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Scientific opinion on the renewal of the authorisation of Fumokomp (SF‐009) 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, p1-39, 39p
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 Fumokomp (SF‐009), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003 (in the renewal application the Primary Product is reported as 'Fumokomp Conc.'). This opinion refers to an assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. Fumokomp Conc. is produced by pyrolysis of beech and hornbeam woods. Gas chromatography–mass spectrometry (GC–MS) was applied for both identification and quantification of the volatile constituents of the Primary Product. Given the limitations of the method, the Panel cannot judge with confidence whether the applied method meets the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. Moreover, the Panel concluded that the absence of furan‐2(5H)‐one from the Primary Product was not convincingly demonstrated. At the maximum proposed use levels, dietary exposure estimates calculated with FAIM ranged from 0.04 to 0.9 mg/kg body weight (bw) per day at the mean and from 0.1 to 1.5 mg/kg bw per day at the 95th percentile. The information available on the 32 identified components of the Primary Product, although limited, did not indicate a concern for genotoxicity for any of these substances. However, whole mixture testing in an in vitro mouse lymphoma assay gave positive results which would require an adequate in vivo follow‐up study. In addition, the potential for aneugenicity of the Primary Product has not been adequately investigated. Accordingly, the potential safety concern for genotoxicity of the Primary Product cannot be ruled out. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
18314732
Volume :
21
Issue :
11
Database :
Complementary Index
Journal :
EFSA Journal
Publication Type :
Academic Journal
Accession number :
173924364
Full Text :
https://doi.org/10.2903/j.efsa.2023.8370