EFSA - European Food Safety Authority

11/06/2023 | Press release | Distributed by Public on 11/06/2023 01:58

Safety and efficacy of feed additives consisting of essential oils from the fruit and stems of Foeniculum vulgare Mill. ssp. vulgare: Bitter fennel oil for use in all animal[...]

Safety and efficacy of feed additives consisting of essential oils from the fruit and stems of Foeniculum vulgare Mill. ssp. vulgare: Bitter fennel oil for use in all animal species and sweet fennel oil for use in dogs and cats (FEFANA asbl)

Published:
6 November 2023
Adopted:
28 September 2023
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EFSA Journal 2023;21(10):8348
Keywords
sensory additives, flavouring compounds, essential oil, Foeniculum vulgare Mill., sweet fennel oil, bitter fennel oil, safety, component‐based approach
On request from
European Commission
Question Number
EFSA‐Q‐2010‐01286 (new EFSA‐Q‐2023‐00587)
Panel members at the time of adoption
Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa and Ruud Woutersen.
Contact
feedap[at] efsa.europa.eu

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of essential oils from fruit and stems of Foeniculum vulgare Mill. (bitter fennel oil and sweet fennel oil), when used as sensory additives (flavourings). For long‐living and reproductive animals, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered of low concern the use of bitter fennel oil (with a content of estragole up to 6.1%) at the proposed use level in complete feed: 0.6 mg/kg for laying hens and rabbits, 1.0 mg/kg for sows and dairy cows, 1.5 mg/kg for sheep/goats, horses and cats, 1.9 mg/kg for dogs and 7.1 mg/kg for ornamental fish. For short‐living animals (animals for fattening), the Panel had no safety concern when bitter fennel oil is used at the proposed use level in complete feed of 18.2 mg/kg for chickens for fattening, 24.3 mg/kg for turkeys for fattening and 25 mg/kg for piglets, pigs for fattening, veal calves, cattle for fattening, sheep/goats, horses, rabbits and salmon. These conclusions were extrapolated to other physiologically related species. The use of sweet fennel oil (with a content of estragole up to 5.0%) was considered of low concern at the proposed use level in complete feed of 2.3 mg/kg for dogs and 1.9 mg/kg cats. The use of bitter fennel oil in animal feed is expected to be of no concern for consumers and the environment. The additives under assessment should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. Due to the high concentration of estragole (> 1%), fennel oils are classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. Since the fruit of F. vulgare Mill. ssp. vulgare and its preparations are recognised to flavour food, no further demonstration of efficacy was necessary.

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