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Scientific opinion on the safety of smoke flavouring Primary Product AM 01 – 2012 Update


Panel members at the time of adoption

Iona Pratt, Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Trine Husøy, Rainer Gürtler, Klaus-Dieter Jany, Catherine Leclercq, Jean-Claude Lhuguenot, Wim C. Mennes, Maria Rosaria Milana, Kettil Svensson, Fidel Toldrá, Detlef Wölfle


The EFSA CEF Panel updated the safety assessment of the smoke flavouring Primary Product AM 01. After the opinion of 2010 the Panel received new data i.e. new use levels, chemical data and a new in vivo Comet assay. In 2010, the Panel concluded that the genotoxic potential of this Primary Product could not be ruled out given the limitations in the data set. Also the margins of safety for this Primary Product were considered insufficient and the proposed use levels were considered of safety concern.

In the new in vivo Comet assay the Primary Product did not induce statistically significant increases in DNA strand breaks at any of the tested doses in the liver or in the duodenum cells. The Panel concluded that based on the available data there is no concern with respect to genotoxicity for the Primary Product.

The chemical data provided demonstrate that the material tested in the Comet assay is representative of the Primary Product evaluated by EFSA in 2010. No additional data were provided in order to mitigate the issue associated with the large degree of batch-to-batch variability and chemical stability during shelf life described for the Primary Product in the opinion of 2010.

Based on newly submitted use levels, the margins of safety are 104-114 (total dietary exposure) and 109-179 (use in traditionally smoke foods only) depending on the exposure scenario used. Given that these margins of safety are based on a 90-day toxicity study, and given the absence of data on reproduction, developmental toxicity and of long term studies, it is concluded that the uses and use levels of Primary Product would require a larger margin of safety. The Panel concluded that the proposed use of the Primary Product at the uses and use levels specified is of safety concern.