Safety and efficacy of a feed additive consisting of a tincture derived from the aerial parts of Filipendula ulmaria (L.) Maxim. (meadowsweet tincture) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the aerial parts of Filipendula ulmaria (L.) Maxim. (meadowsweet tincture) when used as a sensory additive in feed and/or in water for drinking for all animal species. The additive under assessment is a water/ethanol ■■■■■ tincture specified to have a dry matter content of 1.00%-1.60% (w/w) and to contain 70-120 mg/L ellagic acid and 30-80 mg/L rutin. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that meadowsweet tincture is safe at the maximum proposed use level of 50 mg/kg complete feed for ornamental fish. For the other species, the resulting maximum safe levels in complete feed are 6 mg/kg for chickens for fattening; 9 mg/kg for laying hens and turkeys for fattening; 11 mg/kg for piglets; 14 mg/kg for pigs for fattening; 17 mg/kg for sows; 28 mg/kg for veal calves (milk replacer); 25 mg/kg for cattle for fattening, sheep/goats and horses; 16 mg/kg for dairy cows; 10 mg/kg for rabbits; 29 mg/kg for salmonids; 30 mg/kg for dogs; and 25 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 6 mg/kg complete feed. No safety concern would arise for the consumer and the environment from the use of the additive in animal feed. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Exposure of users by any route is considered a risk. Since the aerial parts of F. ulmaria and their preparations are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.