EFSA - European Food Safety Authority
EFSA - European Food Safety Authority
01/03/2023 | Press release | Distributed by Public on 01/04/2023 01:16
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[...]
Metadata
EFSA Journal 2023;21(1):7693
DOI:
https://doi.org/10.2903/j.efsa.2023.7693
Keywords:
sensory additives, flavouring compounds, Foeniculum vulgare Mill. Ssp. vulgare var. dulce, sweet fennel tincture, anisaldehyde, anethole, estragole
On request from:
European Commission
Question Number:
EFSA‐Q‐2010‐01286 (new EFSA‐Q‐2022‐00569)
Contact:
feedap[at] efsa.europa.eu
Panel members at the time of adoption
Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.
Abstract
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.
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