Safety and efficacy of a feed additive consisting of a tincture derived from the leaves of Ocimum basilicum L. (basil 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 Ocimum basilicum L. (basil 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 1.79%. Basil tincture contains on average 0.187% (w/w) total polyphenols (of which 0.0247% are flavonoids). Methyleugenol (0.0006%) and estragole (0.00005%) were detected in the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of basil tincture is very unlikely to induce adverse effects in long-living and reproductive animals and is of no safety concern for species for fattening at the following concentrations in complete feed: 65 mg/kg for chickens for fattening, 97 mg/kg for laying hens, 87 mg/kg for turkeys for fattening, 140 mg/kg for pigs for fattening, 116 mg/kg for piglets, 170 mg/kg for sows, 291 mg/kg for veal calves, 256 mg/kg for cattle for fattening, sheep/goats and horses, 166 mg/kg for dairy cows, 102 mg/kg for rabbits, 292 mg/kg for salmonids, 307 mg/kg for dogs, 256 mg/kg for cats and 500 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to induce adverse effects at 65 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, basil tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to methyleugenol and estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the leaves of O. basilicum 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.