Safety of proline‐specific oligopeptidase as a novel food pursuant to Regulation (EC) No 258/97

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, Peter Willatts & 7 others Karl‐Heinz Engel, Rosangela Marchelli, Annette Pöting, Morten Poulsen, Josef Schlatter, Wolfgang Gelbmann, Henk Van Loveren

Research output: Contribution to journalArticle

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 proline-specific oligopeptidase (Tolerase® G) as a novel food ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. The novel food is an enzyme preparation of prolyl-oligopeptidase produced with a genetically modified Aspergillus niger self clone strain. The target population is the general adult population. The results from a bacterial reverse mutation test and of an in vitro chromosome aberration test did not indicate genotoxicity. The Panel considers that the reported effects observed in a 90-day rat study are treatment-related effects and can be attributed to the higher energy consumption by these animals. Taking into account the intended maximum use level for Tolerase® G, its daily consumption would correspond to 2,746 mg TOS/person or to 39.2 mg TOS/kg body weight (bw) per day, when considering a default body weight of 70 kg for an adult person. The margin between this value and the dose in the rats, which caused effects attributable to the excess energy intake, is approximately 45. Noting this margin, the Panel considers that it is unlikely that such effects would occur in human at the intended use levels. The Panel concludes that the NF, Tolerase® G, is safe for the intended use at the intended use level.
LanguageEnglish
JournalEFSA Journal
Volume15
Issue number2
Early online date1 Feb 2017
DOIs
Publication statusE-pub ahead of print - 1 Feb 2017

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European Community
food
regulation
body weight
allergy
human being
Niger
European Parliament
European Commission
energy consumption
nutrition
animal
energy
Values

Keywords

  • novel foods
  • proline-specific oligopeptidase (Tolerase® G)
  • safety evaluation

Cite this

Turck, D., Bresson, JL., Burlingame, B., Dean, T., Fairweather‐Tait, S., Heinonen, M., ... Van Loveren, H. (2017). Safety of proline‐specific oligopeptidase as a novel food pursuant to Regulation (EC) No 258/97. EFSA Journal, 15(2). https://doi.org/10.2903/j.efsa.2017.4681
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 ; Gelbmann, Wolfgang ; Van Loveren, Henk. / Safety of proline‐specific oligopeptidase as a novel food pursuant to Regulation (EC) No 258/97. In: EFSA Journal. 2017 ; Vol. 15, No. 2.
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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 proline-specific oligopeptidase (Tolerase{\circledR} G) as a novel food ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. The novel food is an enzyme preparation of prolyl-oligopeptidase produced with a genetically modified Aspergillus niger self clone strain. The target population is the general adult population. The results from a bacterial reverse mutation test and of an in vitro chromosome aberration test did not indicate genotoxicity. The Panel considers that the reported effects observed in a 90-day rat study are treatment-related effects and can be attributed to the higher energy consumption by these animals. Taking into account the intended maximum use level for Tolerase{\circledR} G, its daily consumption would correspond to 2,746 mg TOS/person or to 39.2 mg TOS/kg body weight (bw) per day, when considering a default body weight of 70 kg for an adult person. The margin between this value and the dose in the rats, which caused effects attributable to the excess energy intake, is approximately 45. Noting this margin, the Panel considers that it is unlikely that such effects would occur in human at the intended use levels. The Panel concludes that the NF, Tolerase{\circledR} G, is safe for the intended use at the intended use level.",
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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, J, Gelbmann, W & Van Loveren, H 2017, 'Safety of proline‐specific oligopeptidase as a novel food pursuant to Regulation (EC) No 258/97', EFSA Journal, vol. 15, no. 2. https://doi.org/10.2903/j.efsa.2017.4681

Safety of proline‐specific oligopeptidase 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; Gelbmann, Wolfgang; Van Loveren, Henk.

In: EFSA Journal, Vol. 15, No. 2, 01.02.2017.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety of proline‐specific oligopeptidase as a novel food pursuant to Regulation (EC) No 258/97

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

AU - Gelbmann, Wolfgang

AU - Van Loveren, Henk

PY - 2017/2/1

Y1 - 2017/2/1

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 proline-specific oligopeptidase (Tolerase® G) as a novel food ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. The novel food is an enzyme preparation of prolyl-oligopeptidase produced with a genetically modified Aspergillus niger self clone strain. The target population is the general adult population. The results from a bacterial reverse mutation test and of an in vitro chromosome aberration test did not indicate genotoxicity. The Panel considers that the reported effects observed in a 90-day rat study are treatment-related effects and can be attributed to the higher energy consumption by these animals. Taking into account the intended maximum use level for Tolerase® G, its daily consumption would correspond to 2,746 mg TOS/person or to 39.2 mg TOS/kg body weight (bw) per day, when considering a default body weight of 70 kg for an adult person. The margin between this value and the dose in the rats, which caused effects attributable to the excess energy intake, is approximately 45. Noting this margin, the Panel considers that it is unlikely that such effects would occur in human at the intended use levels. The Panel concludes that the NF, Tolerase® G, is safe for the intended use at the intended use level.

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 proline-specific oligopeptidase (Tolerase® G) as a novel food ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. The novel food is an enzyme preparation of prolyl-oligopeptidase produced with a genetically modified Aspergillus niger self clone strain. The target population is the general adult population. The results from a bacterial reverse mutation test and of an in vitro chromosome aberration test did not indicate genotoxicity. The Panel considers that the reported effects observed in a 90-day rat study are treatment-related effects and can be attributed to the higher energy consumption by these animals. Taking into account the intended maximum use level for Tolerase® G, its daily consumption would correspond to 2,746 mg TOS/person or to 39.2 mg TOS/kg body weight (bw) per day, when considering a default body weight of 70 kg for an adult person. The margin between this value and the dose in the rats, which caused effects attributable to the excess energy intake, is approximately 45. Noting this margin, the Panel considers that it is unlikely that such effects would occur in human at the intended use levels. The Panel concludes that the NF, Tolerase® G, is safe for the intended use at the intended use level.

KW - novel foods

KW - proline-specific oligopeptidase (Tolerase® G)

KW - safety evaluation

U2 - 10.2903/j.efsa.2017.4681

DO - 10.2903/j.efsa.2017.4681

M3 - Article

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JO - EFSA Journal

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SN - 1831-4732

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Turck D, Bresson JL, Burlingame B, Dean T, Fairweather‐Tait S, Heinonen M et al. Safety of proline‐specific oligopeptidase as a novel food pursuant to Regulation (EC) No 258/97. EFSA Journal. 2017 Feb 1;15(2). https://doi.org/10.2903/j.efsa.2017.4681