained by an enzymatic proteolysis from northern shrimp (Pandalus borealis) shells and heads. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of the NF is sufficient and does not raise safety concerns. The intention of the applicant is to use this NF as an ingredient in food supplements and to market it to adult consumers at a maximum proposed level of intake of 1,200 mg/day (corresponding to 17 mg/kg body weight (bw) per day for a 70 kg person). There are no concerns with regard to genotoxicity. The available human data do not raise safety concerns. Considering the no observed adverse effect level (NOAEL) of 2,000 mg/kg bw per day from a 90-day repeated-dose oral toxicity study, the maximum proposed level of intake and the nature of the NF, the Panel concludes that the margin of exposure (of 117) is sufficient. The Panel concludes that the NF, shrimp peptide concentrate, is safe to be used as a food supplement at the proposed maximum dose of 1,200 mg/day. The target population is adults. The Panel considered that the conclusion on the safety of the NF could not have been reached without the data from the unpublished study report on repeated-dose 90-day oral toxicity and from the unpublished study reports on two human studies. Article in Journal/Newspaper northern shrimp Pandalus borealis Archive ouverte HAL (Hyper Article en Ligne, CCSD - Centre pour la Communication Scientifique Directe) EFSA Journal 16 5 |