Safety of zinc l-carnosine as a Novel food ...
Type de document :
Article dans une revue scientifique: Article original
DOI :
PMID :
URL permanente :
Titre :
Safety of zinc l-carnosine as a Novel food pursuant to Regulation (EU) 2015/2283 and the bioavailability of zinc from this source in the context of Directive 2002/46/EC on food supplements
Auteur(s) :
Turck, Dominique [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Bohn, T. [Auteur]
Castenmiller, J. [Auteur]
De Henauw, S. [Auteur]
Hirsch-Ernst, K. I. [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]
Neuhauser-Berthold, M. [Auteur]
Poulsen, M. [Auteur]
Maradona, M. P. [Auteur]
Schlatter, J. R. [Auteur]
Loveren, H. V. [Auteur]
Roldan-Torres, R. A. [Auteur]
Knutsen, H. K. [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Bohn, T. [Auteur]
Castenmiller, J. [Auteur]
De Henauw, S. [Auteur]
Hirsch-Ernst, K. I. [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]
Neuhauser-Berthold, M. [Auteur]
Poulsen, M. [Auteur]
Maradona, M. P. [Auteur]
Schlatter, J. R. [Auteur]
Loveren, H. V. [Auteur]
Roldan-Torres, R. A. [Auteur]
Knutsen, H. K. [Auteur]
Titre de la revue :
EFSA Journal
Nom court de la revue :
EFSA J.
Numéro :
20
Pagination :
e07332
Date de publication :
2022-06-27
ISSN :
1831-4732
Mot(s)-clé(s) en anglais :
bioavailability
safety
zinc l-carnosine
zinc
nutrient source
food supplement
Novel Foods
safety
zinc l-carnosine
zinc
nutrient source
food supplement
Novel Foods
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on zinc l-carnosine as a novel food (NF) pursuant to Regulation (EU) ...
Lire la suite >Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on zinc l-carnosine as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and as a source of zinc for use in food supplements. The NF is produced by chemical synthesis and is proposed to be used in food supplements as a source of zinc. The target population proposed by the applicant is individuals above the age of 12, excluding pregnant and lactating women. The NF which is the subject of the application is a chelate-complex, formed between Zn2+ and l-carnosine and is present as a mixture of a monomer and a dimer. The material is a powder with particulate nature and is insoluble in water at neutral pH. No relevant data using an existing zinc source as comparator have been made available by the applicant and the actual bioavailability of the zinc provided by the NF at the proposed use levels remains uncharacterised. Owing to the lack of a correct characterisation of the fraction of small particles, including nanoparticles of the NF, the Panel is not in the position to evaluate specification limits for the size of the constituent particles in the NF. Owing to the lack of information on the size distribution and the physico-chemical properties of the particles constituting the NF, the Panel is not in the position to confirm whether the ADME studies and the toxicological studies provided by the applicant are appropriate to assess the safety of the NF. The Panel concludes that the NF is absorbed and provides zinc, but as it is in an insufficiently characterised particulate form, its safety has not been established and the bioavailability has not been determined.Lire moins >
Lire la suite >Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on zinc l-carnosine as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and as a source of zinc for use in food supplements. The NF is produced by chemical synthesis and is proposed to be used in food supplements as a source of zinc. The target population proposed by the applicant is individuals above the age of 12, excluding pregnant and lactating women. The NF which is the subject of the application is a chelate-complex, formed between Zn2+ and l-carnosine and is present as a mixture of a monomer and a dimer. The material is a powder with particulate nature and is insoluble in water at neutral pH. No relevant data using an existing zinc source as comparator have been made available by the applicant and the actual bioavailability of the zinc provided by the NF at the proposed use levels remains uncharacterised. Owing to the lack of a correct characterisation of the fraction of small particles, including nanoparticles of the NF, the Panel is not in the position to evaluate specification limits for the size of the constituent particles in the NF. Owing to the lack of information on the size distribution and the physico-chemical properties of the particles constituting the NF, the Panel is not in the position to confirm whether the ADME studies and the toxicological studies provided by the applicant are appropriate to assess the safety of the NF. The Panel concludes that the NF is absorbed and provides zinc, but as it is in an insufficiently characterised particulate form, its safety has not been established and the bioavailability has not been determined.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
Inserm
CHU Lille
Inserm
CHU Lille
Date de dépôt :
2024-01-12T01:14:49Z
2024-03-15T10:11:15Z
2024-03-15T10:11:15Z
Fichiers
- EFSA Journal - 2022 - - Safety of zinc l‐carnosine as a Novel food pursuant to Regulation EU 2015 2283 and the.pdf
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