Klaus-Dieter Jany, the Chair of the CEF Panel, said: “With regard to Unismoke and Zesti Smoke Code 10, the Panel concluded that there were insufficient margins of safety between estimated exposure to the two flavouring products and intake levels above which they may cause adverse health effects. However, the Panel concluded that the margins of safety for Smoke Concentrate 809045 were wide enough. In all three cases, the Panel considered that studies were sufficient to remove concerns over genotoxicity – in other words, damage to the genetic material of cells.”

EFSA’s exposure estimates – which looked at cumulative exposure to the different flavouring products in different categories of food, based on proposed uses and use levels supplied by the manufacturers – indicated that exposure mainly arises:

• for Unismoke, through meat and meat products, as well as soups and sauces;
• for Zesti Smoke Code 10, through meat and meat products, fish and fish products, composite foods (such as casseroles and meat pies) and processed fruits and vegetables;
• for Smoke Concentrate 809045, through meat and meat products, soups, sauces, protein products and ready-to-eat savouries.

Studies showed that Unismoke and Zesti Smoke Code 10 caused adverse health effects in rats above certain intake levels. Due to the absence of data on reproduction and developmental toxicity and the lack of long-term studies on these two flavouring products, the CEF Panel concluded that the uses and use levels specified by their manufacturers would require larger margins of safety. Smoke Concentrate 809045 was found to cause no adverse health effects in rats at the highest levels tested.