Safety of dried fruits of <i>Synsepalum ...
Document type :
Article dans une revue scientifique: Article original
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Title :
Safety of dried fruits of <i>Synsepalum dulcificum</i> as a novel food pursuant to Regulation (EU) 2015/2283.
Author(s) :
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Castenmiller, J. [Auteur]
European Food Safety Authority [EFSA]
De Henauw, S. [Auteur]
Hirsch-Ernst, K. I. [Auteur]
Kearney, J. [Auteur]
Maciuk, A. [Auteur]
Mangelsdorf, I. [Auteur]
Mcardle, H. J. [Auteur]
Naska, A. [Auteur]
Pelaez, C. [Auteur]
Pentieva, K. [Auteur]
Siani, A. [Auteur]
Thies, F. [Auteur]
Tsabouri, S. [Auteur]
Vinceti, M. [Auteur]
Cubadda, F. [Auteur]
Frenzel, T. [Auteur]
Heinonen, M. [Auteur]
Marchelli, R. [Auteur]
Neuhäuser-Berthold, M. [Auteur]
Poulsen, M. [Auteur]
Maradona, M. P. [Auteur]
Schlatter, J. R. [Auteur]
Van Loveren, H. [Auteur]
Matijević, L. [Auteur]
Knutsen, H. K. [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Castenmiller, J. [Auteur]
European Food Safety Authority [EFSA]
De Henauw, S. [Auteur]
Hirsch-Ernst, K. I. [Auteur]
Kearney, J. [Auteur]
Maciuk, A. [Auteur]
Mangelsdorf, I. [Auteur]
Mcardle, H. J. [Auteur]
Naska, A. [Auteur]
Pelaez, C. [Auteur]
Pentieva, K. [Auteur]
Siani, A. [Auteur]
Thies, F. [Auteur]
Tsabouri, S. [Auteur]
Vinceti, M. [Auteur]
Cubadda, F. [Auteur]
Frenzel, T. [Auteur]
Heinonen, M. [Auteur]
Marchelli, R. [Auteur]
Neuhäuser-Berthold, M. [Auteur]
Poulsen, M. [Auteur]
Maradona, M. P. [Auteur]
Schlatter, J. R. [Auteur]
Van Loveren, H. [Auteur]
Matijević, L. [Auteur]
Knutsen, H. K. [Auteur]
Journal title :
EFSA Journal
Abbreviated title :
EFSA J
Volume number :
19
Pages :
e06600
Publication date :
2021-07-03
ISSN :
1831-4732
English keyword(s) :
food supplement
safety
novel food
Dried fruits of Synsepalum dulcificum
safety
novel food
Dried fruits of Synsepalum dulcificum
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on dried fruits ofSynsepalum dulcificumas anovel food (NF) pursuant to ...
Show more >Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on dried fruits ofSynsepalum dulcificumas anovel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is pitted and dried (by lyophilisation)fruits ofS. dulcificum. The NF contains the glycoprotein miraculin (≤2.5%) which causes sour andacidic foods to taste sweet. The fruits have a documented history of consumption in Africa andproducts thereof can be found in different markets worldwide. Information on the production processand the composition of the NF is sufficient and does not raise safety concerns. The applicant proposesto use the NF as or in food supplements for the adult population, excluding pregnant and lactatingwomen, at a maximum daily amount of 0.9 g. Taking into account these conditions of use, thePanel considers that the consumption of the NF is not nutritionally disadvantageous. The providedgenotoxicity studies do not raise concerns for genotoxicity of the NF. The Panel concludes that the onlydose tested in a 90-day oral toxicity study of 2,000 mg/kg body weight (bw) per day was notassociated with adverse effects. By applying an uncertainty factor of 200, the Panel concludes that theNF is safe at an intake level of 10 mg/kg bw per day, corresponding to a maximum daily intake of 0.7 g ofthe NF for the target population, rather than 0.9 g/day as proposed by the applicant.Show less >
Show more >Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on dried fruits ofSynsepalum dulcificumas anovel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is pitted and dried (by lyophilisation)fruits ofS. dulcificum. The NF contains the glycoprotein miraculin (≤2.5%) which causes sour andacidic foods to taste sweet. The fruits have a documented history of consumption in Africa andproducts thereof can be found in different markets worldwide. Information on the production processand the composition of the NF is sufficient and does not raise safety concerns. The applicant proposesto use the NF as or in food supplements for the adult population, excluding pregnant and lactatingwomen, at a maximum daily amount of 0.9 g. Taking into account these conditions of use, thePanel considers that the consumption of the NF is not nutritionally disadvantageous. The providedgenotoxicity studies do not raise concerns for genotoxicity of the NF. The Panel concludes that the onlydose tested in a 90-day oral toxicity study of 2,000 mg/kg body weight (bw) per day was notassociated with adverse effects. By applying an uncertainty factor of 200, the Panel concludes that theNF is safe at an intake level of 10 mg/kg bw per day, corresponding to a maximum daily intake of 0.7 g ofthe NF for the target population, rather than 0.9 g/day as proposed by the applicant.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
Inserm
CHU Lille
Inserm
CHU Lille
Submission date :
2024-01-12T06:42:38Z
2024-02-28T12:25:47Z
2024-02-28T12:25:47Z
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