Scientific Opinion on the safety of smoke flavour Primary Product Scansmoke R909

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Article
Acknowledgements

the Panel wishes to thank the members of the Working Group on Smoke Flavourings for the support provided to this EFSA scientific output: D. Arcella, A. Carere, K.-H. Engel, D.M. Gott, J. Gry, R. Gürtler, D. Meier, I. Pratt, I.M.C.M. Rietjens, R. Simon and R. Walker.

Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2010; 8(1):1395 [24 pp.].
doi
10.2903/j.efsa.2009.1395
Panel members at the time of adoption
Arturo Anadón, David Bell, Mona-Lise Binderup, Wilfried Bursch, Laurence Castle, Riccardo Crebelli, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Thomas Haertlé, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean-Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Kettil Svensson, Fidel Toldrá, Rosemary Waring, Detlef Wölfle
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2005-259
Adopted
26 novembre 2009
Published
8 janvier 2010
Last Updated
10 février 2010. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

This opinion concerns the safety of the smoke flavouring Primary Product Scansmoke R909. The Panel considered the technical and analytical data provided acceptable to characterise the Primary Product and to demonstrate its batch-to-batch variability and stability. Two in vivo genotoxicity tests were negative and sufficient to eliminate the concerns over the in vitro genotoxicity. The Panel derived a NOAEL of 1250 mg/kg bw/day from a 90-day study in rats. Based on this NOAEL and on the intake data calculated with the use levels of the Primary Product Scansmoke R909 provided by the applicant for the 18 food categories, the margins of safety would amount to 100 and 160 for the intake estimates based on the upper use levels, and to 350 and 420 when normal use levels are considered. When assuming the use in traditionally smoked products only, the margins of safety would amount to 210 and 300 for the intake estimates based on the upper use levels, and to 520 and 735 when normal use levels are considered. The fact that these margins of safety based on a 90-day toxicity study are inadequate, and in addition, data on reproduction and developmental toxicity and long term studies are absent, it is concluded that the uses and use levels for the Primary Product in a wide range of product categories would require a larger margin of safety. The Panel concludes that the margins of safety are insufficient and that the use of Primary Product Scansmoke R909 at the proposed uses and use levels is of safety concern.

Keywords
Smoke flavouring, Primary Product, Scansmoke R909
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Number of Pages
24