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Scientific opinion on the renewal of the authorisation of proFagus Smoke R709 (SF‐008) as a smoke flavouring Primary Product.

Authors :
Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Degen, Gisela
Engel, Karl‐Heinz
Fowler, Paul J
Frutos Fernandez, Maria Jose
Fürst, Peter
Gundert‐Remy, Ursula
Gürtler, Rainer
Husøy, Trine
Manco, Melania
Moldeus, Peter
Passamonti, Sabina
Shah, Romina
Waalkens‐Berendsen, Ine
Wright, Matthew
Benigni, Romualdo
Boon, Polly
Bolognesi, Claudia
Source :
EFSA Journal; Nov2023, Vol. 21 Issue 11, p1-58, 58p
Publication Year :
2023

Abstract

The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product proFagus Smoke R709 (SF‐008), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. ProFagus Smoke R709 is obtained by pyrolysis of beech and oak wood as main source materials. The panel concluded that the compositional data provided on the Primary Product are adequate. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.8 to 12.2 mg/kg body weight (bw) per day at the mean and from 2.3 to 51.4 mg/kg bw per day at the 95th percentile. The Panel concluded that three components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan‐2(5H)‐one, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for this component are above the TTC of 0.0025 μg/kg bw per day for DNA‐reactive mutagens and/or carcinogens, the panel concluded that the Primary Product raises concern with respect to genotoxicity. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
18314732
Volume :
21
Issue :
11
Database :
Complementary Index
Journal :
EFSA Journal
Publication Type :
Academic Journal
Accession number :
173924363
Full Text :
https://doi.org/10.2903/j.efsa.2023.8369