Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Foeniculum vulgare Mill. ssp. vulgare var. dulce (sweet fennel 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 fruit of Foeniculum vulgare Mill. ssp. vulgare var. dulce (sweet fennel tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a solution, with a dry matter content of approximately 2.16%. The product contained 0.0586% polyphenols (of which 0.0052% were flavonoids), anethole (0.0006%), anisaldehyde (0.0035%) and estragole (0.0006%). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that sweet fennel tincture is safe at the maximum proposed use levels of 200 mg/kg complete feed for horses and 50 mg/kg complete feed for all other animal species. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount which is considered safe when consumed via feed. No safety concern would arise for the consumer from the use of sweet fennel tincture up to the maximum proposed use levels in feed. Sweet fennel 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 estragole cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised. F. vulgare is native to Europe. The use of sweet fennel tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the fruit of F. vulgare and its preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary. (c) 2023 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.