Safety and efficacy of a feed additive consisting of a tincture derived from the leaves of L. (sage 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 leaves of L. (sage tincture) when used as a sensory additive in feed and in water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.76%. The product contains on average 0.314% (w/w) total polyphenols (of which 0.0458% are flavonoids). Estragole was not detected in the tincture. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of sage tincture is safe at the proposed use level of 500 mg/kg complete feed for ornamental fish. For the other species the calculated safe concentrations in complete feed are: 35 mg/kg for chickens for fattening, 52 mg/kg for laying hens, 47 mg/kg for turkeys for fattening, 75 mg/kg for pigs for fattening, 62 mg/kg for piglets, 91 mg/kg for sows, 156 mg/kg for veal calves, 137 mg/kg for cattle for fattening, sheep/goats and horses, 89 mg/kg for dairy cows, 55 mg/kg for rabbits, 156 mg/kg for salmonids, 164 mg/kg for dogs and 137 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 35 mg/kg complete feed. No safety concerns were identified for the consumer and the environment from the use of the additive in animal feed. Regarding user safety, the additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Any exposure is considered a risk. Since the leaves of are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was necessary.