Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Dominique Turck, Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Marco Vinceti & 8 others Peter Willatts, Karl Heinz Engel, Rosangela Marchelli, Annette Pöting, Morten Poulsen, Josef Rudolf Schlatter, Leonard Matijević, Henk van Loveren

Research output: Contribution to journalArticle

1 Citation (Scopus)
39 Downloads (Pure)

Abstract

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The Panel considered that the conclusion on the safety of the NF could not have been reached without the data from the unpublished study report on repeated-dose 90-day oral toxicity and from the unpublished study reports on two human studies.

Original languageEnglish
Article numbere05267
Pages (from-to)1-174
Number of pages17
JournalEFSA Journal
Volume16
Issue number5
Early online date16 May 2018
DOIs
Publication statusPublished - May 2018

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novel foods
shrimp
concentrates
peptides
Safety
Food
Peptides
Pandalus borealis
drug toxicity
Dietary Supplements
Pandalidae
dietary supplements
Body Weight
dosage
No-Observed-Adverse-Effect Level
Dietetics
Food Safety
Health Services Needs and Demand
no observed adverse effect level
body weight

Keywords

  • ACE-inhibitors
  • bioactive peptides
  • novel food
  • safety
  • shrimps (Pandalus borealis)

Cite this

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Turck, D., Bresson, J. L., Burlingame, B., Dean, T., Fairweather-Tait, S., ... van Loveren, H. (2018). Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 16(5), 1-174. [e05267]. https://doi.org/10.2903/j.efsa.2018.5267
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; 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 ; Matijević, Leonard ; van Loveren, Henk. / Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283. In: EFSA Journal. 2018 ; Vol. 16, No. 5. pp. 1-174.
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abstract = "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.",
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EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Turck, D, Bresson, JL, Burlingame, B, Dean, T, Fairweather-Tait, S, Heinonen, M, Hirsch-Ernst, KI, Mangelsdorf, I, McArdle, HJ, Naska, A, Neuhäuser-Berthold, M, Nowicka, G, Pentieva, K, Sanz, Y, Siani, A, Sjödin, A, Stern, M, Tomé, D, Vinceti, M, Willatts, P, Engel, KH, Marchelli, R, Pöting, A, Poulsen, M, Schlatter, JR, Matijević, L & van Loveren, H 2018, 'Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283', EFSA Journal, vol. 16, no. 5, e05267, pp. 1-174. https://doi.org/10.2903/j.efsa.2018.5267

Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283. / EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); 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; Matijević, Leonard; van Loveren, Henk.

In: EFSA Journal, Vol. 16, No. 5, e05267, 05.2018, p. 1-174.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

AU - Turck, Dominique

AU - Bresson, Jean Louis

AU - Burlingame, Barbara

AU - Dean, Tara

AU - Fairweather-Tait, Susan

AU - Heinonen, Marina

AU - Hirsch-Ernst, Karen Ildico

AU - Mangelsdorf, Inge

AU - McArdle, Harry J.

AU - Naska, Androniki

AU - Neuhäuser-Berthold, Monika

AU - Nowicka, Grażyna

AU - Pentieva, Kristina

AU - Sanz, Yolanda

AU - Siani, Alfonso

AU - Sjödin, Anders

AU - Stern, Martin

AU - Tomé, Daniel

AU - Vinceti, Marco

AU - Willatts, Peter

AU - Engel, Karl Heinz

AU - Marchelli, Rosangela

AU - Pöting, Annette

AU - Poulsen, Morten

AU - Schlatter, Josef Rudolf

AU - Matijević, Leonard

AU - van Loveren, Henk

PY - 2018/5

Y1 - 2018/5

N2 - 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.

AB - 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.

KW - ACE-inhibitors

KW - bioactive peptides

KW - novel food

KW - safety

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EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Turck D, Bresson JL, Burlingame B, Dean T, Fairweather-Tait S et al. Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal. 2018 May;16(5):1-174. e05267. https://doi.org/10.2903/j.efsa.2018.5267