Title :

Safety of 2'-fucosyllactose (2'-FL) produced by a derivative strain (APC199) of <i>Corynebacterium glutamicum</i>ATCC 13032 as a novel food pursuant to Regulation (EU) 2015/2283.

Author(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]
Neuhäuser-Berthold, M. [Auteur]
Poulsen, M. [Auteur]
Prieto Maradona, M. [Auteur]
Schlatter, J. R. [Auteur]
Van Loveren, H. [Auteur]
Colombo, P. [Auteur]
Noriega Fernández, E. [Auteur]
Knutsen, H. K. [Auteur]

Journal title :

EFSA Journal

Abbreviated title :

EFSA J

Volume number :

20

Pages :

e07647

Publication date :

2022-12-24

ISSN :

1831-4732

English keyword(s) :

2'-fucosyllactose
2'-FL
human milk oligosaccharide
HMO
HiMO
novel food
safety

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 and Food Allergens (NDA) was asked to deliver an opinion on 2′-fucosyllactose (2’-FL) as a novel food (NF) pursuant to Regulation ...
Show more >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 2′-fucosyllactose (2’-FL) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is mainly composed of the human-identical milk oligosaccharide (HiMO) 2’-FL, but it also contains d-lactose, l-fucose, 3-fucosyllactose, difucosyllactose, d-glucose and d-galactose. The NF is produced by fermentation with a genetically modified strain (APC199) of Corynebacterium glutamicum ATCC 13032. 2’-FL, when chemically synthesised or produced by fermentation with derivative strains of Escherichia coli K-12 DH1 or E. coli BL21 (DE3), is already authorised and included in the EU list of NFs. This application refers to a change in the production process and specifications, while target population, conditions of use and consequently, the anticipated intake remain unchanged. The information provided on the identity, production process, composition and specifications of the NF does not raise safety concerns. The intake of other carbohydrate-type compounds structurally related to 2’-FL is also considered of no safety concern. In line with other milk oligosaccharides that are natural components of human milk, the safety assessment of this NF is mainly based on the comparison between the intake of breastfed infants and the estimated intake as NF. Given that the NF would be consumed at the same extent as the already authorised 2’-FL, the Panel considers that the consumption of the NF at the proposed uses and use levels does not raise safety concerns. The Panel concludes that the NF is safe under the proposed conditions of use.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
Inserm
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2024-01-11T23:52:07Z
2024-03-21T10:33:45Z