Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283
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 proteoly...
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ftunivhelsihelda:oai:helda.helsinki.fi:10138/298810 2024-01-07T09:45:31+01:00 Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 EFSA Panel Dietetic Prod Nutr All Department of Food and Nutrition Food Quality & Safety Food Sciences 2019-02-08T08:32:01Z 17 application/pdf http://hdl.handle.net/10138/298810 eng eng EFSA European Food Safety Authority 10.2903/j.efsa.2018.5267 EFSA Panel Dietetic Prod Nutr All 2018 , ' Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 ' , EFSA Journal , vol. 16 , no. 5 , 5267 . https://doi.org/10.2903/j.efsa.2018.5267 ORCID: /0000-0002-9930-4009/work/53825686 85062107662 cd706914-d9af-474e-9179-ae98ebcb4941 http://hdl.handle.net/10138/298810 000434095800016 cc_by_nd openAccess info:eu-repo/semantics/openAccess shrimps (Pandalus borealis) bioactive peptides ACE-inhibitors novel food safety RATS 416 Food Science Article publishedVersion 2019 ftunivhelsihelda https://doi.org/10.2903/j.efsa.2018.5267 2023-12-14T00:12:17Z 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. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Peer reviewed Article in Journal/Newspaper northern shrimp Pandalus borealis HELDA – University of Helsinki Open Repository EFSA Journal 16 5 |
institution |
Open Polar |
collection |
HELDA – University of Helsinki Open Repository |
op_collection_id |
ftunivhelsihelda |
language |
English |
topic |
shrimps (Pandalus borealis) bioactive peptides ACE-inhibitors novel food safety RATS 416 Food Science |
spellingShingle |
shrimps (Pandalus borealis) bioactive peptides ACE-inhibitors novel food safety RATS 416 Food Science EFSA Panel Dietetic Prod Nutr All Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 |
topic_facet |
shrimps (Pandalus borealis) bioactive peptides ACE-inhibitors novel food safety RATS 416 Food Science |
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 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. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Peer reviewed |
author2 |
Department of Food and Nutrition Food Quality & Safety Food Sciences |
format |
Article in Journal/Newspaper |
author |
EFSA Panel Dietetic Prod Nutr All |
author_facet |
EFSA Panel Dietetic Prod Nutr All |
author_sort |
EFSA Panel Dietetic Prod Nutr All |
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 |
EFSA European Food Safety Authority |
publishDate |
2019 |
url |
http://hdl.handle.net/10138/298810 |
genre |
northern shrimp Pandalus borealis |
genre_facet |
northern shrimp Pandalus borealis |
op_relation |
10.2903/j.efsa.2018.5267 EFSA Panel Dietetic Prod Nutr All 2018 , ' Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283 ' , EFSA Journal , vol. 16 , no. 5 , 5267 . https://doi.org/10.2903/j.efsa.2018.5267 ORCID: /0000-0002-9930-4009/work/53825686 85062107662 cd706914-d9af-474e-9179-ae98ebcb4941 http://hdl.handle.net/10138/298810 000434095800016 |
op_rights |
cc_by_nd openAccess 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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1787427075541434368 |