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EFSA: SmokEz Enviro 23 in Food a “Safety Concern”

Posted: June 19, 2009

The European Food Safety Authority (EFSA) has concluded that margins of safety in use of SmokEz Enviro 23 in or on foods are insufficient and that the product’s proposed uses and use levels are of safety concern.

While EFSA’s analysis confirmed that the volatile fraction and total mass identified was in compliance with Commission Regulation (EC) 627/2006 (EC, 2006) and that the product’s in vivo genotoxicity tests were negative and sufficient to eliminate the concerns over the in vitro genotoxicity, the 90-day toxicity study revealed that the safety margins were “inadequate in the product’s use in total dietary exposure (9/14 upper use levels; 24/32 normal use levels) and traditionally smoked products (21/36 upper use levels; 44/72 normal use levels).” The organization noted that the data on reproduction and developmental toxicity, as well as long term studies was absent.

Note: It is outside the remit of the Panel to decide whether, despite the low margins of safety, the use of Primary Product SmokEz Enviro 23 might be approved for traditionally smoked products, at use levels specified, to replace smoking.